Cohera Medical's® U.S. No-Drain Clinical Study Confirms TissuGlu® is a Superior Alternative for Fluid Management, Eliminates Need for Drains Results establish clear benefits for first-of-its-kind surgical adhesive, including fewer post-operative treatments and faster recovery
PITTSBURGH, Nov. 12, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced that its pivotal U.S. clinical trial concluded that TissuGlu® Surgical Adhesive is a superior alternative to drains for fluid management following large flap procedures such as abdominoplasties. The study revealed that using TissuGlu reduces post-operative treatments and enables patients to resume normal activities more quickly.
"The results are clear – TissuGlu is the superior alternative to drains. No other method will get patients back to their daily routine faster," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "With these outstanding outcomes, we are now prepared to submit the final module of our PMA application to the FDA, bringing us that much closer to getting this beneficial technology into the hands of surgeons throughout the U.S."
The study compared the use of drains (standard of care) to using TissuGlu without drains following abdominoplasty in 130 patients. The study concluded that TissuGlu is a clinically superior alternative to using closed-suction drains for fluid management in large flap procedures. Additionally, when TissuGlu was used, patients had fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
"The results of the No-Drain study are extremely impressive. With the ability to eliminate drains, TissuGlu has the potential to truly advance patient care and comfort," said Dr. Joseph P. Hunstad, M.D. of the Hunstad-Kortesis Center for Plastic Surgery, Charlotte, N.C.
Currently, most patients who undergo abdominoplasty procedures or other large flap procedures, such as mastectomy or inguinal lymph node dissection, require the insertion of drains to remove fluid that accumulates under the skin at the surgical site. Drains are often uncomfortable for the patient and may lead to additional complications. TissuGlu forms a strong bond between tissue layers, helping to reduce the fluid that can accumulate during healing.
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.