Stentys enrolls first patient in left main clinical trial

The TRUNC study is designed to evaluate Xposition S efficacy in 200 patients suffering from Left Main disease

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 commenced enrolling patients in the TRUNC trial, which is designed to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main coronary artery disease.

The first implantation was performed at Treant hospital in Emmen, the Netherlands. Dr Rutger Anthonio and Dr Gillian Jessurun commented: “The procedure went very smoothly. The Xposition S stent is perfectly suited for the treatment of left main lesions, because it guarantees excellent apposition in a vessel segment with substantial diameter variation. In addition, the stent allows easy access to any anatomical side branch without the need to perform kissing balloon inflation, which minimizes overall manipulation.”

Christophe Lottin, Chief Executive Officer of STENTYS, adds: “We are delighted by the start of this study, as left main interventions account for nearly 10% of PCI. We are aiming to demonstrate that the unique properties of our Self-Apposing technology make it the most optimal treatment for this complex indication.”

About the TRUNC study

TRUNC is a prospective, single-arm multi-center trial to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main lesions in routine clinical practice. It is scheduled to include 200 patients in approximately 20 European clinical sites. The primary endpoint is Target Lesion Failure at 12 months. The trial’s steering committee is composed of Prof. Tamburino and Dr. Briguori (Italy) and Dr. Baumbach (UK).

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.
More information is available at www.stentys.com.

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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