|Durham, NC – December 6, 2017 — Micell Technologies, Inc. announced that The Lancet has published data from the 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). The article, “A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial,” was published online in The Lancet.
The Lancet – DESSOLVE III abstract link
The article’s lead author, Prof. Robbert J. de Winter, worked in conjunction with the European Cardiovascular Research Institute (ECRI) along with Professors Patrick Serruys and William Wijns. Professors Serruys, de Winter, and Wijns together comprised the steering committee that oversaw the DESSOLVE III study design and conduct.
DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center all-comers study comprising ~1,400 patients. The primary non-inferiority endpoint of the trial was target lesion failure (TLF) at 12 months. MiStent met the endpoint, showing numerically lower TLF (p=0.0001 for non-inferiority) and target lesion revascularization (TLR) rates. TLR rates for MiStent were numerically lower at all time points following the procedure, and at one year the difference increased to 1.2%. In addition, MiStent maintained numerically lower rates of definite or probable stent thrombosis (ST) at 12 months.
The article also highlights positive six-month outcomes in a DESSOLVE III substudy focused on optical coherence tomography (OCT) images. These showed neointimal hyperplasia volume obstruction was statistically lower for MiStent vs Xience (15.0+4.1% vs 18.9+6.2%); (p=0.0081). Also, abluminal neointimal hyperplasia volume and area were both significantly lower with MiStent versus Xience by 13.0 mm3 (p=0.0150) and 0.33 mm2 (p=0.0022), respectively. Images for both MiStent and Xience-treated lesions showed equal and nearly complete strut coverage.
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.
Prof. Serruys commented, “These important results show positive clinical benefits in MiStent’s performance versus a market-leading drug eluting coronary stent. MiStent’s unique combination of a crystalline drug formulation and a fast-dissolving polymer stent coating has provided a beneficial point of clinical differentiation.”
Dennis Donohoe, M.D., chief medical advisor to Micell, added, “It is an honor to have the DESSOLVE III data published by a prestigious peer-reviewed medical journal such as The Lancet. This adds to the growing body of evidence in support of the clinical and health economic benefits of Micell’s supercritical fluid technology”.
MiStent is designed to optimize clinical performance and healing in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains 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.
About The Lancet
The Lancet is committed to applying scientific knowledge to improve health and advance human progress. It is currently ranked second out of 151 journals in the Medicine, General & Internal subject category (2016 Journal Citation Reports®, Clarivate Analytics 2017). For more information see www.thelancet.com.
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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 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.
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