Tryton Announces Enrollment Completion of Two European Registries

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced completion of
enrollment in E-Tryton 150 and E-Tryton Benelux, two European registry
studies of the company’s TRYTON Side Branch Stent™ System for the
treatment of atherosclerotic lesions in the side branch at the site of a
bifurcation.

Tryton Medical is conducting various registries in Europe evaluating the
Tryton Side Branch Stent System in real-world clinical settings. In
addition to E-Tryton 150 and ETryton Benelux, E-Tryton Spain (TRES)
continues to enroll patients.

More than 1,000 patients in Europe have been treated with the Tryton
Side Branch Stent System.

“Early data for the Tryton Side Branch Stent System is very promising.
The E-Tryton studies will help us understand the use of the TRYTON Side
Branch Stent System in real-world practice,” said Pieter R. Stella,
M.D., Ph.D., director of the Heart Catheterization Laboratories and
Clinical Cardiovascular Research at the University Medical Centre in
Utrecht, the Netherlands, who participated in E-Tryton Benelux.

Areas of bifurcation in the vascular system are a common location for
plaque and are particularly challenging to treat with currently
available stent systems. 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. Approximately
twenty-two percent of patients treated for coronary artery disease have
diseased bifurcated lesions.

The E-Tryton 150 study enrolled 151 patients, and E-Tryton Benelux
enrolled 155. The primary endpoint of the studies is the overall rate of
major adverse cardiac events (MACE) at six months following the
procedure. MACE is defined as cardiac death, myocardial infarction and
target lesion revascularization (main and/or side branch). The studies
will also assess the technical success of the Tryton stent, procedural
success, and the rate of target lesion revascularization (TLR) at six
(6) months after the procedure.

“Completion of enrollment in E-Tryton 150 and E-Tryton Benelux are
important milestones for Tryton,” said J. Greg Davis, president and CEO
of Tryton Medical. “We look forward to completing enrollment in E-Tryton
Spain (TRES) and sharing the real-life practice results of these
studies.”

About the Tryton Side Branch Stent System

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 highly deliverable cobalt chromium stent
is deployed in the side branch artery using a standard single-wire
balloon-expandable stent delivery system. A conventional drugeluting
stent is then placed in the main vessel.

The Tryton Side Branch Stent System demonstrated excellent six-month
clinical results in a first-in-man study of the system in 30 patients,
with no restenosis occurring in the side branch artery. The stent system
has received CE Mark approval in Europe and 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`s Side Branch Stent System, approved for sale in Europe, is
designed to offer a dedicated strategy for treating these challenging
cases. The privately held company is backed by Spray Ventures, PTV
Sciences, and RiverVest Ventures. For more information please visit trytonmedical.com.