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Micell Technologies completes enrolment in DESSOLVE II study

Date: 2011/08/02

Press Release

Opto Circuits’ subsidiary, Eurocor’s partner, Micell Technologies, completes enrolment in DESSOLVE II study of the MiStent® Drug-Eluting Coronary Stent

Bonn, Germany | Bengaluru, India | August 2, 2011


Opto Circuits (I) Ltd.’s wholly-owned subsidiary Eurocor GmbH is pleased to announce that their partner Micell Technologies has completed patient enrolment in its DESSOLVE II CE Mark clinical study of the MiStent® Drug-Eluting Coronary Stent System. The MiStent® DES is an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Enrolment of 183 patients across 26 study centres throughout Europe and New Zealand was accomplished ahead of schedule.

Micell previously announced that, based on results observed in the DESSOLVE I first-in-human trial, the sample size in the DESSOLVE II CE Mark study was reduced from 270 to 171 subjects.

"We believe that by exceeding the projected enrolment rate for this study and completing enrolment in just 5 months, participating clinicians have demonstrated their enthusiasm for the novel MiStent drug-eluting stent," commented Dennis J. Donohoe, M.D., Micell's Chief Medical Advisor.

The MiStent® DES employs Micell’s proprietary and patented supercritical fluid technology which applies a precisely controlled absorbable polymer - active drug (Sirolimus) matrix onto Eurocor’s leading Genius® Magic Cobalt Chromium Bare Metal (BMS) stent system. The polymer dissolves and releases the drug into the surrounding tissue in a controlled manner, designed to optimize dosing of the drug throughout the effected artery. In GLP preclinical trials, the drug and the polymer are cleared from the stent within 45 to 60 days in vivo, resulting in a bare-metal stent.

The DESSOLVE II CE Mark trial is a multi-centre study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent® DES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® Sprint DES, as measured by the angiography core laboratory in de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent.
More information on the DESSOLVE II trial can be found at www.ClinicalTrials.gov.

In 2009, Maxcor Lifesceince, Inc., a subsidiary of Opto Circuits (I) Ltd entered into a strategic cooperation agreement with Micell Technologies for developing and commercializing leading edge Rapamycin (Sirolimus) - based drug-eluting stents (DES) and drug-eluting balloons (DEB).


About: Micell Technologies Inc.

Micell Technologies is a biomedical company that is enhancing the performance of medical devices with innovative drug-delivery systems. Its unique surface and polymer modification technologies enable Micell to precisely and consistently control drug elution and polymer exposure duration, creating the potential for a therapeutic solution to coronary artery disease without the long-term safety concerns of currently available drug-eluting stents. Micell is also developing a drug-coated balloon for vascular interventions. Visit us at www.micell.com.

The MiStent Drug Eluting Coronary Stent System is an investigational device. It is not yet approved or available for sale in any market.

Micell, Micell Technologies, the Micell Logo, and MiStent DES are among the registered trademarks of Micell Technologies, Inc.

Micell Technologies, completes enrolment in DESSOLVE II study