STENTYS Reaches 10,000 Self-Apposing Stent implantations

Regulatory News:

STENTYS (FR0010949404 – STNT) (Paris:STNT), a medical technology company commercializing the world’s first and only Self-Apposing^® Stent to treat acute myocardial infarction (AMI), today announced that the Self-Apposing stent has been implanted over 10,000 times in patients worldwide. This milestone further illustrates the popularity of STENTYS’ technology among cardiologists in Europe and a growing number of regions globally.

The Self-Apposing stent was first implanted during a "first-in-man” study in 2007. Since then, STENTYS has enrolled more than 2,000 patients in clinical evaluations and conducted nine international clinical trials that have demonstrated the benefits of Self-Apposing technology over conventional options. The company has expanded marketing in Europe, the Middle East, Asia and South America, and is currently expecting approval of its Sirolimus-eluting stent in Europe before year end.

The STENTYS Self-Apposing Stent solves the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients with conventional stents. The STENTYS Self-Apposing Stent’s 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, thereby eliminating malapposition and the major complications seen with conventional stents.

"The 10,000^th stent implanted represents a major milestone in the company’s history,” said Gonzague Issenmann, CEO and co-founder of STENTYS. "We look forward to educating an even greater number of cardiologists and continuing our expansion to the benefit of all the patients worldwide that cannot be optimally treated with conventional balloon expandable stents.”

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’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 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, 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 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