Micell Technologies’ MiStent SES® Now Commercially Available in Europe
— Novel Drug-delivery Technology Provides Sirolimus-Eluting Stent with Unique Bioabsorbable Polymer Absorption and Drug Release Profile —
DURHAM, N.C. – Feb. 4, 2015 – Micell Technologies, Inc., a biomedical company that is enhancing the performance of cardiovascular medical devices with innovative drug-delivery systems, today announced the commercial availability of the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) in Europe. STENTYS, Micell’s distribution partner in Paris, plans a controlled launch in Western Europe followed by a full commercial launch for the second half of 2015 in selected countries within Europe, Middle East, South-East Asia and Latin America.
Arthur J. Benvenuto, chairman and chief executive officer of Micell said, “Patients with cardiovascular disease and their physicians now have access to a new class of drug-eluting stent that allows the drug to remain in the tissue for an extended period — well beyond a rapidly- absorbing polymer. This performance feature is unique to MiStent and until now, has been largely impossible. Most importantly, it has translated into meaningful clinical benefits.”
MiStent SES has received CE Mark in the European Union, and will be distributed exclusively by STENTYS around the world, with the exception of the United States, Canada, China, South Korea and Japan. Micell is in the process of expanding its manufacturing capabilities through its partner, Surgical Technologies, Inc., based in St. Paul, Minn.
“We are very excited to be partnering with Micell on the distribution of MiStent,” said Gonzague Issenmann, chief executive officer for STENTYS. “We believe MiStent is a great addition to our stent portfolio, and we look forward to launching this innovative product.”
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 is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure, thereby potentially reducing the safety risks associated with current commercially available drug-eluting stents. The MiStent SES includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer drug-eluting stents.
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare-metal stent, and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery. The crystalline drug remains in the tissue and continues to elute sirolimus for up to 9 months.
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 three-year follow-up of the DESSOLVE clinical studies subjects was completed in 2014, and these patients continue to undergo long-term follow up.
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. STENTYS has built a fast-growing commercial network in Europe and in many countries in the Middle East, Asia and Latin America. More information is available at www.stentys.com.
About Micell Technologies® Inc.
Micell Technologies is a biomedical company that is enhancing the performance of cardiovascular 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.www.micell.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.
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