Cardio3 BioSciences Announces CE Marking for its C-Cath(R) Injection Catheter
MONT-SAINT-GUIBERT, Belgium, May 9, 2012 /PRNewswire/ –
The Belgian biotechnology company, Cardio3–BioSciences (C3BS), a leader in the
discovery and development of regenerative and protective therapies for the treatment of
cardiac diseases, today announces that it has received CE Marking (Conformite Europeenne)
for its intra-myocardial C-Cath(R) Injection Catheter. The CE Mark certifies that C-Cath
complies with applicable European health, safety and environmental protection legislation.
C-Cath is now available for commercial use in the EU and many other countries where the CE
mark allows commercialization.
The C-Cath Injection Catheter is the most advanced device of its kind and was designed
to address three key requirements: ease of use, safety and efficacy. During its
development Cardio3 BioSciences combined its extensive experience in stem cell therapies
and specific knowledge of the properties of heart tissue with key insights from leading
cardiologists in the field. C-Cath’s performance is based on its unique needle design as
well as unique catheter properties. Previously announced pre-clinical data from a head to
head comparison with the ‘best’ injection catheter available until now showed a close to
threefold increase in retention of stem cells within the heart muscle in favour of the
C Cath Injection Catheter. Within a clinical setting, an increased retention rate could
allow an increase in efficacy while reducing side effects.-
Dr Christian Homsy, CEO of Cardio3-BioSciences comments on today’s announcement:
“Today marks an important milestone for Cardio3 BioSciences and our innovative C-Cath
technology. With C-Cath, we developed an advanced injection catheter that meets the
requirements of physicians and has the potential to deliver better outcomes for patients.
C-Cath demonstrates our commitment to continued innovation in regenerative heart therapy.
This is a major step forward in addressing the patient needs for regenerative therapies
for the heart and provides physicians with new treatment options.”
About Cardio3 BioSciences
Cardio3-BioSciences is a Belgian leading biotechnology company focused on the
discovery and development of regenerative and protective therapies for the treatment of
cardiac diseases. The company was founded in 2007 and is based in the Walloon region of
Belgium. Cardio3-BioSciences leverages research collaborations in the US and in Europe
with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.
The Company’s lead product candidate C3BS-CQR-1 is an innovative pharmaceutical
product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on
ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis,
a process to mimic in adult stem cells the natural signals triggered in the early stages
of life during the cardiac tissue development. Cardio3-BioSciences has developed
C-Cath(R), the next-generation injection catheter with superior efficiency of delivery of
bio therapeutic agents into the myocardium.
C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath
logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other
countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of
intellectual property licensed to the company. In addition to historical facts or
statements of current condition, this press release contains forward-looking statements,
which reflect our current expectations and projections about future events, and involve
certain known and unknown risks, uncertainties and assumptions that could cause actual
results or events to differ materially from those expressed or implied by the
forward-looking statements. These risks, uncertainties and assumptions could adversely
affect the outcome and financial effects of the plans and events described herein. These
forward-looking statements are further qualified by important factors, which could cause
actual results to differ materially from those in the forward-looking statements,
including timely submission and approval of anticipated regulatory filings; the successful
initiation and completion of required Phase III studies; additional clinical results
validating the use of adult autologous stem cells to treat heart failure; satisfaction of
regulatory and other requirements; and actions of regulatory bodies and other governmental
authorities. As a result, of these factors investors and prospective investors are
cautioned not to rely on any forward-looking statements. We disclaim any intention or
obligation to update or review any forward-looking statement, whether as a result of new
information, future events or otherwise.
For more information contact:
Cardio3 BioSciences
http://www.c3bs.com
Dr Christian Homsy, CEO
Tel: +32-10-39-41-00
Anne Portzenheim, Communication Manager
aportzenheim@c3bs.com
CitigateDeweRogerson
Tel: +44(0)207-638-9571
Chris Gardner/Nina Enegren
nina.enegren@citigatedr.co.uk
Hill & Knowlton
Tel: +32-2-737-95-00
Katia Delvaille
kdelvail@hillandknowlton.com
SOURCE Cardio3 BioSciences
