|The TissuGlu technology--Courtesy of Cohera Medical|
Medical supply company B. Braun will be selling the surgical adhesive TissuGlu from startup Cohera Medical in Germany, Spain and Portugal under a new deal. The product received an approvable letter from the FDA in early January. At that time, Cohera said it expected FDA approval within a few weeks, but it hasn't come through quite yet.
Under the new deal, B. Braun is the exclusive distributor of TissuGlu in those European countries. Financial details of the partnership were undisclosed. The product has been CE marked since 2012 and was previously sold in Germany via a direct Cohera sales force. It's been used in more than 2,000 surgical procedures.
The approved indication for TissueGlu in Europe is for approximation of tissue layers where subcutaneous dead space exists between tissue planes in large flap surgical procedures such as abdominoplasty. The FDA is expected to go with a narrower label, but it's not clear yet what that might be. The product barely won safety and efficacy votes at an FDA panel in August.
TissuGlu can eliminate the need for a drain in these types of surgeries, which typically require these tubes to allow for drainage of excess fluid for as long as a few days postsurgery. It is an adhesive consisting of a polyurethane prepolymer generated by reacting trimethylolpropane with lysine diisocyanate ethyl ester. It polymerizes at the surgical site upon contact with moisture and is delivered via a handheld applicator that contains 5 milliliters of the adhesive.
"We are looking forward to working with such a great organization and to making our breakthrough TissuGlu product available to more surgeons and patients in Europe," Cohera President and CEO Patrick Daly said in a statement.
Founded in 2006, Cohera is backed by investors including Bradford Capital Partners and Kern Whelan Capital. It has raised more than $78 million, including $4 million in SBIR grants. The company's most recent venture financing was a $26.3 million Series D round in January 2014.
- here is the release