Posted on Jul 19, 2021 8:24 AM
This is a new first for the French start-up Carmat. Medtech announced on Monday that it had sold, for the first time since its creation in 2008, its total artificial heart, called Aeson.
The prosthesis was implanted on a patient in Italy to act as a relay while waiting for a transplant. This implantation was “carried out by the team of Dr. Ciro Maiello, cardiac surgeon at the Naples hospital center, one of the centers with the greatest experience in artificial hearts in Italy,” the company said in a statement.
First use outside a clinical study
For Carmat, which carried out a capital increase of 56 million euros in March, this establishment “marks the first sale made. […] since its creation in 2008 ”and represents“ a major step, which opens a new page in the development of the company ”.
This heart aims to offer a therapeutic alternative to patients suffering from terminal biventricular heart failure. No Aeson heart has yet been used outside of a clinical study. The financial cost of the operation, greater than 150,000 euros, was borne by “the regional health system”, pending national reimbursement which, in Italy, takes over “after several years of use”, details to AFP a spokesperson for the company.
Thursday, Carmat announced the first human implantation of his artificial heart in the United States, as part of a clinical study. Ten patients eligible for transplantation must be recruited in this American trial, in accordance with the study protocol approved by the FDA (Food and drug administration). This announcement had made the share price jump 6.77% to 23.65 euros on the Paris Stock Exchange.
Several upcoming sales
In December 2020, Carmat obtained CE marking in Europe, which gave it the green light for the marketing of its artificial heart in Europe. In November 2019, the results of the study of the first 11 patients implanted showed that “73% of these patients achieved six months of survival with the prosthesis or a successful heart transplant” within six months of implantation. – which was the primary objective of the study. In addition to France, these establishments in Europe took place in Denmark, the Czech Republic and Kazakhstan.
Listed on the stock market in 2010, Carmat, which boasts of having received 33 million euros granted by Bpifrance, the largest sum ever granted to a young innovative company by the public investment bank, hopes to announce other commercializations of his artificial heart in Europe by the end of the year.
The company is specifically targeting France and Germany, which together account for 55% of the EU market for mechanical circulatory assistance (MCS) devices. Five German hospitals have already been trained by Carmat and “are currently selecting patients for implantation,” says Carmat. Ultimately, a dozen centers should be trained and commercially active by the end of 2021.