LifeBond launches pivotal LifeSeal sealant trial

Tissue repair-focused developer LifeBond said today it launched a pivotal study of its LifeSeal surgical sealant kit, set to explore the use of the sealant in patients undergoing colorectal anastomosis.

The Israel-based company’s LifeSeal surgical sealant kit includes a specific gastrointestinal sealant designed to minimize staple-line leakage during gastrointestinal resection procedures.

“LifeBond’s team is committed to bringing LifeSeal and other high quality surgical tools to the market, and to providing surgeons worldwide with access to easy-to-use solutions for reducing leaks in GI surgery. We are very pleased with LifeBond’s progress clinically and commercially, and are confident that LifeSeal is the first of a number of novel products the company will introduce in the next few years,” Pitango managing GP Ittai Harel said in a prepared statement.

LifeBond said that 20 medical centers in the US and Western Europe are now recruiting for the study, with an additional 20 clinical sites slated to join the trial in the coming months.

“LifeBond achieved several milestones in 2016. To begin, the FDA granted permission to the company to commence the LifeSeal IDE study as part of the Expedited Access Pathway program. We are deeply appreciative of the FDA’s responsiveness and designation of LifeSeal as part of the EAP program, as well as the medical community’s strong support and participation in validating LifeSeal’s clinical value. We began our pivotal study initially in Europe, to build on the completion of a successful CE study, and then recently expanded to multiple centers in the US. Last year also marked the start of the commercialization of LifeSeal in Europe. We have established strong momentum clinically and commercially, and we intend to build on this in the coming year and beyond,” CEO Gideon Sturlesi said in a press release.

The device already has CE Mark approval in the European Union, which it won in April last year. The company won IDE clearance from the FDA last July to initiate the study.

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