Cardio3 BioSciences’ Advanced Regenerative Technology Featured in European Heart Journal

Regulatory News:

Cardio3 Biosciences (C3BS) (Paris:CARD) (Brussels:CARD) (NYSE Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, announces today the referencing in the European Heart Journal, the official journal of the European Society of Cardiology, of lineage-specified cardioreparative stem cells as next generation regenerative biotherapeutics.¹

The editorial sets out the principles of regenerative cardiology, conceived to halt or reverse disease progression. As the heart has a limited self-renewal capacity, stem cell therapies are applied essentially as adjuvants to standard of care with the goal of fortifying reparative mechanisms. The editorial emphasizes that the inter-trial unevenness and inter-patient variability observed to date with conventional stem cell options has prompted the pursuit of optimization strategies, and lists optimization modalities under consideration, such as the principle to condition the myocardial environment prior to cell delivery, the principle to match regenerative cell source with the target organ, and the principle of rational design of cardioreparative biotherapeutics equipped with an upgraded regenerative potential.

The Cardio3 Biosciences’ C-Cure® product is the first-in-class cardioreparative biotherapeutics derived by the method of lineage-specification for use in heart failure. In the Phase II C-CURE clinical trial, heart failure patients were treated with C-Cure® which consists of patient-derived mesenchymal stem cells oriented into lineage-specified cardiogenic progenitor (cardiopoietic) cells. The C-CURE study indicates that the use of cardiopoietic cells is feasible and safe and documents significant benefit on Left Ventricular Ejection Fraction, a measure of heart function, versus baseline compared to no change for the control group treated with standard of care. C-Cure® is now tested in a Phase III study in Europe and Israel (CHART-1) and has been authorized by the FDA to be tested in the U.S (CHART-2). These phase III therapeutic studies highlight advances in regenerative science.

Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: "Recognition in this editorial published in the prestigious European Heart Journal underscores Cardio3 BioSciences’ continuous advances and leadership in regenerative medicine, progressively bringing innovative science-driven therapeutic options to patients. By choosing the route of lineage specification, we lay the foundation for future standard of care in cardiology.”

*** END ***

¹ Terzic, A. et al. European Heart Journal doi:10.1093/eurheartj/ehu 117 Advanced Access published March 26, 2014

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 Centre Aalst, Belgium.

The Company’s lead product candidate C-Cure® is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure® consists of a patient’s own cells that are harvested from the patient’s bone marrow and lineage-specified to ensure an upgraded cardioreperative potential. This process is known as Cardiopoiesis.

Cardio3 BioSciences has also developed C-Cath®_ez, the most technologically advanced injection catheter with superior efficiency of delivery of biotherapeutic agents into the myocardium.

Cardio3 BioSciences’ shares are listed on NYSE Euronext Brussels and NYSE Euronext Paris under the ticker symbol CARD.

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.