Interface Biologics, Inc, the spin-off company begun by Professor Paul Santerre, has received its second FDA clearance in less than a year for AngioDynamic’s BioFlo Port catheter. The catheter is made with Endexo technology, a biomaterial substance invented by the U of T spin-off company. AngioDynamics holds an approximate 15% market share of the U.S. PICC catheter market worth an estimated $375 million.
Added to existing medical devices such as the BioFlo PICC Catheter and the BioFlo Port during the manufacturing process, the Endexo polymer prevents blood clots from accumulating on the surface of catheters or ports, devices implanted under the skin for long-term delivery of medication and access to a patient’s system. During testing, the BioFlo Port catheter showed significant promise, with a 96% reduction in thrombus, or the accumulation of blood platelets.
The FDA announced its clearance of the BioFlo PICC (peripherally inserted) catheter with Endexo in mid-September 2012. The catheter’s performance was compelling, reducing the occurrence of blood clots by 48%.
The new port catheter, however, could bring enormous savings to the health care system. An estimated $1 billion is lost annually in the U.S. health care system due to blood clots forming in ports and catheters. Up to 50,000 deaths per year are attributed to this issue, with cancer patients being the most susceptible population.
Now that the port catheter has received approval by the FDA, AngioDynamics plans to move it swiftly into the marketplace. Chuck Greiner, Vice President of the Global Vascular Access Franchise, was “pleased to have received BioFlo Port clearance ahead of our expected schedule and plan to launch BioFlo ports during the third fiscal quarter of 2014, bringing a financial impact to the second half of FY14.”
Paul Santerre, who has remained at Interface Biologics, Inc. as its Chief Scientific Officer, was encouraged by the announcement. “Having the FDA approve two products with the Endexo technology from Interface Biologic Inc, within one year provides an amazing opportunity for on-going applications and new innovations by this local young spin-off company from the University of Toronto,” he stated.
Santerre is a Professor in the Faculty of Dentistry and the Institute of Biomaterials & Biomedical Engineering (IBBME), as well as IBBME’s former Director. He was the recipient of the 2013 NSERC Synergy Innovation award, which recognizes outstanding achievements in collaborations between universities and industries.