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PARIS - CARMAT (Euronext Growth Paris:ALCAR), a €21.31M market cap medical device company, announced Monday it has obtained CE marking under the Medical Devices Regulation (MDR) for its Aeson artificial heart system, securing its regulatory status in European markets beyond May 2027. According to InvestingPro data, the company has achieved impressive revenue growth of 91.4% over the last twelve months.
The certification applies to the Aeson system as a Class III active implantable medical device for bridge-to-transplant (BTT) indication, meaning it can be used in patients awaiting heart transplantation.
This new certification replaces the previous Medical Device Directive (MDD) approval the device received in December 2020. Under European regulations, medical devices certified under the older MDD standard must transition to the more stringent MDR certification by May 2027 to remain marketable in the European Union.
The MDR certification was granted following a review conducted by notified body DEKRA and confirms the device’s compliance with updated European standards for patient safety, clinical performance, and risk management.
According to the company, Aeson is currently the only CE-marked implantable total artificial heart available in Europe.
Stéphane Piat, Chief Executive Officer of CARMAT, called the certification "a further independent recognition of Aeson’s quality and performance by health authorities."
The company noted the certification strengthens its foundation for potential future expansion of Aeson’s indications toward destination therapy, where the device would be implanted permanently without subsequent heart transplantation. It also supports CARMAT’s U.S. market access strategy, which is targeted for 2028.
Despite this regulatory milestone, CARMAT’s stock has declined 71.24% year-to-date, trading at €0.36. The company disclosed it has been in receivership procedure since July 1, 2025, and faces "a very high risk of default, including in the very short term," according to the press release statement. InvestingPro analysis reveals the company operates with significant debt burden and is quickly burning through cash reserves.
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The Aeson artificial heart is designed as an alternative to heart transplantation for patients with end-stage biventricular heart failure.
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