Micell Technologies Announces First Patient Enrolled In Landmark Registration Trial Of MiStent In Japan - Seite 2

Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell said, "Cardiovascular disease poses a significant health risk in Japan and even with recent improvements in coronary artery disease treatment, additional advances in drug-eluting stents are still needed. Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement that could provide clinicians and patients worldwide with enhanced treatment options."

About MiStent®

MiStent is designed to optimize healing and clinical performance 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.

EU approval of MiStent 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. Micell also completed enrollment in December 2015 of DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent 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 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 target lesion failure (TLF) of the MiStent group versus the Xience group at 12 months post-procedure. The 12-month primary endpoint results for DESSOLVE III are expected to be released in the first half of 2017.