[May 23, 2013]

Tryton Medical Announces Nordic-Baltic Dedicated Bifurcation Trial Studying the Tryton Side Branch Stent

Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced that the Nordic-Baltic Bifurcation Study Group will investigate the Tryton Side Branch Stent. The trial is a prospective, controlled, randomized, multicenter clinical study examining the role of final kissing balloon inflations in patient outcomes. A total of 150 patients will receive the Tryton Side Branch Stent with a drug-eluting stent, with evaluation by intravascular Optical Coherence Tomography (OCT) imaging technology.

The announcement was made today in Paris at EuroPCR 2013, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

"The use of a dedicated bifurcation stent, such as the Tryton Side Branch Stent, is a natural evolution for the Nordic-Baltic Bifurcation Study Group," said Jens F. Lassen, M.D., of the Department of Cardiology, Aarhus University Hospital, Skejby and principal investigator for the study. "The trial will examine if we can maintain the superb results reported thus far in the literature with the Tryton Stent utilizing a streamlined treatment protocol. Additionally, the Study Group looks forward to utilizing OCT to better characterize complex bifurcation treatment strategies."

The Nordic-Baltic Dedicated Bifurcation Trial is the latest investigation from the Study Group, which has a history of examining different techniques for treating bifurcation lesions in the Nordic I, II, III and IV studies. The publications associated with these studies are among the most frequently cited by interventional cardiologists.

"Tryton Medical is honored the prestigious Nordic-Baltic Bifurcation Study Group has chosen to examine the market-leading Tryton Side Branch Stent in this trial," said Shawn McCarthy, CEO of Tryton Medical. "We are a company committed to investing in evidence-based care as demonstrated in our extensive real-world globa registries, our randomized U.S. pivotal study, and, now, with these world-class investigators studying the optimization of the Tryton Stent in bifurcations."

The Tryton Side Branch Stent is supported by robust clinical evidence in more than 1,000 patients. Published data in a patient pooled analysis from more than 900 patients treated with the Tryton Side Branch Stent in more than 8 European post-marketing registries demonstrated low target lesion revascularization rates of 2.9 percent at six months and 4.0 percent at one year, and a low 0.5 percent thrombosis rate at one year. More than 7,500 patients have been treated with the Tryton Side Branch Stent and it is commercially available throughout Europe, Russia and the Middle East. The Tryton Side Branch SHORT Stent was introduced this week at EuroPCR, enabling physicians to broaden treatment options in bifurcations in large vessels with a short main branch landing zone.

The Tryton Side Branch Stent is an investigational device in the United States. Tryton has completed enrollment in the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent and anticipates study outcomes will be presented at TCT 2013 in San Francisco.

About Coronary Bifurcation Disease

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 (News - Alert)-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. The Tryton Side Branch Stent has not been studied extensively in left main disease.

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 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 3x5 Special Opportunity Fund. For more information please visit www.trytonmedical.com and follow the company on Twitter (News - Alert) at @TrytonMedical1.

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