Stentys announces CE marking of its longest Xposition stent

Portfolio expansion with the addition of a 37mm stent designed for long coronary lesions

PRINCETON, N.J. and PARIS – STENTYS, a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announces that it has received CE Marking for the longest version of its Xposition S Sirolimus-eluting self-apposing stent.

The Xposition stent portfolio already included three lengths (17 mm, 22 mm and 27 mm), and this 37 mm drug- eluting stent is particularly well-suited to the treatment of lesions in the left main coronary artery and in tapered vessels. Segments longer than 25 mm have been demonstrated to have a higher degree of tapering (diameter difference of 0.5 mm or more) and to be an independent predictor of acute stent malapposition with conventional stents1. Cardiologists now only need to implant a single self-apposing stent rather than a long conventional stent, thus minimizing the risk of malapposition and related complications.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, comments: “We are very pleased to be able to offer cardiologists this new Self-Apposing drug eluting stent that is expected to increase our market share in the hospitals where we market our products.”

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.

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Forward-looking statement

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 (AMF) on July 29, 2015 under number D.15-0807 and as updated in section 4.1 of the Registration Document Update filed with the AMF on February 11, 2016 under number D.15-0807-A01.

Source: Stentys