Medical device firm OptMed has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its topical surgical skin adhesive product, BondEase.
The company has developed the topical skin adhesive for the closure of surgical incisions and lacerations, as well as an alternative to sutures and staples.
BondEase is a biocompatible and topical skin adhesive, which aggregates new polymer technology with user-friendly delivery device.
OptMed co-chairman Steven Sands said: "The FDA’s clearance of BondEase builds on Sands Brothers’ prior success in the early-stage financing and continued support towards the development of Dermabond, which was acquired by Johnson & Johnson’s Ethicon division.
"This success resulted in substantial commercialization and creation of value for stakeholders; I am confident that BondEase will yield similar results."
The firm has conducted randomized open label trials, which enrolled 162 patients in six surgical centers in the US, to demonstrate the efficacy of BondEase.
According to the company, the incidence of 100% wound closure at ten days is the primary endpoint, and optimal cosmetic outcome at 28 days and the incidence of >50% wound closure at ten days as the secondary endpoints.
OptMed CEO Dr Ervin Braun said: "FDA clearance of BondEase represents a significant advance for OptMed and its ability to move innovative medical products through clinical development and the regulatory process."
The company plans to make the skin adhesive product available to customers in later part of the year.