Cohera Medical reports top-line results from Tissuglu clinical trial

May 6 2010

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.