Cohera Medical Completes Enrollment of U.S. No-Drain Study for its TissuGlu® Surgical Adhesive Enrollment completion marks key milestone in product's commercialization in U.S.
PITTSBURGH, June 5, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced it has completed enrollment for its U.S. No-Drain Study for its lead product, TissuGlu. The study has enrolled 130 patients at five prominent centers in the U.S. and is investigating the safety and effectiveness of TissuGlu® Surgical Adhesive in the reduction of wound drainage, seroma development and other complications in abdominoplasty patients without the use of postoperative drains.
"We are delighted to complete enrollment in this critical trial for TissuGlu, which has the potential to eliminate wound drainage issues from large flap procedures," said Dr. Joseph Hunstad of the Hunstad-Kortesis Center for Plastic Surgery, Charlotte, NC. "The trial results so far are very promising for both the surgeons and the patients."
Cohera Medical will use the results from the study to submit a PMA application for TissuGlu with the FDA. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
"Completing the enrollment of this study marks yet another key milestone toward the commercialization of our lead product in the U.S.," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "We are encouraged by the positive feedback from the TissuGlu investigators and look forward to our work with FDA to make TissuGlu available to surgeons and patients throughout the country."
Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. To date, TissuGlu has been used successfully in surgical procedures in Germany by leading plastic and reconstructive surgeons.
Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space and ultimately reducing the time to drain removal. The use of TissuGlu may shorten the length of time that drains need to be in place, leading to a more comfortable recovery and a quicker return to normal activity for patients.
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.