Tryton Announces Enrollment of First U.S. Patient in Pivotal Study of Side Branch Stent

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced that the first
U.S. patient has been enrolled in the pivotal trial to evaluate the
Tryton Side Branch Stent System™ for the treatment of coronary artery
disease.

Thomas M. Broderick, M.D., F.A.C.C., of The Christ Hospital Heart and
Vascular Center in Cincinnati, Ohio enrolled the first U.S. patient in
the study.

“Bifurcation lesions are a serious challenge facing U.S. physicians and
many patients with coronary artery disease,” said Dean J. Kereiakes,
M.D., F.A.C.C., medical director of The Christ Hospital Heart and
Vascular Center, and site Principal Investigator. “The Tryton Stent
System offers an innovative solution for these difficult cases. We are
extremely pleased to have enrolled the first U.S. patient in this
important study and we are encouraged by the overall performance of the
device.”

“Initiating this first and only randomized, multi-center bifurcation
trial in the United States is a major milestone, and brings us one step
closer to providing the Tryton Stent System to physicians and patients
in the United States” said J. Greg Davis, president and CEO of Tryton
Medical. “The Tryton Stent has been very positively received in Europe,
where it has been commercially available for more than a year, and this
trial is an important next step in our evolution.”

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 study.

“There is a significant need for alternative solutions for treating
bifurcation disease, a persistent and challenging problem for
interventional cardiologists that occurs frequently – in about two out
of ten cases,” said Dr. Leon. “Data from previous studies of the Tryton
solution have been encouraging, and I look forward to results from this
trial.”

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.

The randomized, controlled study will compare the use of the Tryton
stent in the side branch in conjunction with a standard drug eluting
stent in the main vessel vs. the use of angioplasty in the side branch
with a standard drug eluting stent in the main vessel for the treatment
of complex bifurcation disease. The study will enroll 704 patients at up
to 75 centers in North America and Europe. 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.

About the Tryton Side Branch Stent

The Tryton Side Branch Stent System is designed to offer a dedicated
strategy for treating atherosclerotic lesions in the side branch at the
site of a bifurcation. 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 approval in Europe and is
commercially available in 21 countries throughout Europe 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.