The approval gives a green light for the start of a clinical study in the US to evaluate the efficacy and safety of the LifeSeal® Surgical Sealant Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses
Caesarea, Israel, July 21, 2016 — LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that it has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate a clinical study of the LifeSeal® Surgical Sealant Kit, which includes a unique gastrointestinal (GI) sealant specifically designed to minimize staple-line leakage in 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%,” said Dr. Sachi Norman, Chief Medical Officer at LifeBond. “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 versus 3 leaks in 70 patients. These results indicate that LifeSeal has great potential to improve patient outcomes following colorectal resection procedures.”
Today’s news follows the recent receipt of CE marking in Europe early this year and an Expedited Access Pathway (EAP) designation status from the FDA for LifeSeal in the U.S in 2015. The EAP designation highlights the medical importance of LifeSeal and provides for expedited review by the FDA. Commercialization has already been initiated in several countries in Europe.
“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,” said Mr. Gideon Sturlesi, CEO of LifeBond. “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.”
The FDA trial is designed to be a multicenter, multinational, randomized, double arm, single-blind study that will evaluate the safety and efficacy of the LifeSeal Surgical Sealant Kit. The study will be conducted at leading medical centers in the US and Europe. Patient enrollment is currently open at the clinical sites in Europe, with additional sites to be initiated in the United States in the coming months.
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. 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 an experimental device and is available only for use in the approved IDE study; it 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