Cohera Medical, Inc.® Files for CE Mark Approval for Sylys® Surgical Sealant
, May 15, 2014
/PRNewswire/ -- Cohera Medical, Inc.®
, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has applied for CE Mark approval for Sylys®
Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures. CE Mark approval, expected by the end of 2014 based on this filing, will allow for marketing of the product in the European Union and other countries.
Sylys is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks a serious complication that occurs in up to 23 percent 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 leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality," said James McCormick, DO, FACS, FASCRS, Chief, Division of Colorectal Surgery, The Western Pennsylvania 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 is designed to help reduce anastomotic leakage in intestinal procedures by providing additional support 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 that cures rapidly to create a flexible, elastic seal over the anastomosis site.
"The preparation and filing of the CE Mark application for Sylys, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera Medical," said Chad A. Coberly, JD, Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. "The submission signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities, and we look forward to working with our notified body during the approval process."
The market for Sylys 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.
"Submitting the SylysCE Mark application 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 eliminate drains in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, and latissimus dorsi. 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. TissuGlu is currently approved for sale in the EU. Outside of the EU, TissuGluand the other Cohera Medical products 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.
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, Inc.