Micell Technologies Adds to Portfolio of Intellectual Property Protection
— Newly Issued US Patent Covers Medical Device Coating Process and Compositions —
DURHAM, N.C., July 9, 2014 — Micell Technologies, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued a patent related to Micell’s technology for enhancing the performance of medical devices with precise drug-delivery coatings. These technologies currently are used in producing the company’s drug-eluting stent system, MiStent SES®. The technology has broad applications for coating substrates with one or more crystalline drugs including the company’s development pipeline of fully absorbable stents and drug-coated balloons.
James B. McClain, Ph.D., senior vice president, co-founder of Micell and co-inventor of the technology, said, “Micell is pursuing a product portfolio based on the concept that there is great potential therapeutic benefit in coating biomedical implants with rapidly bioabsorbable formulations while maintaining controlled drug delivery profiles extending beyond polymer presence. Our technologies are designed to confer an advantage to our products by optimizing the duration of drug delivery and minimizing the duration of polymer exposure. Among the many novel claims we believe our technology supports, this patent is one of the most far-reaching and meaningful. With this patent and previously filed and issued core technology patents, we continue to expand our robust international intellectual property portfolio.”
The patent, “Polymer Coatings Containing Drug Powder of Controlled Morphology”, U.S. patent number 8,758,429, covers a coated implantable medical device including a substrate and a polymer-drug coating with the drug in a highly differentiated crystalline form. These patent rights are assigned and wholly owned by Micell.
About the MiStent SES
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (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 control drug elution and limit polymer exposure duration, thereby reducing the safety risks associated with current commercially available drug-eluting stent technologies.
The innovative MiStent SES system 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 softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.
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 the Eurocor (CE Marked) Genius® MAGIC Cobalt Chromium Coronary Stent System, a state-of-the-art bare-metal stent, which has demonstrated excellent deliverability, conformability, and flexibility.
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.
Micell was granted CE (Conformité Européenne) Mark approval for MiStent SES for the European Economic Union in June 2013; it is not approved in the United States or any other countries. Three-year follow-up for DESSOLVE I and two-year follow-up of DESSOLVE II clinical studies’ subjects has been completed, and these patients continue to undergo long-term follow-up.
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 also is 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 clinical trial programs and the use, safety and efficacy 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; including long-term follow-up of the patients that participated in the DESSOLVE I and II trials; the safety of the MiStent SES and its efficacy in controlling drug elution and limiting polymer exposure duration; 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