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Micell Technologies: First Patient Enrolled in All-comers Randomized
Trial of MiStent Against Xience
DURHAM, N.C., March 23, 2015 -- Micell Technologies, Inc. announced it has begun patient
enrollment in DESSOLVE III, a randomized, controlled clinical trial comparing MiStent® Sirolimus
Eluting Absorbable Polymer Coronary Stent System to XIENCE Everolimus Eluting Coronary Stent
System® (Xience®). Robbert J. de Winter, M.D., Ph.D., Department of Cardiology, Academic
Medical Center, Amsterdam, The Netherlands enrolled the first patient in the study. This clinical
investigation is being conducted by the European Cardiovascular Research Institute (ECRI),
Rotterdam, The Netherlands and is supported by Micell in conjunction with STENTYS, the Parisbased medical technology company that is Micell’s distribution partner for MiStent.
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. Candidates for trial participation suffer from symptomatic coronary artery disease,
including those with chronic stable angina, silent ischemia, acute coronary syndromes, and qualify
for percutaneous coronary interventions. Enrollment will include 1,400 patients randomized to
MiStent SES or Xience at approximately 17 clinical sites in Europe. The primary endpoint for this
trial is a non-inferiority comparison of a device-oriented composite endpoint (DOCE) or target
lesion failure (TLF) of the MiStent SES group versus the Xience group at 12 months postprocedure.
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.
Arthur J. Benvenuto, chairman and chief executive officer of Micell said, “We are conducting
DESSOLVE III to further support the importance of MiStent in clinical practice, building on the fouryear results from the DESSOLVE I and DESSOLVE II studies that we plan to report later this year.
As a new class of drug-eluting stent that allows the drug to remain in the tissue for an extended
period – well beyond a rapidly absorbing polymer – MiStent has the potential to offer meaningful
clinical and economic benefits to patients and the healthcare system.”
MiStent SES has received CE Mark in the European Union and will be distributed exclusively by
STENTYS around the world with the exception of the United States, Canada, China, South Korea
and Japan. STENTYS plans a controlled launch in Western Europe followed by a full commercial
launch in the second half of 2015 in selected countries within Europe, Middle East, South-East
Asia and Latin America.
“We are very excited about the early start of this ambitious all-comers study of MiStent SES
against Xience at the time when we are introducing the product in Europe,” said Gonzague
Issenmann, chief executive officer of STENTYS. “MiStent SES is redefining drug-delivery to match
vessel response, and it is an excellent fit in our portfolio for treating complex coronary artery
disease.”
About the 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-ofthe-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. 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.
About STENTYS
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 APPOSITION clinical trials in the treatment of acute
myocardial infarction showed a very low one year mortality rate and a faster arterial healing
compared to 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 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
(919) 313-2104