PRINCETON, N.J. and PARIS – June 4, 2014
STENTYS (FR0010949404 – STNT), a medical technology company commercializing in Europe the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), today announced the signing of the acquisition agreement of Cappella Peel Away Inc. (Delaware, USA) and its assets relating to a novel stent delivery system. The acquisition is subject to closing conditions.
The catheter technology will enable the implantation of the Self-Apposing stent in the same manner as a conventional balloon-expandable stent. To release the stent in the vessel at the desired location, the cardiologist inflates a small balloon that splits open the stent-containing sheath. This technology has been used as part of Cappella’s Sideguard® coronary bifurcation stent, which is CE Marked in Europe and has been clinically validated by an extensive number of Sideguard stent implants.
Cappella Peel Away Inc. assets consist of a license agreement on patents related to the novel peel away sheath technology for a stent delivery system, technical specifications and drawings, clinical and regulatory documentation and equipment from Cappella Inc. The latter will retain the rights to the peel-away sheath technology for its Sideguard coronary bifurcation stent and for other potential applications including peripheral vascular indications.
STENTYS will incorporate the technology into its next-generation delivery system for the company’s line of bare metal and drug-eluting stents and expects to start commercializing these in 2015.
Gonzague Issenmann, co-founder and Chief Executive Officer of STENTYS said: “This is STENTYS’ first strategic acquisition, and it results from our active research efforts, including constant monitoring of the landscape for complementary tools to add to our portfolio. We are very excited about the potential for the Cappella Peel Away catheters to offer cardiologists an even friendlier user experience for implantation of our stents and allow more heart attack patients to benefit from STENTYS’ Self-Apposing technology.”
About the STENTYS Self-Apposing® Stent
The 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.
STENTYS 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.
Cappella Inc. is the parent company of ArraVasc Ltd. (www.arravasc.com), which is involved in developing, manufacturing and marketing novel peripheral balloons and catheters. ArraVasc’s first product line, Pirouette™, is a CE marked, industry leading low profile 4F PTA catheter for below the knee application.
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.
Tel.: +33 (0)1 44 53 99 42
STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT
Financial Communication / Investor Relations
Dusan Oresansky / Pierre Laurent
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US: MacDougall Biomedical Communications
Charles Liles, Tel.: 781 235 3060
Christine Labaree or Hunter Marshall, Tel.: 650 339 7533