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LifeSeal GI surgical sealant receives CE marking, FDA expedited access pathway designation

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LifeSeal Surgical Sealant has received CE marking for use in the European Union as an adjunct to a suture or staple-line to minimize leakage during GI resection procedures, the company announced. The product has also received an Expedited Access Pathway designation and priority processing status from the FDA.

Anastomotic leaks after colorectal resection occurs in up to 15% of patients and is associated with significant mortality and morbidity, according to a press release. LifeSeal (LifeBond) is a GI sealant designed to provide staple-line reinforcement in GI surgery and maintain sealing during the postoperative period by forming a firm but elastic protective layer once applied over colorectal staple-lines. It is the only sealant indicated for use in the GI tract to help reduce leaks, according to the press release.

“LifeSeal offers surgical units and hospitals an innovative, high quality surgical tool that both easily integrates into the surgical practice, and has been proven in clinical studies to make a major positive difference for patients,” Ittai Harel, chairman of the board of LifeBond and managing general partner at Pitango, said in the press release. “The CE Mark as well as the EAP designation are not simply formalities, but a confirmation of the significance of this product and the important benefits it can produce.”

The CE marking will make LifeSeal available to 500 million people in 32 countries, according to the press release. The company is also finalizing preparation to begin an international study at sites in the U.S. and Europe.

“LifeSeal is a unique product that not only provides remedy to an unmet need and improves patient care but also has the potential to benefit health economics by reducing the overall cost associated with post-surgical leakage management,” Gideon Sturlesi, CEO of LifeBond, said in the press release. “In the next year we intend to introduce the product to select European markets and to continue the important work with the FDA to bring this very much needed product to the market in the U.S. as well.”

Disclosure: Harel is employed by LifeBond and Pitango, and Sturlesi is employed by LifeBond.