Cohera Medical Completes Sylys® Surgical Sealant Clinical Trial
Last Patient Treated in the Sylys Clinical Trial to Demonstrate the Sealant’s Safety in Colorectal Anastomosis Procedures
PITTSBURGH, Sept. 3, 2013 /PRNewswire/ — Cohera Medical, Inc.(®), a leading innovator and developer of absorbable surgical adhesives and sealants, today announced it has treated its last patient for the clinical trial for Sylys(®), the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures. The results of the study will be released later this fall.
The European study is evaluating the safety of Sylys as an adjunct to standard closure techniques following bowel resections. The study included patients enrolled at two sites in the Netherlands.
Anastomotic leaks, on average, occur in 3 – 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 – 4B market.
“We are thrilled to be collaborating with leading surgeons in the Netherlands to treat patients with our Sylys product, our second class III product designed to support more natural healing and help reduce post-operative complications,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “Completing the treatment of the last patient in this study brings us one step closer to putting this innovative sealant in the hands of surgeons and reducing anastomotic leakage after colorectal surgery.”
About Cohera Medical
Cohera Medical, Inc.(®) is a leading innovator and developer of absorbable surgical adhesives and sealants. The Company’s first product, TissuGlu(®) Surgical Adhesive, is an internal surgical adhesive for large flap surgeries, such as abdominoplasty (tummy tuck), that eliminates or reduces fluid accumulation and the need for post surgical drains. TissuGlu’s chemical composition is resorbable, non-toxic, forms a strong bond between tissue layers and allows for natural healing, which ultimately may enable faster recovery. TissuGlu has received CE Marking approval to be sold in the European Union (EU). Cohera Medical is also developing a unique and proprietary bowel sealant, and a strong adhesive for mesh fixation. Outside of the EU, TissuGlu and the other Cohera 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.