PARIS–(BUSINESS WIRE)–Regulatory news:
Videoconference in English with Stéphane Piat at 8 p.m. today.
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CARMAT (FR0010907956, ALCAR), designer and developer of the most advanced total artificial heart in the world, aiming to meet an unmet medical need by offering a therapeutic alternative to people suffering from end-stage biventricular heart failure, provides an update on its activities and prospects.
Positive feedback from physicians on Aeson® since its commercial launch in July 2021
Following obtaining CE marking in the BTT indication1 in December 2020, the Company began to generate the first sales in its history from July 2021, with the implantation of 7 Aeson® cores, including 5 in Germany and 2 in Italy.
To date, four patients are treated with Aeson®, either as part of clinical trials or because they have been implanted in a commercial device. Three of these four patients are awaiting a heart transplant.
In response to the strong interest in Aeson® by hospitals and encouraged by the positive feedback from surgeons who implanted its device, the Company continues to train more hospitals, particularly in Germany, to enable a strong recovery in sales once the suspension of the implants are raised.
Resumption of implants scheduled for October 2022
Following the occurrence of quality problems affecting some of its prostheses, CARMAT took the decision on December 2, 2021 to voluntarily suspend all Aeson® implants.
A rigorous investigation concluded that quality defects on two separate components of the prosthesis were the cause of these problems.
Corrective actions aimed at preventing such defects have been defined and are being integrated into the manufacturing processes. Given the deadlines for the full implementation of these actions and the production deadlines, CARMAT estimates that new prostheses should be available by October 2022.
At the same time, the Company is continuing its discussions with the notified body (DEKRA) and the competent authorities (in particular the ANSM in France and the Food & Drug Administration in the United States), whose authorization is required to respectively resume the implants on commercial and in clinical trials.
With this in mind, CARMAT plans to be able to resume its commercial and clinical implants in October 2022.
Based on this schedule, CARMAT confirms that it has the necessary financial resources to finance its activities until July 2022.
Stéphane Piat, Managing Director of CARMAT, declared: “As we have always said, producing a device as innovative and sophisticated as the Aeson® remains a challenge, and quality issues are not unusual in our industry, particularly in the ramp-up phases of production. I am satisfied that our teams were able to quickly identify the root causes of the quality problems that occurred and define the changes to be made to the manufacturing processes to prevent these problems from recurring. This experience will be very useful for the future.
At the same time, we are continuing our very constructive discussions with our notified body, DEKRA, and the regulatory authorities.
There is strong interest and demand from hospitals for our therapy. The feedback from surgeons who implanted the CARMAT heart is positive and our clinical trials continue to demonstrate the superiority of Aeson® compared to other therapies treating advanced biventricular heart failure.
I have the greatest confidence in the potential of Aeson® to become, in the years to come, the reference treatment for advanced biventricular heart failure, and that it will offer patients a real quality of life. I also strongly believe that implants will grow at a healthy pace once they resume in the fourth quarter of this year.”.
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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 heart transplantation, and thus provide a therapeutic solution for people with end-stage biventricular heart failure, faced with a notorious shortage of available human grafts. The world’s first highly hemocompatible, pulsatile and self-regulating physiological artificial heart, Aeson® could save the lives of thousands of patients waiting for a heart transplant every year. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power system permanently connected to the implanted prosthesis. Aeson® is commercially available as a gateway to transplantation in the European Union and other countries that recognize the CE mark. Aeson® is also being evaluated in an Early Feasibility Study (EFS) in the United States. Created in 2008, CARMAT is based in the Paris region, with its head office in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The Company can count 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, visit www.carmatsa.com and follow us on LinkedIn.
Last name: CAR CARPET
ISIN code: FR0010907956
This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an offer to buy or subscribe for CARMAT shares (the “Company”) in any country whatsoever. . This press release may contain forward-looking statements relating to the objectives and prospects of the Company. These forward-looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risks and uncertainties, including, without limitation, the Company’s ability to successfully implement its strategy, the pace of development of production and sales of CARMAT, pace and results of current and future clinical trials, new products or technological developments introduced by competitors, regulatory changes and risks related to growth management . The objectives of the Company 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 of the Company are those described in the Universal Registration Document (“Universal Registration Document”) filed with the Financial Markets Authority (AMF) under number D.21-0076. The attention of readers and investors is however drawn to the fact that other risks, unknown or not considered 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 the CE mark. The Aeson® Total Artificial Heart is intended to replace the ventricles of the native heart and is indicated as a gateway to transplantation in patients with 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 device implantation. The implantation decision and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (doctor’s manual, patient manual and alarm booklet) must be read carefully to understand the characteristics of Aeson® and the information necessary for the selection of patients and the proper use of Aeson® (contraindications, precautions, side effects). In the United States, Aeson® is currently only available as part of an Early Feasibility Study authorized by the Food & Drug Administration (FDA).
1 Bridge to be grafted