Paper Published in American Journal of Cardiology Demonstrates Favorable Vascular Healing Following MiStent SES Implantation
– Notably Lower Rates of Neoatherosclerosis Reported Following MiStent SES® Implantation Versus Other Drug Eluting Stents –
DURHAM, N.C., November 21, 2013 — Micell Technologies, Inc. today announced that The American Journal of Cardiology® published results of a comprehensive analysis of optical coherence tomography (OCT) following MiStent SES implantation. Evaluations of vascular healing taken at multiple time points demonstrated excellent vessel healing with a low rate of neoatherosclerosis. The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is a thin-strut drug-eluting stent that was developed to optimize vessel healing, and which is distinguished by a rapidly absorbable coating that controls the rate of drug release.
Data presented in this paper were additional findings from Micell’s DESSOLVE I trial of MiStent SES, in which 30 patients with coronary artery disease were enrolled. The study design allowed for the assessment of vascular responses at four, six, eight and 18 months post-implantation to enhance the understanding of the vascular healing process over time. An evaluation of the healing process spectrum following DES implantation through serial assessments at various time points of neointimal hyperplasia (NIH), coverage, apposition, and tissue characteristics yielded these key results:
- Lower rates of neoatherosclerosis following MiStent SES implantation as compared to previously reported results with other drug-eluting stents.
- High rates of stent coverage in early follow-up, with further improvement at 18 months’ follow-up.
- Stent strut malapposition that was low at all time points, and an established trend toward additionalreduction at 18 months.
- NIH thickness, area and volume that remained static from eight to 18 months without evidence oflate restenosis.
Marco Costa, M.D., Director, Center for Research and Innovation, University Hospitals Case Medical Center and Director, Interventional Cardiovascular Center, University Hospitals Case Medical Center, commented on these data: “This study is one of the first programs to demonstrate longitudinally and serially the healing process by the use of high-resolution OCT imaging. These results, based on an analysis of more than 13,500 stent struts in 30 patients, suggested an excellent vascular response to MiStent SES as early as four months after implantation. They additionally confirmed favorable vessel interactions by revealing remarkably lower rates of neoatherosclerosis through 18 months follow-up than previously reported with other drug-eluting stents.”Dennis Donohoe, M.D., Micell’s Chief Medical Advisor added, “The study results presented in this journal provide a detailed evaluation of human vascular response to implantation of a novel absorbable- polymer drug-eluting stent. These data, along with two-year follow-up data from Micell’s DESSOLVE I and II clinical studies, suggest that MiStent SES uniquely supports excellent vascular response with a lack of progression of late lumen loss.”
About the Publication
The American Journal of Cardiology is a leading independent, scientific, peer-reviewed journal of original articles that focus on practical clinical approaches to the diagnosis and treatment of cardiovascular disease.
The November 15, 2013 issue of The American Journal of Cardiology includes the paper, “Serial Assessment of Early and Late Vascular Responses After Implantation of an Absorbable-Coating Sirolimus-Eluting Stent: An Optical Coherence Tomography Sub-Study From The First-in-Human DESSOLVE I Trial.” The first author on this paper is Guilherme Attizzani, M.D., Research Associate at University Hospitals Case Medical Center’s Harrington Heart and Vascular Institute.
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 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. Learn more about the company 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 ability of MiStent SES® to control drug elution and limit polymer exposure duration and its ability to reduce safety risks as compared to conventional permanent polymer drug eluting stents. 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 have undergone the DESSOLVE I and DESSOLVE II clinical 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