Company receives FDA Expedited Access Pathway Designation for LifeSeal Surgical Sealant
Caesarea, Israel, April 17, 2016 — LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that it has received CE Marking for its LifeSeal™ Surgical Sealant, a unique gastrointestinal (GI) sealant specifically designed to minimize staple-line leakage in gastrointestinal resection procedures and is the only sealant indicated for use in the GI tract to help reduce leaks. LifeSeal is now CE marked for use in the EU as an adjunct to a suture or staple-line during standard surgical repair of the GI tract (anastomosis or linear) to provide reinforcement and help reduce leaks. CE marking now provides product access to 32 countries with a population of nearly 500 million.
LifeBond also announced today that LifeSeal has received an Expedited Access Pathway (EAP) designation and priority processing status from the U.S. Food and Drug Administration (FDA). The company is now in the final steps of preparation to commence a new, international pivotal study which will include sites in the United States and Europe. The Expedited Access Pathway (EAP) program is for medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions. Under EAP, the FDA works with the company to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA approval standards.
Ittai Harel, chairman of the board of LifeBond and managing general partner at Pitango said, “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.”
“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. 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,” said Gideon Sturlesi, CEO of LifeBond. Mr. Sturlesi continued, “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.”
LifeBond is a leader in the development and manufacturing of bio-surgical medical devices for tissue repair intended to improve the recovery of patients following surgery and to create an environment that supports the body’s natural healing process. Of natural origin, elastic, adhesive, durable and yet absorbable, the company’s devices have the potential to fill a long list of unmet surgical needs. LifeBond’s first product, LifeSeal™, is designed to provide staple-line reinforcement in GI surgery. Anastomotic (point of surgical connection) leakage after a colorectal resection is associated with significant mortality and morbidity, with anastomotic leakage occurring in as many as 15–19% of patients. Once applied over colorectal staple-lines, LifeSeal™ forms an elastic yet firm protective layer designed to maintain sealing during the critical post-operative period. Reducing leakage has the potential to save patient lives, improve patient recovery and avoid re-admissions and repeated surgeries. LifeSeal™ has a CE marking for sale in the EU. In the US, LifeSeal™ is not approved by FDA and is not yet available for sale. The company’s second pipeline product, LifeMesh™, a self-fixating hernia mesh, is in pre-clinical development. Other pipeline products include tissue adhesives and absorbable hemostats. LifeMesh™ and other LifeBond products are investigational and have not yet been approved for sale in the US or in any other market. For more information please visit www.life-bond.com