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BIOTRONIK TO SUPPLY ICD TECH TO CARDIO3 BIOSCIENCES FOR C-CURE
May 25, 2009 (AsiaPulse via COMTEX) --
(Full text of a statement. Contact details below.)
(BW)(BIOTRONIK-GMBH) BIOTRONIK to Supply ICD Technology to
Cardio3 BioSciences for C-Cure? Stem Cell Clinical Trial
Agreement places BIOTRONIK at centre of an innovative
research /scientific area
Health/Medical Writers
BERLIN -(BUSINESS WIRE) - May. 22, 2009-- BIOTRONIK, the
pioneer in wireless remote monitoring technology for patients
with cardiac devices, announced today an agreement regarding a
partnership with Belgian biotechnology company Cardio3
BioSciences in their C-Cure? stem cell clinical trial. This
pivotal trial is designed to evaluate the safety and efficacy
of Cardio3 BioSciences' second generation stem cell therapy in
patients with heart failure. The first patient was treated in
March 2009.
As part of a commitment to providing optimal therapy,
patients who participate in the trial will receive an
implantable cardioverter defibrillator (ICD) with Home
Monitoring?. These devices ensure optimal standard of care for
patients with severe cardiac conditions. BIOTRONIK Home
Monitoring? offers the most advanced remote monitoring for
cardiac patients employing cellular technology in the third
generation. The BIOTRONIK Home Monitoring? system safely
reduces the need for conventional in-office visits, while
improving follow-up adherence, and enables earlier evaluation
of clinically relevant cardiovascular events.
"This partnership with Cardio3 BioSciences, highlights the
quality of the BIOTRONIK Home Monitoring? system and also
provides BIOTRONIK with the opportunity to be directly involved
in one of the most innovative areas of medicine. Longer term,
what we learn through the trial will allow us to evaluate the
potential to combine our innovative device technology with
complementary approaches such as stem cell therapy so as to
offer outstanding solutions to help to restore and secure the
patient's quality of life in a lasting way," remarked Marlou
Janssen, Global Vice President Marketing and Sales at BIOTRONIK
GmbH & Co KG.
Dr Christian Homsy, CEO of Cardio3 BioSciences, commenting
on today's announcement, said: "We are delighted to announce
that we have partnered with BIOTRONIK to provide ICD technology
for the C-Cure trial. In developing our stem cell technologies
we are driven by a desire to provide the best possible quality
of treatment to patients with heart disease and this is carried
through in choosing partners and suppliers for our trial. We
believe that by working with BIOTRONIK we are giving patients
access to the highest quality monitoring technology. We look
forward to further progressing the trial which for the first
time will evaluate in patients whether ?cardiopoietic' cells,
the active ingredient of C-Cure, can be used to re-generate
heart muscle damaged by infarction. If C-Cure can achieve this
goal, it will clearly be a major advance in the treatment of
heart failure, a very common condition where current therapy
does not address the underlying cause of the disease."
About C-Cure? stem cell therapy
C-Cure is a second generation cell therapy for the treatment
of heart failure that involves taking a patient's own stem
cells from bone marrow and through a proprietary culturing
technology generating differentiated ?cardiopoietic' cells
which can regenerate damaged heart muscle. Unlike previous cell
therapies for this indication, C-Cure is designed to produce
new autologous heart muscle cells which behave identically to
those lost in infarction without carrying the risk of
rejection.
C-Cure draws on the unrivalled understanding of the
fundamental science of heart cell development within Cardio3
BioSciences and on technology developed at Mayo Clinic, one of
the world's best respected medical research centres.
In the two-phase, multi-center trial, 240 patients suffering
from ischemic cardiomyopathy at 35 sites in eleven countries
will be treated with C-Cure. The primary endpoint is a change
in left-ventricular ejection fraction at six months post
treatment.
About Implantable Cardioverter Defibrillators (ICD)
An ICD is used in patients at risk for recurrent, sustained
ventricular tachycardia or fibrillation. The device is
connected to leads positioned inside the heart, which are used
to deliver electrical shocks, sense the cardiac rhythm and pace
the heart as needed. The various leads are connected to a pulse
generator, which is implanted in a pouch beneath the skin of
the chest or abdomen. These generators have electronics that
automatically monitor and treat heart rhythms recognized as
abnormal.
About BIOTRONIK
As one of the world's leading cardiovascular medical device
companies, with several million implanted devices, BIOTRONIK is
represented in over 100 countries with its global workforce of
more than 4,500 employees.
Known for having its finger on the pulse of the medical
community, BIOTRONIK assesses the challenges physicians face,
and provides the best solutions for all phases of patient care,
ranging from diagnosis to treatment to patient management.
Quality, innovation and reliability define BIOTRONIK and its
growing success, and deliver confidence and peace of mind to
physicians and their patients worldwide.
About Cardio3 BioSciences
Cardio3 BioSciences is a leading Belgian biotechnology
company specialising in stem cell-based therapies for the
treatment of cardiovascular disease. The Company's lead
product, C-Cure?, is a highly innovative approach to the
treatment of heart failure, one of the world's most pressing
unmet medical needs. Based on a strategy developed by Cardio3
BioSciences' founders and leveraging technology from Mayo
Clinic, C-Cure? allows the differentiation of a patient's own
cells into ?cardiopoietic' cells which grow into new heart
cells and repair heart muscle. The Cardio3 BioSciences team has
extensive experience in developing and commercializing new
pharmaceutical products and medical technologies and the
Company's strategy is to drive the clinical development of
C-Cure? and to market the product itself in major
geographies.
BIOTRONIK GmbH & Co.
KG Amela Malja Director, Marketing Communications
Woermannkehre 112359 Berlin, Germany
Tel. +49 (0) 30 68905 1400
Email amela.malja@biotronik.com
or Cardio3 BioSciences
Dr Christian Homsy, CEO
Tel. +32 10 39 41 00
chomsy@c3bs.com
or Mayra Beydoun, Brand & Communication Manager
Tel. +32 10 39 41 00
mbeydoun@c3bs.com www.c3bs.com
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