STENTYS Revenues for the First Quarter of 2013 Up 47% Over Prior Year

  STENTYS Revenues for the First Quarter of 2013Up 47% Over Prior Year

Business Wire

PRINCETON, N.J. & PARIS -- April 25, 2013

Regulatory News:

STENTYS (FR0010949404 – STNT), a medical technology company commercializing in
Europe the world's first and only Self-Apposing^® stent to treat acute
myocardial infarction (AMI), today reports its first quarter revenues to 31
March 2013 and announces the first distributor contracts signed outside of
Europe.

  *Change in quarterly revenues*

€ thousands  Q1 2013  Q1 2012  Var. (%)
Revenues     725.0    494.0    +47%
* Audited

STENTYS recorded a solid first quarter of 2013 with revenues totaling €725.0
thousand, an increase of 47% compared with the same quarter last year.
Revenues during the quarter were driven largely by sales of Self-Apposing
stents using the new-generation catheter introduced in the third quarter of
2012.

  *Geographic expansion beyond Europe

Backed by experience acquired during the pre-marketing phase of the
Self-Apposing stent, STENTYS is pursuing commercial expansion beyond Europe by
forming partnerships with local distributors in new high-potential countries
where the European CE mark is recognized. STENTYS recently signed agreements
with leading regional distributors of cardiovascular products in Saudi Arabia,
Jordan, Lebanon and Egypt. The Company estimates that the Middle East market
for coronary stenting is about €160 million.

  *Clinical update on recent and ongoing trials

  *APPOSITION III clinical trial
    Definitive 12-month data from the APPOSITION III clinical trial on 1,000
    heart attack patients were presented in early March at the prestigious
    annual American College of Cardiology conference. The impressive results
    were covered in the US press and were well received by cardiologists,
    notably in the United States, the world’s largest stent market. In the
    study, STENTYS’ stent showed the lowest mortality rate (2.0%) of any major
    heart attack trial with conventional stents, and the rate of re-infarction
    was also particularly low (1.3%).

  *APPOSITION IV clinical trial
    This randomized trial enrolled 150 heart-attack patients treated with
    either the STENTYS Sirolimus-eluting stent or the Medtronic Resolute^®
    stent, with the objective of comparing long-term stent apposition. The
    4-month results should be announced during the second half of 2013.

  *APPOSITION V clinical trial
    The IDE for the APPOSITION V pivotal study, the last trial in the
    APPOSITION program, has been approved by the US Food and Drug
    Administration (FDA). The trial aims to compare the clinical efficacy of
    the Self-Apposing stent with that of the stent already approved for the
    AMI indication in the US, the Abbott MultiLink stent. The trial is
    expected to be launched during the second quarter of 2013 and will enroll
    approximately 880 patients who will be evaluated 12 months after
    treatment.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS,
concludes: “The solid growth recorded this quarter confirms STENTYS’ steady
expansion, in line with the Company’s plan. Growth in the new countries
outside Europe is expected to be fueled by the excellent results from the
APPOSITION III clinical trial: these results represent the most significant
developments since the creation of STENTYS and provide further evidence that
the Self-Apposing stent is the optimal solution for treating heart attacks.”

  *Upcoming financial results

STENTYS expects to publish its revenues for H1 2013 on 25 July 2013.

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
Hospital).

About the APPOSITION IV Study

APPOSITION IV is a prospective, randomized, two-arm, multi-center study
designed to compare the apposition of the STENTYS Sirolimus-eluting stent with
Medtronic Resolute^® in 150 patients suffering from ST-elevation Myocardial
Infarction. Patients will be followed up at either 4 or 9 months (double
randomization). The powered primary endpoint is strut apposition at 9 months
under OCT. The secondary endpoints are strut apposition at 4 months under OCT,
and strut coverage at 4 and 9 months. The first results are expected to be
announced in H2 2013.

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 revascularization due to ST-elevation
myocardial infarction (STEMI) as compared to the Multi-Link stent (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 2013.

About STENTYS

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’ 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 www.stentys.com.

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

Contact:

STENTYS
Stanislas Piot, CFO
Tel.: +33 (0)1 44 53 99 42
stan.p@stentys.com
Europe: NewCap.
Dusan Oresansky / Pierre Laurent
Tel.: +33 (0)1 44 71 94 93
stentys@newcap.fr
US: MacDougall Biomedical Communications
Charles Liles, Tel.: 781 235 3060
Christine Labaree, Tel.: 650 339 7533
stentys@macbiocom.com
 
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