Periodic Reporting for period 1 - Aeson® (The World’s Only Bioprosthetic Auto-regulated Artificial Heart: From Total Artificial Heart (TAH) to Physiologic Heart Replacement Therapy (PHRT))
Berichtszeitraum: 2022-10-01 bis 2023-09-30
At Carmat we have designed and developed Aeson®, the world’s most advanced total artificial heart (TAH), aiming to fulfill an unmet medical need by providing a credible therapeutic alternative to heart transplants for people suffering from end-stage biventricular heart failure. Aeson® is an active implantable medical device intended to replace the ventricles of the native heart in patients suffering from advanced heart failure. The device is electro-hydraulically driven with a shape close to that of a human heart. Once the Aeson® is powered, it mimics the action of a normal heart, providing mechanical circulatory support and restoring normal blood flow through the body. Aeson® differs from other existing artificial hearts (or TAH – total artificial hearts) in its unique combination of three features: pulsatility, autoregulation and hemocompatibility. With Aeson®, Carmat is creating a new therapeutic class of “physiologic heart replacement therapy” (PHRT).
Overal clinical experience to date :
- 38 patients suffering from advanced heart failure have been treated with Aeson
- The longest support duraction exceeded 25 months
- 13 patients have been transplanted after Aeson support
- The cumulative experience is 16.9 patient years
Overal clinical experience to date :
- 38 patients suffering from advanced heart failure have been treated with Aeson
- The longest support duraction exceeded 25 months
- 13 patients have been transplanted after Aeson support
- The cumulative experience is 16.9 patient years
The vast majority of these supply difficulties were resolved by the end of June 2023, enabling output to gradually return to normal over the summer.
Carmat’s efforts and resources were predominantly focused on:
- extending its Bois d’Arcy’s manufacturing site, which will enable the Company to increase its production capacity to 500 hearts a year by the end of 2023;
- training more medical centers (25 centers trained to date for commercial implants) and preparing for the launch of Aeson® in eight new countries;
- ramping up for the EFICAS clinical study in France as from the second half of the year;
- continuing discussions with the FDA with a view to ultimately gaining market access for Aeson® in the United States.
SIGNIFICANT EVENTS
IMPLEMENTING THE INDUSTRIAL PLAN
Ramp-up in production
The Company’s production gradually returned to normal over the summer, allowing CARMAT to hold c.20 prostheses on shelf to date. Production has continued to gain momentum since then, and Carmat now anticipates to manufacture more than ten hearts a month between September and December 2023. The Company therefore expects to reach a total output of 60 to 70 hearts for full-year 2023.
Strengthening the supplier portfolio
Carmat’s manufacturing output relies on a large number of suppliers and subcontractors. As it ramps up its production, one of the key factors for the Company’s success will be to develop its supplier portfolio in order to work only with highly reliable partners capable of producing the required volumes at a competitive price, and which meet the strict quality requirements specific to the implantable medical devices market. In order to achieve this goal, Carmat has drawn up an ambitious multi-year roadmap, which it began to action in several tangible ways in the first half of 2023. For example, it entered into a new partnership agreement with France-based Vygon for developing the connector conduits of the Aeson® artificial heart and stepped up its partnership with the Swiss company MPS for producing the motor pump. These initiatives enable Carmat to both strengthen its supply continuity and reduce the production cost of the prosthesis.
Increase in production capacity
During the first half of 2023 the Company also began work on expanding its production capacity, in particular by extending its cleanroom and creating additional production facilities at the Bois d’Arcy site. In view of the current progress of the works, the Company is standing by its objective of reaching a production capacity of 500 hearts a year by the end of 2023.That capacity could represent a potential yearly turnover of 100 M€. Carmat’s aim is to subsequently double its production capacity again, to 1,000 hearts a year, by 2027.
COMMERCIAL DEVELOPMENT
Hospital training and geographic expansion
During the period, the Company continued to actively train hospitals in order to reach its target of 30 medical centers trained for commercial implants by the end of 2023. To date, an overall 40 centers are trained, including 25 for commercial implants and the other 15 for implants in the EFICAS study in France and the EFS in the United States.
As part of this, Carmat also supports the hospitals in getting appropriate funding for the therapy, and can confirm that it is secured in the vast majority of them.
From the second half of 2023, the Company plans to make the Aeson® artificial heart commercially available in eight more countries – both in Europe (Greece, Slovenia, Croatia, Serbia, Austria and Switzerland) and outside Europe (Israel and Saudi Arabia) – in addition to the two countries in which the device has already been sold for commercial implants (Germany and Italy). Hospitals have been trained in five of these eight new countries so far.
Patient numbers and sales forecasts
In view of a solid base of trained medical centers, where a substantial number of eligible patients have already been identified, and given that production has got back to normal, the Company forecasts sales revenue between €4 million and €6 million in the second half of 2023.
Carmat’s efforts and resources were predominantly focused on:
- extending its Bois d’Arcy’s manufacturing site, which will enable the Company to increase its production capacity to 500 hearts a year by the end of 2023;
- training more medical centers (25 centers trained to date for commercial implants) and preparing for the launch of Aeson® in eight new countries;
- ramping up for the EFICAS clinical study in France as from the second half of the year;
- continuing discussions with the FDA with a view to ultimately gaining market access for Aeson® in the United States.
SIGNIFICANT EVENTS
IMPLEMENTING THE INDUSTRIAL PLAN
Ramp-up in production
The Company’s production gradually returned to normal over the summer, allowing CARMAT to hold c.20 prostheses on shelf to date. Production has continued to gain momentum since then, and Carmat now anticipates to manufacture more than ten hearts a month between September and December 2023. The Company therefore expects to reach a total output of 60 to 70 hearts for full-year 2023.
Strengthening the supplier portfolio
Carmat’s manufacturing output relies on a large number of suppliers and subcontractors. As it ramps up its production, one of the key factors for the Company’s success will be to develop its supplier portfolio in order to work only with highly reliable partners capable of producing the required volumes at a competitive price, and which meet the strict quality requirements specific to the implantable medical devices market. In order to achieve this goal, Carmat has drawn up an ambitious multi-year roadmap, which it began to action in several tangible ways in the first half of 2023. For example, it entered into a new partnership agreement with France-based Vygon for developing the connector conduits of the Aeson® artificial heart and stepped up its partnership with the Swiss company MPS for producing the motor pump. These initiatives enable Carmat to both strengthen its supply continuity and reduce the production cost of the prosthesis.
Increase in production capacity
During the first half of 2023 the Company also began work on expanding its production capacity, in particular by extending its cleanroom and creating additional production facilities at the Bois d’Arcy site. In view of the current progress of the works, the Company is standing by its objective of reaching a production capacity of 500 hearts a year by the end of 2023.That capacity could represent a potential yearly turnover of 100 M€. Carmat’s aim is to subsequently double its production capacity again, to 1,000 hearts a year, by 2027.
COMMERCIAL DEVELOPMENT
Hospital training and geographic expansion
During the period, the Company continued to actively train hospitals in order to reach its target of 30 medical centers trained for commercial implants by the end of 2023. To date, an overall 40 centers are trained, including 25 for commercial implants and the other 15 for implants in the EFICAS study in France and the EFS in the United States.
As part of this, Carmat also supports the hospitals in getting appropriate funding for the therapy, and can confirm that it is secured in the vast majority of them.
From the second half of 2023, the Company plans to make the Aeson® artificial heart commercially available in eight more countries – both in Europe (Greece, Slovenia, Croatia, Serbia, Austria and Switzerland) and outside Europe (Israel and Saudi Arabia) – in addition to the two countries in which the device has already been sold for commercial implants (Germany and Italy). Hospitals have been trained in five of these eight new countries so far.
Patient numbers and sales forecasts
In view of a solid base of trained medical centers, where a substantial number of eligible patients have already been identified, and given that production has got back to normal, the Company forecasts sales revenue between €4 million and €6 million in the second half of 2023.