Innocoll Inc. has announced the approval of CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. The product will be launched this year through a network of distribution partnerships. The company also plans to seek approval in a number of additional territories, including Australia, Canada, the MENA region, South East Asia, and to initiate the studies required for registration in the US.
Dr. Michael Myers, President and CEO commented “EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm™ technology and we are on track to launch this year. With Cogenzia® ready to start Phase 3 testing and following the recent announcement of positive XaraColl® Phase 2 clinical data coupled with US/EU approval of a broad range of advanced woundcare products, Innocoll is assembling an exciting portfolio of late stage assets. We look forward to further positive developments for our products and technologies throughout 2012 and beyond.”
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen that has been developed using Innocoll’s proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. CollaGUARD is implanted at the time of surgery and serves as a temporary barrier to separate apposing adhesiogenic surfaces throughout the normal tissue repair process. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
Source: Innocoll
published: October 21, 2011 in: Approval/Clearance, General Surgery, Gynaecology/Obstetrics, Launches / Withdrawals, Regulatory