DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced an initial closing of an aggregate $20 million private equity financing. Participating in this financing were existing investors RiverVest Venture Partners and 3x5 Special Opportunity Fund joined by new investor Canepa Advanced Healthcare Fund and an unnamed investor. Alejandro Sanchez from Canepa U.S., which serves as Investment Advisor to Canepa Advanced Healthcare Fund, will be joining the Tryton Medical Board of Directors.
"The Company will use these proceeds to complete enrollment in the Tryton IDE Extended Access Registry, to support our U.S. Food and Drug Administration (FDA) submission, and to develop the left main market opportunity with the CE approved left main stent indication for our Tryton Side Branch Stent", said Shawn P. McCarthy, President & CEO of Tryton Medical. "Tryton Medical’s differentiated technology addresses the challenges of bifurcation lesions, which affect nearly one third of patients undergoing a PCI procedure. The Tryton Side Branch Stent has now been used to treat more than 10,000 patients around the world, and we're positioned to be the first and only coronary stent approved for use in treating bifurcation lesions in the United States."
The Tryton Side Branch Stent is commercially available in multiple countries within Europe, Middle East & Africa, is investigational in the US, and is not available in Japan. Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75 percent of left main lesions are bifurcation lesions.
About the Tryton IDE Extended Access Registry
The Tryton IDE Extended Access Registry builds on the results of the TRYTON IDE Study, which showed the benefit of the Tryton Side Branch Stent in a post-hoc analysis of the intended population, complex bifurcation lesions involving significant (≥2.25 mm RVD by QCA) side branches. The Tryton IDE Extended Access Registry is designed to confirm these results in the intended population. Results from this registry together with the results from the Pivotal IDE Trial will be submitted to the US Food and Drug Administration to seek approval of the device in the United States. Martin B. Leon, M.D., F.A.C.C., professor of Medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, and founder and chairman emeritus of the Cardiovascular Research Foundation, serves as principal investigator of the Pivotal IDE Trial and Extended Access Registry.
About the Tryton Side Branch Stent System
The Tryton Side Branch Stent System is built for bifurcation using proprietary Tri-ZONE® technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel. For more information please visit www.trytonmedical.com and follow the company on Twitter at @TrytonMedical1.