Absorbable surgical adhesives and sealant company Cohera Medical, Inc., has seen its Sylys® Surgical Sealant receive Priority Review status from the U.S. FDA due to its potential to address the unmet need related to gastrointestinal leaks.
Anastomotic leakage, which occurs in three to twenty three percent of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered, and frequently results in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and death. At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries.
Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.
Priority Review status is a statutory provision in the medical device law that allows the FDA to grant priority review processing to devices that satisfy the unmet need criteria in the law. This process will be applied to the Company’s future Pre-Market Approval application for the Sylys Surgical Sealant.
According to the FDA, “The Sylys Surgical Sealant affects life-threatening gastrointestinal anastomosis leaks, and there are no approved adjuncts to standard closure techniques for the reinforcement of anastomotic junctions in gastrointestinal surgical procedures.”
“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,” said Chad Coberly, JD, Vice President of Clinical, Regulatory, and Legal Affairs for Cohera Medical. “The Priority Status designation is also the first 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.”
“The Priority status designation for Sylys represents the critical need for this product and demonstrates our commitment to our future customers, partners, and investors,” said Patrick Daly, Cohera Medical President and CEO. “We look forward to working with the FDA to make Sylys available to surgeons and patients worldwide as soon as possible.”
Source: Cohera Medical, Inc., PR Newswire