LifeBond said today it won an Investigational Device Exemption from the FDA to initiate a clinical study of its LifeSeal surgical sealant kit.
The company’s LifeSeal kit includes a specific gastrointestinal sealant deisgned to minimize staple-line leakage during gastrointestinal resection procedures.
“Given the associated challenges and complications of low anterior resections (LAR), developing a sealant for preventing leakage in GI resection procedures is an extremely ambitious undertaking since leakage rates can reach more than 20%. LifeBond’s LifeSeal is designed to address these challenges. EU clinical study data demonstrated a trend in leakage reduction with more than twice the number of leaks occurring in patients with standard treatment compared to LifeSeal treated patients – 8 verses 3 leaks in 70 patients. These results indicate that LifeSeal has great potential to improve patient outcomes following colorectal resection procedures,” chief medical officer Dr. Sachi Norman said in a press release.
The Israeli company said it has begun patient enrollment for the multicenter, randomized, double-arm, single-blind study to evaluate the safety and efficacy of the LifeSeal kit. Additional study sites in the U.S. are planned for the coming months, the company said.
“Today’s news marks a major milestone in the development of LifeSeal. The FDA’s nod firmly validates the importance and the maturity of the product as well as its rigorous development to date. We are delighted to have the support of the FDA to begin a larger trial to further confirm existing findings and to inch closer to bringing this important product to the market in the U.S. as well,” CEO Mr. Gideon Sturlesi said in prepared remarks.
In April, LifeBond said that it won CE Mark approval in the European Union for its LifeSeal surgical sealant for gastrointestinal resection procedures, and got on the fast track with the FDA for the surgical sealant.
The FDA’s expedited access pathway granted to LifeSeal is meant for medical devices with the potential to address unmet needs for life-threatening or irreversibly debilitating diseases. LifeBond said it’s in the final stages of preparing a new pivotal study for LifeSeal in the U.S. and Europe.