OCON Medical Ltd., an Israeli start-up company engaged in the development of an advanced intrauterine device, announced that it has commenced the human clinical stage of the contraceptive intrauterine device that it has developed - the IUB™ (Intra Uterine Ball), a technological breakthrough in the contraceptives market.
The IUB™ SCu300A, the first product developed by OCON Medical, has been inserted in ten women in Europe to date and is due to be inserted in additional women. Interim results of the clinical trial are encouraging with the participating women reporting high satisfaction with the product.
The IUB™ is meant to reduce common side effects of IUDs like menorrhagia and discomfort as well as reducing the risks incurred during insertion. In contrast with current IUDs, the IUB™ is a three dimensional device that is formed to be fully compatible with the uterine cavity. The IUB™'s unique profile will enable it to serve other functions and indications in women's health beside contraception such as a drug eluting platform. The technology of the product is based on shape memory alloy used widely for various medical devices such as coronary artery stents.
IUD's have become the most common means of reversible contraception in the world, with more than 185 million users, an estimated market of over $1.6 billion a year and strong growth. A recent opinion published by the United States Food and Drug Administration (FDA) includes a recommendation to use IUDs for contraception by nulliparous women, including teenagers, in addition to childbearing women.
OCON Medical's CEO Ariel Weinstein commented: "Answering an unmet need, the IUB™ is great news for any woman seeking a safe and comfortable contraceptive solution that does not involve highly deterring hormones, a combination that has not existed until now. We expect to gain substantial market share from copper and hormone eluting IUDs."
As a breakthrough in its field, the IUB™ is expected to draw renewed attention to IUDs by women and should contribute to expanding the IUD use. Several recent medical publications, including in the New England Journal of Medicine cite the superiority of IUDs in terms of effectiveness (20 times more effective in pregnancy prevention than contraceptive pills for young women), and lower cost compared with other reversible contraceptive methods such as the pill, condoms, etc.
OCON Medical's product has attracted strong interest in the market and is involved in discussions with several corporations. For the last several months the company has been in negotiations with several strategic partners in order to support its market entry phase. The company is in process of obtaining a CE mark which will enable it to initiate IUB™ sales by mid-2013 and further support its merits through post-marketing studies.
OCON Medical (http://www.oconmed.com) was founded in March 2011 by Dr. Ilan Baram with the support of Docor International BV and the Office of the Chief Scientist of Israel through Van Leer Technology Ventures, Jerusalem. Dr. Baram, a senior gynecologist and the inventor of the IUB™ has more than 16 years experience in women's health. He is one of the most experienced clinicians in intrauterine devices in Israel.
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SOURCE OCON Medical Ltd