STNT Stevia Nutra Corporation (CE)

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.

• Quarterly revenues*

€ thousands         Q1 2014         Q1 2013         % Change Revenues         854.0         725.0         +18%

*Non audited

 

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 IJsselmuiden (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 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® StentThe 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.

About STENTYSSTENTYS 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 ParisISIN: FR0010949404 – Ticker: STNT

STENTYSStanislas Piot, +33 (0)1 44 53 99 42CFOstan.p@stentys.comorNewCap.Dusan Oresansky / Pierre Laurent, +33 (0)1 44 71 94 93Financial Communication / Investor Relationsstentys@newcap.frorUS: MacDougall Biomedical CommunicationsCharles Liles, 781-235-3060orChristine Labaree or Hunter Marshall, 650-339-7533stentys@macbiocom.com