Chronic and acute heart failure is a major public health issue affecting 20 million patients in Europe and the United States. Among them over 100,000 suffer from end-stage biventricular heart failure. At the disease’s irreversible stage, the only possible treatment is a heart transplant. Since its creation in 2008, French company Carmat has been working on a new therapeutic alternative that could overcome the dramatic shortfall of compatible, available heart transplants: a completely artificial heart. This ground-breaking innovation, at the cusp between industry and medicine, was pioneered by the joint research efforts of Carmat co-founders: Professor Alain Carpentier and the Matra Défense company (Airbus Group). After receiving approval from the French ethical research committee in 2011, Carmat started clinical trials. Since December 2013, Carmat has implanted 11 artificial hearts with a patient’s survival rate of 70% six months after the implant.
The company optimized its production process in 2018 with the opening of its automated manufacturing site in Bois d’Arcy, near Paris, which can produce up to 800 units per year. This facility uses robots to assemble hybrid membranes on artificial hearts and a fully automated software station to set up the prosthesis parameters.
September 2019 marked significant milestones for Carmat. The company successfully raised €60m ($66m) from historic and new investors to accelerate its development. At the same time, the US Food and Drug Administration (FDA) conditionally approved Carmat to launch a clinical feasibility study of its total artificial heart in the United States. A first step to enter the coveted American market.