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

Dateline City:
DURHAM, N.C.

Study to Enroll 704 Patients At Up To 75 Centers in North America and Europe

Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced that the first
patient has been enrolled in the pivotal trial to evaluate the Tryton
Side Branch Stent System™ for the treatment of coronary artery disease.

Indulis Kumsars, M.D., chief of the catheterization laboratory at Pauls
Stradins Clinical University Hospital in Riga, Latvia, enrolled the
first patient.

“Our team is very excited and happy to participate in this first
substantial randomized trial of the Tryton bifurcation device. We look
forward to gaining a better understanding of the role of a dedicated
bifurcation stent in the optimal treatment of these lesions,” said Dr.
Kumsars.

“The enrollment of the first patient in the study is yet another
milestone for Tryton in what has been a very exciting year for the
company,” said J. Greg Davis, president and CEO of Tryton Medical. “We
have gained significant momentum in 2010 – from launching our innovative
product across Europe and the Middle East to a successful fundraising
event. We look forward to rapid enrollment in the pivotal study and
growing product adoption internationally in 2011.”

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.

Approximately 374 patients will undergo angiographic follow up at nine
months. The study will also include an IVUS substudy in 96 patients with
IVUS follow up at nine months.

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 not approved in the United States.

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.

Language:
English

Contact:

Media Contact:
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com