
CARMAT Reports its First Half 2023 Results and Provides a Strategic Update on Fully Artificial Heart Progress
CARMAT, a medical device company from France announced its first half 2023 results and provided and update on its strategic roadmap. The company manufactures the Aeson® implant, a fully artificial heart and is seeking FDA approval. Aeson is a sophisticated artificial heart system composed of three main components. The first part is the implanted prosthesis, which includes a motor pump group with two micro pumps responsible for creating systole and diastole by pushing actuator fluid to the membranes. There are two ventricle chambers separated by a membrane, one for blood and the other for actuator fluid, both using biocompatible materials. Embedded electronics, microprocessors, and sensors are included to enable autoregulated responses to the patient’s physiological needs. Additionally, there is an external flexible bag containing the actuator fluid, four biological valves for unidirectional blood flow, two outlet conduits for connecting to the pulmonary artery and aorta, and a percutaneous driveline linking the prosthesis to external components.
Financial Results:
In the first half of 2023, there was a revenue of €0.6 million, but it was adversely affected by supply disruptions. However, production has returned to normal since the summer, resulting in an inventory of approximately 20 Aeson® hearts as of now. A total of 40 hospitals have been trained, with 25 of them prepared for commercial implants. Additionally, 8 more countries are in the process of commercial activation. Sales forecasts for the second half of 2023 anticipate €4 to 6 million in revenue. Efforts are underway to increase annual production capacity to 500 Aeson® prostheses, aimed at facilitating strong and sustained sales growth. As of June 30, 2023, the cash position stands at €23.8 million, with several financing options actively being explored to extend the cash runway beyond the end of October 2023.
Clinical Development and U.S. FDA Approval Path
CARMAT provided an update on its EFICAS clinical study in France, revealing that the first Aeson implant was conducted in December 2022 by Professor André Vincentelli and his team at Lille University Hospital, one of the study’s six participating centers. This study, expected to conclude in 2025, will involve 52 eligible heart transplant patients in France and aims to collect data on the artificial heart’s efficacy, safety, and medico-economic aspects to support reimbursement and the device’s future commercial launch in France and the United States. CARMAT is also actively engaging with the FDA and plans to use data from the EFICAS study and the Early Feasibility Study (EFS) to optimize its US market access strategy, potentially avoiding a substantial PIVOTAL study. The company aims to apply for Premarket Approval (PMA) in the US by the end of 2026, pending successful studies. Furthermore, a scientific article detailing the first US implantation of the Aeson® artificial heart was published, highlighting its significant advantages and success in bridging a patient to transplant.
Access to Capital the Current Challenge:
As stated above, at the end of June the company has €23.8 million in cash and €56.6 million in debt. The company stated that they have sufficient cash runway given their new cash management plan through only Oct. 2023., but are exploring multiple financing alternatives. The stock has been under continued pressure given liquidity concerns and the current market capitalization of approximately $125 million makes equity financing alternatives problematic given potential dilution needed to reach broader commercialization.