Healthcare Industry News:  anastomosis 

Devices Surgery FDA

 News Release - December 9, 2014

Cohera Medical, Inc.(R) Submits Investigational Device Exemption to FDA for Clinical Trial of its Sylys(R) Surgical Sealant

Breakthrough Surgical Sealant Designed to Help Reduce Anastomotic Leaks for Patients Undergoing Gastrointestinal Resections

PITTSBURGH, Dec. 9, 2014 -- (Healthcare Sales & Marketing Network) -- Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, today announced that the Company has submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) to study Sylys Surgical Sealant as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in gastrointestinal surgical procedures. Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.

The randomized study submitted to the FDA will compare patients undergoing gastrointestinal anastomosis after resection with and without the sealant. The study is designed to statistically support the safety and efficacy of the sealant in reducing the leak rate in these procedures. Anastomotic leakage, which occurs in 3 percent to 23 percent of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and death. At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries.

"Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality," said James McCormick, DO, FACS, FASCRS, Program Director, General Surgery, Allegheny Health Network. "We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety."

Upon IDE approval by the FDA, the Company plans to initiate the study across multiple centers in the United States and use the pivotal safety and efficacy data to support a premarket approval application to the FDA for the product. Currently, Sylys is only approved for investigational use in Europe.

"The submission of the IDE for a pivotal safety and efficacy study of Sylys marks a significant milestone in the development process of this breakthrough device," said Chad Coberly, JD, vice president of Clinical, Regulatory, and Legal Affairs for Cohera Medical. "The review of the IDE by the FDA culminates the extensive preclinical and clinical testing conducted by the Company on the product."

The market for Sylys Surgical Sealant is significant, with more than one million procedures per year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.

"This latest submission represents a giant leap towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors," said Patrick Daly, Cohera Medical president and CEO. "We look forward to initiating the study and ultimately making Sylys available to surgeons and patients throughout the world."

About Cohera Medical

Cohera Medical, Inc. is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical's products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. The Company's lead product, TissuGluŽ Surgical Adhesive, is indicated in the EU for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. TissuGlu is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. The Company's second product, Sylys Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process. TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. Outside of the EU, TissuGlu and the other Cohera Medical products are currently indicated for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S. or in any other market.

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Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.

Source: Cohera Medical

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