Pittsburgh-based Cohera Medical is a whisper away from the regulatory finish line.
The hard-working biomedical company on the North Side is on the verge FDA’s seal of approval for its TissuGlu surgical adhesive, a product that promises to improve patient outcomes for large flap surgeries like tummy tucks.
The absorbent surgical adhesive received the CE mark in Europe in 2011. Since then, it has been used successfully in Germany where 1,500 procedures have been performed. This month the FDA General and Plastic Surgery Devices Panel voted unanimously on the safety, efficacy and benefits of the surgical adhesive, paving the way for final FDA approval.
“It’s a key win and overwhelming vote of confidence,” says Daly. “We submitted for the broadest application of TissueGlu and its expanded use is approved.”
“Before the year is out, we will be approved to sell the product in the U.S,” Daly adds.
When TissuGlu is ultimately approved, it will be cleared for use for the more than one million large-flap surgical procedures done in the United States each year with a growth potential of 4.8 percent annually, Daly says. Patients who once had to cope with “barbaric tubes” that are currently used in large-flap surgeries.
The unique composition of Cohera’s surgical adhesives allows it to cure in the presence of moisture. The adhesives also form a bond between tissue that is stronger than other products on the market and promotes faster healing, the company says.
“To take a product from the bench through the CE and FDA (regularly process) for $75 million is pretty spectacular. We’ve done it in half the time with a lot less people. It’s a story that’s been missed in Pittsburgh.”
Cohera’s second product, Sylys Surgical Sealant is a synthetic sealant to help reduce leaking in gastrointestinal procedures, a serious complication of colorectal surgery. CE Mark approval is expected by the end of 2014.
The company employs 22 people. Early this year Daly was appointed to Advanced Medical Technology Association’s (AdvaMed) Board of Directors, an influential group of CEOs in the medical device space.