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Company Update
January 31, 2022
Our technology.
Safe Harbor
This document 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 document 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 document 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.21-0076. 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).
January 2022, CARMAT SA, France
2
Speakers
Stéphane Piat
Chief Executive Officer,
CARMAT
▪ Over 20-year experience in the medical device business
▪ Previously Divisional Vice
President Global Market
Development at Abbott
Dr Piet Jansen | |
Chief Medical Officer, | |
CARMAT | |
▪ Over 20-year experience in | |
cardiology sector, notably in | |
Mechanical Circulatory | |
Support devices | |
▪ Former Medical Director at | |
World Heart Corp, & VP | |
3 | Clinical Affairs at Jarvik Heart |
Carmelo A. Milano, MD
Duke University Medical Center
- Professor of surgery
- Chief, section of adult cardiac surgery
- Surgical director for LVAD program
- Division of cardiothoracic surgery
Agenda
I.
II.
III.
2021 Review
Quality Hold Update
Strategy and Outlook
4
I. 2021 Review
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Carmat SA published this content on 31 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 January 2022 19:51:06 UTC.