
CARMAT Reports Seven Aeson Implants Completed in EFICAS Clinical Trial for Its Total Artificial Heart Following Emergency Financing
CARMAT provided an update on its EFICAS clinical trial at the 36th “Journées de La Pitié” national conference on heart and lung transplantation and circulatory assistance, held from October 18 to 20, 2023, in Paris. The company announced the successful completion of seven Aeson® implants, marking a significant milestone in the study’s progress. These implants have taken place in multiple French centers participating in the trial, and the pace is accelerating, with four implants conducted in the last four weeks. The company noted that post-operative patient recovery has been increasingly satisfactory, instilling confidence in Aeson®’s performance and the study’s anticipated success, with completion expected in 2025.
CARMAT stock has been under increasing pressure given recent liquidity concerns. The company had previously announced it had enough cash to get through October 2023 and recently announced a $7 million emergency financing which the company said would extend its cash runway to early 2024. The company also announced that it foresaw a significant expansion in European sales, with revenues estimated to range between €4 to €6 million in the second half of 2023 followed by a substantial increase in 2024. The company also expected that by the end of 2023 it would have the capacity to manufacture 500 artificial hearts per year as it ramps up production capacity. The company hopes to submit a Pre-Market Approval (PMA) application in the United States by the end of 2026.
The EFICAS study, a prospective research initiative, is designed to enroll 52 patients eligible for transplants across a network of six French cardiology centers. Its primary objective is to assess 180-day post-implantation survival without disabling stroke, or the successful occurrence of heart transplant within 180 days after the implantation. This study will not only provide vital data on the efficacy and safety of CARMAT’s artificial heart but also medico-economic data to support its reimbursement proposition in France.
Professor Vincentelli of the Lille Regional University Hospital hailed the Aeson® heart as an essential addition to the therapeutic options against end-stage heart failure. Noting that it has offered a lifeline for young patients who no longer respond to conventional treatments and require heart transplants.