(BFM Bourse) – The French company announced on Wednesday that it had carried out the first implantation of its artificial hearts at the end of December as part of the French study EFICAS.
Carmat has been able to resume the pace of transplants of its artificial heart, since obtaining the agreement of the ANSM (National Agency for the Safety of Medicines and Health Products) at the end of last October to carry out such operations.
This first implantation was carried out during the last week of December 2022, by Professor André Vincentelli and his team at the Lille CHRU as part of the French study EFICAS. The company had been forced to suspend the implantations of its Aeson artificial heart in December 2021, due to a quality problem detected on certain prostheses.
The news is welcomed on the stock market: the price of Carmat is still up 4.2% to 10.94 euros around 2:45 p.m., after having jumped nearly 7% in the first exchanges.
6 hospitals in France
In addition to the Lille establishment, five other centers are taking part in this study: the AP-HP GHU Pitié Salpêtrière and the European Georges Pompidou Hospital in Paris, the Rennes University Hospital, the Strasbourg University Hospital, and the Hospices Civils de Lyon.
The EFICAS study aims to demonstrate the efficacy and safety of the Carmat total artificial heart in patients with irreversible biventricular heart failure as a bridge to transplantation, and its superiority over existing treatments for the same target patient population in terms of cost and effectiveness.
The primary endpoint of this 52-patient study is survival at 180 days after device implantation without disabling stroke, or successful heart transplantation within 180 days of implantation. Its objective is also to collect medico-economic data and obtain reimbursement for the device, particularly in France.
2023, first full commercial year for Aeson
The EFICAS study is partially financed by the national innovation fund, the latter having allocated a budget of 13 million euros to Carmat. The medtech can also count on the 31.1 million euros raised last December during a flash fundraiser. Camat thus has financial visibility until July 2023. Carmat had indicated that the funds raised would be dedicated to the development of its activities and in particular the ramp-up of its production, the recovery and the growth of sales of Aeson. , his artificial heart.
Before the suspension, Carmat had an annual production capacity of 250 units per year, a rate that the group had reached at the end of last year on a monthly basis, or around 20 artificial hearts per month. Stéphane Piat estimates that the group will return to this rate by the second quarter of 2023. “As we believe that demand will increase rapidly, we will work from next year to increase to 500 per year by the end of 2023” , had indicated the general manager of Carmat on the air of BFM Business.
The medtech recalls that it does not intend “to communicate individually on the state of health of the patients implanted, nor on the realization of each implantation” in accordance with “the principles which it has applied in a constant manner”. Carmat “will continue to communicate on its progress during the crossing of significant stages and on the occasion of the publication of its financial results” indicates the medtech.
Sabrina Sadgui – ©2023 BFM Bourse
Are you following this action?
Receive all the information about CARMAT in real time: