PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable. The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks.
“The receipt of the PMA Approvable Letter is a truly significant milestone for the Company,” said Patrick Daly, Cohera Medical President and CEO. “We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States.”
TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty. Upon approval, TissuGlu will be the first internal surgical adhesive of its kind approved in the United States.
Mr. Daly will be presenting on this latest milestone and other significant updates at the J.P. Morgan Healthcare Conference on January 13th at 4:00pm PST.
TissuGlu is designed to meet a surgeon’s need for a strong, biocompatible, and easy-to-use surgical adhesive. The Approvable PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in abdominoplasty procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
“TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures,” said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. “When approved, it will bring great benefits to both patients and surgeons.”
“Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team,” said Chad Coberly, JD, Vice President of Clinical, Regulatory & Legal Affairs for Cohera.
TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.
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 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. TissuGlu is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), 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. Outside of the EU, TissuGlu 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.
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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cohera-medical-inc-receives-pma-approvable-letter-from-us-fda-for-tissuglu-surgical-adhesive-300015994.html
SOURCE Cohera Medical, Inc.
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