IVUS Cohort Recruitment Complete in Landmark Tryton IDE Study

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced completion of
patient enrollment in the intravascular ultrasound (IVUS) cohort of the
randomized, controlled Tryton IDE Study evaluating the TRYTON Side
Branch Stent for the treatment of bifurcation disease. Results of the
multi-national Tryton IDE Study will be submitted to the U.S. Food and
Drug Administration (FDA) for approval to market the device in the
United States.

“The Tryton IDE Study is the first randomized clinical trial of this
magnitude to evaluate a dedicated bifurcation stent, and will no doubt
make an important contribution to our understanding of PCI-stenting of
bifurcation lesions,” said Martin B. Leon, M.D., professor of Medicine
and director of the Center for Interventional Vascular Therapy at
Columbia University Medical Center, who serves as principal investigator
of the study. “IVUS cohort completion is an important recruitment
milestone for the Tryton IDE Study, demonstrating the dedication of the
superb team of investigators.”

“Tryton Medical is proud of our role in this landmark study,” said Shawn
McCarthy, president and CEO of Tryton Medical. “The Tryton IDE Study is
the capstone of our clinical program, which includes a growing body of
clinical data from more than 700 patients in European registries and
investigator-initiated trials that show target lesion revascularization
rates consistently below 4% at greater than six month follow-up. These
studies complement our experience in approximately 3,500 implants,
demonstrating Tryton’s routine use in clinical practice.”

More than 175 patients have been enrolled to date in the Tryton IDE
study. The randomized trial compares a Tryton stent in the side branch
vs. the use of balloon angioplasty in the side branch, with both arms of
the trial utilizing a standard drug eluting stent in the main vessel.

The primary endpoint of the study is target vessel failure at nine
months. A secondary endpoint is percent diameter stenosis at nine months
in the side branch vessel as assessed in an angiographic subgroup. The
study will enroll 704 patients at up to 75 centers in North America,
Europe and Israel. Approximately 400 patients will undergo angiographic
follow up at nine months.

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.¹ In patients
undergoing PCI-stenting, approximately one-third has 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

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.

The stent system has received CE Mark and is commercially available
throughout Europe, Russia and the Middle East. It is approved in the
United States for investigational use only.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is a 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 to develop stents for the definitive treatment of
bifurcation lesions. The Tryton Side Branch Stent System, approved for
sale in Europe, is designed to offer a dedicated strategy for treating
these challenging cases. Privately held, Tryton is backed by Arnerich
Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest
Ventures. For more information please visit trytonmedical.com.

¹ Scot Garg, et al. EuroIntervention 2011:6: 928-935.
Available online at http://www.pcronline.com/eurointervention/34th_issue/162/