Ocon IUB Intra Uterine Ball Contraceptive Device Going to Clinical Trials (video)

Ocon IUB Intra Uterine Ball Contraceptive Device Going to Clinical Trials (video)

The IUB™ is the first and only three dimensional spherical IUD. It is also the only IUD that takes full advantage of shape memory alloys (SMA), a group of metals that have unique elastic characteristics. The use of SMA allows the IUB™ to better adapt to the uterine cavity. It also has the capability to reduce complications that are every so often encountered with IUD use.

When deployed into the uterine cavity, the IUB™ turns away from the fundus, maintains a diameter larger than the cervical canal and has superior flexibility and minimal tissue protrusion compared to current devices. These characteristics are expected to reduce the rate of complications and side effects.

In addition to these benefits, no special clinician training is required to start using the IUB™. The IUB™ shares the same indications with current IUDs and is positioned to be highly competitive with quality IUDs.

The IUB™ is a platform that will be used to create a line of products. The copper SCu300A IUB™ will be first introduced. Additional products in development are the SCu380A IUB™ as well as drug and hormone eluting versions of the IUB™.

Ocon Medical Ltd. has begun human clinical trials of its new contraceptive intrauterine device (IUD) – the IUB (Intra Uterine Ball), a technological breakthrough in the contraceptives market. It is based on a shape memory alloy used widely for various medical devices, such as coronary artery stents.

The IUB 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. its unique profile will enable it to serve other functions and indications in women’s health beside contraception, such as a drug eluting platform.

Dr. Ilan Baram, a senior gynecologist, founded Ocon Medical in 2011, with the support of the Office of the Chief Scientist and Docor International Management Ltd. through Van Leer Ventures Jerusalem Ltd.

Ocon Medical CEO Ariel Weinstein said, “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.”

Ocon Medical says that 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 US Food and Drug Administration (FDA) includes a recommendation to use IUDs for contraception by nulliparous women, including teenagers, in addition to childbearing women. The company expects the IUB 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 and condoms.

Published by Globes [online], Israel business news – www.globes-online.com – on July 31, 2012

Source : http://www.globes.co.il/serveen/globes/docview.asp?did=1000770611&fid=1725

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  • Karl Kurz, MD scientist, gynec

    The round spherical IUB is a slider and has already shown high expulsion rates up to ~20% within a half year in a clinical trial and in the use by women e.g. in Austria..A gynecologist offers the costfree replacement by IUDs with proven low expulsion rates. The device irritates the anterior posterior muscle wall thus irritates the extension receptors causing pressures up to 200 mm Hg. The non pregnant uterus has a two dimensional cavity, is very sensible at certain time of the menstrual cycle due also to steroidal hormones like estrogen and prostaglandins.

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