CARMAT announces its participation in several scientific and investor conferences during the second quarter of 2024

Paris, September 11, 2023 – 6:00 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, announces today that it will hold a video conference in English to provide an update on its achievements and perspectives.

Date/time:

• Monday, September 25, 2023, at 8 pm (CEST)

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://us02web.zoom.us/webinar/register/WN_LiE_walxR06zpa7NqQNQUw#/registration 

• 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 placed in a queue for the Q&A session at the end of the meeting.

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

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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.

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Disclaimer

This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in CARMAT (the “Company”) in any country. This press release may contain forward‐looking statements that relate to the Company’s objectives and prospects. Such forward‐looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risk and uncertainties including, without limitation, the Company’s ability to successfully implement its strategy, the rate of development of CARMAT’s production and sales, the pace and results of ongoing and future clinical trials, new products or technological developments introduced by competitors, changes in regulations and risks associated with growth management. The Company’s objectives as mentioned in this press release may not be achieved for any of these reasons or due to other risks and uncertainties.

The significant and specific risks pertaining to the Company are those described in the Universal Registration Document (“Document d’Enregistrement Universel”) filed with the Autorité des Marchés Financiers (AMF, the French stock market authorities) under number D. 22-0332. Readers and investors’ attention is, however, drawn to the fact that other risks, unknown or not deemed to be significant or specific, may or could exist.

Aeson® is an active implantable medical device commercially available in the European Union and other countries that recognize CE marking. The Aeson® total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant in patients suffering from end-stage biventricular heart failure (INTERMACS classes 1-4) who are not amenable to maximal medical therapy or a left ventricular assist device (LVAD) and are likely to undergo a heart transplant within 180 days of the device being implanted. The decision to implant and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (clinician manual, patient manual and alarm booklet) should be read carefully to understand the characteristics of Aeson® and information necessary for patient selection and the proper use of Aeson® (contraindications, precautions, side effects). In the United States, Aeson® is currently exclusively available within the framework of an Early Feasibility Study authorized by the Food & Drug Administration (FDA).

Paris, August 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, informs its shareholders that due to practical considerations, the publication of its half-year results, initially scheduled for September 13, 2023, will take place on September 25, 2023 after the market close.

On the same day, the Company will hold a videoconference in French and English. Times and connection details will be communicated to shareholders and the financial community shortly.

The company confirms its sales target of €10-13 million for 2023

Paris, May 11, 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, informs its shareholders that the Combined General Meeting (AGM) held on May 11, 2023 was able to validly deliberate, the required quorum having been reached.

The AGM adopted all proposed resolutions, with the exception of the 28^th resolution which was rejected, in accordance with the recommendations of the Board of Directors.

The company’s shareholders approved the appointment of Therabel Invest S.À.R.L., represented by Mr. Laurent Kirsch, as a director; and ratified the appointment of Mr. Alexandre Conroy. The Board of Directors, chaired by Mr. Alexandre Conroy, now consists of 12 members, 9 of whom are independent.

At the AGM, CARMAT also confirmed its objective of delivering sales of around €10-13 million in 2023, in line with the gradual build-up of its inventory of prostheses during the year.

The Company would like to thank all shareholders, either present, represented or having voted by post, for their commitment and support.

The consolidated result of the vote by resolution and the minutes of the AGM of May 11, 2023 will be available on the Company’s website, under Regulated Information / General Meetings, within the legal deadlines.

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.

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Disclaimer

This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in CARMAT (the “Company”) in any country. This press release may contain forward‐looking statements that relate to the Company’s objectives and prospects. Such forward‐looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risk and uncertainties including, without limitation, the Company’s ability to successfully implement its strategy, the rate of development of CARMAT’s production and sales, the pace and results of ongoing and future clinical trials, new products or technological developments introduced by competitors, changes in regulations and risks associated with growth management. The Company’s objectives as mentioned in this press release may not be achieved for any of these reasons or due to other risks and uncertainties.

The significant and specific risks pertaining to the Company are those described in the Universal Registration Document (“Document d’Enregistrement Universel”) filed with the Autorité des Marchés Financiers (AMF, the French stock market authorities) under number D. 23-0323. Readers and investors’ attention is, however, drawn to the fact that other risks, unknown or not deemed to be significant or specific, may or could exist.

Aeson® is an active implantable medical device commercially available in the European Union and other countries that recognize CE marking. The Aeson® total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant in patients suffering from end-stage biventricular heart failure (INTERMACS classes 1-4) who are not amenable to maximal medical therapy or a left ventricular assist device (LVAD) and are likely to undergo a heart transplant within 180 days of the device being implanted. The decision to implant and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (clinician manual, patient manual and alarm booklet) should be read carefully to understand the characteristics of Aeson® and information necessary for patient selection and the proper use of Aeson® (contraindications, precautions, side effects). In the United States, Aeson® is currently exclusively available within the framework of an Early Feasibility Study authorized by the Food & Drug Administration (FDA).

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”.