Bioheart has received a non-binding term sheet and investment offer in the amount of $2 million from Grupo Vitalmex in Mexico, a global leader in the healthcare sector in Latin America and Europe. The offer will be voted on August 6 at the Bioheart board.
“In as much as this provides additional capital for Bioheart for our clinical trials, it also affirms our strong belief in the long term viability and commercialization of our technology, identifies new markets worldwide and allows us to take the Company to the next level in a relatively short period of time,” said Mike Tomas, Bioheart’s President/CEO. “By working with leading interventional cardiologists throughout the world, we believe our Company can quickly bring these therapies to patients by establishing the safety and efficacy data required for FDA approval.”
The Vitalmex investment will enable Bioheart to reinitiate the MARVEL and REGEN clinical trials as well as initiate the Angel trial putting the company on its way towards FDA-approval and commercialization of these products. Bioheart’s cell therapy products address an unmet need in the cardiac market by providing true regenerative medicine where the MyoCell® product line may regenerate muscle in areas of scar tissue and the LipiCell® product may help reduce inflammation and promote the growth of new blood vessels.
The trials will be conducted at numerous clinical sites in the US including Columbia University, Minneapolis Heart, Cleveland Clinic, Mt Sinai, University of Miami, and more. In addition, Bioheart intends to initiate clinical sites in top clinical centers in Mexico. The products will be produced at both the Vitalmex labs in Mexico and Bioheart labs in the US. The collaboration will enable Vitalmex to market and distribute Bioheart’s technology in Mexico, Latin America, the Caribbean — and potentially other countries that may include Spain, Russia, Germany, Hungary, the Czech Republic and Bulgaria. Vitalmex views Bioheart’s cardiac regenerative medicine therapies as a viable solution to a variety of patient bases.