Transforming medical devices for improved patient outcomes

Positive Two-Year Data from MiStent® DESSOLVE III Trial Presented at EuroPCR – Excellent safety and low target lesion revascularization (TLR) rates persist –

Durham, NC – May 23, 2018 — A 24-month update on the DESSOLVE III trial of the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent) was presented this week at EuroPCR 2018, an international congress of interventional cardiovascular medicine researchers and clinicians held in Paris, France.

Data were presented by William Wijns, M.D., Ph.D., of The Lambe Institute for Translational Medicine at the National University of Ireland and Co-Director of EuroPCR, in a late-breaking trial update session on drug-eluting stents (DES). Key points in the discussion included the continued lower rate of clinically-driven target lesion revascularization (CD-TLR) for the MiStent group compared to Xience, as well as a continued lower rate of definite stent thrombosis.

Additionally, this trial is unique in that MiStent has maintained numerically lower point estimates versus Xience for any revascularization, target vessel revascularization (TVR), and target vessel failure (TVF).

DESSOLVE III 24-Month Endpoint MiStent Xience
Clinically-Driven Target Lesion Revascularization (CD-TLR) 4.6% 5.4%
Definite stent thrombosis 0.6% 1.0%
Any revascularization 12.5% 15.5%
Target Vessel Revascularization (TVR) 6.9% 8.5%
Target Vessel Failure (TVF) 9.7% 10.8%

“As we expected, there was no evidence of late catch-up in TLR in the MiStent group,” noted Dr. Wijns. “Additionally, these DESSOLVE III data reinforce MiStent’s outstanding safety profile that we first noted in the DESSOLVE I and II trials, as evidenced by very low probable or definite stent thromboses.”

Dr. Wijns continued, “This ultra-thin strut stent should become an essential component to a best practices approach to coronary artery disease management, in which advances in both technology and technique are embraced. MiStent is an innovative tool that has the potential to improve long-term clinical outcomes.”

Two additional presentations featuring MiStent clinical data are planned for EuroPCR:

  • Professor Robbert J. de Winter, M.D., Ph.D., Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands will present a MiStent case study.
  • Professor Krzysztof Milewski, M.D., Ph.D., General Director, Center for Research and Development for the American Heart of Poland S.A., published the most recent update from the DESSOLVE III optical coherence tomography (OCT) sub-study in a poster presentation.

Commenting on the growing body of clinical evidence in support of MiStent, Dennis Donohoe, M.D., Micell’s chief medical advisor, said, “In the DESSOLVE III data, we are pleased to observe the same overall progression of TLR over time that was noted in earlier studies, despite the significant challenges represented by patients in the DESSOLVE III all-comers population.”

He also noted, “The clinical results we are seeing in these studies validate the hypotheses generated from Tzafriri et. al. recently published in the Journal of Controlled Release (link to article).  This research found that crystalline sirolimus combined with MiStent’s proprietary coating technology could lead to optimized drug delivery and enhanced clinical results.”

About MiStent®

MiStent, a coronary stent with a sirolimus-eluting absorbable polymer coating, is designed to optimize clinical performance and healing in patients with coronary artery disease. The rapidly absorbable coating of MiStent, comprising crystalline drug and an absorbable polymer, is intended to precisely and consistently provide extended 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, and improve long-term clinical outcomes.

MiStent has received CE marking, but is not approved for sale in the United States. Micell currently is preparing an FDA IDE submission for the CRYSTAL study, a prospective, multi-center, randomized trial comparing MiStent to commercially available everolimus drug-eluting stents.

About DESSOLVE III

DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center all-comers study comprising 1,400 patients. Enrollment was completed in December 2015. The study is being conducted independently by the European Cardiovascular Research Institute, Rotterdam, The Netherlands and is supported by Micell Technologies.

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 MiStent 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 in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent 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, the Micell Logo, and MiStent are among the trademarks of Micell Technologies, Inc.

Contact for Micell Technologies

Arthur J. Benvenuto, Chairman & CEO

(919) 313-2104