Cohera Medical, Inc.® Receives Approval To Begin Human Clinical Trials Of Sylys™ Surgical Sealant In Europe
PITTSBURGH, March 12, 2013 /PRNewswire/ -- Cohera Medical, Inc. (www.coheramedical.com), a leading innovator and developer of absorbable surgical adhesives and sealants, has announced today that it has received approval to begin human clinical trials of its Sylys™ Surgical Sealant product, designed for colonic and small bowel anastomoses.
The study will investigate the safety and efficacy of Sylys, and its effect on leakage following bowel repair and associated complications in colorectal surgeries. The study will be conducted at two hospitals in the Netherlands. Patient enrollment is expected to begin in April 2013.
Anastomotic leakage rates following colon resection range on average from 3-15%. Such leakage is considered the most serious complication of bowel repair, causing one third of mortalities following colorectal surgery.
"Approval of this trial will move Cohera towards a regulatory approval application in Europe and a larger, U.S. based pivotal trial," said Chad Coberly, JD, vice president of clinical, regulatory and legal affairs of Cohera.
"There is a high clinical and economic need for a product that effectively reduces anastomotic leakage rates," added Patrick Daly, president and CEO of Cohera Medical. "This approval marks the first step for Cohera towards revolutionizing colorectal procedures and ultimately, improving patient outcomes."
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.