4000th Patient Treated With Innovative Tryton 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 more than
4000 patients have been treated with the company’s Tryton™ Side Branch
Stent in Europe, Russia and the Middle East.

New data continues to demonstrate positive results for the Tryton side
branch stent. Results from 250 patients in the SAFE-TRY registry were
presented last week by Giuseppe Tarantini, M.D., of the department of
Cardiac, Thoracic and Vascular Sciences at the University of Padova,
Italy, during the annual Joint Interventional Meeting (JIM) in Rome.

SAFE-TRY is a prospective, multicenter registry to test safety and
feasibility of the Tryton stent to treat de novo bifurcation
lesions. Findings showed a rate of target lesion revascularization (TLR)
of 4.8 percent at nine months follow up, and no incidents of late stent
thrombosis.

“This real-world data continues to reinforce the excellent safety and
effectiveness of the Tryton stent system,” said Dr. Tarantini. “The
results are especially impressive because of the inclusion of complex
bifurcations and left main lesions, which are particularly difficult to
treat. These results underscore why the Tryton stent represents the
standard of care in my lab.”

“In study after study, Tryton has demonstrated consistently favorable
results, with TLR rates around 4 percent in more than 900 patients at
greater than six months follow up,” said Shawn P. McCarthy, president
and CEO of Tryton Medical. “Our commitment to generating meaningful
clinical outcomes is clear, as we remain on schedule to complete
enrollment in the landmark randomized Tryton IDE study this year. We are
carrying significant momentum into 2012, with more than 4,000 patients
treated with the Tryton side branch stent demonstrating substantive
adoption and routine use in clinical practice.”

The Tryton stent is being studied in the first and only randomized U.S.
IDE clinical trial evaluating dedicated bifurcation stents in 704
patients. The results of the trial will be submitted to the U.S. Food
and Drug Administration (FDA) for approval to market the device in the
United States.

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.¹ In patients
undergoing PCI-stenting, approximately one-third has 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 Study

The landmark Tryton IDE 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 clinical trial of a bifurcation stent,
will enroll over 700 patients from up to 75 centers in North America,
Europe and Israel. 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.