Press release Communiqué de presse
Press release Communiqué de presse
February 12, 2002 12 February, 2002
Pheromone Sciences Corp Reports Positive Trial Results on Fertility Monitor
Pheromone Sciences Corp (CDNX: PHS), is
announce that it has received positive results
from its PSC
Fertility MonitorÃ?Â¢Ã¯Â¿Â½Ã?Â¢ U.S.
The trial, which enrolled 105 subjects, was carried out at Duke University, Durham, N.C., under the direction of Dr. A. Haney Professor of Obstetrics and Gynecology of Duke University and Dr. Stephen Corson Professor, Obstetrics and Gynecology at The Women's Institute of Fertility, Sterility and Menopause, Thomas Jefferson University Medical School in Philadelphia. Results showed that 73% of the ovulatory women had their ovulation date correctly predicted to within +/-2 days of the ovulation date determined by blood serum levels. These results are consistent with those previously reported (76%) from a pilot study conducted at Toronto General Hospital under the direction of Dr. Robert Casper, Professor and Head of Reproductive Sciences at the University of Toronto.
As expected, due to the product's non-invasive nature, no safety or side effects issues were reported throughout the trial.
Based on these results, the Company will, within 30 days, file a 510K submission to the FDA for marketing approval of the Fertility Monitor in the United States.
It is well recognized by the medical community that conception occurs when sexual intercourse occurs within a 6 day period starting approximately four to five days before ovulation. The PSC Fertility Monitor confirmed its unique ability to predict a women's fertility window. Discreetly housed within a wristwatch-like device that is worn during sleeping hours, the PSC Fertility Monitor offers women an easy to use, non-invasive means of obtaining advance notice of their fertility window.
"Based upon the data analysis of the patients who completed the trial, the PSC Fertility Monitor detected more days of the conception window (the days when sexual intercourse can lead to a pregnancy) than the LH test strip product. This determination, coupled with the published literature on the chances of conception during this window (Wilcox, New England Journal of Medicine), strongly suggests that women who use the PSC Fertility Monitor as a means of identifying their fertile window to time intercourse, can expect a substantially higher probability of conception or a substantially shorter time to pregnancy than if they relied solely on home based LH test kits as a means to time intercourse," said Dr. A. Haney, Professor of Obstetrics and Gynecology of Duke University. "This is based upon the PSC Fertility Monitor's unique ability to identify the 6 day fertility window with up to a four day advance notice of the predicted ovulation day. For women who are seeking to become pregnant, the PSC Fertility Monitor would seem to offer some unique advantages in helping these women to discover their entire fertility window."
As a non-invasive device designed for in-home testing to identify the complete fertility window without the inconvenient and unpleasant use of urine or blood samples, the PSC Fertility Monitor offers a new level of convenience, ease of use and the knowledge that the entire fertility window is now easily identified," said Dr. Stephen Corson, Professor, Obstetrics and Gynecology at The Women's Institute of Fertility, Sterility and Menopause, Thomas Jefferson University Medical School in Philadelphia.
"Providing the ability to utilize more of the fertility window is an element that will aid women wishing to conceive", said Christopher Neuman, President and Chief Executive Officer of Pheromone Sciences. "Combining advance notice along with convenience and ease of use, make this a product we believe women will embrace".
Pheromone Sciences Corp. is a biotechnology and medical diagnostics device research and development company that focuses on commercializing technologies in the field of human reproduction and sexuality.
Statements contained in this press release, including those pertaining to scientific and clinical research, commercialization plans, strategic alliances, and intellectual property protection, other than statements of historical fact, are forward-looking statements subject to a number of uncertainties that could cause actual results to differ materially from statements made. The Canadian Venture Exchange has not reviewed and does not accept responsibility for the adequacy or the contents of this news release.
Lorne Woods 1-(800) 937-3095 email@example.com www.pheromonesciences.com