STENTYS 2012 annual revenues up 77% over prior year

Regulatory News:

STENTYS (Paris:STNT) (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 fourth quarter and full year revenues¹ for the year 2012.

• 2012 fourth quarter and annual revenues

Over 2012 as a whole, STENTYS revenues were up 77.0% at €2,530.7 thousand. Sales continued to grow (53%) in the fourth quarter of 2012 for a total of €707.5 thousand, characterized by increased pressure on hospital budgets at the year end. The sales performance recorded in 2012 continues to indicate substantial appeal for the STENTYS Self-Apposing stent amongst cardiologists in countries where it has been pre-marketed.

• 2013: expanding globally

STENTYS anticipates that 2013 will be a fruitful year in terms of scientific and sales development, with substantial news flow.

• Clinical trials in Europe and the United States

The final results of the APPOSITION III clinical trial on 1,000 patients, one year after heart attack treatment with a STENTYS stent, will be presented in March at the American College of Cardiology conference in San Francisco (ACC.13). The results of the APPOSITION IV clinical trial, which compares the new STENTYS Sirolimus-eluting stent to Medtronic’s DES in 150 patients, are also expected to be presented this year at a major medical conference.

Lastly, the Company is actively preparing the start of the pivotal clinical trial in the United States (APPOSITION V), with the first patients scheduled to be enrolled during the first half of the year. This first trial in the US will considerably expand the Company’s visibility in the world’s largest market.

• Sales expansion beyond Europe

Based on the experience acquired during pre-marketing activities underway in a number of European countries, STENTYS will enlarge its sales network to new geographical regions where the European CE Mark is recognized by working with local distributors. Furthermore, the Company will continue to develop its own sales force in the European countries where it is already present in order to improve its geographical coverage and increase the number of hospitals in which its products are available.

• Solid cash position at end-2012

At 31 December 2012, STENTYS had cash of €45.6 million. The strong cash position is due in part to €36 million in gross proceeds from the capital increase with rights issue successfully carried out in the fourth quarter of 2012.

• STENTYS shares transferred from compartment C to compartment B of NYSE Euronext

Since 17 January 2013, STENTYS shares have been transferred to compartment B of NYSE Euronext, which includes companies with a market cap of between €150 million and €1 billion. This transfer is a result of the Company’s capitalization at 31 December 2012 and its average capitalization over the last 60 trading days of the year. Such a transfer can be beneficial in enhancing the liquidity of STENTYS shares.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, stated: "In 2013, STENTYS is entering a new era: the initiation of our FDA-approved US pivotal clinical trial as well as new financial resources enable us to execute our global strategy. We hope to confirm the excellent results of the APPOSITION III clinical trial seen to date when we report further data in March, and we will move on to the next stage of our sales strategy by establishing distribution contracts in many new parts of the world.”

• Upcoming Financial Results

STENTYS expects to publish its 2012 annual financial results on 28 March 2013, before market.

¹ Unaudited

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 30-day 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 Compartment B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT