SafeStitch Medical's AMID Stapler receives European CE Mark

Feb 10 2010

SafeStitch Medical, Inc. (OTCBB: SFES) announced today that it has received CE Mark authorization to commercialize its AMID Stapler^TM in the European Economic Community. The new stapler is to be used for fixation of mesh in the repair of hernia defects and also for the approximation of tissues, including skin. The AMID Stapler™ is the first surgical stapler designed specifically for use in inguinal hernia repairs using the Lichtenstein method, in which mesh is implanted for reinforcement. SafeStitch announced in November 2009 that it had received 510(k) clearance from the Food and Drug Administration for sale of the AMID Stapler^TM in the U.S. market.

“The AMID StaplerTM is angled for safety and better visibility and its patented mesh manipulators permit easy and safe mesh placement. Its 17 box–shaped, sharp-tipped titanium staples are designed specifically for this repair”

SafeStitch designed the stapler in collaboration with Dr. Parviz Amid, a pioneer of and renowned expert in the Lichtenstein repair. Dr. Charles J. Filipi, SafeStitch’s Medical Director and former President of the American Hernia Society, noted that “approximately one million hernia repairs are performed in the U.S. each year and the Lichtenstein repair is used in as many as 70% of inguinal hernia repairs worldwide. Based on clinical experience to date, we believe the AMID Stapler^TM will make the Lichtenstein repair faster and more attractive to surgeons presently affixing mesh and closing incisions with sutures.”

“The AMID Stapler^TM is angled for safety and better visibility and its patented mesh manipulators permit easy and safe mesh placement. Its 17 box–shaped, sharp-tipped titanium staples are designed specifically for this repair,” explained Dr. Stewart Davis, SafeStitch’s COO.

Jeffrey Spragens, SafeStitch’s President and CEO, noted that, “this CE Mark and FDA clearance marks the completion of the development phase for SafeStitch’s first four products: the SMART Dilator^TM, Standard BiteBlock, Airway BiteBlock and the AMID Stapler^TM. We continue our commercialization efforts for these products, starting with the launch of the AMID Stapler^TM. Our product development efforts are now fully focused on SafeStitch’s minimally invasive gastroplasty devices for obesity and GERD procedures. We have successfully completed our pre-clinical laboratory studies with these gastroplasty devices, and are preparing IDE applications for FDA clearance to conduct multicenter clinical trials.”