Ask Gideon Sturlesi, CEO of Caesarea, Israel-based LifeBond, about the surgical sealant market and he'd tell you it’s imperfect.
The existing products on the market all have their benefits, but none offer a complete solution and leakage after colorectal resections is a life-threatening issue.
"There is no solution to the leakage issue," Mr. Sturlesi says.
Anastomotic leakage is a major cause of serious complications following bowel repair involving increased hospital readmission and mortality rates. LifeBond designed its LifeSeal Surgical Sealant to address prevalence of leakage and the unmet need in the marketplace.
"Leaking after colorectal surgery is a big headache. Physicians are losing sleep over it, and if we can solve this specific issue we will improve people's live," Mr. Sturlesi says.
LifeBond’s LifeSeal is a gelatin-based sealant that isn't limited like those that rely on blood derivatives or synthetic components. It's primarily used in open and laparoscopic procedures through an applicator which applies the sealant to tissues. When it's applied the gel forms into an elastic layer which conforms to the patient's tissue.
The seal is CE marked and available in Europe. LifeBond tested it in a multinational randomized study with 70 high-risk patients. In the study, physicians used either LifeSeal or a standard procedure with no additional reinforcement. Only three experienced a form of leaking after LifeSeal compared to six that underwent the standard treatment.
The company received FDA approval through an Investigational Device Exemption. Mr. Sturlesi is in the process of coordinating a pivotal study in the U.S. which will test the sealant at up to 30 U.S. and 20 European sites.
"For a company of our size, this is a big undertaking," Mr. Sturlesi says. "It's a big study for a big company. There are not many companies that do trials of this size."
Mr. Sturlesi says LifeSeal is met with a certain amount of skepticism because of the inefficiencies the current market products have, but once physicians see what it's about "they have been embracing the product."
Physician praise is going a long way for LifeBond. After surveying several physicians Frost & Sullivan awarded the company a 2016 European New Product Innovation Award for LifeSeal.
Mr. Sturlesi is hoping LifeSeal will be the transformative product in the sealant market.
"We really hope we can bring it also to the US market soon," he says. "It is a privilege to be able to save people's lives, even if it's only one patient."
Mr. Sturlesi says LifeBond is always open for new investors. The company is still young and is working to establish itself in the European and North American market. In 2018, it'll pursue an additional financing. It's looking to secure funds through three methods: a partnership, a public offering or through private financing.
For more information on LifeBond click here.