Tryton Medical Enrolls First Patient in the EXTENDED Access Registry

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents to treat bifurcation lesions, announced that the first patient has been enrolled in the EXTENDED Access Registry (Tryton IDE XA registry), a single arm study of its Tryton Side Branch Stent. The Tryton IDE XA registry is designed to support FDA submission for US approval and is expected to enroll 133 patients from Europe and the United States. Indulis Kumsars, M.D. of P. Stradins University Hospital, Latvian Centre of Cardiology enrolled the first patient.

The Tryton IDE XA registry builds on the results of the TRYTON IDE Study, which showed the benefit of the Tryton Side Branch Stent in the intended population, complex bifurcation lesions involving significant (>2.25 mm RVD by QCA) side branches. The Tryton IDE XA 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.

“We look forward to the Extended Access Registry to confirm the improved outcomes observed in patients with complex bifurcation lesions involving significant side branches, the intended cohort of the TRYTON IDE Study.” said Dr. Leon. “I thank the EXTENDED Access Registry investigators for continuing to contribute to this important work.”

“The Tryton Side branch Stent allows me to treat complex bifurcation lesions in a predictable way securing the large side branch from onset of procedure.” said Indulis Kumsars, M.D. of P. Stradins University Hospital, Latvian Centre of Cardiology. “I am excited to participate in this study that I expect to confirm the low Tryton peri-­‐procedural MI rates in side branches larger than 2.25mm, confirming the post-­‐hoc analysis from the pivotal study.”

“Tryton Medical is excited to reach this next milestone on its pathway to US approval,“ said Shawn McCarthy, CEO of Tryton Medical. “We remain on track to be the first and only approved stent for coronary bifurcations in the U.S.”

The Tryton Side Branch Stent is commercially available in Europe and parts of the Middle East, 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. In patients undergoing PCI-­‐stenting, approximately one-­‐third have a bifurcation lesion. 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 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.

About the Bifurcation Institute

The Bifurcation Institute is a comprehensive education resource established to advance the standard of care for bifurcated coronary artery disease, a common, and often untreated, clinical need. For more information please visit www.bifurcationinstitute.com.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is the leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth-­‐Hitchcock Medical Center) and Dan Cole of Spray Venture Partners to develop stents for the definitive treatment of bifurcation lesions. Privately held, Tryton is backed by PTV Sciences, RiverVest Venture Partners, Spray Venture Partners, and the 3×5 Special Opportunity Fund. For more information please visit trytonmedical.com and follow the company on Twitter at @TrytonMedical1.