Positive Four-Year Clinical Data from Micell Technologies’ MiStent SES Presented at TCT 2015
DURHAM, N.C., October 13, 2015 — Micell Technologies, Inc. today announced four- year clinical results from the DESSOLVE I and II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) were presented at the 27th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference held in San Francisco, October 11-15. TCT is the world’s largest educational meeting specializing in interventional cardiovascular medicine. MiStent SES was designed to optimize vessel healing in patients with coronary artery disease, and data presented at TCT demonstrated both sustained and desirable long-term clinical and safety outcomes.
An oral presentation titled, “Device and Clinical Program Highlights: Micell” was delivered by Alexandra Lansky, M.D., Director of Interventional Cardiovascular Research, Yale University School of Medicine, New Haven, Conn. Highlights of the data included no target lesion events in the DESSOLVE I study and sustained clinical outcomes in both DESSOLVE I and II through four years’ follow-up. There have been no probable or definite stent thromboses in either study. Importantly, the MiStent SES continues to show a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at 4 years’ follow-up, which is consistent with previously demonstrated lack of late loss progression in the DESSOLVE I study.
Dr. Lansky commented, “A key advantage that appears to be conferred by MiStent SES is sustained local drug delivery beyond the presence of the polymer. That’s exciting to me as a clinician because it means MiStent may provide therapeutic sirolimus levels in the tissue around the stent for up to nine months, while limiting the duration of that patient’s exposure to polymer. Currently, there is no approved drug-eluting stent that provides full elimination of the polymer by three months without concomitant loss of anti-restenotic drug effects.”
Dennis Donohoe, M.D., Micell’s Chief Medical Advisor, added, “DESSOLVE data, now reported out to four years’ follow-up, has been remarkably consistent in demonstrating that the unique bioabsorbable drug-eluting stent design of MiStent SES provides clinically meaningful results without probable or definite stent thromboses related to its use.”
About MiStent SES
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents.
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. MiStent SES leverages the benefits of a cobalt chromium coronary stent system — a state-of-the-art, thin-strut, bare-metal stent that has demonstrated excellent deliverability, conformability and flexibility.
The European Union’s approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II. DESSOLVE II demonstrated superior in-stent late lumen loss rates and an excellent safety profile. In 2015, clinical sites in Europe and China began enrolling patients in DESSOLVE III and DESSOLVE C, respectively. DESSOLVE III is a prospective, randomized, balanced, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent SES and Xience in a “real world, all-comers” patient population. DESSOLVE C is a prospective, randomized, controlled, single-blind, multi- center clinical trial to demonstrate MiStent SES’ efficacy and safety. DESSOLVE C, intended to support regulatory approval of MiStent SES in China, is being sponsored by Hefei Life Science Technology Park Investment and Development Co., Ltd. in conjunction with Micell.
MiStent SES is not approved by the Food and Drug Administration for sale or use in the United States.
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The company’s product portfolio also includes MiStent SES®, a coronary DES whose new drug delivery mechanism is designed to match vessel response, and is marketed through STENTYS’ commercial network in Europe, the Middle East, Asia and Latin America. More information is available at http://www.stentys.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, China 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, China 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, (919) 313-2104