Innocoll Announces European Approval for CollaGUARD®, Surgical Adhesion Barrier
ASHBURN, Va., Oct. 11, 2011 /PRNewswire/ -- Innocoll, Inc. announces 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."
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.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPressTM and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
SOURCE Innocoll, Inc.
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