Interface Biologics Inc. (IBI), a privately held commercial stage developer of transformative biomedical-polymer products, is pleased to announce that AngioDynamics has been granted 510(k) clearance by the U.S. Food and Drug Administration for its BioFlo PICC with IBI's Endexo technology. These vascular access products are expected to launch in the U.S. in the next 30 days and are currently CE marked for Europe and approved in Canada and other international markets. Following its acquisition of Navilyst Medical earlier this year, Angiodynamics now has an exclusive license to incorporate IBI's Endexo technology in its PICCs, ports and dialysis catheter products.
Endexo is a self-locating bio-medical polymer additive that results in a passivating surface that reduces platelet adhesion, protein adsorption and thrombus formation on medical devices. In vitro blood loop model test results show the BioFlo PICC with Endexo technology has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.(i)
"BioFlo with Endexo technology provides AngioDynamics with a truly disruptive technology" said Joseph DeVivo, President and CEO of AngioDynamics. "It 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", stated Tom Reeves, President and CEO of IBI. "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 our Endexo Technology - a significant milestone for IBI and evidence of our continued commercial traction."
(i)Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
About Interface Biologics Inc.
Interface Biologics (IBI) is an early commercial stage privately held company that develops transformative biomedical polymer technology to improve the safety and effectiveness of medical devices. IBI's primary technology focus areas are anti-thrombogenic devices that reduce thrombosis and programmable combination drug delivery devices. For more information about Interface Biologics, please visit www.interfacebiologics.com
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics' diverse product lines include market-leading ablation systems, fluid management systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.
Contacts: Hageman Communications Julie Fotheringham Partner 416-951-7988