Carmat, designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure, has announced that it has reached the milestone of 50 implants of its total artificial heart, and provides an update on its achievements and outlook.
Stéphane Piat, chief executive officer of Carmat, says, “Carmat celebrated its 15th anniversary in 2023. The company and its teams are extremely proud to have reached the milestone of 50 Aeson implants since the first in December 2013. This milestone is a major success and is a testimony of the recognition of our therapy by leading names in cardiology.
Founded on the work of the icon of cardiac surgery professor Alain Carpentier, Carmat aims to treat heart failure, a major health issue and the world’s leading cause of death, by replacing the diseased heart with a bioprosthetic artificial heart. The last 15 years have been a period of intense research and development, resulting in a breakthrough innovation that is unique in the field of cardiology.
The year 2023 has been particularly structuring year for the company, with a substantial acceleration in sales in the last quarter, a significant number of hospitals trained for implants, increased manufacturing capacity to meet demand, and a reinforcement of the Aeson heart’s safety profile thanks, in particular, to software improvements, which represents a significant catalyst for our long-term ambition to make Aeson a “destination therapy” device, i.e. enabling long-term patient support without subsequent heart transplantation.
Taken together, these advances provide a solid foundation for a sizable commercial roll-out, enabling Carmat to achieve its ultimate goal of providing patients waiting for a human heart with a therapeutic solution and a good quality of life. We look forward to 2024 with confidence and are very determined to achieve our goals.”
15 years of innovation to serve patients
The fruit of 15 years of research and the convergence of several cutting-edge technologies, the Aeson artificial heart is a unique device, that aims to “replicate” as closely as possible the functioning of a human heart.
The only device in the world to be pulsatile, hemocompatible and self-regulated, Aeson saves lives and offers patients a better quality of life.
An “intelligent” device, Aeson adapts blood flow in real time and manages differentiated flows between the right and left parts of the heart, depending on the patient’s needs and activity; and does so without risk of rejection, without heavy drug regiment, and with a safety profile superior to that of all other comparable devices.
A therapy adopted by the medical community: 50 implants in 8 countries since inception.
Since the first implant in December 2013, Aeson has spread widely through clinical trials and then commercially: 50 patients have benefited from the Aeson heart in 8 different countries, bringing the cumulative experience to more than 19 patient-years. To date, 13 patients are living with the Aeson device.
Among the 17 implants carried out in 2023, 10 were part of the EFICAS clinical trial in 6 different hospitals in Paris, Lille, Lyon, Le Plessis-Robinson and Montpellier; and 7 in the commercial setting, internationally, in Germany and Italy.
Aeson, which is strongly supported by leading cardiologists in Europe and the United States, is becoming a reference solution for patients eligible for transplantation, waiting for an available human heart.
Solid sales momentum since the last quarter of 2023
During the 2023 financial year, Carmat generated sales of 2.8m Euros, corresponding to the sale of 17 Aeson prostheses, including 11 in the last quarter, demonstrating solid early commercial dynamics (with a rate of around one implant per week achieved since the end of September), underpinned by Carmat’s ability to roll out its therapy on a large scale industrially and commercially.
33 hospitals in 11 different countries have been trained and are therefore ready to carry out Aeson implants on a commercial basis, and 8 French hospitals[5] have also been trained for implants as part of the EFICAS clinical trial.
Manufacturing capacity increased to 500 hearts per year
In 2023, Carmat has continued to invest in its industrial facilities, notably with the opening of its second production building in Bois-d’Arcy, enabling it to increase its manufacturing capacity to 500 hearts per year from early 2024, corresponding to potential annual sales of around 100m Euros.
Enhanced Aeson reliability
In 2023, Aeson continued to confirm a safety profile that clearly sets it apart from all other mechanical circulatory support systems: since its inception, Aeson has not resulted in any gastrointestinal bleeding or disabling stroke.
At the end of the year, Carmat announced a software enhancement for Aeson, which significantly strengthens the safety profile of the device: from now on, for many potential malfunctions linked to the prosthesis’s electronic components, the Aeson software will automatically ‘correct’ these faults by adapting the prosthesis’s performance in an appropriate manner, so that the patient’s support remains unaffected.
Strong growth outlook starting as early as 2024
Given the decisive steps taken in 2023, and the sales trends seen in recent months, the Company is confident in the continued momentum of its implants and the successful deployment of its strategic roadmap.
Carmat’s key objectives for 2024 are: Sales of 14m Euros to 20m Euros; around 50 hospitals trained for commercial implants by the end of the year; around 30 implants carried out as part of the EFICAS study in France; A cash burn reduction (operations and capital expenditure) of around 20% compared to 2023.
A ‘destination therapy’ objective
Carmat’s ultimate goal is to offer not only a temporary solution for transplant-eligible patients waiting for a human graft, but also a “definitive” solution for patients who are not eligible for a transplant, who would therefore remain under the support of the Carmat device over the long term, commonly referred to as ‘destination therapy (DT)’.
