"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 verses 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.
