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CARMAT achieves the milestone of 100 implants of its Aeson® total artificial heart

  • Flexible financing of up to 3,500,000 shares over 24 months
  • CARMAT to receive immediately €2.2 million under this financing, thus extending the Company’s cash runway until the end of September 2024.

 

Paris, July 5, 2024 – 6:00 pm (CEST)

 

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 implementation of an equity financing line with Vester Finance, in the form of a PACEO, for a maximum of 3,500,000 shares (i.e. 9.96% of its current share capital[1]) over a 24-month period.

 

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “This financing line enables us to immediately extend our cash runway to the end of September 2024, and to benefit from a total amount of around €8 million in potential financing (based on our current share price) over the next 24 months, which gives us useful room for manoeuvre.

Meanwhile, buoyed by the encouraging trend in Aeson® sales since the start of 2024, we also continue to work on securing other financing, in order to strengthen our financial structure and sustain our long-term development, particularly our sales growth.

We are confident in the gradual growth of Aeson® implants and in progressively making our artificial heart a reference therapy for patients suffering from advanced biventricular heart failure, as well as a commercial success.”

[1] Share capital as of June 30, 2024, on a non-diluted basis.

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  • Equitization of the first tranche of the EIB loan will reduce its repayment in cash and optimize the Company’s cash position
  • Set-up of a trust and issuance of share warrants to the trustee, enabling it to subscribe shares of the Company to be then sold on the market, the proceeds of which being allocated to the repayment of the tranche

Paris, June 13, 2024 – 6:00 pm (CEST)

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”), today announces the equitization of the first tranche of its loan contracted with the European Investment Bank (EIB) by the set-up of a trust and issuance of share warrants to the trustee.

This implementation is part of the final agreement reached on March 22, 2024 by CARMAT with its financial creditors[1], including the EIB, on new repayment terms for its bank loans. The terms of the equitization are in all respects similar to those described when the agreement was announced.

Stéphane Piat, CEO of CARMAT, comments: “The equitization of the first tranche of the loan contracted with the EIB is part of the agreement we reached last March with all our financial creditors on the rescheduling of our bank loans and their new  repayment terms.

The effective start of this equitization is an important step and very good news, since it will enable us to significantly reduce the cash repayment of our debt, thereby contributing to contain our funding requirements.

As our cash runway currently extends to mid-August 2024, we continue to work on several options to strengthen our equity and cash position over the coming months; and remain fully mobilized to pursue the commercial development of our therapy, which at this stage is very encouraging.”

[1] Press release March 22, 2024

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  • EFICAS study reaches the milestone of 20 implants
  • Interim study results above expectations
  • Confirmation of short-term financial support from several key shareholders

Paris, May 6, 2024 – 7.00 am CEST

 

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”), today provides an update on the EFICAS study and reiterates confidence in its 2024 outlook.

 

 

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “I’m very pleased with the progress of the EFICAS study, both in terms of the pace of inclusion and results observed to date.

With 20 patients implanted, we have already completed 38% of the planned inclusions (out of a total of 52), which once again underlines the very strong interest shown by French doctors and hospitals in the Aeson® heart. Moreover, the interim results of the study are better than expected, although we are treating increasingly sick patients.

These achievements make us optimistic not only about the completion of the EFICAS study in the first half of 2025, but also about the growth potential of Aeson® sales over the coming months.

I am also delighted to be able to rely on several of our reference shareholders who have already confirmed their intention to support CARMAT financially in the short term, which will enable us to focus on our objectives and our development.”

 

  • EFICAS study on track

 

To date, 20 patients have been implanted with the Aeson® heart as part of the EFICAS study, 9 of them in the first 4 months of 2024.

 

The EFICAS study is conducted exclusively in France, in 10[1] hospitals whose teams are fully trained and ready to carry out the implants. To date, 8 hospitals have already enrolled patients in the study.

 

The primary objective of the study is a minimum survival of 6 months on CARMAT support, without disabling stroke, or a successful heart transplant within the first 6 months.

 

The study’s interim success rate of 75%[2], which exceeds expectations, is very promising compared to previous CARMAT studies[3] and existing therapies, given the poor state of health of the patients concerned.

 

In view of these advances, CARMAT confirms its target of completing the EFICAS study, with a total of 52 Aeson® implants, in the first half of 2025.

 

The EFICAS study is essential both for the reimbursement of Aeson® in France and for obtaining PMA (marketing authorization in the United States, issued by the FDA), which the Company anticipates for 2027.

 

Study data are also an important catalyst for the adoption of Aeson® across Europe.

  • 2024 outlook reiterated

 

Bolstered by the clinical results of the EFICAS study, the progression in implants over the first 4 months of 2024, and its solid base of 39 hospitals trained in commercial implants, CARMAT reiterates its sales forecast of around €14 million for 2024.

 

Given its cash position and business plan, the Company’s financial horizon currently extends to the end of May 2024, and CARMAT estimates its 12-month financing requirement at around €45 million.

 

The Company is working very actively on strengthening its equity, with the already-confirmed participation of some of its reference shareholders, enabling it to extend its financial horizon in the short-term.

 

[1] AP-HP GHU Pitié Salpêtrière, Hôpital Européen Georges Pompidou, CHU de Rennes, CHU de Strasbourg, Hospices Civils de Lyon, CHRU de Lille, Hôpital Marie-Lannelongue, CHU de Montpellier, CHU de Nantes and CHU de Dijon.

[2] Among the 8 patients who have already crossed the 6-month threshold.

[3] CE-marked PIVOTAL study: 73% success rate on 15 patients.

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