STENTYS Self-Apposing® Stent Demonstrates Lowest Mortality Rate Among Large Heart Attack Trials

  STENTYS Self-Apposing® Stent Demonstrates Lowest Mortality Rate Among Large
  Heart Attack Trials

 One-year APPOSITION III results in 1,000 heart attack patients presented at

Business Wire

PRINCETON, N.J. & PARIS -- March 9, 2013

Regulatory News:

STENTYS (Paris:STNT - FR0010949404), a medical technology company
commercializing in Europe the world's first and only Self-Apposing^® Stent to
treat acute myocardial infarction (AMI), announced today one-year results of
the APPOSITION III clinical trial in 1,000 patients post treatment of a severe
heart attack at ACC.13, the American College of Cardiology’s Scientific
Session & Expo.

The APPOSITION III trial is a prospective, single-arm, multi-center study
designed to assess the long term performance of STENTYS Self-Apposing Stents
in routine clinical practice in Europe among patients suffering from
ST-elevation myocardial infarction (STEMI). The primary endpoint, Major
Adverse Cardiac Events rate (MACE, defined as cardiac death, target vessel
re-MI, emergent by-pass, or clinically-driven TVR) at one year, was 9.3%,
where conventional stents average 11.1% in a pooled analysis from ACTION Study
Group (Pitié-Salpêtrière Hospital, Paris). At the one-year time point, the
cardiac death rate was 2.0%, as compared with rates for conventional stents in
other published trials which average 3.9%, the lowest rate being 2.2%.

“The very low rates of mortality (2.0%) and target-vessel re-infarction (1.3%)
in the APPOSITION III study clearly highlight the excellent safety profile of
Self-Apposing stents,” commented Prof. Gilles Montalescot, M.D., Ph.D., Head
of the Cardiac Care Unit at Pitié-Salpêtrière Hospital and investigator of the
study, who presents the data at the conference.

“The strong results reported today continue to suggest the superiority of the
Self-Apposing Stent in the treatment of AMI,” said Gonzague Issenmann, CEO and
co-founder of STENTYS. “We expect these data will contribute to the ongoing
adoption of the technology among cardiologists in Europe and further support
the initiation of our FDA-approved U.S. pivotal trial, APPOSITION V, during
the first half of 2013.”

In its latest guidelines on AMI treatment, the European Society of Cardiology
(ESC) calls attention to the importance of selecting the appropriate stent
size. During a heart attack treatment procedure, the presence of a thrombus
(clot) and the natural vessel contraction prevent cardiologists from
determining the artery diameter with certainty. When selecting a conventional
stent size, there is a risk of under sizing, causing malapposition, or
oversizing, causing vessel wall injury; either leads to increased risk of
heart attack recurrence. The STENTYS Self-Apposing Stent solves that
“stent-sizing dilemma”: it fits into the contour of a blood vessel, and its
shape and diameter adapt as the vessel dilates and the initial clot dissolves
during the post-AMI phase.

About the STENTYS Self-Apposing^® Stent

The STENTYS Self-Apposing^® Stent addresses the stent-sizing dilemma that
cardiologists are confronted with when treating heart attack patients. It fits
into the contour of a blood vessel, and its shape and diameter adapt as the
vessel dilates and the initial clot dissolves during the post-AMI phase, thus
reducing the risk of malapposition and complications associated with
conventional stents in this setting. The STENTYS Self-Apposing Stent has been
marketed in Europe since receiving CE Mark in 2010.

About the APPOSITION III Study

APPOSITION III is a prospective, single-arm, multi-center (50 hospitals across
Europe) post-market trial to assess the long term performance of the STENTYS
Self-Apposing stent in routine clinical practice in 1,000 patients suffering
from ST-Elevation Myocardial infarction (STEMI). The trial’s primary endpoint
is Major Adverse Cardiac Events (MACE) at 12 months. MACE is defined as
cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven TVR
by percutaneous or surgical methods. The MACE rate at one year was 9.3% for
the full study population, where conventional stents average 11.1%. Mortality
rate at one year was 2.0%, where conventional stents average 3.9% (pooled
analysis from ACTION Study Group, Prof. G. Montalescot at Pitié-Salpêtrière

About the APPOSITION V Study

APPOSITION V is a prospective, multi-center, randomized, two-arm clinical
trial to evaluate the safety and effectiveness of the STENTYS
Self-Apposing®Stent in the treatment ofde novostenotic lesions in coronary
arteries in 880 patients undergoing primary revascularization due to
ST-elevation myocardial infarction (STEMI) as compared to the Multi-Link
Vision™ coronary system (Abbott Vascular, Inc.). The trial’s primary endpoint
is target vessel failure (TVF), which is defined as a composite of cardiac
death, target vessel recurrent myocardial infarction or clinically driven
target vessel revascularization (TVR) at 12 months post-procedure. The powered
secondary endpoint is acute stent malapposition and will be assessed by
intravascular ultrasound (IVUS) on the first 225 patients. All patients will
undergo clinical follow up at 30 days, six months, nine months and 12 months,
with an annual checkup through three years. Fifty sites are expected to
participate in the U.S. and worldwide. Enrollment is expected to begin in H1


STENTYS is developing and commercializing innovative solutions for the
treatment of patients with acute myocardial infarction (AMI, or heart attack)
and complex coronary artery disease. STENTYS’s Self-Apposing^® Stents are
designed to adapt to vessels with ambiguous or fluctuating diameters,
particularly in the post-infarction phase, in order to prevent the
malapposition problems associated with conventional stents. In the APPOSITION
III clinical trial, STENTYS stents demonstrated a very low one year mortality
rate among 1,000 high-risk AMI patients when compared to recent studies with
conventional stents. More information is available at

This press release contains forward looking statements about the Company’s
business. Such forward looking statements are based on numerous assumptions
regarding the Company’s present and future business strategies and the
environment in which it will operate in the future which may not be accurate.
Such forward-looking statements involve known and unknown risks which may
cause the Company’s actual results, performance or achievements to differ
materially from any future results, performance or achievements expressed or
implied by such forward-looking statements. Such factors include, among
others, risks associated with the development and commercialization of the
Company’s products, market acceptance of the Company’s products, its ability
to manage growth, the competitive environment in relation to its business area
and markets, its ability to enforce and protect its patents and proprietary
rights, uncertainties related to the U.S. FDA approval process, including with
respect to a pre-market approval for the Company’s BMS, slower than expected
rates of patient recruitment for clinical trials, the outcome of clinical
trials, and other factors, including those described in the Section 4 “Risk
Factors” of the Company’s 2011 Registration Document (document de référence)
filed with the Autorité des marchés financiers in France on June 25, 2012
under number R.12-033 as such section may be updated from time to time.

STENTYS is listed on Comp. C of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT


Stanislas Piot, CFO
Tel.: +33 (0)1 44 53 99 42
Europe: NewCap.
Dusan Oresansky / Pierre Laurent
Tel.: +33 (0)1 44 71 94 93
US: MacDougall Biomedical Communications
Kari Watson, Tel.: +1 781 235 3060
Hunter Marshall, Tel.: +1 650 339 7533
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