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Cohera Medical Gets Priority Review Status Designation from FDA for its Sylys Surgical Sealant

Published on 2014-12-30. Author : SpecialChem

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced that its Sylys® Surgical Sealant has received Priority Review status from the U.S. Food and Drug Administration (FDA). 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.

Anastomotic leakage, which occurs in three to twenty three percent of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered, and frequently results in the rapid development of severe peritontis, 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.

The FDA has granted Priority Review Status to Sylys due to its potential to address the unmet need related to gastrointestinal leaks. According to the FDA, “The Sylys Surgical Sealant affects life-threatening gastrointestinal anastomosis leaks, and there are no approved adjuncts to standard closure techniques for the reinforcement of anastomotic junctions in gastrointestinal surgical procedures.”

Priority Review status is a statutory provision in the medical device law that allows the FDA to grant priority review processing to devices that satisfy the unmet need criteria in the law. This process will be applied to the Company’s future pre-market approval application for the Sylys Surgical Sealant.

“The granting of Priority Review status for Sylys by the FDA is a significant designation that should help speed the approval process for this breakthrough device,” said Chad Coberly, JD, Vice President of Clinical, Regulatory, and Legal Affairs for Cohera Medical. “The Priority Status designation is also the first step in the Company’s plan to work with the FDA, under its draft program, for expedited access to premarket devices intended for unmet medical needs. This new program could significantly reduce the pre-market approval pathway for the product.”

The worldwide market for Sylys Surgical Sealant is significant, with more than one million procedures per year representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys represents a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
“The Priority status designation for Sylys represents the critical need for this product and demonstrates our commitment to our future customers, partners, and investors,” said Patrick Daly, Cohera Medical President and CEO. “We look forward to working with the FDA to make Sylys available to surgeons and patients worldwide as soon as possible.”

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, TissuGlu® 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.

Forward Looking Statements
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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