Transforming medical devices for improved patient outcomes

EuroPCR Late-Breaking Clinical Trials: MiStent SES® Shows Clinical Superiority over Market-Leader Xience V in Propensity Analysis at One and Three Years Post- Treatment

Paris, France – May 19, 2015 — At the late-breaking trials session today at EuroPCR, the official congress of European Association of Percutaneous Cardiovascular Interventions, data from a retrospective cross-study propensity analysis were presented comparing MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) to XIENCE V Everolimus Eluting Coronary Stent System (Xience). These data were presented by Alexandra Lansky, M.D., Director, Interventional Cardiovascular Research, Yale University School of Medicine, New Haven, CT. The analysis was conducted independently by Dr. Lansky and Dr. Robert Byrne, German Heart Center, Munich, Germany with funding from Micell Technologies, Inc., MiStent’s developer.

The objective of the analysis was to compare the clinical outcomes of the MiStent SES to the durable polymer coated everolimus-eluting cobalt chromium coronary stent (Xience V) at one and three years post-implantation. A retrospective patient level propensity-matched analysis was performed comparing data from the DESSOLVE I and DESSOLVE II studies evaluating the MiStent SES to the everolimus-eluting Xience V arm of the ISAR-TEST-4 study using pre-specified baseline and lesion characteristics. ISAR-TEST-4 used very similar event definitions to the DESSOLVE studies, with a Clinical Events Committee (CEC) review process. Clinical and angiographic endpoints were compared between the two treatment groups in the matched cohort. The pre-specified primary endpoint was target lesion failure at 12 months and three years.

The propensity-matched analysis demonstrated statistically-significant reduced target lesion failure (TLF) and target lesion revascularization (TLR) rates at one and three years of the MiStent SES compared to the durable Xience V stent:

These results are hypothesized to be due to improvements in device design and a study has been initiated to confirm these results in DESSOLVE III, a 1,400 patient, all-comers randomized clinical trial. DESSOLVE III will also include an optical coherence tomography (OCT) sub-study evaluation of 60 patients at six and 24 months post-treatment to evaluate and compare for superiority of MiStent SES against Xience in the progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time.

MiStent SES
(n=102)
Xience V
(n=102)
P Value
TLF – 1 Year 2.9% 12.3% 0.010
TLF – 3 Year 5.0% 16.5% 0.006
TLR – 1 Year 1.0% 8.7% 0.009
TLR – 3 Year 2.0% 12.3% 0.004

Dr. Lansky said, “Acknowledging this is a cross-study comparison, the patient level propensity analysis provided for the identification of well-matched populations. Our results suggest that the design of the MiStent SES may offer clinical benefit compared to Xience.”

Also at EuroPCR, Micell presented updated DESSOLVE I data which showed a long-term safety profile with 0% TLR and 0% stent thrombosis (ST) through four years. Previously reported imaging studies have revealed high rates of initial healing after implantation of the MiStent SES with early stent strut coverage, normal endothelial function at nine months combined with a minimal progression of neointimal hyperplasia through 18 months.

About the MiStent SES® System
MiStent SES is designed to optimize healing in patients with coronary artery disease. MiStent SES is currently in commercial distribution in the European Union and not for sale in the United States.

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 are designed to 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, which has demonstrated excellent deliverability, conformability and flexibility.

The potential benefit of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated safety and a superior in-stent late lumen loss rate. The three-year follow-up of the DESSOLVE clinical studies subjects was completed in 2014 and these patients continue to undergo long-term follow up.

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 registered and unregistered trademarks of Micell Technologies, Inc.

Contact for Micell Technologies
Dr. Dennis Donohoe, Chief Medical Advisor
(919) 767-1902