Micell Technologies, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the company's surface and polymer modification technology. This intellectual property protection is related to Micell's investigational MiStent@ Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SEST), as well as potential additional biomedical products. The patent rights are assigned to and wholly owned by Micell.
The patent, "Polymer Coatings Containing Drug Powder of Controlled Morphology" (US Patent Number 8,298,565), covers: -- Coating methods enabling medical devices with unique and potentially advantageous clinical properties.
-- Coating methods that are key to Micell's proprietary manufacturing technology.
-- Formulations for implantable device/drug combination products, which are intended to confer enhanced stability and delivery by controlling the morphology of the drug(s) in the coating.
James B. McClain, Ph.D., Senior Vice President and co-founder of Micell, said, "This marks an important milestone in the execution of Micell's international intellectual property strategy. This patent issuance is the beginning of the realization of over 6,000 filed patent claims and supports our belief that Micell's coating technology and methods are novel, differentiated, scalable and transferable." Micell currently is using its proprietary technology in products under development including the MiStent SES -- a thin-strut sirolimus-eluting stent distinguished by a rapid-absorbing drug/polymer coating designed to control drug release. The MiStent SES clinical development program recently completed the 12-month patient follow-up in the DESSOLVE II study and 18 month patient follow-up in the DESSOLVE I study. In addition, Micell also has a drug-coated balloon under development for vascular interventions.
These products are not currently approved or available for sale in any market.
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. MiStent's rapidly absorbable coating is intended to precisely and consistently control drug elution and limit polymer exposure duration to reduce 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.
As the polymer softens and disperses from the stent into the adjacent tissue, the coating provides controlled and sustained release of therapeutic levels of drug within the surrounding 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 Eurocor's (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 in 90 days to promote long-term patency and compatibility with the artery.
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System is an investigational device currently being evaluated in international clinical studies and is not yet approved or available for sale in any market.
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.
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," "intends," "believes" and words and terms of similar substance in connection with the results of clinical properties of our coating methods; the cost, scalability and transferability of our manufacturing technology' our intellectual property strategy; the safety and efficacy of the MiStent SES, and approval of the MiStent SES. 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 the MiStent SES clinical trials; our ability to obtain regulatory approval of the MiStent SES; 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.