STENTYS (FR0010949404 – STNT), a medical technology company
commercializing in Europe the world's first and only Self-Apposing®
Stent to treat acute myocardial infarction (AMI), today announced the
signing of the acquisition agreement of Cappella Peel Away Inc.
(Delaware, USA) and its assets relating to a novel stent delivery
system. The acquisition is subject to closing conditions.
The catheter technology will enable the implantation of the
Self-Apposing stent in the same manner as a conventional
balloon-expandable stent. To release the stent in the vessel at the
desired location, the cardiologist inflates a small balloon that splits
open the stent-containing sheath. This technology has been used as part
of Cappella’s Sideguard® coronary bifurcation stent, which is
CE Marked in Europe and has been clinically validated by an extensive
number of Sideguard stent implants.
Cappella Peel Away Inc. assets consist of a license agreement on patents
related to the novel peel away sheath technology for a stent delivery
system, technical specifications and drawings, clinical and regulatory
documentation and equipment from Cappella Inc. The latter will retain
the rights to the peel-away sheath technology for its Sideguard coronary
bifurcation stent and for other potential applications including
peripheral vascular indications.
STENTYS will incorporate the technology into its next-generation
delivery system for the company’s line of bare metal and drug-eluting
stents and expects to start commercializing these in 2015.
Gonzague Issenmann, co-founder and Chief Executive Officer of STENTYS
said: “This is STENTYS’ first strategic acquisition, and it results
from our active research efforts, including constant monitoring of the
landscape for complementary tools to add to our portfolio. We are very
excited about the potential for the Cappella Peel Away catheters to
offer cardiologists an even friendlier user experience for implantation
of our stents and allow more heart attack patients to benefit from
STENTYS’ Self-Apposing technology.”
About the STENTYS Self-Apposing® Stent
The
STENTYS Self-Apposing® Stent addresses the stent-sizing
dilemma that cardiologists are confronted with when treating heart
attack patients or patients with atypical artery anatomy. Its flexible,
self expanding design takes the shape of the patient’s unique vessel
anatomy and apposes to the irregular contours of a blood vessel, in
particular after an AMI as the vessel dilates and the clot dissolves. It
reduces the risk of malapposition and complications associated with
conventional stents in this setting. The STENTYS Self-Apposing Stent has
been marketed in Europe since receiving CE Mark in 2010. The STENTYS
Sirolimus-eluting stent should receive the CE Mark during the second
half of 2014.
About STENTYS
STENTYS is developing and commercializing
innovative solutions for the treatment of patients with acute myocardial
infarction (AMI, or heart attack) and complex coronary artery disease.
STENTYS’ Self-Apposing® Stents are designed to adapt to
vessels with ambiguous or fluctuating diameters, particularly in the
post-infarction phase, in order to prevent the malapposition problems
associated with conventional stents. In the APPOSITION III clinical
trial, STENTYS stents demonstrated a very low one year mortality rate
among 1,000 high-risk AMI patients when compared to recent studies with
conventional stents. More information is available at www.stentys.com.
About CAPPELLA
Cappella Inc. is the parent company of
ArraVasc Ltd. (www.arravasc.com),
which is involved in developing, manufacturing and marketing novel
peripheral balloons and catheters. ArraVasc’s first product line,
Pirouette™, is a CE marked, industry leading low profile 4F PTA catheter
for below the knee application.
This press release contains forward looking statements about the
Company’s business. Such forward looking statements are based on
numerous assumptions regarding the Company’s present and future business
strategies and the environment in which it will operate in the future
which may not be accurate. Such forward-looking statements involve known
and unknown risks which may cause the Company’s actual results,
performance or achievements to differ materially from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among others, risks
associated with the development and commercialization of the Company’s
products, market acceptance of the Company’s products, its ability to
manage growth, the competitive environment in relation to its business
area and markets, its ability to enforce and protect its patents and
proprietary rights, uncertainties related to the U.S. FDA approval
process, including with respect to a pre-market approval for the
Company’s BMS, slower than expected rates of patient recruitment for
clinical trials, the outcome of clinical trials, and other factors,
including those described in the Section 4 “Risk Factors” of the
Company’s 2011 Registration Document (document de référence)
filed with the French Autorité des Marchés Financiers on August
27, 2013 under number R.13-040 as such section may be updated from time
to time.
STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN:
FR0010949404 – Ticker: STNT
Copyright Business Wire 2014