The FDA awarded priority review status to Cohera Medical‘s surgical sealant Sylys because the product addresses a significant unmet medical need.
Sylys is designed to prevent anastomotic leaks in patients undergoing gastrointestinal surgery. Anastomotic leaks, between sections of surgically joined intestine, are often life-threatening and can lead to septic shock, peritonitis and multiple organ failure. About ⅓ of deaths following colorectal surgery are associated with anastomotic leaks, according to Cohera.
“The granting of priority review status for Sylys by the FDA is a significant designation that should help speed the approval process for this breakthrough device,” Chad Coberly, vice president of clinical, regulatory & legal affairs, said in prepared remarks. “The priority status designation is also the 1st step in the company’s plan to work with the FDA, under its draft program, for expedited access to premarket devices intended for unmet medical needs. This new program could significantly reduce the pre-market approval pathway for the product.”
Cohera closed a safety trial for the Sylys sealant in sealing anastomoses almost exactly 1 year ago. The Pittsburgh-based company submitted an application Dec. 9 the FDA to initiate an investigation device exemption study for Sylys for the same indication; the product is already cleared for investigational use in Europe, according to Cohera’s website.
Early this year, Cohera announced that it had raised $26.3 million in a Series D funding round. The company said it planned to use the cash to seek additional regulatory approvals for Sylys and its predecessor, the TissuGlu surgical sealant. That product won a recommendation for approval from an FDA advisory panel in August.