Endogun device gets EU CE Mark approval

The FDA approved the company’s Endofast Reliant soft tissue fastener in September 2006.

Meytav Technological Enterprises Innovation Center Ltd. portfolio company Endogun Medical Systems Ltd. has obtained EU CE Mark approval to market its Endofast Reliant device for closing and securing internal tissue during surgery. Endofast Reliant is designed for use in pelvic floor reconstruction in women and to treat stress urinary incontinence.

Endogun already obtained US Food and Drug Administration (FDA) approval for the Endofast Reliant in September 2006. In contrast to FDA approval for pharmaceuticals, which generally guarantee sales, in the case of medical devices, sales of an approved device usually require marketing support and additional clinical trials. Obtaining CE Mark certification should make it easier for Endogun to conduct clinical trials, which will lead to initial sales in Europe.

Endogun planned to hold an IPO on the Tel Aviv Stock Exchange (TASE), but withdrew its prospectus, saying that private investors were interested in investing in the company. The company added that it hoped to recruit a partner for further development of the Endofast Reliant once the clinical trials had been completed.

Endogun was founded by in 2004, by Dr. Adrian Paz, a urologist and head of the laparoscopy department at Barzilai Medical Center in Ashkelon. The company’s technology can fasten soft tissue using a special spider web-like fastener inserted into the body via minimally-invasive means.

Published by Globes [online], Israel business news - www.globes.co.il - on August 1, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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