Cohera Medical, Inc.®, a rapidly growing medical device company, announced today that it has received CE Mark approval for its lead product, TissuGlu® Surgical Adhesive. CE Mark approval allows TissuGlu to be sold in the European Union.
TissuGlu is an internal surgical adhesive for large flap surgeries, such as abdominoplasties, that helps reduce fluid accumulation and the need for postsurgical drains. Its unique chemical composition is resorbable, non-toxic, forms a strong bond between tissue layers and allows for natural healing, which ultimately may provide the patient with a quicker return to normal activity.
"TissuGlu Surgical Adhesive provides an innovative approach to the way plastic surgeons address wound drainage challenges and helps plastic surgeons improve the overall care of their patients," said Dr. Peter Rubin, Chief, Division of Plastic and Reconstructive Surgery at the University of Pittsburgh Medical Center. "Surgeons will be eager to apply this product to their procedures, which we believe will ultimately save them time and money through the reduction of post-surgical complications and additional OR time."
TissuGlu will be commercially available in Germany in the third quarter of 2011. Cohera Medical is also actively pursuing U.S. FDA approval.
"CE Mark approval moves Cohera from an early-stage company to a commercial entity," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "We look forward to beginning our commercialization in Germany, a strategic market, which we believe will demonstrate commercial viability for TissuGlu Surgical Adhesive and serve as a springboard for expansion across the EU and to other important markets, including the US."
According to the American Society of Plastic Surgeons, the global market for cosmetic surgery and treatments now exceeds $30 billion, with a sustainable compound annual growth rate in the range of 25%. In Europe, the market for cosmetic surgery is about $2.2 billion with a compound annual growth rate of 19% (Frost & Sullivan), and total sales of wound closure devices are expected to reach approximately $740 million in 2012 (Medtech Insight). Abdominoplasty (tummy tucks) is the fourth most common plastic surgery procedure performed worldwide.
Currently, most patients who undergo abdominoplasty procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate, and the excess fluid accumulation (seroma) often requires additional procedures for removal. TissuGlu adheres the tissue flap to the underlying tissue (which is created during the procedure) to reduce fluid that can accumulate in the space and ultimately reduce the time to drain removal. With the use of TissuGlu, patients may have drains removed faster, which may lead to a more comfortable recovery and a quicker return to normal activity.
"Achieving the CE Mark on our TissuGlu Surgical Adhesive represents a significant milestone and achievement by all of the employees of Cohera Medical," said Chad A. Coberly, Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. "The certification signifies that we have met the rigorous clinical, quality, and performance requirements of the EU authorities and demonstrates the commitment we have to our future customers, partners, and investors."