Bio-surgical medical devices maker LifeBond has received CE mark approval for its LifeSeal surgical sealant for use in gastrointestinal (GI) procedures.
The sealant has been designed to minimize staple-line leakage in GI resection procedures. It is claimed to be the only sealant indicated for use in the GI tract to help reduce leaks.
The approval was granted for LifeSeal for use as an adjunct to a suture or staple-line during standard surgical repair of the GI tract.
Now, the sealant can be marketed in 32 European countries that include population of about 500 million.
The firm has also received an expedited access pathway (EAP) designation and priority processing status from the US Food and Drug Administration (FDA) for LifeSeal.
LifeBond will soon begin a new international pivotal trial for the sealant at the sites in the US and Europe.
LifeBond CEO Gideon Sturlesi said: "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."
The company is also engaged in the development of self-fixating hernia mesh called LifeMesh. It also produces tissue adhesives and absorbable hemostats.