Publication in the JACC: Heart Failure of the initial clinical experience with Aeson® total artificial heart in cardiogenic shock patients initially placed on extracorporeal life support

Cash runway extended to mid-October 2023

Paris, April 24, 2023 – 6 pm CEST         

CARMAT (FR0010907956, ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, today announces that it has obtained non-dilutive financing of €13.2 million as part of the “France 2030” plan, and the extension of its cash runway through to mid-October 2023.

Non-dilutive financing of €13.2 million to increase and optimize production

The purpose of the financing of €13.2 million obtained by CARMAT as part of the “Industrialisation et Capacités Santé 2030” call for proposals is to support the increase in the annual production capacity of Aeson® artificial hearts to 1,000 a year within 5 years, and the reduction of the production cost of the prosthesis.

It consists of a €7.9 million grant and a €5.3 million repayable advance. The total financing will be received in four tranches over 2023-2026, in accordance with the project’s progress. The Company anticipates to receive a first tranche of €3.3 million no later than in the third quarter of 2023.

Subject to the success of the project, the repayable advance will be reimbursed over a period of 5 years starting on September 30, 2029.

Cash runway extended to mid-October 2023

Based exclusively on its current financial resources[1], including the €3.3 million first tranche of the “Industrialisation et Capacités Santé 2030” financing, CARMAT can fund its activities, according to its updated Business Plan, until mid-October 2023 without the need for any further financing.

Moreover, the Company continues to work on additional financing options to extend its cash runway beyond that date.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “This significant funding further demonstrates the French State’s confidence in the strength of our project and the potential of our Aeson® artificial heart. Not only is it crucial to enable us to rapidly increase our production capacity, it will also help us – via its optimization – to considerably reduce our prosthesis’ production cost. In this way, we will be able to meet the substantial demand from the medical community, and thus enable a large number of patients to benefit from our therapy, while embarking on the road to profitable growth. We are also very proud to be able to contribute to the reindustrialization and the growth of employment in France”.

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About CARMAT

CARMAT is a French MedTech that designs, manufactures and markets the Aeson® artificial heart. The Company’s ambition is to make Aeson® the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world’s first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson® could save, every year, the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson® is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson® is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The Company can rely on the talent and expertise of a multidisciplinary team of more than 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).

For more information, please go to www.carmatsa.com and follow us on LinkedIn.

The publication highlights the effectiveness of the device based on the combination of hemocompatibility and autoregulation

Paris, March 6, 2023 – 7:00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, today announced that the first U.S. clinical experience with Aeson® has been published in the Annals of Thoracic Surgery Short Reports, the journal of the U.S. Society of Thoracic Surgeons.

The article, entitled The First Autoregulated Total Artificial Heart Implant in the United States, describes the Aeson®’s implant performed at Duke University Hospital in the summer of 2021 within the framework of the Early Feasibility Study (EFS).

The authors report that Aeson® total artificial heart (TAH) provides right- and left-sided heart replacement for a patient suffering from biventricular failure with notable improvements over prior-generation circulatory support devices. These include enhanced hemocompatibility and autoregulation enabling increased output in response to higher filling pressures.

The authors conclude that the first U.S. experience demonstrates the effectiveness of the Aeson® TAH while preventing stroke and bleeding complications. The patient was successfully bridged to transplant as a donor organ became available after 5 months of support on the device, and has made a full recovery.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are gratified that our device provided such an efficient support to the first U.S. patient. Aeson®’s hemocompatibility translates in an unparalleled safety profile with absence of bleeding complications or stroke, which are the main drawbacks of conventional mechanical circulatory support devices. Furthermore, the blood flow autoregulation, which is unique to Aeson®, facilitates physical activity and patient readiness for a successful cardiac transplant. These distinctive features once again confirm our belief that Aeson® will become the therapy of choice for advanced biventricular heart failure. We continue to work with the FDA to resume the EFS, a key step towards obtaining authorization to market Aeson® in the U.S.”

• Gradual resumption in Aeson^® implantations in line with progressive production ramp-up over the year 2023
• Cash position of €51 million as of December 31, 2022 and active exploration of financing options to extend cash runway beyond July 2023
• Confirmation of a sales target of €10 to €13 million in 2023

Paris, February 23, 2023 – 7 am CET

CARMAT (FR0010907956, ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, today announces its annual results for the year ending December 31, 2022[1] and confirms its 2023 objectives.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “Thanks to the efforts of the whole CARMAT team, we have achieved our main objective for 2022: resuming implantations of our Aeson^® artificial heart in the fourth quarter, as previously announced.

In order to address the strong interest of healthcare professionals in our therapy, we are confident in our ability to gradually increase our production volumes over the coming months, with an acceleration in the second half of the year, and initiate the commercial success of our artificial heart as early as 2023.

At the same time, we will deploy the EFICAS study in France, the largest clinical study ever initiated by the Company, which will enable us to confirm the efficacy and safety of our therapy, but also to collect essential medico-economic data for reimbursement, notably in France.

Furthermore, we carry-on working with the FDA to resume our Early Feasibility Study in the United States, a key step on the road to obtaining the marketing approval (‘PMA’) for Aeson^® in this country.

We are also actively reviewing all funding options to extend our cash runway beyond July 2023, and are confident in our ability to do so despite a challenging external environment.

2023 will be a pivotal year to position Aeson^® as the benchmark treatment for advanced heart failure”.

• Based on the gradual resumption in Aeson^® implantations CARMAT targets net sales of €10 million to €13 million in 2023
• The Company anticipates break even in 2027

Paris, January 23, 2023 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR,), designer and developer of Aeson^®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, provides a business update, and communicates its financial targets for the first time.

Sales forecast of €10 to €13 million in 2023

CARMAT resumed commercial implants of its Aeson^® artificial heart in November 2022. The Company continues to train additional hospitals very actively, and targets 30 operational centers in Europe by the end of 2023, primarily in Germany and Italy.

In France, Aeson^® will be made available to patients via the EFICAS study, which was initiated last December, in 6 hospitals: Lille Regional University Hospital, Pitié Salpêtrière University Hospital and Georges Pompidou European Hospital in Paris, Rennes University Hospital, Strasbourg University Hospital and Lyon University Hospital (Hospices Civils de Lyon). The Company aims to complete the study in 2025.

The production ramp-up will be gradual and should allow more than 100 artificial hearts to be produced in 2023.

Based on this, the Company forecasts sales of €10 million to €13 million in 2023.

Break-even anticipated in 2027

Moreover, in order to support a strong demand for Aeson^® in Europe, and its commercial launch in the United States, anticipated in 2026, CARMAT has planned an ambitious industrial plan which should enable the Company to achieve a manufacturing capacity of 500 prostheses in 2024 and 1,000 prostheses by 2027.

Based on this, the Company anticipates to be in position to achieve break even within 5 years, i.e. in 2027.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “The last few months have been full of valuable learnings and have allowed us to fine-tune our market access and our industrial strategies. Given the progress made in various areas (commercial, manufacturing, quality, clinical, etc.), we are now in a position – for the first time – to communicate financial targets, and in particular revenue guidance of 10 to 13 million euros for 2023. Strong interest in, and demand for Aeson^® make us particularly confident about the development of our sales. Our entire team is more determined than ever to make Aeson^® the new benchmark treatment in advanced biventricular heart failure, to successfully ramp up our production, and so embark on the journey to profitable growth”.

Paris, January 17, 2023 – 7:30 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces today that it will hold a video conference in English to provide an update on its developments.

Date/time:

• Monday, January 23, 2023 at 8 pm (CET)

The conference will be hosted by:

• Stéphane Piat, Chief Executive Officer
• Pascale d’Arbonneau, Chief Financial Officer
• Francesco Arecchi, Director of Global Market Development
• Dr Piet Jansen, Chief Medical Officer

Register by clicking on this link:

https://channel.royalcast.com/landingpage/carmat-en/20230123_1/  

• This link allows you to both register and participate in the virtual meeting.
• At any time during the presentation, you can send your questions in writing via the web conferencing platform. They will be queued for the Q&A session.

A video conference in French will be held on the same day at 6 pm (CET) for French investors.

Paris, January 5, 2023 – 7:00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces its indicative financial calendar for 2023.

This preliminary agenda may be modified. Each publication will be released before market opening.

CARMAT (FR0010907956, ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced the first implantation of its Aeson® artificial heart within the framework of the EFICAS clinical study in France.

On October 26, 2022, CARMAT announced that it had received the necessary regulatory approvals to resume the EFICAS clinical study.

The first Aeson® implantation within the framework of this study was performed during the last week of December 2022 by Prof. André Vincentelli and his team at Lille Regional University Hospital.

In addition to the Lille hospital, five other medical centers take part in this study: Pitié Salpêtrière University Hospital and Georges Pompidou European Hospital in Paris, Rennes University Hospital, Strasbourg University Hospital and Lyon University Hospital (Hospices Civils de Lyon).

This prospective study will involve a total of 52 patients eligible for a heart transplant in France and will allow CARMAT to collect both additional data on the efficacy and safety of its artificial heart and medico-economic data to support its value proposition and the device’s reimbursement, notably in France. The study’s primary endpoint is survival for 180 days after implantation of the device without a disabling stroke, or a successful heart transplant within 180 days of implantation.

CARMAT benefits from 13 million euros in funding from the French National Innovation Fund to partially finance this study.

In accordance with the principles it has consistently applied, the Company does not plan to communicate on the state of health of individual patients nor on the performance of each implantation. CARMAT will continue to communicate on its progress when it reaches significant milestones and when it publishes its financial results.