Closely held Interface Biologics’ licensing partner, AngioDynamics (Nasdaq:ANGO), has been granted 510(k) clearance by the FDA for its BioFlo PICC with Interface’s Endexo technology.
Endexo is a bio-medical polymer additive that results in a passivating surface that reduces platelet adhesion, protein adsorption and thrombus formation on medical devices.
Following its acquisition of Navilyst Medical earlier this year, Angiodynamics now has an exclusive license to incorporate Interface’s Endexo technology in its PICCs, ports and dialysis catheter products.
These vascular access products are expected to be launched in the U.S. in the next 30 days and are currently CE marked for Europe and approved in Canada and other international markets.
“BioFlo with Endexo technology provides AngioDynamics with a truly disruptive technology,” AngioDynamics CEO Joseph DeVivo said in a statement, adding that Endexo shows promise in decreasing the accumulation of catheter-related thrombus, without incorporation of heparin, antibiotics, antimicrobials or any other transient materials typically associated with coated or impregnated technologies.
“This is a transformative event for Interface Biologics,” said CEO Tom Reeves. “We’ve been working with Angiodynamics (previously Navilyst Medical) since November 2009 and have been extremely impressed with the depth and thoroughness of their testing regime.”
The launch of BioFlo PICC with Endexo technology represents the first FDA clearance of a medical device that utilizes the Endexo technology, “a significant milestone for Interface and evidence of our continued commercial traction,” he added.
