LifeSeal, the no-leak sealant solution for patients who have undergone gastrointestinal (GI) surgery, is now approved for use in the European Union. The sealant, developed by Caesarea-based LifeBond, will allow doctors in 32 countries to use the unique “glue” that prevents leaks after bariatric and GI operations.
In addition, the company said, LifeSeal is now also on the fast track to FDA approval. The product was given the FDA’s Expedited Access Pathway (EAP) designation, and is now eligible for quicker approval consideration, which the company hopes will take place after it begins its new international study which will include sites in the United States and Europe. The FDA reserves its EAP designation for products that provide a solution for an unmet medical need.
“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,” said Ittai Harel, chairman of the board of LifeBond and managing general partner at Pitango, the venture capital firm that led the company’s recent $27 million Series D investment round. “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.”
Generally, patients who have undergone bariatric or GI surgery will have their incisions stapled or glued, neither of which is an ideal solution. Staples have been known to leak, while glues can break down over time. In both cases, the risk of infection rises considerably as the patient’s insides are exposed to air. In addition, the closures, which must remain in place for months, are difficult for patients to live with, and they often break, even if they have been secured well, because of patient activity like scratching.
To solve this, LifeBond has developed a proprietary adhesive platform technology that quickly turns into a polymer (in the form of a hydrogel matrix, a clear, flexible and strong seal) that adheres strongly to physiological tissue surfaces. The properties of the polymerization process and the hydrogel matrix can be controlled to fit a variety of applications. According to the company, the sealant is stronger and longer-lasting than others on the market, and uses only natural ingredients instead of chemicals so it is much better tolerated in patients than other sealants.
“Commercialization of a new product is a meaningful milestone. For nine years, the LifeBond team has been pioneering new technology through thorough scientific investigations and successful clinical studies, said Gideon Sturlesi, CEO of LifeBond. “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 US as well.”