LifeBond said today 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.
LifeSeal is designed to minimize staple-line leakage during anastomosis or linear surgical repair of the GI tract, Caesarea, Israel-based LifeBond said.
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.
“Commercialization of a new product is a meaningful milestone. For 9 years, the LifeBond team has been pioneering new technology through thorough scientific investigations and successful clinical studies. At this juncture, it is especially important to remember our beginnings and acknowledge the co-founders of the company, entrepreneurs Orahn Preiss-Bloom and Ishay Attar,” CEO Gideon Sturlesi said in prepared remarks. “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. 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.”
“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. 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,” added chairman Ittai Harel, a managing general partner at Pitango Venture Capital.
Last August LifeBond closed a $27 million Series D equity round, with participation from Pitango, Adams Street Partners, Sino Biopharmaceutical and existing investors.