09.07.2014 17:46:00

STENTYS Expands Marketing of the Self-Apposing Stent in South America

Regulatory News:

STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company commercializing the world’s first and only Self-Apposing® stent to treat acute myocardial infarction (AMI), today announced its first distribution contracts in South America.

STENTYS has established distributor agreements in Argentina, Chile and Colombia. These contracts represent the first step in STENTYS’ strategy to expand its commercial presence into the Latin American coronary stent market, which is estimated to be worth over $200 million.

STENTYS intends to extend its coverage to other countries in this region, notably Brazil, Mexico and Venezuela, by the end of 2015.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, commented: "After recent expansion into the Middle East in 2013 and Southeast Asia at the beginning of this year, entering into new distributor relationships in South America clearly indicates the successful execution of our worldwide growth strategy. The ramp up in these high-potential emerging markets will be further supported next year by the commercialization of the Sirolimus-eluting stent, which should obtain CE Marking during the second half of 2014.

  • 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
The 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 second half of 2014.

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 French Autorité des Marchés Financiers on August 27, 2013 under number R.13-040 as such section may be updated from time to time.

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

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