Top-Line Human Clinical Study Results Demonstrate Safety and Preliminary Effectiveness of Cohera Medical's TissuGlu(R) Positive Results for Surgical Adhesive in Abdominoplasty (Tummy Tuck) Procedures Move Product Toward CE Mark Application in Europe and Clinical Study in U.S. This Year
PITTSBURGH, May 5 /PRNewswire/ -- Cohera Medical, Inc.® today announced that top-line clinical study results demonstrate the safety and preliminary effectiveness of the company's lead surgical adhesive product, TissuGlu®.
The prospective, open-label, randomized study involving 40 patients at three sites in Germany met its primary endpoints of safety and preliminary effectiveness related to time to drain removal and secondary endpoints of associated wound healing complications, cumulative wound drainage, number of additional procedures and visits, and improved quality of life. In the trial, investigators compared standard wound closure techniques used in abdominoplasty surgeries, or "tummy tuck," to standard wound closure techniques plus the application of TissuGlu. The purpose of the study was to determine TissuGlu's effect on wound drainage and associated complications in the surgeries.
"We are pleased that the top-line clinical trial results demonstrate both the safety and preliminary effectiveness of TissuGlu," said Klaus Walgenbach, M.D., Ph.D., of the Universitatsklinikum Bonn and the principal investigator for the study. "The product has the potential to change the way plastic surgeons address the wound drainage challenges of abdominoplasty procedures. We look forward to presenting detailed study results at an upcoming medical conference as well as submitting them for publication."
The positive results from the first-in-man study of Cohera's surgical adhesive in abdominoplasty procedures move the product toward CE Mark application in Europe and a larger clinical study in the U.S. this year.
"We are moving quickly to address a significant unmet medical need while helping plastic surgeons to improve the overall care of their patients," said Patrick Daly, president and chief executive officer of Cohera Medical. "The positive study results add to the extensive preclinical data that show the safety and effectiveness of TissuGlu. We envision the TissuGlu market opportunity in plastic surgery to encompass applications beyond tummy tuck, such as breast reconstruction and body contouring. This is a large opportunity that can exceed $700 million world wide."
Currently, patients who undergo abdominoplasty 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 called seroma requires an additional procedure for removal. TissuGlu adheres the tissue flaps created during the procedure to reduce fluid accumulation, and, ultimately, the duration of use of the surgical drains. With the use of TissuGlu, patients may experience a significant reduction of fluid accumulation and a more comfortable recovery, which may lead to a quicker return to normal activity.
About Cohera Medical
Cohera Medical, Inc. is a Pittsburgh-based company that is developing a revolutionary line of surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is an adhesive for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation, small bone fixation and other plastic surgery indications that will fill similar market needs in plastic, orthopedics and general surgery. For more information, visit www.coheramed.com. 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.
Certain statements made throughout this news 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.