Ocon Medical, an Israeli start-up company, has begun the human clinical stage of the contraceptive intrauterine device, called IUB (intra uterine ball).
The IUB SCu300A has so far been inserted in ten women in Europe and is due to be used in additional women. According to the company, interim results of the clinical trial are encouraging with the participating women reporting high satisfaction with the product.
The IUB is designed to reduce common side effects of IUDs such as menorrhagia and discomfort as well as reducing the risks incurred during insertion. In contrast with current IUDs, the IUB is a 3D device that is formed to be fully compatible with the uterine cavity. the company says its 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.
For the last several months, Ocon 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 it expects will enable the start of IUB sales by mid-2013.