The French company has raised 50 million euros to finance the last phase of testing of its revolutionary prosthesis.
One month after the end of the feasibility study in France, which enabled the implantation of the artificial heart in four patients who are now all deceased, the Carmat company is finalizing the protocol for the third phase of experimentation with its revolutionary prosthesis. This pivotal study “should cover twenty to twenty-five patients” in Europe, followed up to 180 days, according to a press release from the company. Its data is essential to obtain the CE marking, which will allow the device to be marketed in Europe.
Secure production
Carmat will however have to obtain the green light beforehand from the Patient Protection Committee (CPP) and the National Agency for the Safety of Medicines and Health Products (ANSM). A step taken with confidence by the company, which has just completed a record fundraising of 50 million euros from its historic shareholders, including the Airbus group.
This funding will be dedicated to “the pursuit of clinical trials in France and abroad”, but also to the industrial production of the next artificial hearts, which combine electronics and bio-materials taken from bovine tissues. According to Marcello Conviti, director of Carmat, “key elements” of the logistics and series production chain will thus be secured.
Refund discussed
In the meantime, the Carmat teams are continuing their work on several fronts. The full results of the feasibility test enabled engineers to develop a software device for predicting malfunctions to ensure better patient follow-up.
Preliminary discussions with European health technology assessment agencies have also been initiated, with the objective of obtaining reimbursement for the artificial heart, once the CE marking has been obtained.
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