PARIS--(BUSINESS WIRE)--Regulatory News:
STENTYS (Paris:STNT) (FR0010949404 – STNT), a medical technology company commercializing the Xposition S self-apposing coronary stent, today announces the pre-commercialization of Serpentis, its new Sirolimus-eluting stent with a bio-absorbable coating for routine procedures.
Co-developed with a French industrial partner, Serpentis has received CE Marking and will be pre-commercialized by the end of the year to a selection of pilot centers across Europe. This new latest-generation active coronary Sirolimus drug-eluting stent is made of thin cobalt chromium mesh with a bio-absorbable polymer coating.
With Serpentis, dedicated to routine procedures, and Xposition S, designed for more complex indications, STENTYS expands its product portfolio to cover all of its clients’ requirements. Furthermore, Xposition S has proven its efficacy in the SIZING study, of which the interim results were presented earlier this month at Transcatheter Cardiovascular Therapeutics (TCT) 2017, the international cardiac interventional conference in Denver, Colorado.
Christophe Lottin, Chief Executive Officer of STENTYS, comments: “We are very pleased with the launch of Serpentis and firmly believe in its potential. This new stent enables us to address a large number of routine procedures at a competitive price, in addition to our flagship product, Xposition S, of which the clinical benefit, for the treatment of complex lesions and blood vessels with fluctuating diameters, has once again been demonstrated by the SIZING study. With Serpentis and Xposition S, our portfolio now covers a large number of coronary indications and will enable us to support our growth. The rapid implementation of the Serpentis project illustrates our momentum and our ambitions for STENTYS and I want to thank all the teams involved.”
About the results of the SIZING study
The aim of the SIZING international registry, conducted on 1,300 patients, is the large-scale assessment of Xposition S, the proprietary coronary stent of STENTYS, within the framework of clinical practice. The results of the analysis of the cohort treated with Xposition S (588 patients) validate the benefits of using this self-apposing stent for complex anatomies. In 36% of cases, Xposition S was selected for lesions on vessels of varying diameters, in 17% for thrombotic lesions, in 16% for bifurcations, in 7.5% for vein grafts. 27% of analyzed cases presented a substantial vessel diameter (≥ 4.5mm). Despite these complex anatomies, a low rate of major adverse cardiac events (MACE) was observed after 12 months of monitoring, as well as a low rate of stent thrombosis (0.75%). The positive results of this exploratory analysis of the SIZING data confirm the benefits of self-apposing coronary stents in the treatment of specific lesions, leading to a low MACE rate.
STENTYS develops and commercializes innovative solutions for the treatment of patients with complex artery disease. STENTYS’ Self-Apposing® drug-eluting stents (DES) 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 for the treatment of acute myocardial infarction showed a very low mortality rate at one year and a faster arterial healing compared to conventional stents. The company’s product portfolio also includes MiStent SES® and Serpentis, two innovative coronary DES for routine interventions, and is marketed through STENTYS’ commercial network in Europe, the Middle East, Asia and Latin America.
Additional information is available at www.stentys.com
STENTYS is listed on Compartment C of Euronext Paris
ISIN: FR0010949404 – Ticker: STNT
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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 2015 Registration Document (document de référence) filed with the French Autorité des Marchés Financiers (AMF) on August 30, 2016 under number D.16-804.