Micell Technologies Completes Enrollment in OCT Study Designed to Evaluate Superior Performance of MiStent SES Compared to Xience
DURHAM, N.C., March 22, 2016 — Micell Technologies, Inc. announced completion of enrollment in the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) Optical Coherence Tomography (OCT) study. The study will compare changes in coronary arteries between six and 24 months following treatment with MiStent or XIENCE V Everolimus Eluting Coronary Stent System (Xience). The clinical investigation and data analysis are being conducted by Cardialysis and the European Cardiovascular Research Institute (ECRI), in Rotterdam, The Netherlands.
The OCT study will evaluate 60 patients randomized to MiStent or Xience. A prior MiStent clinical study has shown essentially no increase in late lumen loss between six and 18 months’ follow-up. Xience has demonstrated almost a doubling of late lumen loss in long-term follow- up. This OCT study has the potential to show superiority of MiStent SES against Xience, with significantly less progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time. It is part of the larger DESSOLVE III study, which is a 1:1 randomized comparison of Target Lesion Failure (TLF) at 12 months for MiStent versus Xience in 1,400 patients. Results from DESSOLVE III are expected to be available in the first quarter of 2017.
Dennis Donohoe, M.D., Micell’s chief medical advisor said, “Many drug-eluting stents have a yearly increase in revascularization rate, typically doubling the one year revascularization rate by four to five years’ follow-up. We are optimistic that we will find significantly less progression of neointimal hyperplasia with MiStent, suggesting a low rate of late revascularization. This would represent a patient benefit over current drug-eluting stents.”
“Micell thanks the Steering Committee consisting of Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at Erasmus University, Rotterdam, The Netherlands; Robbert J. de Winter, M.D., Ph.D., Professor of Clinical Cardiology, Academic Medical Center, Amsterdam, The Netherlands; and William Wijns, M.D., Ph.D., Co-Director of the Cardiovascular Center, Aalst, Belgium; Cardialysis and ECRI,” said Arthur J. Benvenuto, chairman and chief executive officer. “We greatly appreciate their expert guidance and assistance with this study.”
MiStent SES has CE Mark in the European Union and is being distributed exclusively by STENTYS around the world, with the exception of the United States, Canada, China, South Korea and Japan. STENTYS currently is conducting a controlled launch in select countries in Western Europe, the Middle East and Asia.
About MiStent SES
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the 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. The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art, thin-strut, bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
EU approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Four-year data were presented in October 2015 at the 27th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference by Alexandra Lansky, M.D., Director, Yale Cardiovascular Clinical Research Program, Yale School of Medicine, New Haven, Conn. Highlights of the data include 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, MiStent SES continues to show a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at four years’ follow-up, which is consistent with the previously demonstrated lack of late loss progression in the DESSOLVE I study.
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 includes MiStent SES®, a coronary DES with a new drug delivery mechanism that is designed to match vessel response. MiStent SES 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 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.
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