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Press Release Communiqué de presse - September 20, 2006 20 September, 2006
Diabetic Product Development Leads to Name Change: Sernova Corp.
Kelowna, B.C. - Pheromone Sciences Corp.
is
pleased to announce it has changed its name to
Sernova
Corp. ("Sernova"). The company's new stock
symbol is
SVA.
"The new name fits better with projects such as
our
current development of a potential breakthrough
treatment
for diabetes," said Chairman Dr. William
Cochrane. "We
wanted a new name to help make it clear to
investors that
our focus is no longer centred around
pheromones, but
can include all kinds of biotechnology
developments."
Shareholders approved the name change at the
Company's annual general meeting held on
August 18th
2006 and elected 5 directors to the Board: Dr.
William
Cochrane (Chair), Charles Allard, Justin
Leushner,
Devinder Randhawa and Dr. Eldon Smith.
The Company's officers are: Chief Executive
Officer-
Devinder Randhawa, President-Justin Leushner,
and Chief
Financial Officer and Corporate Secretary-Patrick
Groening.
Sernova Corp. is a biotechnology research and
development company focused on
commercializing
medical technologies.
This news release may contain forward-looking
statements. Forward-looking statements address
future
events and conditions and therefore involve
inherent risks
and uncertainties. Actual results may differ
materially from
those currently anticipated in such statements.
ON BEHALF OF THE BOARD
"Dev Randhawa"
Dev Randhawa, CEO
For further information contact:
TEL: (888) 318-7062 Mr. Phil Morehouse
FAX: (250) 868-8493 Sernova Corp.
Press Release Communiqué de presse - April 28, 2009 28 April, 2009
New Strategic Plan
APPOINTMENT OF DR. PHILIP TOLEIKIS AS
PRESIDENT
AND CEO
*
PRIVATE PLACEMENT FINANCING
*
GRANT OF STOCK OPTIONS
London, Ontario - April 28, 2009 - Sernova Corp.
(TSX-V:
SVA)
At the Annual General Meeting of Shareholders
held
today, the Sernova Board of Directors issued its
report on
the internal review of the Corporation's research
and
development, financing and partnering activities
and
strategies that had been conducted over the last
three
months by Mr. Jeffrey Bacha, an independent
Director of
the Corporation. Based on the analysis of the
Corporation's scientific progress to date,
regulatory
requirements, and financial and human
resources, the
Board of Directors has approved Mr. Bacha's
recommended strategic plan.
Sernova's immediate priority will be to seek
scientific
collaborations with key international transplant
centres
that currently offer islet transplantation (known
as the
Edmonton Protocol) to patients suffering from
Type 1
diabetes. Sernova strongly believes that its
proprietary
Sertolin(tm) technology, which utilizes co-
transplantation of
porcine islets and Sertoli cells in a unique
transplantation
device, offers a quantum leap forward over the
Edmonton
Protocol, the current standard of care. The
limitations of
the Edmonton Protocol are well understood: very
small
source of donated human islets, potential
damage to the
patient's liver, significant loss of islets following
transplantation, severe immune and
inflammatory
responses to the transplanted islets, and the
permanent
need for the patient to take toxic and expensive
anti-
rejection drugs. The Sertolin(tm) treatment would
potentially overcome all of the Edmonton
Protocol
limitations in a simpler, less invasive, safer and
less
expensive way, since it is based on the
availability of a
large supply of porcine islets and sertoli cells
from
controlled herds, reduced loss of islets following
transplantation, no minimal immune or
inflammatory
responses, and no need for any antirejection
drugs.
Sernova has already initiated discussions with
several key
transplantation centres in the United States with
a view to
establishing scientific collaborations to
demonstrate proof
of concept and commercialize Sertolin(tm). Mr.
Bacha
stated: "By working together with leading
transplant
centres, we can achieve far more in a shorter
period of
time, and ensure the highest quality studies that
will meet
the standards of the FDA and the international
scientific
community."
Sernova is also aggressively seeking
government and
private grants to fund key projects within the
overall
Sertolin(tm) development plan. Until further
funding and/or
scientific collaborations are secured, the
Corporation has
significantly reduced its overhead and operating
expenses.
The Board of Directors also announces the
appointment of
Dr. Philip Toleikis as the President and CEO of
the
Corporation. Dr. Toleikis is a seasoned and
experienced
biotechnology executive, with over 20 years of
research,
intellectual property, management and business
experience in the pharmacology and
biotechnology
sectors. His most recent position was as Vice
President,
R&D Pharmacology and Drug Screening, for
Angiotech
Pharmaceuticals, Inc. of Vancouver, British
Columbia,
where he built a major scientific and information
technology team that included senior scientists,
research
scientists and technicians. Dr. Toleikis' major
achievements at Angiotech included successful
completion of Phase II European Clinical Trials,
chairing
the Joint Research Committee, in-licensing and
out-
licensing of technologies, and management of
key patents
and patent applications. Dr. Toleikis is the author
of
multiple issued patents and over 110 patent
applications.
His research training and experience includes
biochemical
pharmacology, diabetes, oncology, inflammatory
diseases
(psoriasis, multiple sclerosis, surgical adhesions,
Alzheimer's disease and rheumatoid arthritis),
osteoarthritis, neurological diseases and
cardiovascular
conditions including ischemic heart disease,
cardiomyopathy, hypertension and aneurysms.
Dr.
Toleikis will be presenting on the Corporation's
behalf at
the BioFinance Conference in Toronto on
Wednesday,
April 29, 2009.
Dr. George Adams, Chairman of the Board of
Directors,
welcomed Dr. Toleikis, stating "Sernova is
privileged to
now be led by such a distinguished scientist and
executive. We are fully confident that Dr. Toleikis
will drive
our technology through the worldwide regulatory
process
and into commercialization. The treatment of
insulin-
dependent diabetes will be just the first
commercial
application of our platform technology. On behalf
of the
Board of Directors and our shareholders, I
welcome Dr.
Toleikis to the Sernova family."
Sernova also announces that it will be seeking
the
approval of the TSX Venture Exchange for a
private
placement of up to 14 million shares at a price of
$0.03
per common share, for aggregate consideration
of
$420,000. A commission of 10%, along with a
10% agents
warrant to purchase common shares at $0.05
per
common share, will be paid.
The Corporation also announces the granting of
incentive
stock options to an officer to purchase up to
700,000
common shares at $0.10 per share for a period
of 5 years
expiring April 28, 2014.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using its patented Sertolin cell
technology.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every 8 dollars spent
on health
care in the United States is spent on treating
diabetes and
its complications. Worldwide expenditures on
insulin alone
are estimated to be $15 billion annually and
growing.
This news release may contain forward-looking
statements. Forward-looking statements address
future
events and conditions and therefore involve
inherent risks
and uncertainties. Actual results may differ
materially from
those currently anticipated in such statements.
For further information contact:
Craig Gauld, Executive Vice President
Tel: (888) 318-7062; (519) 858-5126
info@sernova.com
www.sernova.com
THE TSX VENTURE EXCHANGE HAS NOT
REVIEWED
AND DOES NOT ACCEPT RESPONSIBILITY
FOR THE
Press Release Communiqué de presse - July 12, 2010 12 July, 2010
Sernova Announces Positive Results of its Proprietary Cell Pouch System(tm) in Preclinical Diabetes Model
Source: Sernova Corp
July 12, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire -- July 12,
2010) -
Sernova Corp. (TSX VENTURE:SVA) is pleased
to report
positive results from a long-term study
evaluating the
safety and efficacy of the Cell Pouch System(TM)
in a pre-
clinical model of diabetes.
Detailed data will be presented at the 23rd
International
Conference of the Transplant Society,
Vancouver, British
Columbia, Canada, August 15th-19th in a
presentation
entitled, "A novel Cell Pouch(TM), an alternative
to
intrahepatic islet transplantation."
Dr. Philip Toleikis, Sernova's President & CEO,
noted "Our
Cell Pouch System(TM) is a proprietary medical
device
implanted under the skin rapidly forming into a
tissue-
engineered, organ-like structure that provides a
natural
environment for the survival and function of
therapeutic
cells. These long-term results represent a
significant
achievement as a possible alternative to the
current
practice of injecting islets directly into the portal
vein of the
liver."
"Our data are profound because they suggest
the
potential to reduce side-effects associated with
the current
standard of care and achieve glucose control
with
significantly fewer islets than normally required,"
said
Toleikis.
On March 16, 2010, Sernova reported initial
results
demonstrating that the Cell Pouch System(TM)
becomes
rapidly vascularised and achieved initial glucose
control in
subject animals.
The following summarizes important new
findings reported
today:
Long-term insulin independence was
successfully
achieved with significantly fewer islets than the
current
standard of care, requiring only about 10% of
insulin-
producing islets normally used for the Edmonton
Protocol.
Animals in the study achieved long-term glucose
normalization throughout the course of the study.
Standard laboratory tests demonstrated
transplanted islets
produced insulin and responded similarly to non-
diabetic
animals to provide control of glucose.
No adverse events related to the Cell Pouch
System(TM)
occurred during the study.
About the Study
The Cell Pouch System(TM) was implanted in
pigs which
were then made diabetic through removing the
pancreas
and chemical induction. The animal's own islets
(Autograft)
isolated from the pancreas were transplanted
into the
device. Standard measures of efficacy including
fasting
and non-fasting glucose levels, glucose
tolerance tests
(IVGTT), and C-peptide were taken up to 72 days
post-
transplant. At the end of the study period, the
device
containing the islets was removed and the
animals
returned to a diabetic state.
Following transplantation, a substantial number
of study
animals maintained glucose levels within the
normal
range, showed glucose tolerance tests (IVGTT)
similar to
non-diabetic animals and were C-peptide
positive, an
important confirmation of insulin-producing islet
function.
Microscopic fluorescence analysis of the device
revealed
both microvessels and insulin associated with
islets.
Upon removal of the Cell Pouch System(TM)
containing
islets, fasting glucose levels returned to the
diabetic range
and animals required daily insulin injections to
maintain
normal glucose levels. The animals return to the
diabetic
state was further confirmed by IVGTT and C-
peptide
analysis.
From a safety perspective, no adverse events
occurred
related to the Cell Pouch(TM) throughout the
study
following implantation of over 40 devices for up
to 5
months. The devices were well-incorporated with
collagen
at all time points and yet were not visible under
the skin,
an important consideration for patients.
Dr. David White, Chair of Sernova's Scientific
Advisory
Board stated, "I am particularly enthusiastic
about these
results and the potential clinical relevance to
patients
suffering from diabetes. These new data suggest
that the
Cell Pouch System(TM) represent a possible
clinically
relevant alternative to injection of islets into the
portal vein
of the liver and may reduce the side effects of
transplantation including the instant blood-
mediated
reaction (IBMR). The indication that our device
achieves
glucose control with a reduction in the number of
islets
normally required is also of profound clinical
importance
as it may increase the availability of life-changing
islet
transplantation to many diabetic patients."
Sernova believes that the Cell Pouch
System(TM) has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, and
other chronic
debilitating diseases. Based on these
encouraging results,
the Company is taking steps towards clinical
evaluation of
its Cell Pouch System(TM).
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every eight dollars
spent on
health care in the United States is spent on
treating
diabetes and its complications. Worldwide
expenditures on
insulin alone are estimated to be $15 billion
annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - March 03, 2011 3 March, 2011
Sernova To Present Cell Pouch System™ Research Results At Transplantation Conference
Source: Sernova Corp
FOR RELEASE
March 3, 2011, 6:00 a.m. EST
LONDON, ONTARIO--(Marketwire - March 3,
2011) -
Sernova Corp. (TSX VENTURE:SVA) is pleased
to
announce the Company will present results of
preclinical
studies with its Cell Pouch System(TM), at the
Canadian
Society of Transplantation 2011 Annual Scientific
Conference at Mt-Tremblant, Quebec, Canada
held March
2-5.
The conference brings together eminent
scientists and
clinicians in the cell and organ transplantation
field from
across Canada and around the world. Sernova
will be
making three poster presentations entitled:
"The establishment of a stringent large animal
model of
insulin-dependent diabetes"
"A subcutaneous Cell Pouch(TM) as an
alternative to
intraportal infusion of islets of Langerhans to
restore
carbohydrate control in the diabetic recipient,"
and
"Islets transplanted into a subcutaneous Cell
Pouch(TM)
demonstrate long-term efficacy measured by C-
peptide."
"The conference provides a venue to discuss the
attributes of Sernova's novel Cell Pouch
System(TM) as
an alternate site for insulin-producing islet
transplantation
and its potential for additional cellular therapies
with
leaders from the medical transplantation
community,"
stated Delfina Siroen, Sernova's Research and
Development Head.
The Cell Pouch System(TM) is a proprietary
medical
device which may offer a revolutionary
improvement over
the current practice of injecting therapeutic cells
into blood
vessels. Based on previous pre-clinical research,
the Cell
Pouch System(TM) becomes a vascularised
organ-like
endocrine structure when placed in the body,
providing
the microcirculation thought to be essential to
early
function and long-term survival of therapeutic
cells.
Sernova has conducted efficacy studies in small
and large
animal models of diabetes and shown the device
with
insulin-producing islets to control blood glucose
levels
long-term without the need for daily insulin
injections.
Sernova believes the Cell Pouch System(TM)
has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, spinal
cord injury,
Parkinson's disease and other chronic
debilitating
diseases.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every 8 dollars spent
on health
care in the United States is spent on treating
diabetes and
its complications. Worldwide expenditures on
insulin alone
are estimated to be $15 billion annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - October 25, 2011 25 October, 2011
Sernova Enters Into Collaboration With Edmonton's Clinical Islet Transplant Program To Expand Cell Pouch(tm) Applications For Diabetes Treatment
Source: Sernova Corp
LONDON, ONTARIO - (Marketwire - October 25,
2011) -
Sernova Corp. (TSX-V: SVA), is pleased to
announce it
has entered into a collaboration with The Clinical
Islet
Transplant Program at the University of Alberta
Hospital.
The Program is headed by Dr. James Shapiro,
MD, Ph.D.
FRCS (Eng) FRCSC, the leader of the team that
developed
the Edmonton Protocol, the current standard of
care for
islet transplantation. In September 2010,
following review
of Sernova's preclinical data, Dr. Shapiro joined
the
Corporation's Scientific Advisory Board.
"Dr. Shapiro's contributions to date position us to
enter
into this important collaboration which is targeted
to
expand access to islet transplantation for the
treatment of
diabetes to a much wider base of patients using
Sernova's
Cell Pouch(tm)," said Dr. Philip Toleikis, Ph.D.,
President
and CEO of Sernova.
The current procedure for islet transplantation to
treat
diabetes, commonly known as the "Edmonton
Protocol"
involves transplanting islets directly into a blood
vessel
(portal vein) of the liver. The Cell Pouch(tm) is
expected to
solve a number of issues arising from portal vein
delivery.
For example, the Cell Pouch(tm) provides a
natural setting
where blood vessels grow adjacent to the islets
rather
than being bathed in blood which can result in
the death of
up to 75% of the islets through an instant blood
mediated
inflammatory response (IBMIR). Use of the Cell
Pouch(tm)
would eliminate portal vein hypertension and
thrombosis
associated with portal vein islet delivery and
potentially
reduce the cost of the procedure as the
catheterization
laboratory is not required for implantation of the
Cell
Pouch(tm) or islet transplantation. Importantly,
preclinical
studies of the Cell Pouch(tm) have consistently
shown
excellent safety and efficacy profiles with
significantly
fewer islets than for portal vein delivery, which
could
increase the number of recipients treated with
the current
donor pool. Furthermore, implantation of the Cell
Pouch(tm) just under the skin allows for imaging
of the
islets and microvessels and for local
immunoprotection of
therapeutic cells.
Sernova's Cell Pouch(tm) is a scalable medical
device
providing a natural "organ-like" environment for
therapeutic cells. Once implanted under the skin,
the Cell
Pouch(tm) develops pancreas-like function when
infused
with islets, controlling blood sugar levels as
shown by
published preclinical data which also suggests
that the
natural environment promotes cell survival
reducing the
number of islets required for therapy.
Sernova is currently pursuing upcoming human
testing of
the Cell Pouch(tm) based on the strong
preclinical safety
and efficacy data generated to date.
This collaboration will further seek to position the
Cell
Pouch(tm) through next generation
improvements to the
Edmonton Protocol to expand access to cell
transplant to a
much wider patient population. The collaboration
will
include work related to:
Assessment of islet protective agents that could
further
reduce the islet mass required for each
transplant using
the Cell Pouch(tm)
Assessment of locally administered anti-rejection
strategies within the Cell Pouch(tm) with the goal
of
reducing or eliminating systemic antirejection
regimens
Assessment of a proprietary, ethically derived
insulin-
producing stem cell technology within the Cell
Pouch(tm)
as an enabling technology which could
significantly
expand the number of patients treated
Development of high resolution imaging systems
to enable
physicians to better assess and optimize long-
term islet
function
A video describing the Edmonton Protocol and
the
collaboration of Sernova with Dr. Shapiro may
be viewed
on Sernova's website at www.sernova.com
"The safety and efficacy of the Cell Pouch(tm) in
preclinical
studies is impressive. We are excited to be
working with
Sernova in both preparing for its upcoming
clinical trial and
in this collaboration. We are hopeful that
Sernova's Cell
Pouch(tm) will significantly increase the number
of diabetic
patients that can be treated with islet
transplantation," said
Dr. Shapiro, Director of the Clinical Islet
Transplant
Program, at the University of Alberta and
member of
Sernova's Scientific Advisory Board.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - May 02, 2012 2 May, 2012
Sernova Receives Health Canada Approval to Initiate Human Clinical Trials of its Cell Pouch ™
-Patients with insulin-dependent diabetes to be
treated
with Sernova's subcutaneous Cell Pouch (TM)
and insulin-
producing islets-
Source: Sernova Corp
LONDON, ONTARIO--(Marketwire - May 2,
2012) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE: SVA - News) today announced it
received
Health Canada Approval to conduct a human
clinical trial
assessing both the safety and efficacy of
Sernova's Cell
Pouch(TM) with transplanted insulin-producing
islets in
patients with insulin-dependent diabetes. The
study will be
conducted in collaboration with Dr. James
Shapiro at the
University of Alberta Health Science Centre in
Edmonton.
"Sernova's compelling pre-clinical results
provide
optimism that the Cell Pouch(TM) has the
potential to
change the standard of care of patients with
diabetes
receiving islet transplantation," said Dr. James
Shapiro,
principal investigator of the study. "I am excited
to begin
enrolment of patients in this ground breaking
clinical study
to evaluate the Cell Pouch(TM) in humans."
The study, entitled "A Phase I/II Study of the
Safety and
Efficacy of Sernova's Cell Pouch(TM) for
Therapeutic Islet
Transplantation," is an open label, non-
randomized,
single-arm, Phase I/II safety and efficacy study
of up to 20
patients with insulin-dependent diabetes
undergoing
allograft pancreatic islet transplantation.
In this study, patients who have met the
enrolment criteria
and provided informed consent will be implanted
with the
Cell Pouch(TM) approximately 2-12 weeks prior
to
transplantation of donor human islets. To prevent
islet
graft rejection, patients will be treated with the
standard
immunosuppressive regimen.
The primary endpoint of the study is to assess
the safety
of the Sernova Cell Pouch(TM) in adult
participants with
Type-1 diabetes receiving islet transplantation
for the first
time. This endpoint will be assessed just prior to
islet
transplantation and one month thereafter.
The secondary endpoint of the study is to
determine the
proportion of subjects implanted with the Cell
Pouch(TM)
and transplanted with islets who achieve and
maintain
insulin independence as measured three months
post-final
islet transplantation.
In addition, the study will provide preliminary
data on the
efficacy of the Cell Pouch(TM) to maintain
adequate
immunological protection against both allo- and
autoimmunity of islet transplant recipients.
Following assessment of primary and secondary
endpoints, patients will be followed for a
minimum of three
years to assess long-term safety and efficacy of
the Cell
Pouch(TM). It should also be noted that the study
allows
for interim analysis of the data at various study
time
points.
"The initiation of this study marks a significant
milestone
for Sernova, and is the result of years of hard
work and
dedication from our company's staff and
collaborators,"
said Dr. Philip Toleikis, President and CEO of
Sernova
Corp. "We have developed the subcutaneous
Cell
Pouch(TM) for Sernova's first clinical application,
insulin-
dependent diabetes, as an alternative site for
islet
transplantation that may allow for safer, more
efficient
engraftment of islets and potential improved
long-term
insulin independence using a marginal islet
mass. We are
pleased to have Dr. Shapiro and his team
conduct this
study at this world class institute for islet
transplantation."
The Cell Pouch(TM) is a proprietary medical
device that,
once implanted subcutaneously, incorporates
with tissue
and microvessels. It has been shown in multiple
preclinical
studies to provide a safe environment for
transplantation,
as well as long-term survival and efficacy of
therapeutic
cells. Sernova's goals for the diabetes indication
include
making the Cell Pouch(TM) available to a wider
group of
patients than currently possible with intraportal
delivery of
islets. Sernova also plans to make the Cell
Pouch(TM)
available as a natural, improved site for non-
primary-
derived, insulin-secreting cells for long-term
function to
enable large numbers of patients with insulin-
dependent
diabetes to be treated without limitation to
availability of
cells.
About Sernova
Sernova Corp. is a clinical stage health-sciences
company
focused on commercializing medical
technologies.
Sernova is currently developing a platform
technology for
a number of serious disease indications, starting
with a
novel treatment for insulin-dependent diabetes,
using the
novel Cell Pouch System(TM) for transplantation
and long-
term survival of therapeutic cells and its patented
Sertolin(TM) cell technology which can provide
an
immune-protected local environment for
therapeutic cells.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Forward Looking Information This release may
contain
forward-looking statements. Forward-looking
statements
are statements that are not historical facts and
are
generally, but not always, identified by the words
"expects", "plans", "anticipates", "believes",
"intends",
"estimates", "projects", "potential" and similar
expressions, or that events or conditions "will",
"would",
"may", "could" or "should" occur. Although
Sernova
believes the expectations expressed in such
forward-
looking statements are based on reasonable
assumptions,
such statements are not guarantees of future
performance
and actual results may differ materially from
those in
forward looking statements. Forward-looking
statements
are based on the beliefs, estimates and opinions
of
Sernova's management on the date such
statements
were made. Sernova expressly disclaims any
intention or
obligation to update or revise any forward-
looking
statements whether as a result of new
information, future
events or otherwise.
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
Press Release Communiqué de presse - August 15, 2012 15 August, 2012
World First - Islet Transplant Into Man Using Sernova's Cell Pouch™ For Treatment Of Diabetes
-Company to Host Conference Call at 9 a.m.
EDT,
Today, Aug. 16, to Discuss Clinical and Business
Developments-
Source: Sernova Corp
LONDON, ONTARIO and EDMONTON,
ALBERTA
(Marketwire -- August 16, 2012) -- Sernova
Corp.
("Sernova" or the "Company") (TSX VENTURE:
SVA -
News) and the University of Alberta today
announced the
treatment of the first patient with insulin-
producing islets
transplanted into Sernova's Cell Pouch(TM) in a
Phase I/II
clinical study to treat Type-1 diabetes led by Dr.
James
Shapiro, Professor of Surgery and Medicine,
University of
Alberta and Director, Clinical Islet Transplant
Program.
Sernova will host a conference call at 9 a.m.
EDT, today,
Aug. 16, 2012, to discuss the company's clinical
and
business developments.
"The Sernova Cell Pouch(TM) implantation and
transplantation processes are simple, rapid
minimally
invasive procedures, conducted on an outpatient
basis
under local anesthesia," said Dr. Shapiro. "This
offers
substantial potential benefit over the Edmonton
protocol
and the ease of use provides an opportunity for
the Cell
Pouch(TM) to become the standard of care for
people with
diabetes if it proves to be effective in these initial
trials."
The objectives of the human clinical trial are to
assess the
safety and efficacy of the Cell Pouch(TM) with
transplanted islets in up to 20 patients with Type-
1
diabetes. The study is sponsored by Sernova
Corp and
the University of Alberta. In the study, patients
who have
met the enrolment criteria and provided informed
consent
are implanted with the Cell Pouch(TM) prior to
transplantation of donor human islets. To prevent
islet
graft rejection, patients in this study are treated
with the
best in class standard of care
immunosuppression
protocol. Interim analysis of the data from this
clinical
study is expected during H1, 2013. Further
information on
the trial may be found at www.clinicaltrials.gov
(Identifier:
NCT01652911).
"The Cell Pouch(TM) is a breakthrough
technology which
has the potential to significantly improve the lives
of
people living with chronic diseases such as
diabetes," said
Philip Toleikis, Ph.D., President and CEO of
Sernova Corp.
"Supported by Sernova's strong preclinical
results, the
treatment of patients in this clinical trial of the Cell
Pouch(TM) further advances our vision for the
future of
providing millions of diabetic patients with the
Cell
Pouch(TM), and an unlimited source of insulin-
producing
cells protected with a local anti-rejection
technology."
Conference Call
The conference call to discuss Sernova's clinical
and
business developments may be accessed by
dialing 866-
532-1852 for domestic callers and +443-842-
7644 for
international callers. Please specify to the
operator that
you would like to join the "Sernova conference
call" or
"conference ID: 21155379."
About The Cell Pouch(TM)
The Cell Pouch(TM) is a proprietary medical
device that,
following subcutaneous implantation,
incorporates with
tissue and microvessels forming a natural
environment for
transplantation of therapeutic cells. Multiple
preclinical
studies demonstrated the Cell Pouch(TM) to
provide a safe
environment for transplantation, as well as long-
term
efficacy of therapeutic cells. Sernova's goals for
the Cell
Pouch(TM) for diabetes include providing a safe
and
natural site for islets to significantly increase the
number of
patients currently treated with intraportal delivery
of donor
islets and to provide a safe environment for
virtually
unlimited available sources of insulin-secreting
cells such
as insulin-producing stem cells and xenogeneic
cells. This
vision combined with local anti-rejection
protection of the
cells could enable millions of patients with
insulin-
dependent diabetes to be treated without
limitation to
availability of cells.
About Sernova
Sernova Corp. is a clinical stage health-sciences
company
focused on commercializing medical
technologies.
Sernova is currently developing a platform
technology for
a number of serious disease indications, starting
with a
novel treatment for insulin-dependent diabetes,
using the
novel Cell Pouch System(TM) for transplantation
and long-
term survival of therapeutic cells and its patented
Sertolin(TM) cell technology which can provide
an
immune-protected local environment for
therapeutic cells.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Dr. James Shapiro MD PhD FRCS
Professor of Surgery and Medicine, University of
Alberta
Director, Clinical Islet Transplant Program
Tel: (780) 407-7330
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Forward Looking Information This release may
contain
forward-looking statements. Forward-looking
statements
are statements that are not historical facts and
are
generally, but not always, identified by the words
"expects", "plans", "anticipates", "believes",
"intends",
"estimates", "projects", "potential" and similar
expressions, or that events or conditions "will",
"would",
"may", "could" or "should" occur. Although
Sernova
believes the expectations expressed in such
forward-
looking statements are based on reasonable
assumptions,
such statements are not guarantees of future
performance
and actual results may differ materially from
those in
forward looking statements. Forward-looking
statements
are based on the beliefs, estimates and opinions
of
Sernova's management on the date such
statements
were made. Sernova expressly disclaims any
intention or
obligation to update or revise any forward-
looking
statements whether as a result of new
information, future
events or otherwise.
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
Press Release Communiqué de presse - February 28, 2013 28 February, 2013
Sernova and Centre for Commercialization of Regenerative Medicine Partner To Treat Chronic Diseases
February 28, 2013 (TORONTO and LONDON,
ON) -- The
Centre for Commercialization of Regenerative
Medicine
(CCRM) is pleased to announce the addition of
Sernova
Corp. ("Sernova" or the "Company") (TSX
VENTURE: SVA
- News) to its member-based industry
consortium.
Sernova's combination of immuno-protective
technology
and therapeutic cells for the treatment of chronic
diseases
advances CCRM's goal of developing innovative
cell-
based product.
"Sernova's technology for transplanting
therapeutic cells
into an implanted medical device for the
treatment of
diabetes and other chronic diseases goes hand-
in-hand
with our strategy of translating cell-based
medical
discoveries into commercial products and
therapies," says
Dr. Michael May, CEO of CCRM. "Sernova's
expertise in
the area of cell therapy will bring great value to
CCRM's
core development platforms and to other
consortium
members."
CCRM is working with its industry consortium to
address
real-life bottlenecks in cell-based product
pipelines. Its
industry consortium now numbers over 20
members.
These companies represent the key sectors of
the
industry: therapeutics, devices, reagents, and
cells as
tools.
"Becoming a member of CCRM offers the
opportunity for
further validation for our technology and
demonstrates our
company's commitment to the advancement of
our Cell
Pouch System(tm) as an effective, safe, long-
term and
convenient therapeutic option for the treatment
of chronic
diseases," says Dr. Philip Toleikis, President and
CEO of
Sernova Corp. "We will work together with the
other
consortium members to achieve CCRM's
objectives in
treating and managing devastating diseases
such as
diabetes."
CCRM has built three core development
platforms: cell
reprogramming and engineering; cell
manufacturing; and,
biomaterials and devices to carry out projects
commissioned by academia and industry. CCRM
has a
fully resourced, 6,000 square foot development
facility
where all development work takes place.
Please visit www.ccrm.ca/industry-consortium to
see a
complete list of CCRM's members.
About the Centre for Commercialization of
Regenerative
Medicine (CCRM)
CCRM, a Canadian not-for-profit organization
funded by
the Government of Canada's Networks of
Centres of
Excellence program and six academic partners,
supports
the development of technologies that accelerate
the
commercialization of stem cell- and biomaterials-
based
technologies and therapies. A network of
academics,
industry and entrepreneurs, CCRM aims to
translate
scientific discoveries into marketable products for
patients.
CCRM launched in Toronto's Discovery District
on June
14, 2011.
About Sernova
Sernova Corp. is a clinical stage health-sciences
company
focused on commercializing medical
technologies.
Sernova is currently developing a platform
technology for
a number of serious disease indications, starting
with a
novel treatment for insulin-dependent diabetes,
using the
novel Cell Pouch System(TM) for transplantation
and long-
term survival of therapeutic cells and its patented
Sertolin(TM) cell technology, which can provide
an
immune-protected local environment for
therapeutic cells.
For more information on CCRM, please contact:
Stacey Johnson
Manager, Communications
Centre for Commercialization of Regenerative
Medicine
647-309-1830
stacey.johnson@ccrm.ca
www.ccrm.ca
For further information on Sernova, please
contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Press Release Communiqué de presse - September 09, 2013 9 September, 2013
Sernova And Medicyte To Collaborate On Cell-Based Therapy To Treat Haemophilia
* Novel Approach to Address Unmet Need for an
Effective Therapy *
LONDON, ONTARIO and HEIDELBERG, GERMANY--
(Marketwire -- September 10, 2013) - Sernova Corp. (TSX-
V: SVA) and Medicyte GmbH, today announced that the
companies have entered into a Material Transfer
Agreement (MTA) to jointly evaluate the use of Medicyte's
upcyte® cells in Sernova's Cell Pouch(TM) for the
treatment of patients with haemophilia A.
The two companies have also entered into a nonbinding
term sheet outlining the general terms of a collaboration
for the pre-clinical and clinical development of the novel
Cell Pouch(TM)/upcyte® combination product for the
treatment of haemophilia A. The parties intend to complete
negotiations of a definitive agreement while initial research
is being carried out under the terms of the MTA.
"The joint development program with Medicyte is further
indication that our Cell Pouch(TM) technology is versatile
and has high potential to be employed for the treatment of
a range of chronic diseases," said Dr. Philip Toleikis,
President and CEO Sernova Corp. "We are in line with our
strategy to expand the testing of the Cell Pouch(TM) in
various indications by collaborating with leading cell-based
therapy companies, such as Medicyte."
Dr. Joris Braspenning, CEO of Medicyte, added, "There is
a great unmet medical need for the treatment of severe
haemophilia A. We believe that Medicyte's upcyte® cells
being sheltered in Sernova's Cell Pouch(TM) represent a
promising combination of technologies to produce
effective levels of Factor VIII, and to prevent excessive
bleeding episodes of patients suffering haemophilia A.
Together with Sernova, we are looking forward to
evaluating the potential of a combined product."
Haemophilia A is the most common form of haemophilia
and results from a deficiency of clotting Factor VIII to a
level of less than 1% of the normal blood concentration.
Haemophiliacs have prolonged bleeding which in areas
such as the brain can be fatal or inside joints can be
permanently debilitating. Approximately 20,000 people in
the United States have the moderate or severe form of
haemophilia A, as well as approximately 2,500 in Canada
and 10,000 in Europe. Though there is no cure for
haemophilia A, it is currently controlled with regular
injections of recombinant clotting Factor VIII. Annual costs
for the treatment of the disease may range from $60,000
to $260,000 per patient for a total cost of between $2-4B
per year in North America and Europe.
Development of a product capable of producing an
effective level of Factor VIII within the Cell Pouch(TM)
environment has the potential to provide haemophilia A
patients with better protection against dangerous episodes
of excessive bleeding and greatly reduce annual therapy
costs.
Continuation of the parties' joint studies beyond the MTA
is subject to negotiation and execution of a definitive
collaboration agreement.
About Medicyte
Medicyte is specialised in the controlled generation and
standardisation of human primary cell products in virtually
unlimited quantities and of highest quality for cell therapy
and cell-based R&D. Medicyte's proprietary technologies
upcyte® and vericyte® enable researchers to expand
human cells from different donors and from multiple
tissues in a standardized procedure, thereby making these
cells for the first time commercially available in high
numbers and consistent quality. Beside their therapeutic
applications, pharmaceutical companies are using
upcyte® and vericyte® products for in vitro assays and
ADMET testing.
For further information contact:
Joris Braspenning, Ph.D., CEO
Tel: +49 (6221) 72925-30
j.braspenning@medicyte.com
www.medicyte.com
About Sernova
Sernova Corp. is a clinical stage health-sciences company
focused on commercializing medical technologies.
Sernova is developing a platform technology based on the
Cell Pouch(TM), Sertolin(TM) and therapeutic cells, for a
number of chronic diseases, including insulin-dependent
diabetes as a first indication and other cell therapies for
diseases such as parathyroid disease, haemophilia, and
Parkinson's disease. Sernova's goals for the Cell
Pouch(TM) for diabetes include increasing the number of
patients currently treated with intraportal delivery of donor
islets and to provide a safe environment for sources of
unlimited insulin-secreting cells such as insulin-producing
stem cells and xenogeneic cells. This vision combined with
local anti-rejection protection of the cells could enable
millions of patients with insulin-dependent diabetes to be
treated without limitation to availability of cells.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Neither the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking information,
which involves known and unknown risks, uncertainties
and other factors that may cause actual events to differ
materially from current expectation. Important factors -
including availability of funds, the results of financing
efforts, the results of research and product development
activities -- that could cause actual results to differ
materially from Sernova's expectations are disclosed in
Sernova's documents filed from time to time on SEDAR
(see www.sedar.com). Readers are cautioned not to place
undue reliance on these forward-looking statements,
which speak only as of the date of this press release. The
company disclaims any intention or obligation, except to
the extent required by law, to update or revise any
forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - April 21, 2014 21 April, 2014
Sernova’s Cell Pouch™ Diabetes Clinical Trial Demonstrates Interim Safety and Biocompatibility
Sernova’s Cell Pouch with insulin-producing islets is safe and
biocompatible in patients with unstable diabetes
Source: Sernova Corp
FOR RELEASE
April 22nd, 2014, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire – April 22nd, 2014) - Sernova Corp. (TSX-V: SVA), a clinical stage company developing medical technologies for the long-term treatment of chronic metabolic diseases including diabetes, blood disorders such as haemophilia and other diseases, today announced interim results in an ongoing type 1 diabetes human clinical trial with the Company’s Cell Pouch(TM).
Sernova’s human clinical trial is designed to assess the safety and efficacy of the Cell Pouch in subjects with unstable diabetes receiving an islet transplant. Interim study results in the first group of patients support that the implanted Cell Pouch, transplanted with insulin-producing islets is showing longer-term safety and biocompatibility with one of the patients beyond the 180 day time point.
Encouraging early results up to 30 days post-islet transplant were presented at the International Pancreas and Islet Transplantation Congress in September, 2013. These results showed after implantation under the skin, the Cell Pouch is safe and biocompatible. Following islet transplantation, the islets living within a natural tissue matrix were supported with a rich supply of blood vessels, similar to the pancreas. Of further importance, the islets were shown to make insulin, somatostatin and glucagon – key hormones in the control of blood sugar levels. The ongoing study is being conducted with Dr. James Shapiro as principal investigator at the University of Alberta Health Sciences Centre in Edmonton, Alberta.
"The fact that the Cell Pouch continues to exhibit both safety and biocompatibility in longer term follow-up is an important milestone in the early clinical testing of this device, and provides encouragement that human islets transplanted within the device may provide the opportunity to change the standard of care of patients with diabetes," said Dr. James Shapiro. “I look forward to the ongoing results of the investigation as the study progresses."
The study, entitled “A Phase I/II Study of the Safety and Efficacy of Sernova's Cell Pouch for Therapeutic Islet Transplantation,” is an open label, non- randomized, Phase I/II safety and efficacy study of up to 20 patients with type 1 diabetes undergoing allograft pancreatic islet transplantation. Patients who have met the enrolment criteria and provided informed consent are implanted with the Cell Pouch approximately 2-24 weeks prior to transplantation of donor human islets. To prevent islet graft rejection, the standard of care immunosuppressive regimen is provided.
The primary endpoint of the study is to assess the safety of the Sernova Cell Pouch in these patients just prior to islet transplantation, following islet transplantation and at various points during follow up. The secondary endpoint of the study, efficacy, is to determine the proportion of subjects implanted with the Cell Pouch and transplanted with islets who achieve and maintain insulin independence. Patient follow up occurs for a minimum of three years to assess long-term safety and efficacy.
“In the second half of 2014, we expect to provide further preliminary safety and efficacy data”, remarked Dr. James Shapiro.
"This interim update by Dr. Shapiro suggests we are making positive strides forward. The Cell Pouch could potentially be a game changer for patients suffering from this debilitating disease. Indeed, this is the result of years of hard work and dedication from our company's staff and collaborators," said Dr. Philip Toleikis, President and CEO of Sernova Corp. "We have developed the subcutaneous Cell Pouch for Sernova's first clinical application, insulin- dependent diabetes, as an alternative site for islet transplantation that may allow for safer, more efficient engraftment of islets and potential improved long-term insulin independence using a marginal islet mass. What adds further credence to the Cell Pouch’s mechanism of action is the application of the Cell Pouch for other clinical indications which Sernova is undertaking”, added Dr. Toleikis."
About the Cell Pouch
The Cell Pouch is a proprietary, scalable, biocompatible medical device, that once implanted subcutaneously, incorporates with the patient’s tissue and microvessels. The Cell Pouch is contract manufactured (ISO13485) to meet international regulatory standards. Sernova’s research has demonstrated that when the Cell Pouch is inserted under the skin, it forms an ideal environment, rich in microvessels and tissue matrix for the placement and function of therapeutic cells. The Cell Pouch is currently being evaluated in clinical trials at the University of Alberta with Dr. James Shapiro as principal investigator in patients with type 1 diabetes receiving an islet transplant.
It has been shown in multiple preclinical studies to provide a safe environment for transplantation, as well as for the long-term survival and efficacy of therapeutic cells. Sernova's goals for the diabetes indication include making the Cell Pouch available to a wider group of patients than currently possible with intraportal delivery of islets. Sernova also plans to make the Cell Pouch available as a natural, improved site for non-primary-derived, insulin-secreting cells. This may enable long-term treatment in large numbers of patients with insulin-dependent diabetes without limitation to availability of donor-derived cells.
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including haemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch, an implantable medical device for therapeutic cells (donor, xenogeneic or stem cells) which then release proteins and/or hormones as required.
About Clinical Islet Transplantation Program
Please view www.islet@ca for more information on the Clinical Islet Transplantation Program at the University of Alberta.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 11, 2015 11 February, 2015
Sernova is Awarded Patents in Multiple Countries for Cell Pouch™ and Therapeutic Cell Transplantation Technologies
Source: Sernova Corp
February 12, 2015, 6:00 a.m. EDT
LONDON, ONTARIO (Marketwire – February 12, 2015) - Sernova Corp. (TSX-V: SVA), today announced that the Patent Offices in China, Israel, Singapore and New Zealand have issued Notices of Allowance and issued patents to Sernova for its patent application entitled "Methods and Devices for Cellular Transplantation.”
These patents help protect Sernova’s entire Cell Pouch(TM) system, including the Cell Pouch(TM) itself, as well as the Cell Pouch(TM) combined with therapeutic cells and surgical tools for cell transplantation. These issued patents, in addition to patent rights already granted or actively being pursued in other countries, will provide Sernova with patent protection through 2030.
“Patent applications on Sernova’s technologies are being pursued in multiple countries around the world and we are confident that additional patents will be granted on an international basis,” stated Dr. Philip Toleikis, Sernova’s President and CEO.
"Potential strategic partners, including major pharmaceutical companies place significant value in issued patents,” stated Dr. Philip Toleikis, Sernova’s President and CEO. He continued, “Since 2009, we have been relentless at carrying out our strategy to secure exclusive patent rights on our core technologies, to develop an international footprint for our products.”
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable medical device for therapeutic cells (donor, xenogeneic or stem cells) which then release proteins and/or hormones as required. The therapeutic cells are protected from immune attack by Sernova’s proprietary local immune protection technology.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - April 22, 2015 22 April, 2015
Sernova Receives Issued Patent in the United States for its Cell Pouch™ and Therapeutic Cell Transplantation Technologies
Sernova Receives Issued Patent in the United States for its Cell Pouch(TM) and Therapeutic Cell Transplantation Technologies
Sernova’s cell transplantation and local immune protection patent families are secured and protected to maximize stakeholder value
Source: Sernova Corp
April 23, 2015, 6:00 a.m. EDT
LONDON, ONTARIO (Marketwire – April 23, 2015) - Sernova Corp. (TSX-V: SVA), is pleased to announce that the U.S. Patent and Trademark
Office (USPTO) has issued Sernova a patent that helps protect Sernova’s entire Cell Pouch System (TM).
This patent entitled "Methods and Devices for Cellular Transplantation” includes claims covering implantable polymer devices such as the Cell
Pouch(TM) itself, as well as methods using the same combined with therapeutic cells such as self‐cells, donor cells, stem cells and genetically
modified cells as well as surgical tools for cell transplantation. This new patent provides Sernova with patent protection through 2030. Sernova
currently has over 55 issued patents and patent pending applications worldwide covering its therapeutic cell transplantation and local immune
protection technologies.
The USPTO grants a patent after a vigorous search of the existing technology and a determination that a claimed invention is novel and
nonobvious over that technology. Gaining such patent protection is commercially important because the United States represents one of the
world’s largest markets for Sernova’s various therapeutic products in development.
“Since 2009, we have pursued patent rights around the world for our cell transplantation and local immune protection technologies and we will
continue our rigorous strategy to secure and protect our proprietary technologies,” stated Dr. Philip Toleikis, Sernova’s President and CEO.
Within its patented technological armamentarium, Sernova uses biocompatible polymers to develop unique, highly vascularized subcutaneous
tissue chambers for the placement, survival and long term function of therapeutic cells. Over the past six years, Sernova has demonstrated an
excellent safety profile and efficacy benefit for its technologies in small and large animal models of disease and, more importantly, in humans
with severe diabetes where transplanted therapeutic cells become highly vascularized and able to produce their therapeutic product.
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating
metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable medical device for therapeutic
cells (donor, xenogeneic or stem cells) which then release proteins and/or hormones as required. The therapeutic cells are protected from
immune attack by Sernova’s proprietary local immune protection technology.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are
generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and
similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations
expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future
performance and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the
beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention
or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - September 09, 2015 9 September, 2015
Sernova Secures Commercial Rights to Proprietary Stem Cell Derived Technologies
– UHN (University Health Network) agreement transitions Sernova to an integrated therapeutic cell regenerative medicine Company –
Source: Sernova Corp
September 10, 2015, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – September 10, 2015) – Sernova Corp.
(TSX-V: SVA) (FSE: PSH), a clinical stage company developing medical technologies for the long-term treatment of chronic metabolic diseases including diabetes, blood disorders such as haemophilia and other diseases, announced today it has signed a license agreement with the University Health Network (UHN) of Toronto, Canada to gain exclusive worldwide rights to certain patent-pending technologies developed by distinguished UHN researchers, Dr. Cristina Nostro and Dr. Gordon Keller. These technologies relate to the development of stem cells into glucose-responsive therapeutic cells for the treatment of patients with insulin-dependent diabetes.
”This agreement provides us with a proprietary source of stem cell derived glucose responsive therapeutic cells. When placed within Sernova’s prevascularized Cell Pouch(TM), and protected locally from immune system attack, we believe that Sernova has the potential to provide a significant break-through in the quality of treatment for the millions of people suffering from insulin-dependent diabetes, said Dr. Philip Toleikis, Sernova’s President and CEO”. “Such individuals could essentially be liberated from their current onerous daily regime of multiple blood glucose testing and insulin administration delivered through injections or electronic means which is expected to materially improve their quality of life, prevent or reduce abnormal glucose complications, and reduce short term and longer term health care costs.”
The current standard of care for islet transplantation is limited to diabetic patients with severe hypoglycemia unawareness due to both a lack of cadaveric donor islets and a requirement for life-long use of toxic anti-rejection drugs.
“We believe that a virtually unlimited supply of glucose responsive therapeutic cells could be generated from ethically derived stem cells which, if shown to have positive safety and efficacy in clinical trials, could be used to treat millions of patients,” commented Delfina Siroen, Sernova’s head of Research and Development. “The addition of the UHN stem cell technologies moves Sernova one step further toward being able to provide a full solution (device, unlimited cell supply and local immune protection) for cell therapy applications.”
About Diabetes
The worldwide incidence of diabetes is approximately 370 million. Sernova’s potential addressable market which includes Type-1 patients and those Type-2 patients requiring insulin is over 30 million people. Although there is currently no cure for diabetes, blood glucose levels are being controlled with frequent blood glucose testing combined with regular injections of insulin via syringe or insulin pump; however, blood glucose control using this treatment approach can be poor, leading to side effects such as heart, kidney and eye diseases as well as ischemia-induced amputations. According to the Juvenile Diabetes Research Foundation, annual health care costs for the treatment of diabetes and its debilitating side effects are estimated to be over US $245 billion per year in North America (http://jdrf.org/).
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable medical device for therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch and our expectations of the potential benefits of the license agreement, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - December 20, 2015 20 December, 2015
Sernova Awarded Europe’s Prestigious Horizon 2020 Grant to Fund Development of Cell-based Hemophilia Therapeutic Product into the Clinic
Distinguished European consortium awarded approximately $8.5 Million CAD by the European Commission via its Horizon 2020 Program to partner advanced cell based Factor VIII therapy in collaboration with Sernova and its Cell Pouch(TM) device technologies
Source: Sernova Corp
December 21, 2015, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – December 21, 2015) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage regenerative medicine company, announced today that the European Commission’s Horizon 2020 program has awarded a Euro 5.6M ($8.5M CAD) grant to a consortium consisting of Sernova Corp and five European academic and private partners to advance development of a GMP clinical grade Factor VIII releasing therapeutic cell product in combination with Sernova’s Cell Pouch(TM) for the treatment of severe hemophilia A, a serious genetic bleeding disorder caused by missing or defective factor VIII in the blood stream.
The current market for factor VIII is US$5.0B/year, with a cost of up to US$260,000 per patient each year. Current standard of care involves regular infusions of factor VIII, which achieves normal factor VIII blood levels for only a few hours at a time. The product being developed by the HemAcure consortium will seek to provide constant delivery of Factor VIII to normalize blood levels in an effort to significantly improve the quality of life of patients suffering from hemophilia A.
The product being developed by the HemAcure consortium is expected to be highly disruptive to the current standard of care treatments for hemophilia A. The therapeutic goal of the product is to use the patient’s own cells corrected for the factor VIII gene. These cells placed in the implanted Cell Pouch will release factor VIII on a continual basis at a rate that would be expected to significantly reduce disease-associated hemorrhaging and joint damage. The constant delivery of factor VIII is also expected to reduce or eliminate the need for multiple weekly infusions which is the current standard of care using plasma-derived or recombinant, genetically engineered factor VIII for the prophylactic treatment of hemophilia A.
“The therapeutic potential to have a constant release of factor VIII from a hemophilia A patient’s own genetically corrected cells placed within the implanted Cell Pouch would be a very significant advance in the treatment of hemophilia A,” remarked Dr. David Lillicrap, MD, FRCPC Professor Department of Pathology and Molecular Medicine Queens University, Canada Research Chair in Molecular Hemostasis and member of the HemAcure Scientific Advisory Board. “Sernova’s Cell Pouch with its vascularized tissue lined chambers for therapeutic cells, which has already been proven for islet safety and survival in human clinical assessment of diabetes, is an ideal, fully scalable first-in-class medical device suitable for the potential treatment of hemophilia,” added Dr. Lillicrap.
“It has been exciting working together with the highly skilled team of experts in the HemAcure consortium in hemophilia and cell therapy. The scientific strength of this consortium was evident from the inception of the idea through the development and awarding of the grant to the stimulating kick off meeting,” said Delfina Siroen, Sr. Director of Sernova’s Research and Development team. “In a very short time, Sernova’s hemophilia program has achieved great strides and the addition of this European grant and team will ensure the best possible outcome for this program to the clinic,” continued Ms. Siroen.
The preliminary preclinical proof of concept data used as a basis to support the foundation of the grant was generated in a collaborative agreement between Medicyte GmbH under the FP7 ReLiver project, grant agreement 304961 and Sernova Corp where cryopreserved cells with the ex vivo inserted corrected gene for factor VIII were successfully shipped and assessed in Sernova’s Cell Pouch at its headquarters in Canada. Regarding Sernova’s participation in the consortium, the review of the HemAcure grant proposal stated the following, “Participation of the third country partner (Sernova Corp) is essential for carrying out the (program). This is justified by the fact that the partner in question is the one who possesses the technology that will be the basis of the whole proposal, and which will perform all the in vivo studies. Sernova uses a scalable, contract manufactured, proprietary patented worldwide implantable medical device (Cell Pouch) transplanted with therapeutic cells. (It) has been in development for more than six years and has shown success in multiple small and large animal preclinical models and is now in a clinical trial for another therapeutic indication. This Cell Pouch device is the only such device that when implanted under the skin is proven to become incorporated with blood vessel enriched tissue-forming chambers for the placement of therapeutic cells. This implies that the Canadian partner (Sernova) is an essential partner for the success of this project.”
About Hemophilia A
People with Hemophilia have prolonged abnormal bleeding as a result of trauma. Hemophilia A, also called factor VIII (FVIII) deficiency is the most common form of Hemophilia and is a genetic disorder caused by missing or defective factor VIII, a blood clotting protein. Severe hemophilia occurs in about 60% of cases where the deficiency of Factor VIII is less than 1% of normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene. According to the US Centers for Disease Control and Prevention hemophilia occurs in about 1 in 5,000 births. If the prolonged bleeding occurs in the brain of a person with hemophilia, it can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint damage. Approximately 20,000 people in the United States and 10,000 in Europe have the moderate or severe form of hemophilia A, as well as approximately 2,500 in Canada. All races and ethnic groups are equally affected by hemophilia A. Though there is no cure for the disease, it can be controlled with regular infusions of recombinant clotting Factor VIII. Annual costs for the treatment of the disease for each patient may range from $60,000 to $260,000 US for a total cost of between $2-5B per year in North America and Europe.
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly Euro 80 billion of funding available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project is funded as part of societal challenges “personalizing health and care” in a specific call about innovative treatments and technologies. New therapies, such as gene or cell therapies, often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. The European Union aims to improve the development of advanced methods and devices for targeted and controlled delivery, and to bring these innovative treatments to the patient.
About HemAcure
HemAcure is the name of the consortium developing a product for hemophilia A. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 667421. The consortium members include the University Hospital Wurzburg (Coordinating Institute), Integrierte Management Systeme IMS e.K., Universita del Piemonte Orientale “Amedeo Avogadro,” Loughborough University, GABO:mi Gesellschaft für Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo prepared cell based therapy within Sernova’s prevascularized Cell Pouch to treat this bleeding disorder that should ultimately lead to improved quality of life of the patients.
About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch and our expectations of the potential benefits of the consortium and the Horizon 2020 hemophilia project, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - January 25, 2016 25 January, 2016
Sernova Announces Agreement with CCRM to Produce Specialized Cells for the Treatment of Diabetes
CCRM to establish, optimize and validate methods for producing Sernova’s transformative cell-based therapies for Type-1 diabetes
Source: Sernova Corp
January 26, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – January 26, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing medical technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, announced today it has entered into a service agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) to establish, optimize and validate Sernova’s licensed technology for creating stem cell derived therapeutic cells that produce insulin and are glucose responsive.
“Sernova’s Cell Pouch System(TM) is a novel, preclinically validated and clinically tested platform for multiple types of therapeutic cells, including human islets,” said Dr. Philip Toleikis, President and CEO Sernova Corp. “Sernova’s CCRM partnership with CCRM’s expertise in developing production processes for cellular therapies is an important step in Sernova’s plan to commercialize an unlimited supply of glucose responsive, insulin producing cells for the Cell Pouch System. Sernova continues to seek out and evaluate optimal unlimited cell sources both internally developed and through corporate partnerships involving stem cell derived, and xenogeneic cell sources. Our manufacturing partnership with CCRM will provide the ability for the scale up production required to ensure successful commercialization of Sernova’s cellular therapies for diabetes,” added Dr. Philip Toleikis.
CCRM is a unique not-for-profit group that is solely focused on developing and commercializing cell therapy and regenerative medicine technologies. Sernova is a member of CCRM’s industry consortium, a group of nearly 50 companies formed to address bottlenecks in cell therapy and regenerative medicine product pipelines by enabling industry to engage with CCRM’s broad network of researchers and institutions. Industry consortium members represent key sectors in regenerative medicine – therapeutics, devices, reagents and cells as tools – and tremendous industry experience.
"As a member of CCRM’s industry consortium, Sernova is a valued partner in our quest to develop global breakthroughs in regenerative medicine,” remarked Michael May, President and CEO of CCRM. “Commercializing a regenerative medicine therapy for diabetes – the goal for Sernova and CCRM – has the potential to disrupt and transform current standard of treatment. We are excited about the timing of this partnership,” added Dr. May, “as it is our expectation that projects like this become candidates for the new advanced manufacturing initiative that we announced during a visit by Prime Minister Trudeau in mid-January.”
About Sernova
Sernova Corp. is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch System and our cell technologies, and manufacturing capabilities of CCRM are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - February 04, 2016 4 February, 2016
Sernova Honoured as Member of the “2016 TSX Venture 50” and Ranked #4 in Life Sciences and Clean Technologies
Sernova resides in the top 3% of TSX Venture Exchange Companies in market performance
Source: Sernova Corp
February 5, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – February 5, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing medical technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, announced today it has received the ranking of fourth in the category of Life Sciences and Clean Technologies and has been selected as member of the “2016 TSX Venture 50” Companies. This is a prestigious group of top market performers from among the 1,791 companies listed on the Toronto Venture Exchange as of December 31, 2015.
"We are honoured to be distinguished by the TSX from amongst all TSX Venture Companies and are appreciative of our investors who have rewarded our progress as acknowledged through the TSX Venture Exchange,” remarked Dr. Philip Toleikis, President and CEO. “We congratulate our peer companies in this category who have shown superior results in key metrics of market performance such as market capitalization growth, share price appreciation and trading volume – with Sernova providing a return of 118% in market cap appreciation in 2015. The shares of these companies also enjoyed a liquid market, with a total of 3.0 billion shares traded over the course of 2015,” added Dr. Toleikis.
“Sernova’s ongoing development of its platform technologies for cell therapy, the advancement of it programs in diabetes and hemophilia, and its focus on forging mutually beneficial pharmaceutical collaborations will, we believe, make 2016 another rewarding year for our shareholders and investors,” stated Frank Holler, Sernova Chairman. “This TSX Venture recognition adds to our growing profile in the public markets and we are most appreciative of receiving this distinction," added Mr. Holler.
About Sernova
Sernova Corp. is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch System and our cell technologies, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - July 11, 2016 11 July, 2016
Sernova and JDRF Announce Funding of Joint Research Collaboration to Advance Human Clinical Trials for the Treatment of Hypoglycemic Unawareness Patients with Severe Type 1 Diabetes
$2.45 million USD awarded to advance Sernova’s Cell Pouch System(TM) (CPS) technologies in a US FDA Clinical Trial with Initiation Scheduled for the Second Half of 2016
Source: Sernova Corp
July 12, 2016, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – July 12, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, is pleased to announce today it has entered into a research funding agreement with JDRF, the leading global organization funding and advocating for type 1 diabetes (T1D) research. The purpose of the funding is to advance human clinical trials of Sernova’s CPS technologies for treatment of hypoglycemia unawareness patients with severe type 1 diabetes. T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose.
JDRF will provide Sernova up to $2.45 million USD to support a clinical trial at a major transplantation center in the United States. The goal of the study is to provide patients with hypoglycemia unawareness a novel cell therapy treatment utilizing Sernova’s proprietary, highly vascularized, cell macroencapsulated implantable and scalable device to reduce or eliminate the need for injections of exogenous insulin.
“JDRF has previously provided funding to advance the development of Sernova’s technologies through a preclinical collaboration with Massachusetts General Hospital, and we are proud to continue our support as Sernova’s technologies progress into new safety and efficacy clinical trials,” said Derek Rapp, JDRF President and CEO. “JDRF is excited about this collaboration, which advances research in encapsulated cell therapies, and will continue to drive progress toward our mission to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications.”
“Sernova and JDRF are tightly aligned in our vision to see cell-based therapies developed to reduce disease burden and significantly increase the quality of life for people living with T1D,” remarked Dr. Philip Toleikis, Sernova’s President and CEO. “We see our work with JDRF on this important clinical trial as an exciting opportunity to more rapidly advance Sernova’s therapies to treat people with diabetes and address many of the shortcomings and challenges of current insulin therapy.”
“Sernova’s progression to human clinical trials is an incredible accomplishment in the global diabetes research agenda,” said Dave Prowten, President and CEO of JDRF Canada. “I am particularly proud of this trial being a part of the JDRF portfolio because it supports advancements of the best and brightest research minds in Canada at Sernova. Also, this is a shining example of the international collaboration fostered by projects funded by JDRF. Working together with our global partners, we can accelerate this type of transformative research and ensure it becomes available for the T1D community.”
To date, there is no cure for T1D, and people living with the disease are dependent on insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing highly disruptive medical technologies to improve the treatment and quality of life of people with chronic debilitating metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device which forms highly vascularized chambers, ideal for therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required to treat disease. For more information, please visit Sernova.com or follow us on Twitter: @SernovaCorp
About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which include our belief that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - December 10, 2017 10 December, 2017
Sernova Receives US FDA IND Allowance to Initiate a US Clinical Trial of its Cell Pouch for the Treatment of Type 1 Diabetes
Source: Sernova Corp
December 11, 2017, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – Monday December 11, 2017) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing regenerative medicine technologies for the long-term treatment of diseases including diabetes and hemophilia, is pleased to announce it has received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (TM) (CPS) in the United States. The Company will host a conference call for shareholders with Dr. Philip Toleikis, President and CEO on Monday, December 11th at 10:00am Eastern Standard Time to discuss the trial.
Sernova plans to initiate the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.
JDRF has previously committed to provide Sernova up to $2.45 million USD to support the clinical trial.
“Hypoglycemia unawareness is a serious consequence of type 1 diabetes,” said Derek Rapp, President & CEO, JDRF International. “We are excited to see progress in this and other potentially life-saving JDRF-funded research, which could help prevent people with hypoglycemia unawareness from experiencing dangerous lows, as we strive to achieve our vision of a world without T1D.”
“We are extremely enthusiastic about the promise of Sernova’s regenerative medicine platform to provide a new therapeutic option for diabetes patients with hypoglycemia unawareness. We believe Sernova’s multiple advancing cell based therapies have the potential to deliver significant improvement in the quality of life of patients suffering from diabetes and other debilitating diseases,” said Dr. Philip Toleikis, Sernova’s president & CEO.
About the Trial
The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development, a dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year.
“Sernova’s FDA clearance to commence human clinical trials in the United States is an exciting step forward in diabetes research, initially focused to reduce the risk of hypoglycemia unawareness, a complication in which a patient is unaware of a deep drop in blood sugar that can have life threatening consequences,” said Dave Prowten, President and CEO of JDRF Canada. “This is also an example of the international collaboration fostered by JDRF-funded projects to accelerate transformative research to benefit the T1D community,” added Mr. Prowten.
About Sernova’s Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells (donor, stem cell derived cells and xenogeneic cells) which then release proteins and/or hormones as required to treat disease. The device is designed upon implantation to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells. The device with therapeutic cells has been shown to provide long term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin producing cells in humans.
About Diabetes
T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, and people living with the disease are dependent on exogenous insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
Conference Call Details
To participate in this live conference call, please dial + 1-877-858-5743 prior to the scheduled conference call time. International callers should dial +1-858-609-8959. The conference participant pass code is 355 040. Following the conference call a recording will be available at www.sernova.com
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778\
www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which include our belief about the conduct and outcome of clinical trials and that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 21, 2018 21 February, 2018
Sernova’s Cell Pouch Regenerative Medicine Clinical Trial for Patients with Type 1 Diabetes Supported with Continuous Glucose Monitoring Systems
Continuous Glucose Monitoring System (CGM) to provide sensitive tracking of key efficacy measures in patients at important time points throughout the study
Source: Sernova Corp
February 22, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – February 22, 2018) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing regenerative medicine technologies for the treatment of chronic diseases including diabetes and hemophilia, is pleased to announce continuous glucose monitoring systems (CGM (Medtronic Minimed, Northridge, CA)) will be provided to patients in Sernova’s US regenerative medicine clinical trial of its Cell Pouch(TM). CGM will be used to track the function of the transplanted cells in the measurement of key efficacy measures at multiple time points following transplantation of the therapeutic cells into the Cell Pouch.
Glucose variability and hypoglycemia duration can be determined using CGM. CGM involves the subcutaneous placement of a glucose sensor connected to a pager-sized monitoring device that stores glucose data over a 6-day period. Data from each period will be analyzed for mean glucose concentration, mean glucose variability, number and duration of hyper- and hypo- glycemic episodes, and total duration of hypoglycemia.
“We believe continuous glucose monitoring of patients may be an important and sensitive method to closely track the function of the transplanted therapeutic cells within the Cell Pouch,” said Dr. Philip Toleikis, Sernova’s President and CEO. “We are pleased with our collaborators in this study who have shown the foresight to support Type 1 diabetes patients seeking treatment via next-generation regenerative medicine technologies.”
Sernova has recently received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (CPS) in the United States. Sernova is taking final steps to begin enrollment of patients in the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.
About the Trial
The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development, a dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. CGM is planned to provide a sensitive and accurate tracking method to follow important efficacy measures at various time points throughout the study.
About Sernova’s Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells (donor, stem cell derived cells and xenogeneic cells) which then release proteins and/or hormones as required to treat disease. The device is designed upon implantation to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells. The device with therapeutic cells has been shown to provide long term safety and efficacy in small and large animal models with diabetes and has been proven to provide a biologically compatible environment for insulin producing cells in humans.
About Diabetes
T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, and people living with the disease are dependent on exogenous insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778\
www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which include our belief about the conduct and outcome of clinical trials and that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - May 07, 2018 7 May, 2018
Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator
Leading Surgeon and Researcher in Islet Transplantation at the University of Chicago to
act as Clinical Trial Principal Investigator. Study to focus on severely diabetic patients
with hypoglycemia unawareness
Source: Sernova Corp
May 8, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire May 8, 2018) – Sernova Corp. (TSX-V: SVA)
(OTCQB: SEOVF) (FSE: PSH), announces Dr. Piotr Witkowski, M.D., Ph.D., a leading
expert in type 1 diabetes (T1D) and islet transplantation, as the Clinical Trial Principal
Investigator for Sernova’s new clinical study. Dr Witkowski, at the University of Chicago
site, will work closely with Sernova’s team to conduct the clinical and regulatory aspects
of the Cell Pouch trial.
Dr. Witkowski is a widely published diabetes researcher and respected surgeon with a
longstanding record of success in both basic science and clinical research pertaining to
islet cell and abdominal organ transplantation. Among other accomplishments, he was
instrumental in developing an optimized islet isolation technique that greatly improved
success in clinical transplants. Under Dr. Witkowski's leadership, multidisciplinary
research teams at the University of Chicago are currently conducting several studies
designed to improve the quality and outcomes of islet cell transplantation in patients with
T1D.
“Sernova’s achievement to commence US human clinical trials is a key step to
improving the therapeutic treatment for people living with diabetes. This Cell Pouch
safety and efficacy trial aims to reduce the risk of hypoglycemia unawareness, a
complication in which a patient is unable to recognize and control impending
hypoglycemia resulting in a drop in blood sugar that can have life threatening
consequences,” said Dr. Witkowski. “Our experienced diabetes treatment team at the
University of Chicago sees the potential of this transformative therapy to benefit and
substantially improve the care of T1D.”
“Improving the quality of life and outcomes of people with diabetes are Sernova’s main
priorities, and we are grateful to have the opportunity to work with Dr. Witkowski and his
expert team at the University of Chicago, a team known for outstanding diabetes
research and patient care,” stated Dr. Philip Toleikis, Sernova’s President & CEO.
The study is a Phase I/II, non-randomized, unblinded, single-arm, company sponsored
trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine,
patients with hypoglycemia unawareness will be enrolled in the study under informed
consent. Patients then will be implanted with the Cell Pouch including sentinel devices.
Following vascularized tissue development in the Cell Pouch, an initial dose of purified
islets under strict release criteria will be transplanted into the Cell Pouch and patients
followed for safety and efficacy measures for approximately six months. At this point a
decision will be made with regards to the transplant of a second islet dose with
subsequent safety and efficacy follow up. Patients will then be further followed for one
year, with interim patient results released at periodic intervals consistent with an open
label study.
About Dr. Witkowski
Piotr Witkowski M.D. Ph.D. is an Associate Professor of Surgery and a transplant
surgeon at the University of Chicago Medicine. He has been involved in islet
transplantation research for the past 17 years, initially at Columbia University in New
York City and then as a Director of the Pancreatic Islet Transplantation Program at the
University of Chicago Medicine. For the last nine years, Dr. Witkowski has been
conducting multiple clinical studies in intraportal islet allotransplantation in patients with
brittle type diabetes as well as islet autotransplantation in patients with chronic
pancreatitis. Recently, he accomplished a phase 3 clinical trial and is currently preparing
application to the FDA for islet graft as a biological product, which is pivotal to enable
islet transplantation to become available to patients as a standard of care procedure.
Being aware of shortcomings of intrahepatic islet transplantation, Dr Witkowski has been
working on optimization of the subcutaneous location for improved islet engraftment. He
has proven the concept that this pre-vascularized site enhances islet survival in a
preclinical diabetes model.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a
medical device (Cell Pouch) and immune protected therapeutic cells to improve the
treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated
through replacement of proteins or hormones missing or in short supply within the body.
For more information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939;
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778; www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are
statements that are not historical facts and are generally, but not always, identified by
the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”,
“potential” and similar expressions, or that events or conditions “will”, “would”, “may”,
“could” or “should” occur. Although Sernova believes the expectations expressed in such
forward-looking statements are based on reasonable assumptions, such statements are
not guarantees of future performance and actual results may differ materially from those
in forward looking statements. Forward-looking statements, are based on the beliefs,
estimates and opinions of Sernova’s management on the date such statements were
made, which include our belief about the conduct and outcome of clinical trials and that
Sernova will be able to raise additional capital to fund its clinical programs including its
US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - May 13, 2018 13 May, 2018
Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study
IRB Approval Signals ‘Green Light‘ for Sernova’s Clinical Protocol to Proceed
Source: Sernova Corp
May 14, 2018 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – Monday May 14, 2018 ) – Sernova Corp.
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), announces today it has received University
of Chicago Institutional Review Board (IRB) approval to begin a new clinical protocol for
the FDA-cleared human clinical trial to investigate the Cell Pouch™ for treatment of type
1 diabetes (T1D) in individuals with hypoglycemia unawareness.
The University of Chicago Institutional Review Board (IRB) is a committee established to
review and approve research involving human subjects. The purpose of the IRB is to
ensure that all human subject research is conducted in accordance with all federal,
institutional, and ethical guidelines. The primary goal of an IRB is to safeguard the rights,
safety and welfare of participants in research studies.
"The approval of our clinical protocol by the University of Chicago IRB represents a
significant milestone enabling the company to expand the clinical testing of our Cell
Pouch System to the US. Patient selection and enrollment can now proceed," said Dr.
Philip Toleikis, Sernova President and CEO.
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-
sponsored trial, where diabetic subjects with hypoglycemia unawareness will be enrolled
into the study under informed consent. Subjects will then be implanted with Cell Pouches.
Following development of vascularized tissue chambers within the Cell Pouch, subjects
will then be stabilized on immunosuppression and a dose of purified islets under strict
release criteria will be transplanted into the Cell Pouch.
A sentinel pouch, also transplanted with islets, will be removed for an early assessment
of the islet transplant. Subjects will be followed for safety and efficacy measures for
approximately six months. At this point, a decision will be made with regards to the
transplant of a second islet dose with subsequent safety and efficacy follow up. Patients
will then be further followed for one year. The primary objective of the study is to
demonstrate safety and tolerability of islet transplantation into the Cell Pouch™. The
secondary objective is to assess efficacy through a series of defined measures.
About Sernova’s Cell Pouch™ Technologies
The Cell Pouch™ is a novel, proprietary, scalable, implantable macroencapsulation
device designed to prevent device fibrosis for the long-term survival and function of
therapeutic cells (donor, stem cell-derived cells and xenogeneic cells) which then release
proteins and/or hormones as required to treat disease. The device is designed upon
implantation to incorporate with tissue, forming highly vascularized tissue chambers for
the transplantation and function of therapeutic cells. The device with therapeutic cells has
been shown to provide long-term safety and efficacy in small and large animal models of
diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans
About Diabetes
T1D is a life-threatening disease, affecting more than 3.3 million individuals in Canada
and US, in which the body's immune system mistakenly attacks and kills the pancreatic
cells that produce insulin a hormone that is essential for life because of its role to help the
body use glucose. The existing standard of care for patients with TID is suboptimal. To
date, there is no cure for T1D, and people living with the disease are dependent on
exogenous insulin therapy to help keep their blood-sugar levels from spiking too high,
which can lead to long-term complications such as kidney and heart diseases or an
acute, potentially deadly health crisis. Present-day insulin therapy is, however, an
imperfect treatment method that requires people with T1D to carefully monitor their
blood sugar throughout the day and take multiple, calculated doses of insulin based on
food intake, exercise, stress, illness and other factors. A miscalculation or unexpected
variable leading to high or low blood sugar episodes are daily threats, and only a third of
people with T1D achieve their long-term blood glucose targets, placing them at risk for
T1D-related health complications.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a
medical device and immune protected therapeutic cells to improve the treatment and
quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases. For more
information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939;
philip.toleikis@sernova.com www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778; www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are
statements that are not historical facts and are generally, but not always, identified by
the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”,
“potential” and similar expressions, or that events or conditions “will”, “would”, “may”,
“could” or “should” occur. Although Sernova believes the expectations expressed in such
forward-looking statements are based on reasonable assumptions, such statements are
not guarantees of future performance and actual results may differ materially from those
in forward looking statements. Forward-looking statements, are based on the beliefs,
estimates and opinions of Sernova’s management on the date such statements were
made, which include our belief about the conduct and outcome of clinical trials and that
Sernova will be able to raise additional capital to fund its clinical programs including its
planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to
update or revise any forward-looking statements whether as a result of new information,
future events or otherwise.
Press Release Communiqué de presse - July 04, 2018 4 July, 2018
Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes
Source: Sernova Corp
July 5, 2018, 6:00 a.m. EDT
LONDON, ONTARIO –July 5, 2018 – Sernova Corp.
(“Sernova” or the “Company”)
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH)
announces that patient screening and
recruitment has begun in its regenerative medicine
US clinical trial for diabetic patients
with hypoglycemia unawareness.
Sernova’s initial clinical evaluation of the
prevascularized Cell Pouch (TM) demonstrated
biocompatibility and safety of the Cell Pouch as well
as viability and vascularization of its
transplanted insulin-producing islets, a first in world
achievement in a prevascularized
implantable medical device.
“This first-in-human work helped frame the design
of Sernova’s new Phase I/II clinical
protocol. Our clinical team at the University of
Chicago is excited to initiate this trial of
Sernova’s transformative technology,” said
principal investigator, Dr. Piotr Witkowski,
M.D., Ph.D.
“To support the clinical study’s timely execution
under the highest quality standards,
Sernova and CTI (Clinical Trial and Consulting), a
well-respected clinical research
organization with deep experience in the
regenerative medicine field, are working
closely with Dr. Witkowski’s team,” said Dr. Philip
Toleikis, Sernova’s President and
CEO.
The study is a Phase I/II, non-randomized, open
label, single-arm, company-sponsored
trial. Under the clinical leadership of Dr. Witkowski,
University of Chicago Medicine,
subjects with hypoglycemia unawareness enrolled
in the study under informed consent
will be implanted with the Cell Pouch. Following
vascularized tissue development in the
Cell Pouch, an initial dose of purified islets under
strict release criteria will be
transplanted into the Cell Pouch.
A sentinel pouch, also transplanted with islets, will
be removed for an early assessment
of the islet transplant. Subjects will be followed for
safety and efficacy measures for
approximately six months. At this point, a decision
will be made with regards to the
transplant of a second islet dose with subsequent
safety and efficacy follow up. Subjects
will then be further followed for one year, with
interim participants results released at
periodic intervals consistent with an open-label
study.
About Sernova’s Cell Pouch Technologies
The Cell Pouch is a novel, proprietary, scalable,
implantable prevascularized
macroencapsulation device for the long-term
survival and function of therapeutic cells
(donor, stem cell derived cells and xenogeneic cells)
which then release proteins and/or
hormones as required to treat disease. The device
is designed to eliminate concerns of
fibrosis upon implantation by incorporating with
tissue, forming highly vascularized
tissue chambers for the transplantation and function
of therapeutic cells. The device with
therapeutic cells has been shown to provide long-
term safety and efficacy in small and
large animal models of diabetes and has been
proven to provide a biologically
compatible environment for insulin-producing cells
in humans.
About Diabetes
Type1 Diabetes (T1D) is a life-threatening disease
in which the body's immune system
mistakenly attacks and kills the pancreatic cells that
produce insulin—a hormone that is
essential for life because of its role to help the body
use glucose. The existing standard of
care for patients with TID is suboptimal. To date,
there is no cure for T1D, and people
living with the disease are dependent on exogenous
insulin therapy to help keep their
blood-sugar levels from spiking too high, which can
lead to long-term complications such
as kidney and heart diseases or an acute,
potentially deadly health crisis. Present-day
insulin therapy is, however, an imperfect treatment
method that requires people with
T1D to carefully monitor their blood sugar
throughout the day and take multiple,
calculated doses of insulin based on food intake,
exercise, stress, illness and other
factors. A miscalculation or unexpected variable
leading to high or low blood sugar
episodes are daily threats, and only a third of
people with T1D achieve their long-term
blood glucose targets, placing them at risk for T1D-
related health complications.
About Sernova Corp
Sernova Corp is developing regenerative medicine
therapeutic technologies using an
implantable medical device and immune protected
therapeutic cells to improve the
treatment and quality of life of people with chronic
metabolic diseases such as insulin-
dependent diabetes, blood disorders including
hemophilia, and other diseases treated
through replacement of proteins or hormones
missing or in short supply within the body.
For more information, please visit
www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
Philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking
statements. Forward-looking statements are
statements that are not historical facts and are
generally, but not always, identified by
the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”,
“potential” and similar expressions, or that events
or conditions “will”, “would”, “may”,
“could” or “should” occur. Although Sernova
believes the expectations expressed in such
forward-looking statements are based on
reasonable assumptions, such statements are
not guarantees of future performance and actual
results may differ materially from those
in forward looking statements. Forward-looking
statements, are based on the beliefs,
estimates and opinions of Sernova’s management
on the date such statements were
made, which include our belief about the conduct
and outcome of clinical trials and that
Sernova will be able to raise additional capital to
fund its clinical programs including its
planned US clinical trial. Sernova expressly
disclaims any intention or obligation to
update or revise any forward-looking statements
whether as a result of new information,
future events or otherwise.
Press Release Communiqué de presse - November 20, 2018 20 November, 2018
Sernova Highlights Achievements from the HemAcure Consortium in Developing a Novel Cell-Based Therapy for Hemophilia A
Source: Sernova Corp
November 20, 2018, 8:30 a.m. EST
LONDON, ONTARIO –November 20, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) a
clinical-stage regenerative medicine company, highlights the achievements in developing a novel cell-based
therapy in combination with Sernova’s Cell Pouch™ for treatment of Hemophilia A.
The therapeutic significance of this work supports the HemAcure Consortium’s concept that Factor VIII
genetically corrected human cells from a blood sample of patients with Hemophilia A transplanted into the Cell
Pouch can improve blood clotting.
“I am impressed with the achievements of this International Consortium within the limited time allowed. The
technical teams worked closely together to complete this work in developing a first-in-world ex vivo gene
therapy approach in an implanted vascularized medical device for the treatment of Hemophilia A.” said Dr.
David Lillicrap, Professor in the Department of Pathology and Molecular Medicine at Queen’s University,
member of the Medical Advisory Board of the World Federation of Hemophilia, and HemAcure Scientific
Advisory Board member.
A summary of the Consortium’s achievements are as follows:
• In blood donated from patients with Hemophilia A, endothelial outgrowth cells to be corrected for the
Factor VIII gene were isolated and grown successfully in a specialized Good Manufacturing Process (cGMP)
compliant medium developed by the Consortium.
• Using a human Factor VIII gene insertion technique, the cells were corrected and confirmed to produce
Factor VIII.
• A preliminary experiment showed these cells could release Factor VIII in the blood over time and improve
blood clotting in an animal model of Hemophilia A, in preparation for transplant into the Cell Pouch.
• The corrected cells were proven to be successfully replicated through a production scale-up process.
Following amplification, these cells maintained their normal healthy behavior in producing Factor VIII.
Additional safety metrics were achieved using established tests.
• The cells were then cryopreserved and shipped from the European partners to Sernova in North America
where they were shown to remain healthy through quality control testing in preparation for transplantation.
• The Cell Pouch, manufactured under cGMP, and following implantation in the Hemophilia A animal model
showed development of vascularized chambers suitable to receive the corrected cells.
• Following transplantation into the Cell Pouch in a Hemophilia A animal model, the patient’s Factor VIII
corrected cells survived at three months (the duration of the study).
• Initial results showed Factor VIII released from the cells in the Cell Pouch was detected in blood and
notably, showed improved clotting when compared to the Hemophilia A animal control which did not receive
human corrected cells.
• The steps of the cell production process were documented towards development of the cGMP
manufacturing process for the corrected cells for future clinical use. An Instructions-for-Use document was
also developed for implantation of the cGMP Cell Pouch and transplantation of patient corrected Factor VIII
producing cells applicable for future human testing in patients with Hemophilia A.
Sernova’s President & CEO, Dr. Philip Toleikis added, “These series of breakthroughs demonstrate success in
correcting a Hemophilia A patient’s own cells to produce the missing Factor VIII protein and to improve blood
clotting in an animal model of Hemophilia A in preparation for future human clinical trials.”
Technical results will continue to be presented by HemAcure Consortium members at scientific conferences and
disseminated in scientific publications. Furthermore, steps are to complete cGMP manufacturing of the cells
using the tools and methods developed by the Consortium, optimize dosing of cells in the Cell Pouch to achieve
optimal therapeutic blood levels of Factor VIII, and conduct final formal studies in preparation for a first-in-
human clinical study.
HemAcure’s webinar in which the consortium expert leaders present an overview of the findings is now available
both on Sernova’s website at www.sernova.com and the HemAcure project website at www.hemacure.eu
About HemAcure
The overall objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex
vivo prepared cell-based therapy to treat the bleeding disease, Hemophilia A (caused by a genetic deficiency in
clotting Factor VIII (FVIII)) that should ultimately lead to improved quality of life of the patients. The European
Union's Horizon 2020 research and innovation program has awarded approximately €5.5 million (CDN$8.5) to
support the project. International consortium members include the University Hospital Wuerzburg
(Coordinating Institute), Germany, IMS - Integrierte Management, Heppenheim, Germany, Università del
Piemonte Orientale “Amedeo Avogadro,” Novara, Italy, Loughborough University, Loughborough, United
Kingdom, ARTTIC International Management Services, Munich, Germany and Sernova Corp., London, Ontario,
Canada. This project has received funding from the European Union’s Horizon 2020 Research and Innovation
Programme under grant agreement No 667421. The Consortium has been working together to provide sets of
design and manufacturing protocols, based on current European GMP regulations to prepare an Investigational
Medicinal Product Dossier (IMPD) for an Investigational Medicinal Product (IMP), composed of therapeutic cells
and an implantable medical device (Sernova’s Cell Pouch). For more information, visit www.hemacure.eu
About Hemophilia A
People with Hemophilia A have prolonged abnormal bleeding as a result of trauma. Hemophilia A is the most
common form of Hemophilia and is a genetic disorder caused by missing or defective FVIII, a blood clotting
protein. Severe Hemophilia A occurs in about 60% of cases where the deficiency of FVIII is less than 1% of
normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused
by a spontaneous change in the gene. According to the US Centers for Disease Control and Prevention,
Hemophilia A occurs in about 1 in 5,000 births. Prolonged bleeding, in areas such as the brain, of a person with
Hemophilia A, can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint
damage. Approximately 20,000 people in the United States, 2,500 in Canada and 10,000 in Europe have
moderate to severe forms of Hemophilia A. Though there is no cure for the disease, Hemophilia A can be
controlled with regular infusions of recombinant clotting FVIII. Annual worldwide costs for the treatment of the
disease for each patient may range from $60,000 to $260,000 US for a total cost of approximately $15B per
year.
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly €80 billion of funding
available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by
taking great ideas from the lab to the market. The project is funded as part of societal challenges “personalizing
health and care” in a specific call about innovative treatments and technologies. New therapies, such as gene or
cell therapies, often require technological innovation in the form of development of specific component tools
and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the
therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving
therapeutic scale production and cGMP standards at reasonable cost is often underestimated. The European
Union aims to improve the development of advanced methods and devices for targeted and controlled delivery,
and to bring these innovative treatments to the patient.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic
diseases such as insulin-dependent diabetes, blood disorders including Hemophilia A, and other diseases
treated through replacement of proteins or hormones missing or in short supply within the body. For more
information, please visit www.sernova.com
For further information contact:
Danny Matthews,
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
Dominic Gray,
Corporate Communications
Tel: (519) 858-5126
Dominic.Gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of the Hemophilia
A program. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking
statements whether as a result of new information, future events or otherwise.
HemAcure Webinar: https://youtu.be/ihyHefvJ8cQ
Press Release Communiqué de presse - December 20, 2018 20 December, 2018
Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes
Initiating Treatment Phase of the Study at the University of Chicago
December 20, 2018 9:00 a.m. EST
LONDON, ONTARIO – December 20, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a
clinical-stage regenerative medicine company announces the enrollment of the first patient in its Phase I/II
trial of Sernova’s Cell Pouch for Clinical Islet Transplantation in type 1 diabetes.
“There is a real need for new treatment options in the field of type 1 diabetes,” said Dr. Piotr Witkowski,
principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago
School of Medicine. “Due to Sernova’s novel approach to demonstrate vascularization of the Cell Pouch and
remarkable preclinical and first-in-human data, we are hopeful this study will provide a new functional
therapeutic option in the treatment of patients with diabetes.” Dr. Witkowski added, “We expect completion
of enrollment of the first patient cohort to be January 2019 and full enrollment to be completed by mid-
2019 as we continue to screen patients for the Sernova study.”
“The initiation of this Phase I/II trial is an important milestone for Sernova as our team looks to showcase
our research and development efforts in diabetes on a clinical level at the University of Chicago, a world
leader in regenerative medicine,” added Dr. Philip Toleikis, President and CEO of Sernova. “In our pilot first-
in-human study, Sernova’s regenerative medicine approach, involving therapeutic cells within Sernova’s Cell
Pouch, showed surviving vascularized islets able to produce all the hormones necessary to control blood
glucose levels. Based on these positive initial results, we expect our therapeutic approach will demonstrate
continued safety and therapeutic benefit to people suffering from type 1 diabetes.”
The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of
2019 and preliminary efficacy data in the second half of 2019.
About the Study
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial,
where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent.
Participants are then implanted with Cell Pouches. Following the development of vascularized tissue
chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified
islets, under strict release criteria, is transplanted into the Cell Pouch.
A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed
for additional safety and efficacy measures for approximately six months. At this point, a decision will be
made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up.
Patients will then be further followed for one year. The primary objective of the study is to demonstrate
safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess
efficacy through a series of defined measures.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939 . For
more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact
(773) 702-2504.
About Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune
system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body
use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent
on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along
with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or
unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people
with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-
related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals
experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1
diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue,
forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which
then release proteins and hormones as required to treat disease. The device along with therapeutic cells has
been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has
been proven to provide a biologically compatible environment for insulin-producing cells in humans.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement
of proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
For further information contact:
United States:
Danny Matthews
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
For investor inquiries and media inquiries in Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”,
“anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that
events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the
expectations expressed in such forward-looking statements are based on reasonable assumptions, such
statements are not guarantees of future performance, and actual results may differ materially from those in
forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions
of Sernova’s management on the date such statements were made, which include our beliefs about the
conduct and outcome of clinical trials. Sernova expressly disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - April 11, 2019 11 April, 2019
Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes
April 11, 2019, 9:00 a.m. EDT
LONDON, ONTARIO – April 11, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage
regenerative medicine company today announced the first Cell Pouch™ transplant of insulin-producing cells in
its U.S. Phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for Clinical Islet
Transplantation in type 1 diabetes.
“Sernova’s Cell Pouch technologies are positioned to provide the most severe patients with improved, long
term options to manage their diabetes,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and
Director of the Pancreatic Islet Transplant Program at the University of Chicago. “The current standard of care,
involves islet transplants into the portal vein which has significant limitations including the development of an
immediate blood-mediated inflammatory reaction (IBMIR), limited supply of donor organs and the challenges in
isolating and obtaining a consistent quality of islet preparations.”
In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This
procedure enables the development of vascularized tissue chambers and provides an interval for patient
stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was
assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In
accordance with the protocol the Sentinel Pouch will be removed approximately 90 days post-transplant to
assess islet survival as an interim indicator of efficacy.
“Sernova’s Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic
cells, to enhance the curative potential of islet transplantation and other cell therapies,” said Dr. Philip Toleikis,
President and CEO of Sernova. “We are thrilled with Dr. Witkowski’s progress as well as his decision to move
forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch.”
“This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for
cell therapies across a range of indications including type 1 diabetes, hemophilia and thyroid disease,” added
Dr. Toleikis.
The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of
2019 and preliminary efficacy data in the second half of 2019.
About the Study
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where
diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants
are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the
Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict
release criteria, is transplanted into the Cell Pouch.
A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for
additional safety and efficacy measures for approximately six months. At this point, a decision will be made
with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will
then be further followed for one year. The primary objective of the study is to demonstrate the safety and
tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a
series of defined measures.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
About Hypoglycemia Unawareness and Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune
system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body
use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on
insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with
multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected
variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1
diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health
complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop
in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming
highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release
proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to
provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to
provide a biologically compatible environment for insulin-producing cells in humans.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
United States:
Danny Matthews
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - July 03, 2019 3 July, 2019
Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes
Sernova’s Cell Pouch (TM) with transplanted islet cells reached primary safety measurements and clinically
significant efficacy outcomes including glucose-stimulated C-peptide and the release of insulin in the first
patient transplanted
July 3, 2019 5:30 a.m. EDT
LONDON, ONTARIO – July 3, 2019 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF), a clinical-stage regenerative
medicine company today announced that in an interim analysis of its human Phase I/II clinical trial, Sernova’s
Cell Pouch transplanted with islet cells showed initial safety, as well as key efficacy measures, including glucose
stimulated C-peptide, insulin production and additional clinically significant measures of glucose control in the
first study patient with type-1 diabetes and severe hypoglycemia unawareness.
Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study
principal investigator presented on Sernova’s Cell Pouch technology and preliminary data from Sernova’s
current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet
Transplantation today at the 17th World Congress of the International Pancreas and Islet Transplantation
Association (IPITA) in Lyon, France.
Highlights of the presentation of the data from the first patient who received islet transplanted into Sernova
Cell Pouch included:
• No incidences of adverse events determined to be related to the Cell Pouch implant.
• The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the
purified islets
• A weight reduction of 6.35kg (12% total body weight)
• Stabilizing improvements in all glycemic control parameters as indicated by Continuous Glucose
Monitoring (CGM) as assessed by Medtronic
• 87.5% reduction in hypoglycemic events from baseline collected over a two-week monitoring period
• Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point
as indicated in a mixed meal tolerance test
“I am quite pleased with these interim results in the first implanted patient,” said Dr. Witkowski. “The first of
two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy.
Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is
definitive proof of islet survival and function in the Cell Pouch. These results are an important first step towards
a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-
term results in enrolled patients as the trial progresses,” said Dr. Witkowski, principal study investigator.
ABOUT IPITA
The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant
scientific community in providing a forum for the open exchange of knowledge and expertise in order to
facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of
human diabetes.( https://www.tts.org/ipita/home)
ABOUT THE STUDY
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where
diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are then implanted with
Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are
then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is
transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects will be followed for
additional safety and efficacy measures for approximately six months. At this point, a decision will be made
with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will
then be further followed for one year. The primary objective of the study is to demonstrate safety and
tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a
series of defined measures.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
United States:
Danny Matthews
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
For investor inquiries and media inquiries in Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - October 16, 2019 16 October, 2019
Sernova Confirms Enduring Levels of Fasting C-Peptide in Bloodstream of First Patient in its Phase I/II Clinical Trial for Type-1 Diabetes
Findings further validate Cell Pouch and therapeutic cell performance in Type-1 diabetes
October 16, 2019 9:00 a.m. EDT
LONDON, ONTARIO – October 16, 2019 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage regenerative medicine company, is pleased to announce the detection of enduring levels of C-peptide
(measured up to 30 days and ongoing), a biomarker of transplanted beta cell insulin production, in the
bloodstream of a fasting patient in its ongoing Phase I/II Cell Pouch(TM) US clinical study of type-1 diabetes.
The detection of fasting C-peptide in the bloodstream of our first patient, in addition to Sernova’s recent
announcement of glucose-stimulated C-peptide and other early efficacy indicators, demonstrate a normalizing
response of the Cell Pouch therapeutic cells to the body’s varied need for insulin production. This is an
important step forward and evidence of ongoing islet engraftment within the Cell Pouch.
“Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide
levels in the patient’s bloodstream after recent transplant, not only following stimulation with a meal but also
when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring
islet survival and function within Sernova’s Cell Pouch,” said Dr. Piotr Witkowski, Director of Pancreatic, and
Islet Transplant Program at the University of Chicago and study principal investigator. “We look forward to
reporting ongoing results in additional patients as the trial progresses.”
The entry criteria of Sernova’s clinical study require patients to be C-peptide negative upon enrolment. C-
peptide measured in the bloodstream is a biomarker of insulin and is widely used as a measure of insulin
production by islet cells. C-peptide is typically measured following overnight fasting (fasting C-peptide) and
during a glucose tolerance test (glucose-stimulated C-peptide). Together these measures provide an index of
the patient’s ability to control blood glucose through their production of insulin.
With the goal of improved blood glucose control and stabilization of fluctuating blood sugar levels commonly
experienced in people with type-1 diabetes, a normalizing response can also decrease the likelihood of life
threatening hypoglycemic unaware events, a key efficacy measure in the Sernova trial.
Sernova’s clinical trial is continuing active recruitment and enrollment of study participants and further results
will continue to be reported as the study progresses.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, to assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in participants with
diabetes and hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of
defined measures. Importantly, patients enrolled in Sernova’s clinical trial are incapable of producing C-
peptide prior to implantation of Sernova’s Cell Pouch and therapeutic cells.
Eligible subjects are implanted with Cell Pouches. Following development of vascularized tissue chambers
within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under
strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional
safety and efficacy measures for approximately six months. At this point, a decision is made with regards to the
transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then further
followed for one year to assess longer-term safety and efficacy.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For
more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming
highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release
proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to
provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to
provide a biologically compatible environment for insulin-producing cells in humans.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials. The information disclosed represents results from one patient and may not be representative of all study
patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 10, 2020 10 February, 2020
Sernova Announces Positive DSMB Review and Recommendation for Continuation of Phase I/II Diabetes Clinical Trial of Cell Pouch
Ongoing Safety of Sernova’s Clinical Trial Confirmed
February 10, 2020 9:00 a.m. EDT
LONDON, ONTARIO – February 10, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage company and leader in regenerative medicine therapeutics is pleased to announce that the independent
Data Safety Monitoring Board (“DSMB”) completed its first interim analysis of the ongoing Safety, Tolerability
and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation Phase I/II clinical trial in patients
with severe hypoglycemia unawareness.
The DSMB did not raise any concerns regarding safety and recommended the continuation of the study.
“We are very pleased with the recommendation of the DSMB. In light of this positive assessment, Sernova
continues the trial as we carry on compiling safety and efficacy results from our treated patients along with
advancing further patient enrollment at the University of Chicago,” said Dr. Philip Toleikis, President and CEO
of Sernova. “We thank the DSMB for its diligence, guidance, and support as we continue moving forward with
our mission to provide people suffering from diabetes and other chronic diseases improved treatment options
and a better quality of life.”
The DSMB is an independent group of clinical research experts who review the accumulated safety data
throughout the clinical trial to safeguard the safety and interests of participating patients while ensuring the
scientific validity and integrity of the trial. This interim analysis was the first of three planned DSMB reviews of
this clinical trial.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial to assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in diabetic subjects
with hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined
measures. Patients enrolled in Sernova’s clinical trial are incapable of producing c-peptide, a biomarker for
insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue chambers
within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under
strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional
safety and efficacy measures for approximately six months. At this point, a decision will be made with regards
to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then
further followed for one year to assess longer-term safety and efficacy.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long- term survival and function of therapeutic cells. The device
is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and
function of therapeutic cells which then release proteins and hormones as required to treat disease. The Cell
Pouch along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large
animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-
producing cells in humans. In early assessments of its ongoing Phase I/II clinical trial, Sernova has shown
presence of blood levels of c-peptide both during glucose tolerance tests as well as under fasting conditions.
Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 13, 2020 13 February, 2020
Sernova Achieves Positive Efficacy Endpoint in Phase I/II Clinical Trial for Type 1 Diabetes
Most advanced subject in the clinical trial continues to show positive indicators of islet function following
islet
transplant into the Cell Pouch
February 13, 2020 9:00 a.m. EDT
LONDON, ONTARIO – February 13, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a
clinical-
stage company and regenerative medicine therapeutics leader, is pleased to announce that Sernova’s first
treated patient in its Phase I/II clinical trial of its Cell Pouch with therapeutic cells for type 1 diabetes at the
University of Chicago, has demonstrated survival of endocrine tissue (insulin-producing islets) in the sentinel
Cell Pouch following 90 days transplant.
This efficacy outcome, namely, survival of endocrine tissue (insulin-producing islets) in the sentinel Cell
Pouch
following 90 days transplant, is measured by positive staining of islets during histological analysis. According
to
the independent pathologist who conducted the analysis, “The explanted sentinel pouch shows abundant
viable, organized islet cells intimately associated with blood vessels within a collagen matrix after 90 days of
transplantation. These surviving islet cells strongly express insulin.”
A representative histological image from the islet-transplanted mini-sentinel Cell Pouch explanted from a
patient at 90 days post-transplant. Islets with positive insulin staining (red), and new blood vessels (green)
are
detected. (A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet
Transplantation.)
This achievement is important because it is an indicator of transplanted islet health in the therapeutic Cell
Pouches remaining in the subject, including the islets ability to produce insulin into the bloodstream. This
has
been demonstrated by our previous reported findings of blood levels of both glucose-stimulated and fasting
C-
peptide as well as other efficacy indicators in this patient who had no measurable levels of this biomarker of
insulin prior to the Cell Pouch islet transplant.
“We believe these accumulating positive results continue to validate our Cell Pouch technologies as a viable
regenerative medicine therapeutic platform for humans in insulin-dependent diabetes and other chronic
diseases,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “With these encouraging results and
the
positive review and recommendation from the Data Safety and Monitoring Board (DSMB), we are excited to
continue the clinical trial and carry on compiling safety and efficacy data from our current and future treated
patients.”
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, Company-sponsored trial to
assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in diabetic
subjects
with hypoglycemia unawareness. The primary objective of the study is to assess the safety of the Cell Pouch
following implantation and transplantation. The secondary objective is to assess efficacy through a series of
defined measures. Patients enrolled in Sernova’s clinical trial are incapable of producing C-peptide, a
biomarker for insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue
chambers
within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets,
under
strict release criteria, is transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for
additional
safety and efficacy measures for approximately six months. At this point, a decision will be made with
regards
to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then
further followed for one year to assess longer-term safety and efficacy.
For more information on the clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For
more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch System including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long- term survival and function of therapeutic cells. The
device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for
the
transplantation and function of therapeutic cells which then release proteins and hormones as required to
treat
disease. The Cell Pouch along with therapeutic cells has been shown to provide long-term safety and
efficacy in
small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans. In early assessments of its ongoing Phase I/II clinical
trial,
Sernova has shown in its first treated patient presence of blood levels of C-peptide both during glucose
tolerance tests as well as under fasting conditions. Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins
or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements within the meaning of applicable Canadian securities
laws. Forward-looking statements in this press release are statements that are not historical facts and are
generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”,
“estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”,
“may”,
“could” or “should” occur. Forward-looking statements include statements about subsequent clinical
activity,
including enrolment of patients and continuing results therefrom, and the potential benefits, safety, and
efficacy
of the Cell Pouch for various indications, including type 1 diabetes.
While Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to
significant scientific, business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors that could cause Sernova’s actual results,
performance
or achievements to be materially different from any future results, performance or achievements expressed
or
implied by the forward-looking statements contained in this press release. Results in early-stage clinical
trials
may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure
regulatory approval. Readers should not place undue reliance on these statements or the scientific data
presented and should refer to the risk factors identified in the company’s continuous disclosure filed on
SEDAR.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - June 08, 2020 8 June, 2020
Sernova to Acquire Cellular Local Immune Protection Technology Accelerating Expansion of its Regenerative Medicine Therapeutics Platform
June 8, 2020 8:00 a.m. EDT
LONDON, ONTARIO – June 8, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage
regenerative medicine therapeutics company, announced today its acquisition of an innovative cellular immune
protection technology. This acquisition represents a strategic accelerator for expansion of Sernova’s total
regenerative medicine cell therapy therapeutics platform.
Said Dr. Philip Toleikis, President and CEO Sernova Corp., “This is a game-changer for Sernova. We have
strategically focused on adding local immune protection technologies to our portfolio as they represent the last
essential pillar for our cell therapy therapeutics platform. This technology acquisition, in addition to our
recently announced collaboration with AgeX Therapeutics, Inc. to use their UniverCyte™ gene-editing
technology to protect cells, positions Sernova with multiple potential approaches to guard therapeutic cells
within our Cell Pouch against host immune-response across multiple clinical applications.”
Pursuant to an asset purchase agreement with Converge Biotech, Inc. (“Converge”), Sernova is acquiring all
intellectual property associated with Converge’s conformal coating cell encapsulation technology (“Conformal
Coating Technology”), including issued patents, patent applications, and know-how. The transaction is
expected to close by June 11, 2020.
“Conformal coating technology could be very synergistic with the Sernova Cell Pouch, as it could confer
protection from the immune attack, decreasing or eliminating the need for immunosuppressive drugs. The
minimal volume of the conformal capsules makes it possible to include immuno-protected insulin-producing
cells in the Sernova Cell Pouch. If the combination of these technologies proves successful, it will represent an
important step towards elimination of the need for immunosuppressive medications, bringing a functional cure
closer to reality for patients suffering from this debilitating disease,” said Dr. Camillo Ricordi, Stacy Joy
Goodman Professor of Surgery and Chief, Division of Cellular Transplantation, Distinguished Professor of
Medicine, Professor of Biomedical Engineering, Microbiology and Immunology and Director, Diabetes Research
Institute and Cell Transplant Center. The Diabetes Research Institute (DRI) is a designated Center of Excellence
at the University of Miami Miller School of Medicine.
Why is the Conformal Coating Technology Important?
The Conformal Coating Technology consists of a thin proprietary coating layer that effectively cloaks coated
therapeutic cells to protect them from an auto-response attack by one’s own immune system post cell
transplantation into the body.
The advantages and potential benefits of this cell encapsulating technology are as follows:
• provides protection of the therapeutic cells from immune system attack locally within the Cell Pouch
chambers potentially avoiding the need for life-long immunosuppression medications, that are typically
required after cell transplantation;
• enables close contact of the transplanted therapeutic cells with the vascularized tissue matrix within the
Cell Pouch to enable closer interactions unlike standard microencapsulation technologies in which the capsules
are significantly larger than the cells limiting required tissue interactions;
• improves the diffusion of small molecules and biomolecules (i.e., glucose, insulin, and other proteins or
hormones), providing a physiological glucose-stimulated insulin response without delay that occurs with other
encapsulation technologies; and
• due to the improved diffusion of biomolecules, it may require a smaller load of therapeutic cells to achieve
the desired therapeutic effect in comparison to standard microcapsules.
Local immune protection technologies to cloak cells, such as the Conformal Coating Technology and the
UniverCyte™ gene technology, have the potential to protect cells from immune system attack within Sernova’s
Cell Pouch through different and independent mechanisms.
“The potential to eliminate antirejection medications with these complementary technologies to our proprietary
Cell Pouch, both for human donor and stem cell-derived cells, will enable us to increase patient safety and
quality of life, and significantly expand the number of treatable patients suffering from chronic diseases. With
extensive preclinical studies already conducted at DRI, we look forward to the possibility of advancing this local
immune protection technology into human trials following successful preclinical proof-of-concept testing. We
believe that this could accelerate Sernova’s opportunity to be first-to-market to provide a functional cure to the
many diabetic patients worldwide. Our vision is to bring a new standard of care approach for chronic
debilitating diseases to the healthcare landscape,” said Dr. Philip Toleikis.
Acquisition Funding
To fund the Conformal Coating Technology acquisition, Sernova will issue to a strategic investor a $1,000,000
convertible debenture that is unsecured, repayable in 30 months (unless earlier converted or redeemed), and
carries an 8% interest rate (the “Debenture”). The Company will also issue 3,000,000 non-transferable share
purchase warrants (the “Warrants”) to the strategic investor, each Warrant being exercisable into one common
share at a price of $0.20 per share for 30 months. The Debenture holder will have the right to convert the
principal amount of the Debenture into common shares of Sernova at a conversion price of $0.25 per share.
“Securing the debenture financing commitment on these favorable terms when Sernova’s Covid-19 impacted
shares were trading in the range of $0.13-0.15 was strategic to reduce our cost of capital and minimize both
dilution and any impact on existing cash resources,” said David Swetlow, Sernova’s CFO.
Neither the Debenture or Warrants have been or will be registered under the United States Securities Act of
1933, as amended (the “U.S. Securities Act”), or any state securities laws and such securities may therefore not
be offered or sold in the United States or to or for the account or benefit of a person in the United States or a
U.S. Person (as defined in Regulation S of the U.S. Securities Act) absent registration or an applicable exemption
from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This
press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale
of the debenture units in any jurisdiction in which such offer, solicitation or sale would be unlawful.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat
disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy
in small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FORWARD-LOOKING INFORMATION
This news release contains forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur, and include statements about the closing of the Conformal
Coating Technology acquisition and the Debenture issuance and funding. Although Sernova believes the
expectations expressed in such forward-looking statements are based on reasonable assumptions, such
statements are not guarantees of future performance, and actual results may differ materially from those in
forward-looking statements. While Sernova considers these assumptions to be reasonable, these assumptions
are inherently subject to significant scientific, business, economic, competitive, market and social uncertainties
and contingencies. Additionally, there are known and unknown risk factors that could cause Sernova’s actual
results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements contained in this press release.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the effect on company operations and capital
markets of events related to the COVID-19 pandemic, the conduct and outcome of discussions with strategic
partners, and expected progress in preclinical programs and clinical trials. Sernova expressly disclaims any
intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - June 15, 2020 15 June, 2020
Sernova Completes Acquisition of Cellular Local Immune Protection Technology
June 15, 2020 9:00 a.m. EDT
LONDON, ONTARIO – June 15, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage regenerative medicine therapeutics company, is pleased to announce it has completed the acquisition of
cellular local immune protection technology from Converge Biotech, Inc. (“Converge”).
“This acquisition is a strategic accelerator for expansion of Sernova’s total regenerative medicine cell
therapy therapeutics platform,” stated Dr. Philip Toleikis, Sernova’s President and Chief Executive Officer.
“Local immune protection technologies to cloak therapeutic cells have the potential to protect cells from
immune system attack within Sernova’s Cell Pouch™ through different and independent mechanisms to
eliminate the need for life-long immunosuppression medications.”
Pursuant to the asset acquisition, Sernova acquired all intellectual property associated with Converge’s
conformal coating cell encapsulation technology (“Conformal Coating Technology”), including issued
patents, patent applications, and know-how.
ABOUT SERNOVA’S CONFORMAL COATING TECHNOLOGY
The Conformal Coating Technology consists of a thin proprietary coating layer that effectively cloaks coated
therapeutic cells to protect them from an auto-response attack by one’s own immune system post cell
transplantation into the body.
The advantages and potential benefits of this novel cell encapsulating technology are as follows:
• provides protection of therapeutic cells from immune system attack locally within Sernova’s Cell Pouch,
potentially avoiding the need for life-long immunosuppression medications, that are currently required after
cell transplantation;
• enables intimate contact of therapeutic cells with the vascularized tissue matrix of the Cell Pouch
improving essential physiological interactions of the cells for survival and function, unlike other micro and
macro-encapsulation technologies;
• improves the diffusion of small molecules and biomolecules (i.e., glucose, insulin, and other proteins or
hormones), providing a physiological glucose-stimulated insulin response without delay that occurs with
other encapsulation technologies; and
• with improved diffusion of biomolecules, may require a smaller load of therapeutic cells to achieve the
desired therapeutic effect in comparison to standard microcapsules.
Sernova has also completed its announced $1,000,000 unsecured convertible debenture financing, with the
proceeds used to fund the Conformal Coating Technology acquisition. The debenture is repayable on
December 9, 2022, unless earlier converted or redeemed, and carries an 8% interest rate. The Company
also issued 3,000,000 non-transferable share purchase warrants, each warrant being exercisable into one
common share at a price of $0.20 per share up to December 9, 2022. The debenture holder will have the right
to convert the principal amount of the debenture into common shares of Sernova at a conversion price of
$0.25
per share. The debenture and warrants are subject to a four-month hold period under securities regulations.
Neither the debenture or warrants have been or will be registered under the United States Securities Act of
1933, as amended (the “U.S. Securities Act”), or any state securities laws and such securities may therefore
not be offered or sold in the United States or to or for the account or benefit of a person in the United States
or
a U.S. Person (as defined in Regulation S of the U.S. Securities Act) absent registration or an applicable
exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities
laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there
be any sale of the debenture units in any jurisdiction in which such offer, solicitation or sale would be unlawful.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The
device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers
for the transplantation and function of therapeutic cells, which then release proteins and hormones as
required
to treat disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and
efficacy in small and large animal models of diabetes and has been proven to provide a biologically
compatible environment for insulin-producing cells in humans.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell-derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies
of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FORWARD-LOOKING INFORMATION
This news release contains forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”,
“anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or
conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees
of
future performance, and actual results may differ materially from those in forward-looking statements.
While
Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to
significant
scientific, business, economic, competitive, market and social uncertainties and contingencies. Additionally,
there are known and unknown risk factors that could cause Sernova’s actual results, performance or
achievements to be materially different from any future results, performance or achievements expressed or
implied by the forward-looking statements contained in this press release.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the
date such statements were made, which include our beliefs about the effect on company operations and
capital markets of events related to the COVID-19 pandemic, the conduct and outcome of discussions with
strategic partners, and expected progress in preclinical programs, clinical trials and technology
development.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - August 04, 2020 4 August, 2020
Sernova Enters into Exclusive Worldwide License Agreement with University of Miami for Therapeutic Cell Immune Protection Technologies
Sernova expands its intellectual property portfolio and capabilities to develop first-in-class cell therapy
solutions for type 1 diabetes and other chronic diseases that eliminate the need for life-long
immunosuppression drugs
August 4, 2020 7:00 a.m. EDT
LONDON, ONTARIO – August 4, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage
regenerative medicine company developing a ‘functional cure’ for type 1 diabetes and other chronic diseases,
announced today it has entered into an exclusive, worldwide license with the University of Miami at Coral
Gables, Florida, for the commercial rights to novel conformal coating immune protection technologies. The
technologies were developed by Dr. Alice Tomei, Dr. Jeffrey Hubbell, and Aaron Stock (Graduate Student). Dr.
Tomei is a leading international expert in immunoprotection and diabetes immunoengineering, of the renowned
Diabetes Research Institute (DRI), a designated Center of Excellence at the University of Miami Miller School of
Medicine. Dr. Hubbell is the Eugene Bell Professor of Tissue Engineering at the University of Chicago and
leading international researcher in immunoengineering.
This exclusive worldwide license agreement is important to Sernova because it broadens the technology scope
of Sernova’s immune protection conformal coating technologies and related intellectual property. Furthermore,
it adds to a series of recent strategic acquisitions and collaborations for the Company and builds on our goal of
protecting Sernova’s therapeutic cells or tissues transplanted into Sernova’s Cell Pouch™ from a detrimental
auto-immune system response while eliminating the need for immunosuppressive drugs in treated patients.
“Sernova is further advancing development of its novel Cell Pouch System™ as a therapeutic platform to
provide cell therapy solutions to patients with chronic diseases, such as type 1 diabetes, without the current
need for life-long immunosuppressive drugs. We believe, with the addition of local immune protection, our
breakthrough technologies will have the potential to significantly expand access to and the availability of
therapeutic solutions to millions of people as a ‘functional cure’ for the chronic diseases from which they are
suffering,” said Dr. Philip Toleikis, President and CEO of Sernova Corp.
Dr. Toleikis continued, “As we continue to advance our first-in-class technologies, we have diligently selected
complementary technologies developed by recognized experts in the field such as those by Dr. Tomei and
colleagues to add to our Cell Pouch™ platform. With the continued expansion of our regenerative medicine
therapeutics platform, we are positioning the Company at the forefront in the development of safe, functional
regenerative medicine therapeutics.”
Dr. Alice Tomei, the Director of the Islet Immunoengineering Laboratory at DRI stated, “Following my
postdoctoral training in Dr. Hubbell’s laboratory at École Polytechnique Fédérale de Lausanne, Switzerland, I
joined the University of Miami where I have focussed my academic career in the pursuit and development of
novel cellular immune protection technologies to advance the field of cell therapy. With Sernova’s goal of a
‘functional cure’ for diabetes, supported by its positive preclinical and more recent, emerging clinical safety
and efficacy data from the University Chicago clinical trial, I am excited to contribute to the addition of local
immune protection technologies provided by conformal coatings as the next important step towards this
ultimate goal.”
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch™)
and immune protected therapeutic cells/tissues (i.e., human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH™ SYSTEM
The Cell Pouch™, as part of the Cell Pouch™ System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease. The Cell Pouch™, along with therapeutic cells, has been shown to provide long-term safety and
efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently
conducting a Phase I/II study at the University of Chicago.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp.
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the Company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the Company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the Company’s Cell Pouch System and/or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the Company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.

Dr. Philip M. Toleikis
President, CEO Président, Chef de la Direction
BA, MSc, PhD
Dr. Toleikis is currently President and Chief Executive Officer of Sernova Corp since April 2009. From 2006 until 2009, Dr. Toleikis consulted for multiple device, combination product and pharmaceutical companies. From 1996 to 2006 he held multiple roles at Angiotech Pharmaceuticals, Inc. including Vice President, Research and Development - Pharmacology and Drug Screening where he built a product development team of over 50 scientists and was responsible for multiple corporate and academic product development collaborations. M. Toleikis est actuellement président et chef de la direction de Sernova Corp depuis avril 2009. De 2006 à 2009, le Dr Toleikis a consulté plusieurs sociétés pharmaceutiques, produits combinés et produits à dispositifs multiples. De 1996 à 2006, il a occupé plusieurs postes chez Angiotech Pharmaceuticals, Inc., dont celui de vice-président, Recherche et développement - Pharmacologie et dépistage de drogues. Il a constitué une équipe de développement de produits composée de plus de 50 scientifiques et a collaboré à plusieurs
While at Sernova, Dr. Toleikis has secured over $20 million in various forms of financings, including equity raises and multiple non-dilutive grants and has been responsible for negotiating a worldwide exclusive license with UHN for its stem cell derived technologies as well as developing business relationships and or collaborations with multiple pharmaceutical and academic institutions involving its Cell Pouch™ device and cell technologies. Chez Sernova, M. Toleikis a obtenu plus de 20 millions de dollars de financements variés, y compris des levées de capitaux et de multiples subventions non dilutives, et a été responsable de la négociation d’une licence exclusive mondiale avec UHN pour ses technologies dérivées relations et / ou collaborations avec de nombreuses institutions pharmaceutiques et académiques impliquant son Cell Pouch ™ technologies des appareils et des cellules.
Dr. Toleikis is the author of multiple issued patents, over 110 patent applications, and multiple scientific publications involving transplantation, metabolic, cardiovascular, oncology, and autoimmune disease. He obtained his Ph.D. in Medicine, Pharmacology and Therapeutics from the University of British Columbia, his M.Sc. at the University of Michigan and B.A. at the University of Vermont. M. Toleikis est l'auteur de plusieurs brevets délivrés, de plus de 110 demandes de brevet et de nombreuses publications scientifiques sur la transplantation, les maladies métaboliques, cardiovasculaires, oncologiques et auto-immunes. Il a obtenu son doctorat en médecine, pharmacologie et thérapeutique de l'Université de la Colombie-Britannique, son M.Sc. à l'Université du Michigan et B.A. à l'Université du Vermont.
Among a number of volunteer activities he is a speaker at JDRF events, and a community member of UHP school council in London, Ontario. Parmi plusieurs activités de bénévolat, il est conférencier lors des événements de la FRDJ et membre communautaire du conseil scolaire UHP de London, en Ontario.

David Swetlow
Chief Financial Officer Directeur financier
David is a high tech and life sciences/biotech veteran with over 20 years in various senior management, board & advisory roles predominantly for start-up, acceleration, and high growth stage companies, including multiple companies listed on the TSX and Nasdaq such as QLT Inc., Protox Therapeutics Inc., and Xillix Technologies. David’s life sciences/biotech experience includes biopharmaceutical, medical device, and drug/device combination technologies and products. David est un vétéran de la haute technologie et des sciences de la vie et de la biotechnologie. Il compte plus de 20 ans d'expérience dans divers postes de direction, conseil et conseil, principalement pour des entreprises en phase de démarrage, d'accélération et à forte croissance, dont plusieurs sociétés cotées à la TSX et au Nasdaq, telles que QLT. Inc., Protox Therapeutics Inc. et Xillix Technologies. L’expérience de David dans le domaine des sciences de la vie et de la biotechnologie comprend des technologies et des produits biopharmaceutiques, des dispositifs médicaux et des combinaisons médicaments / dispositifs.
David holds a Bachelor of Business Administration degree from Simon Fraser University (SFU) and obtained his CA designation while at Deloitte. Entrepreneurial in nature, David has also started and run a few businesses of his own during his career. David est titulaire d'un baccalauréat en administration des affaires de l'Université Simon Fraser (SFU) et a obtenu son titre de CA chez Deloitte. De nature entrepreneuriale, David a également créé et dirigé quelques entreprises tout au long de sa carrière.
David currently sits on the Board of Directors for the Saskatchewan Science Center and is a member of its Finance, Audit & Risk Committee. Until recently, David served on the council of CMC-Saskatchewan, the provincial institute of CMC-Canada (the Canadian Association of Management Consultants), as Public Representative appointed and re-appointed for three-year terms by the Brad Wall led provincial government. David siège actuellement au conseil d'administration du Saskatchewan Science Centre et est membre de son comité des finances, de la vérification et des risques. Jusqu'à récemment, David a siégé au conseil de CMC-Saskatchewan, l'institut provincial de CMC-Canada (l'Association canadienne des conseillers en management), en tant que représentant du public nommé et renommé pour un mandat de trois ans par le gouvernement provincial dirigé par Brad Wall.
David was also previously a co-founding Director of TSX Venture company OMNItech Capital Corp. and served as Director and Audit Committee Chairman for successor companies One Person Health Sciences Inc and HealthPricer Interactive Ltd. David a également été cofondateur de OMNItech Capital Corp., société cotée à la Bourse de croissance TSX, et administrateur et président du comité d'audit pour les sociétés remplaçantes One Person Health Sciences Inc et HealthPricer Interactive Ltd.
As an active sports and outdoor enthusiast, David enjoys playing hockey, golf, skiing and outdoor-oriented activities. In the past, David also coached several boys and co-ed soccer teams and served in various executive capacities running a community-based soccer club. Passionné de sports et de plein air, David aime jouer au hockey, au golf, au ski et aux activités de plein air. Dans le passé, David a également entraîné plusieurs garçons et des équipes mixtes de football et a occupé divers postes de direction à la tête d'un club de football communautaire.

Delfina Siroen
Senior Director Research and Development Directeur principal Recherche et développemente
Delfina has over 25+ years of expertise in senior management roles in Research and Development, Clinical, Regulatory and Product Development with extensive working expertise in biochemistry, cell and molecular biology, immunology, animal model development, and surgery with product development experience in regenerative medicine combination products involving therapeutic cells and implantable devices. Delfina possède plus de 25 ans d'expertise dans des postes de direction en recherche et développement, clinique, réglementaire et développement de produits avec une vaste expérience de travail en biochimie, biologie cellulaire et moléculaire, immunologie, développement de modèles animaux et chirurgie avec une expérience de développement de produits en médecine régénérative produits combinés impliquant des cellules thérapeutiques et des dispositifs implantables.
Delfina holds a graduate degree from the University of Western Ontario and has been affiliated with Lawson Health Research Institute, Children’s Health Research Institute, Victoria Research Laboratories, London Health Science Centre and Robart’s Research Institute in the Departments of Biochemistry, Paediatrics, Surgery and Microbiology, Immunology and Virology. Delfina est titulaire d'un diplôme d'études supérieures de l'Université Western Ontario et est affiliée au Lawson Health Research Institute, au Children's Health Research Institute, au Victoria Research Laboratories, au London Health Science Centre et au Robart's Research Institute dans les départements de biochimie, de pédiatrie, de chirurgie et de microbiologie, Immunologie et virologie.
At Sernova, Delfina has overseen the manufacturing and development of the Cell Pouch System along with the clinical trials of Sernova’s Cell Pouch. Throughout her career, she is responsible for multiple patent applications and patents as well as scientific peer-reviewed publications as an author and co-author. Chez Sernova, Delfina a supervisé la fabrication et le développement du Cell Pouch System ainsi que les essais cliniques de Sernova's Cell Pouch. Tout au long de sa carrière, elle est responsable de plusieurs demandes de brevet et brevets ainsi que de publications scientifiques évaluées par des pairs en tant qu'auteur et co-auteur.
Passionate about helping her neighbour and the community, Delfina volunteers with several groups, including being a Chief Scientific Judge in Life Sciences for the Thames Valley District Science Fair, Urban League of London and is a member of the Board for the Northwest London Medway Working Group. Passionnée d'aider son voisin et la communauté, Delfina fait du bénévolat auprès de plusieurs groupes, notamment en tant que juge scientifique en chef des sciences de la vie pour la Thames Valley District Science Fair, Urban League of London et membre du conseil d'administration du Northwest London Medway Working Group. .

Jeffrey Bacha
Director - Board of Directors Directeur - Conseil d'administration
BSc, MBA
Jeffrey A. Bacha, BSc, MBA co-founded DelMar Pharmaceuticals in 2010 and led the company’s growth through its listing on NASDAQ in 2016 and currently serves as a member of the company's board of directors. Previously he served as the Chief Executive Officer and Chairman of the Company prior to recruiting both a seasoned independent Chair and interim Chief Executive to join the DelMar Pharmaceuticals leadership team. He is a seasoned executive leader with 20 years of life sciences experience in the areas of operations, strategy and finance for biotechnology, pharmaceutical and medical device companies in Canada, the United States and Europe. His experiences include successful public and private company building from both a start-up and turn around perspective; establishing and leading thriving management and technical teams; and raising capital in both the public and private markets. Jeffrey A. Bacha, B.Sc., MBA, a cofondé DelMar Pharmaceuticals en 2010 et a dirigé la croissance de la société grâce à son introduction au NASDAQ en 2016 et est actuellement membre du conseil d’administration de la société. Auparavant, il a été chef de la direction et président de la société avant de recruter à la fois un président indépendant et un chef de la direction par intérim pour se joindre à l'équipe de direction de DelMar Pharmaceuticals. Il est un dirigeant chevronné possédant 20 ans d’expérience en sciences de la vie dans les domaines des opérations, de la stratégie et des finances pour des sociétés de biotechnologie, pharmaceutiques et de dispositifs médicaux au Canada, aux États-Unis et en Europe. Parmi ses expériences, citons le développement réussi d'entreprises publiques et privées, à la fois dans une perspective de démarrage et de redressement; établir et diriger des équipes techniques et de gestion prospères; et lever des capitaux sur les marchés publics et privés.
From 2002 through 2005 Mr. Bacha served as President and Founding CEO of Inimex Pharmaceuticals, where he was responsible for establishing the company’s research &development team and leading venture capital financing and grant funding efforts which raised more than $35 million to support the company’s research programs. De 2002 à 2005, M. Bacha a été président et PDG fondateur d'Inimex Pharmaceuticals, où il était responsable de la mise en place de l'équipe de recherche et développement et des efforts de financement de capital-risque et de financement. .
Since 2005 until founding Del Mar Pharmaceuticals, Mr. Bacha has consulted with a number of life sciences companies and served as Executive Vice President, Corporate Affairs and Chief Operating Officer of Clera Inc. He holds an MBA from the Goizueta Business School at Emory University and a degree in BioPhysics from the University of California, San Diego. Depuis 2005 et jusqu'à la fondation de Del Mar Pharmaceuticals, M. Bacha a consulté de nombreuses entreprises du secteur des sciences de la vie et a été vice-président exécutif, affaires générales et chef de l'exploitation de Clera Inc. Il est titulaire d'un MBA de la Goizueta Business School un diplôme en bio-physique de l'Université de Californie à San Diego.

James Parsons
Director - Board of Directors
Directeur - Conseil d'administration
Mr. Parsons is currently Chief Financial Officer of Trillium Therapeutics Inc. since August 2011. From 2010 to May 2013 he was Vice President Finance and Corporate Secretary at DiaMedica Therapeutics Inc. M. Parsons est actuellement chef des finances de Trillium Therapeutics Inc. depuis août 2011. De 2010 à mai 2013, il a été vice-président, finances et secrétaire général chez DiaMedica Therapeutics Inc.
Mr. Parsons has a broad background in the life sciences industry across therapeutics, diagnostics and device companies and over 25 years of financial management experience. Mr. Parsons has secured over $300 million of various forms of financing during his career and has advised and assisted on over $200 million of product licensing deals. M. Parsons a une vaste expérience dans l’industrie des sciences de la vie dans le secteur des produits thérapeutiques, des diagnostics et des appareils, et plus de 25 années d’expérience en gestion financière. M. Parsons a obtenu plus de 300 millions de dollars de diverses formes de financement au cours de sa carrière et a conseillé et aidé plus de 200 millions de dollars en contrats de licence de produits.
Mr. Parsons also serves on the board of directors of DiaMedica Therapeutics Inc. He has extensive experience in public company governance and compliance. He has a Master of Accounting degree from the University of Waterloo and is a Chartered Professional Accountant and Chartered Accountant. M. Parsons siège également au conseil d'administration de DiaMedica Therapeutics Inc. Il possède une vaste expérience en matière de gouvernance et de conformité des sociétés ouvertes. Il est titulaire d'une maîtrise en comptabilité de l'Université de Waterloo et est comptable professionnel agréé et comptable agréé.

Deborah Brown
Director - Board of Directors Directeur - Conseil d'administration
Deborah M. Brown is currently Managing Partner at Accelera Canada Ltd. Ms. Brown has extensive leadership experience with more than 20 years in senior management roles. She served as President of EMD Serono, a division of Merck KGaA, Executive Vice President at Serono US, General Manager, Director of Marketing, and Business Unit Director at Serono Canada and Manager, International Regulatory at Pasteur Merieux Connaught. Ms. Brown is a former Board Chair of Rx&D and former board member of BIOTECanada. Ms. Brown holds an MBA from Ivey School of Business. She sits on the board of several corporate and not-for-profit organizations, including Life Sciences Ontario and the Hamilton/Burlington SPCA. Deborah M. Brown est actuellement associée directrice chez Accelera Canada Ltd. Mme Brown possède une vaste expérience en leadership avec plus de 20 ans dans des rôles de direction. Elle a été présidente d'EMD Serono, une division de Merck KGaA, vice-présidente exécutive de Serono US, directrice générale, directrice du marketing et directrice de l'unité commerciale de Serono Canada et directrice, réglementation internationale de Pasteur Merieux Connaught. Mme Brown a été présidente du conseil d'administration de Rx & D et ancienne membre du conseil d'administration de BIOTECanada. Mme Brown est titulaire d'un MBA de la Ivey School of Business. Elle siège au conseil d'administration de plusieurs entreprises et organisations à but non lucratif, notamment Life Sciences Ontario et la SPCA de Hamilton / Burlington.

Frank Holler
Director and Chairman - Board of Directors Président du conseil d’administration
Mr. Holler is currently President &CEO of Ponderosa Capital Inc. Mr. Holler previously served as Chairman &CEO of BC Advantage Funds (VCC) Ltd., a venture capital firm investing in emerging technology companies in British Columbia, from 2004 to 2016; President and CEO of Xenon Pharmaceuticals Inc., a NASDAQ listed, genomics-based drug development company, from 1999 to 2003; President and CEO of ID Biomedical Corporation, a TSX/Nasdaq vaccine development company, from 1991 to 1998; and a founding director of Angiotech Pharmaceuticals, a TSX/ NASDAQ listed biotechnology company, from 1992 to 1997. M. Holler est actuellement président et chef de la direction de Ponderosa Capital Inc. M. Holler a déjà été président du conseil et chef de la direction de BC Advantage Funds (VCC) Ltd., une société de capital de risque investissant dans des sociétés Président et chef de la direction de Xenon Pharmaceuticals Inc., une société de développement de médicaments génomique cotée au NASDAQ, de 1999 à 2003; Président et chef de la direction de ID Biomedical Corporation, société de développement de vaccins TSX / Nasdaq, de 1991 à 1998; et administrateur fondateur d'Angiotech Pharmaceuticals, une société de biotechnologie cotée à la Bourse de Toronto / NASDAQ, de 1992 à 1997.
Prior to working in biotechnology and healthcare, Mr. Holler was a Vice-President of Investment Banking with Merrill Lynch Canada and Wood Gundy Inc. (now CIBC World Markets). In addition to serving on the Corporation’s Board, Mr. Holler presently serves on the board of directors of Xenon Pharmaceuticals and the Prevention of Organ Failure Centre at St. Pauls’s Hospital (Chairman). Avant de travailler dans le domaine de la biotechnologie et des soins de santé, M. Holler était vice-président des services bancaires d'investissement chez Merrill Lynch Canada et Wood Gundy Inc. (maintenant Marchés mondiaux CIBC). En plus de siéger au conseil d’administration de la société, M. Holler siège actuellement au conseil d’administration de Xenon Pharmaceuticals et du centre de prévention des défaillances des organes de l’hôpital St. Pauls (président).
Mr. Holler was previously a Director of the British Columbia Biotechnology Association from 1992 to 1998, and in 2003 received the BC Biotech Award for Vision and Leadership. He holds an MBA and BA (Economics) from the University of British Columbia. M. Holler était auparavant directeur de la British Columbia Biotechnology Association de 1992 à 1998 et, en 2003, il a reçu le prix BC Biotech pour sa vision et son leadership. Il est titulaire d'un MBA et d'un baccalauréat en économie de l'Université de la Colombie-Britannique.
Privacy PolicyPolitique de confidentialité
Updated July 6, 2018
Please read this Policy carefully along with our Legal Notice that describes our Terms of Use for the Website.
By accessing www.sernova.com (the “Website”) you hereby agree with the practices described in this Privacy Policy (the “Policy”)
This Policy applies to all information gathered through the Website and/or any related marketing technique or events.
Information Collection
The information collected is limited to the information that you decide to share with us through the News Dispatch Service, when participating at event or activities or in the general course of business by expressing an interest in obtaining information about Sernova Corp. and our products, such as name, email, phone number, and similar contact information. This information is stored through MailChimp (please refer to MailChimp Privacy Policy at https://mailchimp.com/legal/privacy/).
Information Sharing
Sernova Corp. is the sole owner of any information collected on the Website. We do not sell, share or rent this information to others.
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Sernova Corp. maintains log files of the traffic on www.sernova.com. This information is not linked to any personal information that you have provided us. Logs are used to manage traffic, identify content accessed, and IT requirements. Information logged and automatically collected includes without being limited to IP addresses and browser types. This information does not reveal your specific identity.
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Updates
This Policy is a living document and may be amended or updated from time to time without further notice. We encourage you to review the Policy periodically.
Contact
If you have any questions or comments about our policy, you can email us at info@sernova.com or by phone at 1(877) 299-4603 or by mail at
Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8
Mis à jour le 6 juillet 2018
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En accédant à www.sernova.com (le «site Web»), vous acceptez les pratiques décrites dans la présente politique de confidentialité (la «politique»).
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Mises à jour
Cette politique est un document évolutif et peut être modifié ou mis à jour de temps à autre sans préavis. Nous vous encourageons à consulter la politique périodiquement.
Contact
Si vous avez des questions ou des commentaires sur notre politique, vous pouvez nous envoyer un courriel à info@sernova.com ou par téléphone au 1 (877) 299-4603 ou par courrier à
Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8