Cardio3 BioSciences Announces CE Marking for its C-Cath® 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 (Conformité Européenne) for its intra-myocardial C-Cath® 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^®, 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