|LifeSeal surgical sealant--Courtesy of LifeBond|
Medical device companies have seen no end to the problems that materials can cause once they're in the human body for the long term. More and more bioabsorbable products--designed to function in the short term by providing a matrix for the body to properly heal but then to be absorbed--are coming to the fore.
Israeli startup LifeBond has a technology to create a hydrogel matrix by using a combination of gelatin and microbial transglutaminase (mTG) enzyme to create a firm, elastic hydrogel. Gelatin is already commonly used in the industry, particularly in surgical sponges and in coatings for medical devices. Transglutaminase is commonly known as "meat glue," and is used by the food industry to amalgamate pieces of meat for human consumption.
Investors have just funneled a $27 million Series D to back a U.S. pivotal trial of its LifeSeal Surgical Sealant in a PMA approval process with the FDA to minimize postoperative complications such as staple-line leakage in GI and bariatric surgeries. The sealant has already completed a multinational, randomized controlled pilot study in Europe--and is slated to receive a CE mark based upon it.
"LifeSeal is a novel product that addresses an urgent unmet need that industry has not been able to solve for, until now. The product has the potential to greatly reduce surgical leaks, which are associated with potential infections and other serious complications, risking the lives of hundreds of thousands every year," Ittai Harel, LifeBond chairman and a general partner at Pitango Venture Capital, said in a statement. The firm participated in the round, along with Adams Street Partners, Sino Biopharmaceutical, and all existing investors.
|LifeBond's LifeMesh technology--Courtesy of LifeBond|
He added, "The company has in recent years made great advances, with compelling pilot clinical results, commercialization prep, and an expanding surgical product line offering."
LifeBond expects to start the pivotal trial next year; it found in the pivotal trial that LifeSeal decreased the anastomotic leakage rate--which can occur in as many as 15% to 19% of patients after colorectal resection and is associated with significant mortality and morbidity. Anastomotic leaks occur at the point of surgical connection.
The startup won't be treading into unknown territory. Earlier this year, Cohera Medical garnered the first FDA approval for a surgical sealant designed specifically for internal use. The label for its TissuGlu is specifically for use during abdominoplasty surgery, a more narrow than the indication the company had sought for large flap surgical procedures.
The agency's decision came only after a contentious FDA review for the urethane-based adhesive, as well as an approvable letter. TissuGlu is an adhesive consisting of a polyurethane pre-polymer generated by reacting trimethylolpropane with lysine diisocyanate ethyl ester. It polymerizes at the surgical site upon contact with moisture and is delivered via a handheld applicator.
LifeBond also has LifeMesh, a preclinical, self-fixating hernia mesh, as well as other pipeline projects including tissue adhesives and absorbable hemostats.
"The technology can be applied to create a nearly endless pipeline of products, said LifeBond CEO Gideon Sturlesi. "And based on the feedback and enthusiasm of leading surgeons worldwide, we have industry confirmation that our technology and products have the potential to effectively fill a large unmet need."
- here is the release