26 Jul 2021
Posted in Medical Devices
CARMAT has potential to become significant player in total heart failure market with Aeson, says GlobalData
- CARMAT announced plans to launch its artificial heart device, Aeson, in Europe, following CE approval in December 2020
- GlobalData currently estimates that CARMAT will receive FDA approval for Aeson in 2026
- The total artificial heart market is much larger in the US, so GlobalData expects CARMAT to seek FDA approval soon
CARMAT announced its intent to launch Aeson, an artificial heart device, in Europe, following CE approval in December 2020. The European total artificial heart (TAH) market is worth $10m in 2021, according to GlobalData. The leading data and analytics company notes that the TAH market, while it may not immediately generate substantial revenues for the company, can be the cornerstone to making CARMAT a significant player in the heart failure market in the future.
Based on the small market size of Europe’s TAH market, GlobalData expects less than $2m annual revenue in Europe unless there is a significant expansion of indications for these devices, particularly as destination therapies, in addition to bridge to transplant. Ventricular assist devices are the main competition to the TAH market and outperform TAH due to tolerability issues with the implant. CARMAT has focused its development on increased tolerance of TAH to increase the likelihood of patients to receive a donor heart. While the TAH market is very small, it does have high visibility in this space.
GlobalData currently estimates that CARMAT will receive Food and Drug Administration (FDA) approval for Aeson in 2026. CARMAT would also benefit from launching Aeson in the US quickly, because it is a much larger market.
Richard Hyde, Medical Analyst at GlobalData, comments: “There is a massive shortage of hearts available for transplant globally, which is why there is so much interest in TAH as a bridge-to-transplant procedure. CARMAT has done well with device innovation so far, and we expect the company to continue innovation in the heart failure device segment.”