PITTSBURGH, June 9, 2015 /PRNewswire/—Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that its Sylys® Surgical Sealant has received Expedited Access Pathway (EAP) designation and priority processing 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 peritonitis, septic shock, multiple organ dysfunction, and death{Alberts, 2003 #1}.  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 designated Sylys Surgical Sealant as an Expedited Access Pathway device due to its potential to address the unmet need related to gastrointestinal leaks. According to the FDA, “…the device is intended to treat or diagnose a life threatening condition… and there are no appropriate alternative approved products.”

“I am delighted that the FDA understands the devastating impact of leaks from colorectal anastomoses and is providing a fast track for development of innovative clinical solutions,” said Deborah Nagle, MD,Chief, Division of Colon and Rectal Surgery,Beth Israel Deaconess Medical Center,Boston, MA.

The Expedited Access Pathway is a recently finalized (April 13, 2015) program at the FDA designed to help patients gain more timely access to critical medical devices by expediting their development, assessment, and review.

“The granting of EAP status for Sylys Surgical Sealant by the FDA is a significant designation,” said Chad Coberly, JD, Vice President of Clinical, Regulatory, and Legal Affairs for Cohera Medical.  “We look forward to working with the FDA under this program to streamline the clinical data collection and PMA approval for this breakthrough device.”

“We are looking forward to the Sylys Surgical Sealant clinical trial that will evaluate this potentially life-saving product for colorectal surgery patients,” said James T. McCormick, DO, FACS, FASCRS, Program Director, General Surgery, Allegheny Health Network, Chief, Division of Colon and Rectal Surgery, Forbes Hospital.

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 Expedited Access Program designation for Sylys Surgical Sealant 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 Surgical Sealant 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 for use in the U.S. for the approximation of tissue planes in abdominoplasty procedures. TissuGlu is currently approved for sale 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, and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty, 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.  Sylys Surgical Sealant 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.

 

 

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.