Micell Technologies Announces MiStent Achieved Primary Endpoint in All-Comers Randomized Clinical Trial Versus Xience; MiStent Data the Subject of Three EuroPCR 2017 Presentations
Paris, France – May 16, 2017 — Micell Technologies announced today at the late-breaking trial session of EuroPCR – the official congress of the European Association of Percutaneous Cardiovascular Interventions – positive twelve-month data from its DESSOLVE III clinical trial. The study met its primary endpoint, showing non-inferior safety and effectiveness outcomes in a complex patient population for the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent) versus the Xience® Everolimus Eluting Coronary Stent System (Xience). Professor Robbert J. de Winter, M.D., Ph.D., Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands presented the data.
Professor de Winter commented, “MiStent met the primary non-inferiority endpoint of target lesion failure (TLF) at 12 months, with numerically lower TLF and target lesion revascularization (TLR) rates. TLR rates for MiStent were numerically lower at all time points following the procedure, and by one year that difference grew to 1.2%. These results speak to the potential value of slower, controlled drug release allowing for sustained drug presence. These trial results, in conjunction with the five-year results from the DESSOLVE I and II studies, provide further evidence of the potential value of this technology relative to current DES performance expectations from the perspectives of both safety and efficacy.”
DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center all-comers study comprising 1,400 patients. Enrollment was completed in December 2015, and today’s presentation highlighted twelve-month primary endpoint outcomes. The study is being conducted independently by the European Cardiovascular Research Institute, Rotterdam, The Netherlands and is supported by Micell Technologies. The study design and conduct were overseen by a steering committee including Professors Patrick Serruys, Robbert de Winter, and William Wijns.
Patients in this trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome (including non-ST-elevation myocardial infarction and ST-elevation myocardial infarction), and qualified for percutaneous coronary interventions. The primary endpoint for this trial was a non-inferiority comparison of TLF for the MiStent group versus the Xience group at 12 months post-procedure.
Dennis Donohoe, M.D., Micell’s chief medical advisor, said, “These results appear to validate the unique premise of Micell’s supercritical fluid technology platform, which allows drug in micro-crystalline form to be combined with a fast-dissolving polymer and applied as a coating on an ultra-thin-strut cobalt chromium stent. These unique features have the potential to offer meaningful clinical and economic benefits to patients and the healthcare system.”
In a session on novel drug-eluting stent technologies, Professor Krzysztof Milewski, lead investigator for the DESSOLVE III OCT sub-study, highlighted positive outcomes from assessments of optical coherence tomography (OCT) images from MiStent and Xience patients at six months. Neointimal hyperplasia volume obstruction was statistically lower for MiStent (15.0±4.1% vs 18.9±6.2%; p<0.01). Similarly, both abluminal neointimal hyperplasia volume and area were significantly better with MiStent by 13.3 mm3 (p=0.02) and 0.33 mm2 (p<0.01), respectively. Both groups demonstrated equal and almost complete strut coverage.
“We observed a statistically significant difference in favor of MiStent,” confirmed Professor Milewski, M.D., Ph.D., General Director, Center for Research and Development for the American Heart of Poland S.A. “These OCT data further demonstrate that the unique pharmacokinetics of MiStent, with its micro-crystalline sirolimus, reduce the factors that lead to late lumen loss requiring vessel revascularization.”
Additional data and an overview of the rationale and design of the OCT assessments presented by Professor Milewski will be the subject of a late breaking trial submission, also at EuroPCR, on May 18. Professor Milewski will present, “OCT and IVUS Imaging for Evaluation of Stent-Based Therapies: DESSOLVE III, a Randomised OCT Sub-Study Comparison of Xience vs MiStent.”
MiStent is designed to optimize clinical performance and healing in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains micro-crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for extended 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 and improve long-term clinical outcomes.
MiStent has received CE marking, but is not approved for sale in the United States.
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 MiStent 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 in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent to effectively and successfully compete with currently 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.
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Contact for Micell Technologies
Arthur J. Benvenuto, Chairman & CEO