STENTYS: Results of Self-Apposing Sirolimus-Eluting Stent Trial Published in EuroIntervention

Regulatory News:

STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing^® coronary stent, today announces that the results of the APPOSITION IV trial, which compared the STENTYS Self-Apposing Sirolimus-eluting coronary stent to the Medtronic Resolute^® stent in patients presenting with ST-segment elevation myocardial infarction (STEMI), were published in the February issue of EuroIntervention, the official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

The clinical study demonstrated that stent apposition was statistically better in the STENTYS group than the balloon-expandable group at 4 months, with a greater percentage of STENTYS stents fully covered, a surrogate marker of healing. At 9 months, the use of STENTYS SES showed no reduction in artery lumen diameter with a near perfect strut coverage.

The authors wrote: "The absence of any reduction in minimum lumen diameter combined with a very high rate of strut coverage is a good indicator of long-term safety for the STENTYS SES”. They added: "Another interesting finding is the augmented lumen size in the STENTYS arm: with the addition of sirolimus elution, this benefit is extended to four and nine months.”

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, commented: "The Self-Apposing Sirolimus-eluting stent, which is now commercialized with its new delivery catheter under the brand Xposition S, is the only stent that can guarantee complete and continuous apposition even when treating heart attack patients. We believe this publication will reinforce the adoption of our technology among cardiologists looking for the optimal stent solution for their patients.”

The publication can be found at http://www.pcronline.com/eurointervention/93rd_issue/volume-11/number-11/248/stentys-self-apposing-sirolimus-eluting-stent-in-st-segment-elevation-myocardial-infarction-results-from-the-randomised-apposition-iv-trial.html

About the APPOSITION IV study

APPOSITION IV is a prospective, randomized, four-arm, multi-center study designed to compare the STENTYS Sirolimus eluting stent (90 patients) with Medtronic Resolute® (62 patients) in the treatment of ST-elevation Myocardial Infarction. Patients were followed up at either 4 months (63 patients) or 9 months (89 patients). Stent apposition was statistically better in the STENTYS group than the balloon-expandable group at 4 months, and a greater percentage of STENTYS stents were fully covered by vessel tissue (33% vs 4%, p=0.02), a marker for healing. At 9 months, the STENTYS SES showed no reduction in artery lumen diameter (Late Lumen Loss of 0.00mm [–0.23; -0.19] under QCA) with a near perfect arterial healing (99% covered struts at 9 months under OCT).

About STENTYS

STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS’ Self-Apposing^® 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 2014 Registration Document (document de référence) filed with the French Autorité des Marchés Financiers on July 29, 2015 under number D.15-0807 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

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