Long-Term Safety and Efficacy of MiStent SES Presented at CRT 2014
— Rapid polymer absorption within three months coupled with drug —
delivery profile up to nine months provides for excellent healing
DURHAM, N.C., March 5, 2014 — Micell Technologies, Inc. today announced that the long-term clinical outcomes from the DESSOLVE I and II clinical trials recently were presented at the Cardiovascular Research Technologies (CRT) Conference held in Washington, D.C., February 22 – 25. The data presentation, “MiStent SES Clinical Program: DESSOLVE I and II Trials 2-Year Follow-up” was delivered by Alexandra Lansky, M.D., Director, Interventional Cardiovascular Research and Angiography Core Laboratory Services with the Yale University School of Medicine, New Haven, Conn.
The MiStent SES is a thin-strut drug-eluting stent with a bioabsorbable polymer developed to optimize vessel healing in patients with coronary artery disease. The mechanism of action is a unique drug delivery profile with three times longer drug presence versus absorbable polymer. Following elimination of the polymer in 90 days, the anti-proliferative effects of sirolimus continue to be delivered to the artery for up to nine months. Although several current bioabsorbable DES also report drug delivery for up to nine months or more, the MiStent SES’ capability to continue drug delivery in the absence of potential inflammatory-causing polymers is distinctive in this generation of DES with bioabsorbable coatings.
Dr. Lansky commented, “MiStent SES is the only product in its class to optimize local drug delivery properties by providing up to nine months of drug presence with only three months for polymer absorption. The rapid elimination of the polymer with the sustained anti-inflammatory and anti-restenotic drug six months beyond the presence of the polymer was designed to allow normal healing while providing effective suppression of neointimal hyperplasia. Detailed imaging by IVUS, OCT and angiography extending from four to 18 months post-stent implantation confirmed desirable bare-metal stent-like healing.”
The DESSOLVE I trial demonstrated minimal progression of late lumen loss between eight and 18 months follow-up, with no target lesion MACE events through two years. The DESSOLVE II randomized trial two-year MACE rate was 6.7% for MiStent and 13.3% for the Endeavor DES control group. There were no probable or definite stent thromboses related to MiStent SES use in either trial through two years. Detailed serial IVUS, angiographic, and OCT imaging through 18 months in DESSOLVE I and angiographic and OCT imaging in conjunction with endothelial function testing in DESSOLVE II demonstrated excellent healing, effective suppression of neointimal hyperplasia with maintenance of normal endothelial function, and a sustained safety profile.
Elazer Edelman, M.D., a Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology at Massachusetts Institute of Technology, Professor of Medicine at Harvard Medical School and Senior Attending Physician in the Coronary Care Unit at the Brigham and Women’s Hospital in Boston, and a consultant to Micell added, “MiStent SES provides an exciting new level of consistency and performance for drug-eluting stents. Detailed tissue evaluations in animal studies, extensive imaging studies in both pre-clinical and clinical settings and two-year clinical data from the DESSOLVE clinical trial program correlate with each other to support a normal tissue healing process.”
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. A two year follow-up of DESSOLVE I and II clinical studies’ subjects was completed in 2013, and these patients currently are undergoing long-term follow-up.
About DESSOLVE I and DESSOLVE II Studies
The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the MiStent SES®, treated thirty patients with de novo lesions in coronary arteries ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm length stent. Subjects were enrolled across five study centers in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months and all available patients at 18 months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point.
The DESSOLVE II CE (Conformité Européenne) Mark trial is a randomized, multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor® Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. The DESSOLVE II study completed enrollment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss, and achieved a strong signal of safety.
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.
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Contact for Micell Technologies
Arthur J. Benvenuto, Chairman &
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