OCON Medical's Scientific Advisory Board to Feature the Industry's Foremost Opinion Leaders
Modiin, Israel – OCON Medical has recently completed the founding of its scientific advisory board (SAB) which includes the world's leading experts and opinion leaders in the field of contraception. Following are details on each of the newly appointed members:
Prof. James Trussell - One of the world's foremost experts on family planning with particular expertise in contraceptive effectiveness and cost effectiveness. He is Professor of Economics and Public Affairs and Faculty Associate at the Office of Population Research at Princeton University as well as a visiting Professor at The Hull York Medical School with over 300 published peer reviewed papers and numerous professional affiliations.
David Hubacher, Ph.D. - A world renowned expert and key opinion leader on contraceptive methods and IUDs in particular, Dr. Hubacher serves as a senior scientist at Family Health International (FHI360). He has over 25 years research experience, authored dozens of key peer reviewed publications and speaks at conferences worldwide. He received his M.P.H. in Biostatistics and his Ph.D. in Epidemiology from UNC Chapel Hill.
Amos Ber, MD – A senior Ob/Gyn, Dr. Ber has authored over 40 peer reviewed papers and has extensive experience with hormonal IUDs, lecturing on their use globally. He is on the Board of the Israeli Society of Contraception and Sexual Health, Israeli Society of Menopause and the European society of contraception and reproductive health (ESC). Dr. Ber graduated from the Sackler faculty of medicine at the Tel Aviv University.
Valerie Tarico, Ph.D. – Dr. Tarico is deeply involved in reproductive rights and improving access to top tier contraceptives. She serves on the Board of Advocates for Youth, a D.C. based nonprofit with programs related to reproductive health and serves on Planned Parenthood's Board of Advocates. Her articles appear on sites including the Huffington Post and the Institute for Ethics and Emerging Technologies.
"The joining of such world renowned experts to our advisory board serves as a vote of confidence in the company and its technology and further supports us in achieving our goals" said Ariel Weinstein, OCON Medical's CEO. Weinstein added that "Apart for our advisor's valuable input they are all admirably active in endorsing our innovation through their activities in promoting women's health".
The company is currently in the clinical phase of its two copper intrauterine device products and is in development of a hormonal based IUD. A therapeutic product based on its proprietary technology is also in development with additional pipeline products due to enter the development phase in the upcoming year.
OCON Medical was established in early 2011 by Dr. Ilan Baram, MD and is dedicated to women's health innovation. The company has developed a proprietary intrauterine platform which is an ideal carrier for multiple substances. The company is in the clinical phase of its initial products that are expected to reach the market in 2014 and is actively developing pipeline products for additional indications.
North American Clinical Trial of the IUB™ SCu380A Intrauterine Contraceptive Device Initiated With Positive Initial Results
Modiin, Israel – OCON Medical is pleased to announce the initiation of its North American clinical trial.
The trial evaluates early expulsion rates of the IUB™ SCu380A. The SCu380A is OCON's second product intended for long term reversible contraception, similar to the SCu300A which differs mostly in its copper surface area.
The trial site is highly skilled with intrauterine device (IUD) clinical work and has over thirty years of IUD insertion experience, currently inserting over 2,500 IUDs of various types each year. Located in Vancouver, Canada the site is expected to recruit 50 women over the next several weeks. So far recruitment rate has been remarkable with over a dozen women expected to be inserted the SCu380A by the end of this month.
Reactions to the insertion procedure were highly positive. Site Investigator Dr. Ellen Wiebe, MD noted the ease of insertion and was quoted as mentioning "I love the IUBs. I found the insertions easier than with any other IUD…our initial nine patients left after 10 minutes saying they felt fine. Usually, out of any nine women, we would have had one or two lying around with a heating pad on her belly for half an hour." Post-insertion ultrasound visualization of the IUB™ was straightforward with the device clearly showing to maintain its three-dimensional structure.
The trial is closely followed by OCON's Medical Director and IUB™ inventor Dr. Ilan Baram, MD who provided on-site support for the insertion procedure of the initial group of women. Dr. Baram noted that "the women found the IUB shape appealing in the sense of it being less intimidating than current IUDs. Some actually came in to have their regular IUDs replaced with the IUB."
The trial will examine expulsion rates after two months and will continue following women over a period of twelve months, gathering other vital data along the way. OCON's strategy calls for gathering clinical evidence to underline the IUB™'s advantages over current IUDs especially with respect to its safety profile and quality of life attributes. To accomplish this OCON is initiating additional multinational clinical trials over the next several months.
OCON Medical was established in early 2011 and is dedicated to women's health innovation. The company has developed a proprietary intrauterine platform which is an ideal carrier for multiple substances and indications. The company is in the clinical phase of its initial products that are expected to reach the market in 2014 and is actively developing pipeline products for additional indications.
OCON Medical's IUB™ SCu300A Novel Copper IUD Gains CE Approval
Modiin, Israel – OCON Medical is pleased to announce that the CE mark has been granted to its IUB™ SCu300A copper intrauterine device (IUD), the first of a line of developed products. The grant concludes an extensive and demanding CE Class III regulatory approval process.
The IUB™ SCu300A is based on the company's innovative spherical intrauterine platform and is intended for long term reversible female contraception. Its effective lifetime is 5 years though it may be removed at any time if return to fertility is desired. The product is intended to lessen the risks involved with current IUDs, particularly uterine perforation during insertion as well as malposition and expulsion while reducing discomfort and bleeding irregularities that often affect copper IUD users.
With the CE approval marketing of the IUB™ SCu300A can be freely conducted in over 30 countries including all European Union member states. OCON plans to initiate marketing of the IUB™ SCu300A in several key markets in the upcoming months and is currently in final stages of entry into its initial European territory.
The CE mark grant follows OCON's ISO 13485 certification obtained earlier this year, marking the company's advancement into a growth phase and allowing it to become the first to achieve this position in the IUD field since the early 1990's. “Over the last three years we have traveled an unbeaten path and gained an immense body of knowledge which is all packed into this exceptional product” said Ariel Weinstein, OCON's CEO. He added that "we are excited to be one of the few who have made such an achievement and are honored to be a pioneer in women's health and offer this long awaited solution".
Side by side with its marketing activities OCON shall continue to conduct and initiate clinical trials of the IUB™ SCu300A that are intended to support the anticipated added safety and quality of life features. A major comparative study of the product is currently underway in Europe with over 300 participants. The device is currently not approved for sale in the U.S. however additional studies are planned in Europe and the US that will also serve to support an FDA clearance.
OCON Medical was established in early 2011 by Ilan Baram, MD, a senior gynecologist, and is dedicated to women's health innovation. The company has developed the IUB™ - Intrauterine Ball, a proprietary intrauterine platform made of a super-elastic alloy which is an ideal carrier for multiple substances and indications. The company is actively developing pipeline products for additional indications and is currently engaged in securing series B financing that will support its continued growth.