Tryton Announces Investigational Device Exemption Conditional Approval from FDA to Conduct U.S. 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 U.S. Food and
Drug Administration (FDA) conditional approval for an Investigational
Device Exemption (IDE) application to initiate the pivotal trial to
evaluate the Tryton Side Branch Stent System™ for the treatment of
coronary artery 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.

Martin B. Leon, M.D., 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, will serve 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 highly encouraging, and I look forward to results
from this important trial.”

“The conditional approval of the investigational device exemption for
the Tryton stent is a significant milestone for our company,” said J.
Greg Davis, president and CEO of Tryton Medical. “We have seen
substantial interest and adoption of the Tryton solution in Europe thus
far and are excited to take the first step to bring this innovative
treatment to patients and physicians in the United States.”

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 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. The
study will enroll 700 patients at up to 75 centers in North America and
Europe.

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.