Cohera Medical landed the 1st of 4 FDA approvals for its TissuGlu surgical adhesive system, which is used as an internal adhesive in large flap procedures, such as "tummy-tuck" surgery.
Cohera earlier this year came to an agreement with the FDA to conduct a modular approach to filing its pre-market approval application, and submitted its 1st module according to plan.
"The 1st module approval of the TissuGlu PMA is another significant milestone for Cohera and its investors," president & CEO Patrick Daly said in prepared remarks. "The approval for this information confirms the basic safety profile of this important new product and allows the Company to proceed with its modular PMA filings on plan."
The 1st section included a pre-clinical testing profile for TissuGlu, including biocompatibility and toxicological testing information, according to a press release.
The Pittsburgh-based company expects to file the 2nd module of its PMA application later this year and the final 2 modules in 2013.
The TissuGlu system is designed to minimize fluid accumulation and other problems associated with procedures such as abdominoplasty, or ‘tummy-tuck’ surgeries. Patients who undergo abdominoplasty require the insertion of drains to remove fluids that accumulate under the skin, but sometimes excess fluid still accumulates, necessitating another surgery. TissuGlu is intended to strongly adhere to the skin that’s cut during surgery, reducing the amount of collected fluid and the time that drains need to be inserted, according to Cohera.
Cohera earlier this year received investigational device exemption approval to begin a prospective, multicenter, randomized clinical trial for its TissuGlu surgical adhesive in the U.S.
In September 2011 TissuGlu won CE Mark approval in the European Union.