|[April 24, 2014]
STENTYS: First Quarter Revenues Up 18% from 2013
PRINCETON, N.J.& PARIS --(Business Wire)--
STENTYS (FR0010949404 - STNT), a medical technology company
commercializing the world's first and only Self-Apposing®
stent to treat Acute Myocardial Infarction (AMI), today announces its
revenues for the first quarter ending March 31, 2014.
Over the first quarter of 2014, STENTYS recorded revenues of €854
thousand, an increase of 18% compared with the same quarter of 2013.
This figure includes sales of the two versions of the Self-Apposing
stent, the bare metal stent (BMS) and the paclitaxel-eluting stent
(DES). STENTYS plans to transition the DES to the Sirolimus-eluting
version, which is more frequently used.
Key clinical data to be presented at the upcoming EuroPCR conference
The STENTYS Self-Apposing stent will be showcased during multiple late
breaking Hotline Sessions at the annual EuroPCR meeting, to be held May
20-24, 2014, in Paris.
Doctor Robert Jan van Geuns (Erasmus Medical Center, Rotterdam, the
Netherlands) will present the final results of the APPOSITION IV
clinical trial, which compares the new STENTYS sirolimus-eluting stent
to Medtronic's Resolute® stent, on May 20 at 1:12 p.m.
Initial 4-month results showed faster arterial healing with the
STENTYS stent, and 9-month results will provide the critical endpoint
of drug elution performance as measured by artery re-narrowing. CE
Mark for this new drug-eluting stent is expected during the second
half of 2014.
Doctor Sander ?sselmuiden (Albert Schweitzer Ziekenhuis, the
Netherlands) will present 6-month results of the ADEPT study,
comparing the STENTYS paclitaxel-eluting stent with STENTYS BMS in 40
patients for the treatment of diseased bypass grafts, on May 20 at
12:48 p.m. The narrowing of coronary bypass grafts represents
approximately 5% of the coronary stent market, and this indication was
added to STENTYS CE certificate in 2013.
Doctor Christoph K. Naber (Contilia Heart and Vascular Center, Essen,
Germany) will present the comparison of the 12-month results of the
OPEN (News - Alert) II study, which enrolled 217 patients treated with the STENTYS
stent, to the landmark BBC trial in the setting of coronary
bifurcation lesion treatment, on May 22 at 3:04 p.m.
Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS,
comments: "In the first quarter of 2014, sales of our stents
continued to grow across all our markets. This momentum should
accelerate, driven both by strong demand among cardiologists for our new
sirolimus-eluting stent, which could receive approval as soon as the
second half of this year, and by the expansion of our distribution
network in high-potential regions."
Upcoming financial publication
STENTYS expects to publish its revenues for the first half of 2014 on
July 24, 2014, after market.
About the STENTYS Self-Apposing® Stent
STENTYS Self-Apposing® Stent addresses the stent-sizing
dilemma that cardiologists are confronted with when treating heart
attack patients or patients with atypical artery anatomy. Its flexible,
self expanding design takes the shape of the patient's unique vessel
anatomy and apposes to the irregular contours of a blood vessel, in
particular after an AMI as the vessel dilates and the clot dissolves. It
reduces 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. The STENTYS
Sirolimus-eluting stent should receive the CE Mark during the 2nd
half of 2014.
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 French Autorité des Marchés Financiers on August
27, 2013 under number R.13-040 as such section may be updated from time
STENTYS is listed on Comp. B of the NYSE Euronext Paris
FR0010949404 - Ticker: STNT
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