CARMAT accelerates its sales momentum and reiterates its confidence in its development outlook

CARMAT launches a capital increase of an initial amount of €15 million as part of its short-term financing

• This capital increase will be made by way of a public offering without preferential subscription rights

• The initial amount of the capital increase could be increased up to €17.25 million should the extension clause be fully exercised, and up to €19.8 million should the extension clause and overallotment option be fully exercised

• Extension of CARMAT’s cash runway to early May 2024, in the event of completion of the initial capital increase (excluding the extension clause and overallotment option).

• After the Offering, the Company’s funding needs for the next 12 months will amount to €37 to 55 million

Paris, January 17, 2024 – 6 pm (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 advanced biventricular heart failure (the “Company” or “CARMAT”), announces the launch of a capital increase by way of a public offering without preferential subscription rights for an initial total of €15 million, which could be increased to a maximum of €19.8 million should the extension clause and overallotment option be fully exercised. The main characteristics of this capital increase are as follows:

• Subscription price: €3.99 per share, representing a discount of 30% on the average of the volume-weighted average share prices over the five trading sessions preceding the setting of this subscription price;
• Subscription and underwriting commitments totaling €9.17 million, or 61.13% of the initial amount of the transaction (including €3.25 million by the historical shareholders Lohas, Santé Holdings and Therabel Invest);
• Subscription period open from January 18 to January 25, 2024, inclusive;
• Extension of CARMAT’s cash runway to early May 2024, should the initial capital increase be implemented (excluding the extension clause and overallotment option).

Stéphane Piat, Chief Executive Officer of CARMAT, said: “15 years of innovations have enabled us to devise Aeson®, the world’s only artificial heart combining pulsatility, hemocompatibility and self-regulation, to replicate as closely as possible the functioning of a human heart and offer patients a quality of live with no complications.

In 2023, CARMAT made decisive progress: 50 implants achieved since inception, 41 hospitals trained to implants of Aeson® in 12 different countries, and opening of a new manufacturing facility with a capacity of up to 500 hearts a year. Out of the 50 implants made so far, 11 were performed during the fourth quarter of 2023, in France, Germany and Italy, demonstrating a strong acceleration in the adoption of Aeson® by the medical community.

This puts us in a position to move towards a substantial commercial deployment of Aeson® in Europe, from the beginning of 2024.

By launching a public offering which, by definition, is open to all, we want to allow both our existing shareholders, who we would like to thank very warmly for their support, and those who are not yet CARMAT shareholders, to participate in our short-term financing, and by doing so, support our long-term objective of providing a solution to the thousands of patients suffering from advanced biventricular heart failure, who currently have no therapeutic options due to the lack of a sufficient number of available human grafts ”.

• 50 patients have benefited from CARMAT’s Aeson® artificial heart since the first implant in 2013
• Aeson® becomes an essential breakthrough innovation in the treatment of advanced biventricular heart failure
• 41 hospitals in 12 countries are trained for implants[1], including 33 for commercial activity
• Turnover of €2.8m in 2023, marked by a substantial acceleration in sales in the fourth quarter, with 11 implants out of the 17 carried out during the year
• Sales of €14-20m anticipated in 2024
• Launch in the very short term of a capital increase to extend the cash runway beyond the end of January 2024 and partially finance the Company’s needs for the forthcoming 12-month period, estimated to a minimum of €50m

Videoconference on January 17 at 20:00 CET.

To participate, please register by clicking on this link

Paris, January 15, 2024 – 7:00 am (CET)

CARMAT (FR0010907956, ALCAR), 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 (the “Company” or “CARMAT“), today 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, declares: « CARMAT celebrated its 15^th 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. 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. »

[1] Excluding the United States, where 9 hospitals are trained as part of the EFS (early feasibility study) clinical trial.

• In compliance with regulations, the implementation of this modification gives rise to the publication of a “field safety notice”.
• Its roll-out will begin over the next few days.

Paris, December 28, 2023 – 5:45 pm (CET)

CARMAT (FR0010907956, ALCAR), 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 (the “Company” or “CARMAT“), today announced a software enhancement which significantly improves the safety profile of its Aeson® artificial heart.

The prosthesis software will now be able to detect on a real time basis, signals of possible Aeson® malfunctions. The software will then immediately adapt the control of the prosthesis so that its performance is not affected, and the patient’s support is not impacted.

These changes, developed and tested by CARMAT’s research teams, will first be deployed on all hearts currently implanted in patients, as part of a software update for which a field safety notice is published[1]. It will then be embedded into the Aeson® production process, after getting the appropriate regulatory approvals.

Stéphane Piat, Chief Executive Officer of CARMAT, declares: “In all industries, electronic components are potentially subject to failure, because perfection of their manufacturing is almost impossible to achieve. It was important to be able to manage such risks in the case of our device, and I’m therefore very proud of the feat achieved by our software engineers: from now on, for many of the potential malfunctions linked to the prosthesis’s electronic components, 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. For me, this is a major and immediate step forward for all the patients who benefit and will benefit from our therapy; but also in the long term, when it comes to obtaining the destination therapy indication for Aeson®, as this improvement significantly strengthens the safety profile and therefore the potential durability of the prosthesis.”

[1] In France, publication is made on the ANSM health authority website.

• This world first for Aeson® was achieved by teams at the Marie-Lannelongue Hospital in France as part of the EFICAS^® study
• The Marie-Lannelongue Hospital is one of the 8 French centers approved to carry out implants as part of this study
• Enrolment of the first 10-patient cohort of the study has been completed

Paris, December 11, 2023 – 5:45 pm (CET)

CARMAT (FR0010907956, ALCAR), 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 (the “Company” or “CARMAT“), today announced the first implantation of the Aeson® heart in a patient suffering from a cardiac tumor.

The patient implanted was suffering from a tumor invading the heart mass, responsible for rhythmic and restrictive cardiopathy, which eluded standard medical treatment. Only complete surgical removal of the heart could be considered as a hope of treatment. It is in this context that the Aeson® total artificial heart was implanted for the first time in the world in this type of indication.

The implant was carried out at the Marie-Lannelongue Hospital in Plessis-Robinson (in the western suburbs of Paris) by the teams of Professor Julien Guihaire, cardiac surgeon, and Professor Elie Fadel, thoracic surgeon.

Prof. Julien Guihaire and Prof. Elie Fadel said: “We are delighted to have been able to provide a solution to this patient in a very difficult situation, for whom there was no other alternative than a total heart replacement with Aeson®. This first-in-man implant performed in our hospital is a continuation of the commitment to the CARMAT project by our teams since the beginning of 2010, including in particular the performance of numerous implant simulations in the Marie-Lannelongue Hospital research laboratory. Aeson® offers real hope for patients with invasive cardiac tumors whose treatment options and survival are currently extremely limited.”

The implant was performed as part of the CARMAT’s EFICAS study, which aims to gather additional data on the efficacy and safety of its Aeson® artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France.

Eight French cardiology centers[1] are now involved in the EFICAS study, which will include a total of 52 patients. To date, enrolment of the first cohort of 10 patients has been finalized, and the study is on track for completion in 2025.

Stéphane Piat, Chief Executive Officer of CARMAT, concludes: “I would like to thank the teams at the Marie-Lannelongue Hospital, a long-standing partner, for giving new hope to a patient suffering from major comorbidities. We are delighted with this world first for CARMAT, which demonstrates the ability of Aeson® to address increasingly complex clinical cases.”

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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 circa 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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About the Marie-Lannelongue Hospital

The Marie-Lannelongue Hospital is a private health establishment of collective interest (ESPIC) in sector 1 (with no out-of-pocket expenses) specializing in the medical, surgical and minimally invasive treatment of cardiac, pulmonary and vascular pathologies. Recognized as a center of excellence in France and internationally, it treats congenital heart malformations, diseases and tumors of the thoracic cavity, pulmonary arterial hypertension and valvular heart disease or coronary artery disease from newborns to adults. The technical expertise of its teams, combined with cutting-edge technology, make it one of the world’s leading hospitals in pediatric and adult cardiology and thoracic oncology.

The Marie-Lannelongue Hospital is currently being rebuilt in Plessis-Robinson (in the western suburbs of Paris). The new hospital is due to open in 2025.

Contacts Media Relations– Hôpitaux Saint-Joseph & Marie-Lannelongue
Fabienne Rouhier – presse@ghpsj.fr
Alix Fournier – presse@ghpsj.fr 
Tel.: +33 1 44 12 80 95

For more information: www.hopitalmarielannelongue.fr

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’ attention is drawn in particular to the financing risk of the Company, whose cash runway currently extends until early 2024. Readers and investors’ attention is also 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)

[1] AP-HP GHU Pitié Salpêtrière, Hôpital Européen Georges Pompidou, Rennes University Hospital, Strasbourg University Hospital, Lyon University Hospital, Lille University Hospital, Marie-Lannelongue Hospital and Montpellier University Hospital

• The facility and its equipment meet the highest standards for the production of medical devices
• Its opening will enable the Company to reach a production capacity of 500 hearts per year as early as 2024, in line with its objectives

Paris, December 4, 2023 – 5:45 pm (CET)

CARMAT (FR0010907956, ALCAR), 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 (the “Company” or “CARMAT“), today announced the opening of its second production facility (“BDA2”) in Bois-d’Arcy, in the immediate vicinity of the Company’s first production facility (“BDA1”).

The works have now been completed, and the entire facility has been reviewed by the notified body DEKRA, which in mid-November 2023 approved it for the production of the Aeson® total artificial heart.

This 1,500 m² building, which meets the highest medical device production standards, will enable CARMAT to significantly increase its capacity in terms of:

• assembly of the electronic parts of the Aeson® heart,
• microbiological testing of the product and the manufacturing process,
• receiving and checking incoming components,
• storage and shipping.

Combined with the extension of the clean room which is currently being completed in the “BDA1” facility, the opening of the “BDA2” facility will enable the Company to reach an annual production capacity of 500 hearts by early 2024, as planned.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “The opening of our new production facility is a major achievement, and I would like to thank all the teams who have worked relentlessly to ensure that it is delivered on schedule before the end of 2023. Today, with the historical “BDA1” facility and this new “BDA2″ facility, we have a high-performance manufacturing tool that is certified to produce up to 500 hearts per year from 2024. In line with our strategic plan, we will further develop our industrial set-up over the next few years, to reach an annual production capacity of 1,000 Aeson® hearts by 2027.”

***

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 circa 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.

• ●●

• ●●

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).

• 7 Aeson® implants have been performed as part of the study, including 4 over the last 4 weeks
• The pace of implants allows the Company to anticipate the completion of the study in 2025, in line with its objective

Paris, October 23, 2023 – 7:00 am (CEST)

CARMAT (FR0010907956, ALCAR), 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 (the “Company” or “CARMAT“), announces that it has presented its progress on the EFICAS clinical trial at the 36^th “Journées de La Pitié” national conference on heart and lung transplantation and circulatory assistance, organized by the cardiology institute of the Pitié Salpêtrière hospital from October 18 to 20, 2023 in Paris.

Prof. Christian Latrémouille, Director of Surgical Affairs at CARMAT, provided an update on the latest progress of this large-scale study at a session dedicated to innovations: “Seven Aeson® implants have been performed as part of the study since its initiation in several of the French centers involved. The pace of study enrollment is accelerating, with 4 implants performed over the last 4 weeks. This ramp-up is the result of growing experience in patient selection and attest to the steep learning curve of the surgical procedure. Post-operative patient recovery is increasingly satisfactory, which gives us great confidence in Aeson®’s performance and the success of the study, anticipated to be completed in 2025. I would like to thank all the participating teams for their commitment and look forward to seeing additional centers join us in our efforts to offer as many patients as possible an effective alternative to heart transplant.”

EFICAS is a prospective study designed to include 52 patients eligible for transplants, currently enrolled by a network of 6 French cardiology centers. It will enable CARMAT to gather additional data on the efficacy and safety of its artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France. The primary objective of the study is 180-day post-implantation survival without disabling stroke, or successful heart transplant within 180 days of implantation.

Pr. Lebreton of Pitié Salpêtrière Hospital (AP-HP), Paris, says: “We are delighted to have implanted a first patient with the Aeson® total artificial heart as part of the EFICAS clinical study. The patient is recovering very quickly, and most of his symptoms of advanced heart failure have already disappeared.”

Pr. Obadia of Hôpital Louis Pradel (Hospices Civils de Lyon), principal investigator of the EFICAS study, comments: “With our second Aeson® implant within a month, our learning curve is rapid, and we remain impressed with the device’s performance. The CARMAT team provides excellent support to the hospital teams, before, during and after each implant.”

Pr. Vincentelli of the Lille Regional University Hospital (CHRU), says: “The Aeson® heart is an absolute necessity in the therapeutic arsenal against end-stage heart failure. This total artificial heart has enabled us to safely prepare and wait for heart transplants in young patients who have no longer responded to conventional treatment.”

CARMAT teams also attended the 7^th “Journée” VAD Meeting, organized by the French-speaking coordination for the development of cardiac assistance (COFDAC), on October 19, 2023. This was an opportunity to demonstrate the Aeson® device to VAD coordinators in France, who play a key role in the management of patients on circulatory assistance.