MiStent SES Shown to be Unique in Clinical Setting
– Demonstrated Lack of Late Lumen Loss Progression Over 18 Months in Conjunction with Excellent Tissue Healing –
Two-Year Clinical Data Presented at TCT 2013
DURHAM, N.C., October 28, 2013 — Micell Technologies, Inc. today announced that imaging and clinical results from the DESSOLVE I and DESSOLVE II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) were presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference held in San Francisco, October 27 – November 1, 2013. The MiStent SES is a thin-strut drug-eluting stent distinguished by a rapidly absorbable coating designed to control drug release, and which was developed to optimize vessel healing in patients with coronary artery disease.
The data presentation, “MiStent: 2-year Randomized Trial Results from a Sirolimus- eluting Stent with a Bioabsorbable Coating,” was part of the Scientific Symposium, “Next Generation DES and Bioabsorbable Scaffolds” conducted on Sunday, October 27. John Ormiston, M.B.Ch.B., Interventional Cardiologist with the Mercy Angiography Unit, Auckland, New Zealand presented the data. Dr. Ormiston is a principal investigator in the DESSOLVE studies.
Two-year follow-up data from the DESSOLVE I and II trials were presented. 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 Endeavor DES control group. There were no probable or definite stent thromboses related to MiStent use in either trial through two years. Detailed IVUS, angiographic and OCT imaging with endothelial function testing conducted across the two trials demonstrated bare-metal stent type healing with maintenance of normal endothelial function.
Dr. Ormiston commented, “MiStent 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. Because the drug persists three times longer than the polymer, MiStent eliminates the inflammatory effect of the polymer quickly and retains the anti-inflammatory and anti-restenotic drug six months beyond the presence of the polymer.”
Dennis Donohoe, M.D., Micell’s Chief Medical Advisor, added, “We were very pleased with the two-year clinical findings in DESSOLVE I and II and specifically with respect to the unique finding of a lack of progression of late lumen loss over an 18 month period, in conjunction with excellent tissue healing as shown through detailed clinical imaging.”
Data featured at TCT recently were included in a peer-reviewed paper published by JACC Cardiovascular Interventions: “First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus–Eluting Stent: Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries)”. Authors of this paper included co-principal investigators for the DESSOLVE I trial, William Wijns, M.D., Ph.D., of the Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., of the Mercy Angiography Unit, Auckland, New Zealand.
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, but 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. 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. William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., Mercy Angiography Unit, Auckland, New Zealand are co-principal investigators for this trial.
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 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 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.
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Contact for Micell Technologies
Arthur J. Benvenuto, Chairman & CEO