Micell Technologies Announces Completion of Enrollment in MiStent Randomized Trial against Xience
• DESSOLVE III clinical trial enrolled 1,400 “all-comers” patients
• Primary endpoint results to be announced in H1 2017
DURHAM, N.C., December 9, 2015 — Micell Technologies, Inc. announced the completion of patient enrollment in DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) to XIENCE Everolimus Eluting Coronary Stent System® (Xience®).
DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent SES and Xience in a “real world, all-comers” patient population. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. 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.
Arthur J. Benvenuto, chairman and chief executive officer of Micell said, “This is another significant milestone in building the clinical data for MiStent. Currently, we have DESSOLVE C enrolling in China with plans to expand our clinical programs to the United States and Japan.”
MiStent is highly differentiated within the new class of bioabsorbable drug-eluting stents in that its design includes a crystalline drug that remains in the tissue for an extended period – well beyond the rapidly absorbing polymer. The long-term performance of this innovative drug delivery profile has been presented in recent publication in EuroIntervention, as submitted by William Wijns, M.D., the Co-Director of Cardiovascular Center, Aalst, Belgium.
MiStent SES has CE Mark in the European Union, and is being distributed exclusively by STENTYS around the world with the exception of the United States, Canada, China, South Korea and Japan. STENTYS is currently conducting a controlled launch in select countries in Europe, the Middle East, Asia and Latin America.
“We are pleased by the speed with which the study was enrolled in the head-to-head comparison against market-leading Xience,” said Gonzague Issenmann, chief executive officer of STENTYS. “Through this study and our ongoing controlled launch of MiStent, we are receiving outstanding feedback on the product’s performance as a workhorse stent”.
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 4- year data was recently presented by Alexandra Lansky, M.D., Director, Yale Cardiovascular Clinical Research Program, Yale University School of Medicine, New Haven, Conn., at the 27th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference held in San Francisco. Highlights of the data included no target lesion events in the DESSOLVE I study and sustained clinical outcomes in both DESSOLVE I and II through four years’ follow-up. There have been no probable or definite stent thromboses in either study. Importantly, MiStent SES continues to show a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at 4 years’ follow-up, which is consistent with previously demonstrated lack of late loss progression in the DESSOLVE I study.
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