Cohera Medical Receives IDE Approval to Begin First No-Drain Clinical Study of TissuGlu® Surgical Adhesive in the U.S. Study to Investigate the Safety and Effectiveness of TissuGlu in Abdominoplasty Surgeries Without the Use of Postoperative Drains
PITTSBURGH, Dec. 13, 2012 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received approval from the United States Food and Drug Administration ("FDA") to begin the first no-drain clinical trial for its TissuGlu® Surgical Adhesive product in the U.S. The randomized, controlled, prospective multicenter non-inferiority study will compare the standard wound closure technique with drains (control) to the standard wound closure technique including TissuGlu and no drains (test) during abdominoplasty procedures.
The study will begin in early 2013 and take place at five prominent surgery centers in the following regions: Washington, DC; Baltimore, MD; Charlotte, NC; Los Angeles, CA; and Dallas, TX. A total of 130 patients undergoing abdominoplasty procedures will be randomized and divided into either a treatment group with the application of TissuGlu or a control group without the use of TissuGlu.
"Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications," said Joseph P. Hunstad MD, FACS, of the The Hunstad-Kortesis Center, Charlotte, N.C. "We are excited to begin enrolling patients and we believe that completely eliminating the use of drains would significantly improve patient care and satisfaction."
"IDE approval to begin the first 'no drain' trial in the U.S. represents a significant step for the Company," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "We believe that the elimination of post-surgical drains has the potential to positively impact surgeries and the recovery of millions of patients worldwide."
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. The drains are often painful for the patient and can lead to infection and impact the recovery process.
TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space during healing and ultimately reducing the need for postoperative drains to remove the fluid. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients.
Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. An earlier no-drain study of 30 patients was successfully completed in Germany in July 2012. In the U.S., Cohera recently completed enrollment of a clinical trial for TissuGlu. TissuGlu has been used successfully in over 600 various surgical procedures by leading surgeons.
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.