PITTSBURGH, Pa., August 13, 2015 – Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received CE Marking approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce leaks after gastrointestinal procedures. CE Marking will allow for marketing of the product in the European Union and other countries. The initial indication for Sylys Surgical Sealant is intended to perform as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in ileostomy reversal procedures.
Sylys® Surgical Sealant is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks – a serious complication that occurs in up to 23% of patients undergoing colorectal surgery. At least one third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries. The additional care required to manage this serious complication can cause up to a five-fold increase in patient management costs.
“Anastomotic leak is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James T. McCormick, DO, FACS, FASCRS, Program Director, General Surgery, Allegheny Health Network, Chief, Division of Colon and Rectal Surgery, Forbes Hospital. “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.”
Sylys® surgical sealant is 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 sealant is applied as a viscous fluid which cures rapidly to create a flexible, elastic seal over the anastomosis site. In-vivo, the product degrades in a few weeks and is resorbed.
“CE marking approval for Sylys® Surgical Sealant, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera,” said Chad A. Coberly, JD Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. “The approval signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities.”
The market for Sylys® Surgical Sealant is significant, with several hundred thousand procedures a 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.
“The Sylys® Surgical Sealant CE marking approval represents a significant milestone 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 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, TissuGlu® Surgical Adhesive, is designed to reduce fluid accumulation and the need for surgical drains in patients undergoing abdominoplasty (tummy tuck) and other plastic procedures that require the creation of large planar flaps of tissue. TissuGlu® is currently approved for sale in the EU and U.S. for specific indications (refer to the full Directions for Use of TissuGlu® Surgical Adhesive in the market desired for the approved indication for use.) TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. The other Cohera products and Sylys® Surgical Sealant in the U.S. are currently indicated for investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other market.
For more information, visit www.coheramed.com.