STENTYS highlighted as a solution to minimize stent malapposition in clinical practice

Regulatory News:

STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company commercializing the world’s first and only Self-Apposing® Stent for treating acute myocardial infarction (AMI), today announced that the Journal of the American College of Cardiology (JACC) published a “State-of-the-Art Paper” entitled “Mechanisms, Pathophysiology, and Clinical Aspects of Incomplete Stent Apposition,” which highlights STENTYS’ Self-Apposing Stent among novel devices to minimize stent malapposition, also known as incomplete stent apposition (ISA), in clinical practice.

According to the authors: “Some particular clinical scenarios such as acute coronary syndromes, bifurcations, tapered vessels, overlapping stents, and chronic total occlusions might predispose to ISA. Interventional cardiologists should be committed to optimal stent choices and techniques of implantation and use intravascular imaging guidance when appropriate to aim at minimizing acute ISA.”

The authors advise that novel devices, such as STENTYS’ Self-Apposing stent, which already demonstrated an early reduction of ISA compared with balloon-expandable stents during primary PCI, can reduce malapposition and the potentially harmful consequences with which it is associated.

Gonzague Issenmann, co-founder and Chief Executive Officer of STENTYS said: “Malapposition continues to be a challenge for cardiologists, particularly when vessel diameter is ambiguous or fluctuating, as in the post-infarction phase. We are pleased that JACC and the authors provided such a detailed discussion of this issue and its dreadful consequences for patients, and that our Self-Apposing Stent technology was highlighted as a solution to malapposition.”

References: Mechanisms, Pathophysiology, and Clinical Aspects of Incomplete Stent Apposition. Attizzani, et al. J. Am. Coll. Cardiol. 2014; 63(14):1355-1367. Article published in the April 15, 2014 issue.

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 second 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 PiotCFOTel.: +33 (0)1 44 53 99 42stan.p@stentys.comorNewCap.Financial Communication / Investor RelationsDusan Oresansky / Pierre LaurentTel.: +33 (0)1 44 71 94 93stentys@newcap.frorUS: MacDougall Biomedical CommunicationsCharles Liles, Tel.: 781 235 3060Christine Labaree or Hunter Marshall, Tel.: 650 339 7533stentys@macbiocom.com

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