CARMAT announces its 2023 annual results and provides an update on its progress and prospects for 2024

• 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.

Paris, December 22, 2022 – 7:00 am CET 

CARMAT (FR0010907956, ALCAR), designer and developer of 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 co-option of Alexandre Conroy to the Company’s Board of Directors in place of Jean-Pierre Garnier, the outgoing Chairman of the Board who is standing down for personal reasons, for the remaining duration of the latter’s term of office, and his appointment as Chairman of the Board.
 
A graduate of HEC business school in Paris, Alexandre Conroy (59) started out in the pharmaceutical and biotechnology industry. He then spent most of his career at Becton Dickinson & Co (NYSE), a group specializing in medical devices, diagnostics and life sciences. During his 31 years with that company, he was notably President of the Pharmaceutical Systems unit, President for the Americas and EMEA regions and President of the Medication Delivery Solutions unit, in growth, turnaround and acquisition integration contexts. From 2019 to 2022, Alexandre Conroy led the group’s global industrial operations within the context of the COVID-19 pandemic and its impacts on supply chains.
 
Alexandre Conroy has been a member of the Executive Committee and a Corporate Officer at Becton Dickinson & Co. His career has also led him to live in Argentina, the United States and Europe.

Jean-Pierre Garnier, the outgoing Chairman of CARMAT’s Board of Directors, said: “I have been delighted to contribute to CARMAT’s development over the last four years, and in particular to successfully reach the commercialization stage for Aeson®. The Board of Directors is eagerly looking forward to continuing its ramping up under the chairmanship of Mr. Alexandre Conroy. Alexandre possesses all the necessary skills to successfully steer, alongside Stéphane Piat, the Company’s industrial and commercial development. This highly experienced duo has all the qualities required to make CARMAT a medical device champion in the field of heart failure”.
 
Stéphane Piat, Chief Executive Officer of CARMAT, added: “I would like to wholeheartedly thank Jean-Pierre Garnier for his support during these crucial years for CARMAT. I am also very pleased to now be able to team up with Mr. Alexandre Conroy. We will be able to rely on his exceptional experience in the health industry to ensure the development of our innovative therapy”.
 
Alexandre Conroy, CARMAT’s new Chairman of the Board of Directors, concluded: “I have spent my entire career in the medical technologies industry, and the Aeson® heart represents what can be described as a genuine groundbreaking innovation. This device has immense potential and can become a new standard in the management of heart failure. I am very pleased to be able to contribute to its development with the rest of the Board of Directors and the managerial team. I have no doubt that, surrounded by such talented teams, we will be able to make the most of Aeson®’s medical potential for the benefit of patients, and make CARMAT a success story in the French medical industry”.

Obtention of a €2.5m grant and potential equity investments of €15m

Paris, December 19, 2022 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of 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 that it has been selected by the European Council to join its acceleration program (EIC Accelerator), which awards the most innovative companies in Europe.

EIC Accelerator is a funding program for innovative companies that aims to support the creation of European unicorns by helping them bring disruptive innovations to market.

Following a highly selective and rigorous evaluation process, the Aeson® artificial heart has been recognized as a high-quality medical innovation aimed at providing a relevant solution to a public health issue with significant unmet needs.

As a result, CARMAT has been awarded the maximum possible funding amount under this program, i.e. a non-dilutive grant of €2.5 million, intended in particular to support the industrialization of Aeson®, and optional equity financing of €15 million from the European Innovation Council Fund (EIC Fund), notably intended to support the marketing of Aeson® in Europe. The terms and conditions of the optional equity financing will be specified later.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are proud and grateful to have been awarded within this prestigious program. The EIC’s decision confirms the very high quality and strong potential of our innovation and gives us access to substantial funding to support our development. I would like to thank all the CARMAT teams involved in this challenging call for projects, which once again highlights the urgent need for an innovative solution to treat advanced biventricular heart failure.”

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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, December 8, 2022 – 7.45 am (CET)

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative to people suffering from end-stage biventricular heart failure (the “Company”), today announces the success of its global offering for a gross amount of €31.1 million, of which €27.2 million was subscribed by specialized investors as defined below and €3.9 million was subscribed by retail investors (via the PrimaryBid platform) (the “Global Offering”).

Stéphane Piat, Chief Executive Office of CARMAT, said: “Following this successful operation, we can now look ahead with confidence and focus on our key objectives for the coming year: develop our sales in Europe, start the EFICAS clinical study in France and continue to rebuild our inventory of devices. 2023 will be the first full commercial year for Aeson®, which represents a real hope for patients suffering from end-stage biventricular heart failure, as it means that for the first time a significant number of them will have access to our therapy.

I am very happy with the continuous support of our historical shareholders, and delighted both to welcome new investors and by the strong interest of retail investors via the PrimaryBid platform. I would like to thank all of them for their trust in the Company”.

CARMAT launches a global offering for an amount of
c. €30 million that has received subscription commitments totaling €5.5 million

• Global Offering composed of a reserved offering aimed at specialized and strategic investors, and a public offering aimed at retail investors via the PrimaryBid platform
• Issue price of new shares at 10.50 euros per share
• Closing of the Primary Bid Offering on December 7, 2022 at 11 pm (CET) and of the Reserved Offering on December 8 before market opening subject to early closing

Paris, December 7, 2022 – 5.45 pm (CET)

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative to people suffering from end-stage biventricular heart failure (the “Company”), today announces the launch of a c. €30 million global offering via the issuance of new shares at a fixed price of €10.50 per share aimed at specialized and strategic investors, as defined below, and retail investors (via the PrimaryBid platform) (the “Global Offering”).

The Company is planning to use the funds raised through this Global Offering to support the development of its activities, and particularly its production ramp-up, the resumption and uptake of Aeson® sales and the initiation of the EFICAS clinical study in France.

In this respect, CARMAT reminds that at the end of October it obtained all the necessary regulatory authorisations to resume commercial implants[1] of Aeson® and initiate the EFICAS[2] study in France. Subsequently, in mid-November, a first patient was implanted in a German hospital in a commercial setting and several French centres are in an active screening phase for the upcoming start of the EFICAS study. The Company confirms that it now intends to gradually develop its implants, depending in particular on the rebuilding of its inventory of implantable prostheses. With regard to the feasibility study in the United States (EFS)[3], discussions with the FDA are continuing and the Company is currently anticipating the recruitment of the second cohort of 7 patients in 2023. Finally, CARMAT also aims to carry out, in 2023, 3 additional implants in its European PIVOTAL study[4], which would bring the total number of implants in this study to 20.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “This new funding happens at a pivotal time for CARMAT as we are preparing for a first full year of sales in the history of the company. The continued support from several of our core shareholders and other investors will notably enable us to progressively rebuild our inventory of implantable prostheses, initiate the EFICAS clinical study in France shortly, and very importantly develop our sales in Europe. We are also pleased that retail investors will again be able to take part in this financing round via the PrimaryBid platform. We have never been so close to making Aeson® successful commercially, and thus giving a large number of patients, access to our unique therapy that saves lives”.

[1] In December 2020, CARMAT obtained the CE marking allowing it to market its Aeson® artificial heart in the “bridge-to-transplant” (BTT) indication in the European Union and other countries recognising the CE marking.

[2] The EFICAS study will enroll 52 patients eligible for heart transplant in France and will provide CARMAT with additional data on the efficacy and safety of its artificial heart, as well as medico-economic data to support the value proposition and reimbursement of the device, particularly in France. As a reminder, CARMAT has obtained €13 million in funding from the French National Innovation Fund to partially finance the EFICAS study; this funding will be perceived as patients are progressively enrolled in the study.

[3] The Early Feasibility Study (EFS) in the US will involve a total of 10 patients in two successive cohorts; a first cohort of 3 patients completed in the second half of 2021, followed by a second cohort of 7 patients which requires the go-ahead from the Food & Drug Administration (FDA) to start.

[4] The PIVOTAL study was initiated in 2016 with an initial enrollment target of 20 patients, a number that could be adjusted up or down during the course of the study. The interim results of this study, for which there was no pre-determined quantitative success threshold, enabled CARMAT to obtain CE marking in December 2020. The latest published results for 15 patients included show a success rate of 73%, with a total of 11 patients achieving the primary objective of the study (7 patients achieving at least 6 months of survival with the prosthesis, and 4 successfully transplanted within 6 months following Aeson® implant).