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Cardio3 BioSciences ReceivesISO-13485 Certification


2/29/2012 10:46:56 AM

MONT-SAINT-GUIBERT, Belgium, February 29, 2012 /PRNewswire/ --

The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces that it has been certified EN ISO 13485:2003 by the National Standards Authority of Ireland.

The ISO certification acknowledges that Cardio3 BioSciences has been assessed and deemed to comply with the requirements of the ISO standard with respect to the design, development, manufacture and distribution of sterile cardiovascular catheters. The certification guarantees that all processes at Cardio3 BioSciences are fully controlled and documented and compliant with the company's Quality Management System.

Cardio3 Biosciences is developing C-Cath®, a proprietary cardiovascular catheter which is designed to administer a range of bio-therapeutics to the heart. C-Cath is designed to take into account organ tissue structure and properties to maximize patients' safety, improve performance and increase user confidence during the injection procedure.

Dr Christian Homsy, CEO of Cardio3 BioSciences comments on today's announcement: "The ISO certification is a significant accomplishment and an important milestone for Cardio3 BioSciences and for our proprietary C-Cath technology. Certification confirmsthat our Quality System meets the highest standards, and is another step for the Company towards reaching the goal of becoming a leader in regenerative therapies for the treatment of heart diseases.With an ISO 13485-compliant quality system in place, Cardio3 BioSciences is now one major step closer to obtaining allowance to affix the CE Mark necessary for commercialization of ourC-Cath Injection Catheter."

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 BioScienceshas developed C-Cath®, the next-generation injection catheter with superior efficiency of delivery of diagnostic and 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(207)638-9571


Chris Gardner/Nina Enegren, chris.gardner@citigatedr.co.uk


Hill & Knowlton, Tel: +32(2)737-95-00


Katia Delvaille, kdelvail@hillandknowlton.com

SOURCE Cardio3 BioSciences



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