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

  • Global Offering aimed at specialized and strategic investors, as well as individual investors via the PrimaryBid platform
  • Issue price of new shares at 10.0 euros per share
  • Closing of the Primary Bid Offering on April 11, 2022 at 10 pm and of the Reserved Offering on April 12, 2022 before market opening

 

Paris, April 11, 2022 – 5.45 pm (CEST)

 

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 euros capital increase via the issuance of new shares at a fixed price of 10.0 euros per share aimed at specialized and strategic investors, as defined below, and at individuals (via the PrimaryBid platform) (the “Global Offering”).

 

The Company is planning to use the funds raised through this Global Offering to ensure the continuity of its activities, and notably to support the restart of the production of its Aeson® artificial heart and ensure the resumption – scheduled for October 2022 – of its implants, both from a commercial standpoint and within the framework of its clinical trials.

 

 

Stéphane Piat, Chief Executive Officer of CARMAT, commented:The funds raised via the operation we are launching today will strengthen our financial structure and allow us to calmly ensure the resumption of implants of our Aeson® artificial heart from October 2022. Indeed, the constructive dialogue we are having with the competent authorities and the notified body DEKRA, as well as the recent restarting of our production, following the incorporation of changes enabling us to strengthen the sturdiness of the various components, give us confidence in our ability to resume our clinical trials and sales as expected and thus address the strong expectations of physicians and patients. The support of our longstanding shareholders is particularly important during this crucial period for the Company, and I would particularly like to emphasize their substantial commitment. I am also pleased that we are able to offer other investors, as well as individuals – via the PrimaryBid system – the possibility of contributing to the development of our Company and its unique technology that we more than ever feel has the potential to radically and lastingly change the care and treatment provided to patients with end-stage biventricular heart failure”.

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Paris, December 23, 2021 – 7 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 the completion of investigations on its prostheses.

 

Following the occurrence of a quality issue affecting some of its prostheses, CARMAT had announced, on December 3, 2021, the voluntary and temporary suspension of implants of its Aeson® artificial heart. The company has subsequently carried out a very rigorous investigation of the situation.

 

This investigation, which is now complete, has enabled the root causes of the quality issue to be identified, and the changes required to prevent its reoccurrence to be determined.

 

The outcome of the investigation will now be shared with the notified body (DEKRA) and the competent authorities (specifically the ANSM in France and the Food & Drug Administration in the United States), starting from this week. The discussions with DEKRA and the competent authorities are expected to take a few weeks and lead to an agreed schedule to resume implants.

 

The company plans to provide a further update in January 2022, including a web conference, the date of which will be communicated in due course.

 

 

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “After more than 2 weeks of in-depth investigation, I am glad that our teams were able to identify the root causes of the quality issue that occurred, and to propose corrective actions. Given the significant unmet need for patients suffering from end-stage biventricular heart failure who cannot benefit from a heart transplant, and the strong demand for Aeson® from many doctors and hospitals, we will now work diligently with all regulatory stakeholders in order to resume implants as soon as possible while keeping quality and patient safety as our top priorities”.

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