PRINCETON, N.J. and PARIS – November 3, 2014
STENTYS (FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announced it has entered into a five year agreement with Micell Technologies Inc. to be the exclusive distributor of the MiStent coronary stent worldwide (excluding the United States, Canada, China, South Korea and Japan).
Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, explains: “We are thrilled to launch this exciting new product that is designed to outperform the market-leading workhorse stents thanks to a unique coating technology. Our customers will now have the opportunity to use MiStent for routine procedures and STENTYS Self-Apposing stent for complex vessel anatomy that requires optimal apposition, both of which are designed for safe vessel healing and improved patient outcomes.“
“This long-term partnership is one more building block of the company’s growth strategy. With two CE marked Sirolimus-eluting stents covering all coronary indications and commercialized through our fast increasing sales network, we will strengthen our market position, increase access to our target audience, as well as create an opportunity for even greater revenue growth,“ concluded Gonzague Issenmann.
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is a balloon-expandable stent designed for rapid healing and slow progression of coronary artery disease. The bioabsorbable coating of MiStent SES disappears within three months of implantation to promote fast vessel healing. However, sirolimus elution is precisely and consistently controlled up to nine months after implantation, thereby inhibiting vessel renarrowing. These unique properties of both fast polymer absorption and sustained drug release are made possible by an innovative proprietary coating technology that allows sirolimus to be encapsulated as tiny crystals; once the polymer is gone, the crystals slowly dissolve into the tissue surrounding the stent providing a continued local anti-proliferative and anti-inflammatory effect for several months.
MiStent SES has been studied clinically in the DESSOLVE I and II trials. The first trial on 30 patients showed no reduction in artery lumen diameter between 8 and 18 months (late lumen loss of 0.09mm). The second trial of 184 patients, which compared MiStent SES and Medtronic Endeavor® DES, showed lower MACE at three years in the MiStent SES arm (8.3% vs 15.3%, p=0.2), with a very low rate of re-intervention for MiStent SES (TLR of 2.5% at 3 years) and no definite or probable stent thrombosis.
MiStent SES has received CE Marking and has not yet been marketed. STENTYS plans to launch the product in H1 2015 in Europe, to be followed by the many geographies where STENTYS has built a commercial network. STENTYS and Micell will partner to conduct MiStent’s post-market study, DESSOLVE III.
About DESSOLVE I and DESSOLVE II Studies
The DESSOLVE I trial treated 30 patients suffering from stable angina with MiStent SES® in de novo coronary artery lesions, across five study centers in New Zealand, Australia and Belgium. The primary efficacy endpoint was in-stent late lumen loss and showed no progression beyond eight months. At three years, MACE was 6.9% due to two non target vessel MI and TLR was 0.0%.
The DESSOLVE II trial is a randomized, multi-center study of 184 patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor® Sprint DES. Data analysis confirms that DESSOLVE II met all study objectives. At three years, MACE was 8.3% and TLR was 2.5%.
About Micell Technologies
Micell Technologies is a biomedical company that is enhancing the performance of cardiovascular medical devices with innovative drugdelivery systems. Its unique surface and polymer modification technologies enable Micell to precisely and consistently control drug elution and polymer exposure duration, creating the potential for a therapeutic solution to coronary artery disease without the long-term safety concerns of currently available drug-eluting stents. Micell is also developing a drug-coated balloon for vascular interventions. More information is available at www.micell.com.
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters 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 heart attack patients when compared to recent studies with conventional stents. More information is available at www.stentys.com.
Safe Harbor Statements
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, 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.
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STENTYS is listed on Comp. B of the Euronext Paris
ISIN: FR0010949404 – Ticker: STNT
Investor Relations / Strategic Communications
Dusan Oresansky / Pierre Laurent
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