Tryton Medical Announces Completion of Patient Enrollment in Landmark Pivotal Study of Side Branch Stent

Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced the completion
of enrollment in the TRYTON Pivotal IDE trial evaluating the Tryton Side
Branch Stent.™

The landmark Tryton pivotal study is an international randomized trial
that compares a Tryton stent in the side branch vs. conventional
provisional stenting (balloon angioplasty) in the side branch, with both
arms of the trial utilizing a standard drug eluting stent in the main
vessel.

The study, which is the first and only randomized IDE pivotal clinical
trial to evaluate a dedicated bifurcation stent, has enrolled 704
patients at 67 centers in North America, Europe and Israel. 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.

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.

“Completion of patient recruitment is a major milestone for the Tryton
IDE Pivotal Trial, which is truly a landmark study. In addition to being
the first powered randomized controlled trial evaluating a dedicated
side branch stent, it is the largest coronary bifurcation study ever
attempted and the first one to have core angiographic (3D and planar)
and IVUS sub-studies. The results of the Tryton study will directly
guide the treatment of patients with complex bifurcation disease,” said
Dr. Leon. “Our current inability to treat these lesions with ‘work
horse’ drug eluting stents, represents an important unmet clinical need
which confronts interventional cardiologists. From my travels to Europe
and Israel, I have been impressed with how easily the Tryton Stent is
incorporated into routine practice. We look forward to results from this
trial.”

“Tryton Medical’s differentiated technology addresses the challenges of
bifurcated lesions, which affect nearly a third of patients undergoing a
PCI procedure. Data from more than 1,000 registry patients in Europe
treated with the Tryton stent are already challenging provisional
stenting, with compelling results of target lesion revascularization of
four percent and thrombosis of 0.5 percent at one year,” said Shawn P.
McCarthy, president and CEO of Tryton Medical. “We are looking to
corroborate this positive registry data in the Tryton Medical randomized
controlled study. With more than 6,000 implants to date, we are
leveraging our impressive data to further expand globally. We are on
track to be the first and only approved stent for coronary bifurcations
in the U.S.”

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. In patients undergoing
PCI-stenting, approximately one-third have 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 the Randomized Tryton IDE Pivotal Study

The landmark Tryton pivotal study is a multi-national randomized trial
that 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 study, which is the
first and only randomized IDE pivotal clinical trial evaluating a
dedicated bifurcation stent, enrolled 704 patients at 67 centers in
North America, Europe and Israel, and includes angiographic and IVUS
substudies. Martin Leon, M.D. (Columbia University, New York) serves as
principal investigator for the study and Patrick Serruys (Thoraxcenter,
Rotterdam) is leading IVUS and three-dimensional angiographic analysis.

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. Privately held, Tryton is backed by Arnerich
Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest
Ventures. For more information please visit trytonmedical.com.