STENTYS’ Next-Generation of Self-Apposing Stent System Receives CE Marking Ahead of Plan

Regulatory News:

STENTYS (Paris:STNT)(FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing^® coronary stent, today announced it received CE Marking for its new Self-Apposing stent system ahead of plan, which will allow the Company to market the new products in Europe and in all the other countries where this certification is recognized. STENTYS will officially launch Xposition S™ at the EuroPCR conference on May 19, 2015.

Xposition S™ is the name of STENTYS’ next-generation sirolimus-eluting Self-Apposing stent. It is delivered by a unique and clinically proven stent delivery system that closely replicates conventional stent implantation techniques, making the implantation of a STENTYS stent easier and requiring practically no training.

The delivery system was designed based on the Cappella Peel Away technology that the Company acquired less than a year ago: a small balloon splits open the sheath containing the stent to release it precisely at the intended location.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, stated: "This CE Marking represents a quantum leap in terms of product design as we now have a stent delivery system that mimics how a conventional stent is implanted, thereby paving the way to much faster adoption of the Self-Apposing technology by interventional cardiologists.”

About STENTYS

STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex artery disease. STENTYS’ Self-Apposing^® drug-eluting stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The APPOSITION clinical trials in the treatment of acute myocardial infarction showed a very low one year mortality rate and a faster arterial healing compared to conventional stents. The company’s product portfolio also includes MiStent SES^®, a coronary DES whose new drug delivery mechanism is designed to match vessel response, and is marketed through STENTYS’ commercial network in Europe, the Middle East, Asia and Latin America. More information is available at www.stentys.com.

Safe Harbor Statements

This press release contains forward-looking statements about the Company that 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 2013 Registration Document (document de référence) filed with the French Autorité des Marchés Financiers on October 29, 2014 under number D.14-1026 as such section may be updated from time to time.

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