Micell Technologies: First Patient Enrolled in All-comers Randomized Trial of MiStent Against Xience
DURHAM, N.C., March 23, 2015 — Micell Technologies, Inc. announced it has begun patient enrollment in DESSOLVE III, a randomized, controlled clinical trial comparing MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System to XIENCE Everolimus Eluting Coronary Stent System® (Xience®). Robbert J. de Winter, M.D., Ph.D., Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands enrolled the first patient in the study. This clinical investigation is being conducted by the European Cardiovascular Research Institute (ECRI), Rotterdam, The Netherlands and is supported by Micell in conjunction with STENTYS, the Paris- based medical technology company that is Micell’s distribution partner for MiStent.
DESSOLVE III is a prospective, randomized, balanced, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent SES and Xience in a “real world, all-comers” patient population. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes, and qualify for percutaneous coronary interventions. Enrollment will include 1,400 patients randomized to MiStent SES or Xience at approximately 17 clinical sites in Europe. The primary endpoint for this trial is a non-inferiority comparison of a device-oriented composite endpoint (DOCE) or target lesion failure (TLF) of the MiStent SES group versus the Xience group at 12 months post- procedure.
DESSOLVE III will also include an optical coherence tomography (OCT) sub-study evaluation of 60 patients at six and 24 months post-treatment to evaluate and compare for superiority of MiStent SES against Xience in the progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time.
Arthur J. Benvenuto, chairman and chief executive officer of Micell said, “We are conducting DESSOLVE III to further support the importance of MiStent in clinical practice, building on the four- year results from the DESSOLVE I and DESSOLVE II studies that we plan to report later this year. As a new class of drug-eluting stent that allows the drug to remain in the tissue for an extended period – well beyond a rapidly absorbing polymer – MiStent has the potential to offer meaningful clinical and economic benefits to patients and the healthcare system.”
MiStent SES has received CE Mark in the European Union and will be distributed exclusively by STENTYS around the world with the exception of the United States, Canada, China, South Korea and Japan. STENTYS plans a controlled launch in Western Europe followed by a full commercial launch in the second half of 2015 in selected countries within Europe, Middle East, South-East Asia and Latin America.
“We are very excited about the early start of this ambitious all-comers study of MiStent SES against Xience at the time when we are introducing the product in Europe,” said Gonzague Issenmann, chief executive officer of STENTYS. “MiStent SES is redefining drug-delivery to match vessel response, and it is an excellent fit in our portfolio for treating complex coronary artery disease.”
About the MiStent SES
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents.
Using an approved drug (sirolimus) and polymer (PLGA), Micell’s patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of- the-art, thin-strut, bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
EU approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. The three-year follow-up of the DESSOLVE clinical studies subjects was completed in 2014 and these patients continue to undergo long-term follow up.
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. 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 http://www.stentys.com.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as “anticipates,” “estimates,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of the MiStent SES® in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of and expectations about future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent SES in other jurisdictions; the successful development and commercialization of the MiStent SES in Europe and other markets; the ability of the MiStent SES to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release.
Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.
Contact for Micell Technologies
Arthur J. Benvenuto, Chairman & CEO