Forconti Medical Ltd.

Forconti Medical develops and produces disposable medical devices for Fecal Incontinence treatment. Contix™ our flagship product, is a novel disposable device, that provides a superior alternative to adult diapers and other existing products in the market today. Our CE mark products compete in a huge and rapidly growing market. The company has recently performed a successful pilot clinical trial at the Shaarey Zedek Medical Center in Israel and is now continuing the study at another clinical site in Israel (Sheba Medical Center at Tel Hashomer). A pre-submission meeting has been held with the FDA and the FDA has designated the 510(k) de-novo regulatory path. The products are protected by a US and Israeli patent issued in 2016 and pending in Europe. Currently only few medical devices are marketed for helping to control ABL. However, these devices have limited success. Local treatments such as injection of bulking agents and anal electrical stimulation demonstrate varying degrees of effectiveness in clinical studies. Devices such as anal plugs have shown some effectiveness but as their use is associated with discomfort and pain patients may prefer not to use them. Devices positioned below the Dentate/Pectinate line are liable to cause considerable pain and discomfort to the user during insertion, use and removal as this part of the anal canal is highly sensitive. The built-in advantage of the ForConti FIMS is that it is designed to be located higher in the anal canal, ie, above the dentate line, which is a much less sensitive area of the rectum.