CARMAT Announces a New Commercial Implant of Its Aeson® Artificial Heart at University Medical Center Schleswig-holstein in Kiel, Germany

PARIS–(BUSINESS WIRE)–Regulatory News:

CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the third implant of its Aeson® bioprosthetic artificial heart in a commercial setting.

This new commercial implant of the Aeson® device was performed by Prof. Assad Haneya and his team of the Department of Cardiovascular Surgery at University Medical Center Schleswig-Holstein (UKSH) in Kiel (Director: Prof. Jochen Cremer). With 14,000 employees in over 85 clinics and institutes, UKSH is one of the largest medical care centers in Europe and the first training provider in Schleswig-Holstein. UKSH in Kiel is recognized as one of Germany’s leading heart centers with a history of thoracic transplantation for several decades. It provides maximum medical care in this federal state and guarantees medical-technical care at the highest level, especially for patients who require highly differentiated diagnosis and therapy.

Prof. Assad Haneya, Director of the Transplantation and Mechanical Circulatory Support Program at UKSH, declared: “We are pleased to have successfully implanted the CARMAT TAH in our center last week. The patient who received the device suffered from severe end-stage biventricular heart failure and he was eligible to an urgent heart transplant. During the last weeks, we noticed a further deterioration with signs of a beginning multi-organ failure and the use of Aeson® was a natural choice.”

Dr. Bernd Panholzer, Director of Cardiovascular Intensive Care Unit, added: A few days after the procedure, the device is providing all the necessary support and the patient is recovering well. Since the device has some key characteristics similar to a real heart, such as pulsatility, hemo-compatibility and self regulation, we expect to meet the needs of many other patients placed on the waiting lists with this new type of therapy.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We are proud that University Medical Center Schleswig-Holstein, one of the largest in Germany and even in Europe in terms of the use of mechanical circulatory support, has chosen Aeson® as a treatment option for this critically ill patient. I would like to thank Prof. Assad Haneya and his teams for their trust and our technical staff for the support during the entire process. We are experiencing growing interest in our therapy and are pursuing its commercial deployment in Europe as planned.”

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About CARMAT: the world’s most advanced total artificial heart

A credible response to end-stage heart failure: CARMAT aims to provide a response to a major public health issue associated with heart disease, the world’s leading cause of death: advanced heart failure. Thanks to its total artificial heart, Aeson®, composed of an implantable bioprosthesis and its portable external power supply system to which it is continuously connected, CARMAT intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end-stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.

The result of combining two types of unique expertise: the medical expertise of Professor Carpentier, known throughout the world for inventing Carpentier-Edwards® heart valves, which are the most used in the world, and the technological expertise of Airbus Group, world aerospace leader.

The first physiologic heart replacement therapy: given the use of highly biocompatible materials, its unique self-regulation system and its pulsatile nature, the Aeson® heart constitutes a new therapeutic class – Physiologic Heart Replacement Therapy (PHRT) – and could save the lives of thousands of patients every year without risk of rejection and with a good quality of life. Aeson® is commercially available in the bridge-to-transplant indication in Europe and other countries that recognise the CE mark. Aeson® is also currently being evaluated in an Early Feasibility Study in the United-States.

For more information: www.carmatsa.com

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Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR

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 contains forward‐looking statements that relate to the Company’s objectives. Such forward‐looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company’s products, new products or technological developments introduced by competitors, and risks associated with managing growth. 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.

No guarantee can be given as to any of the events anticipated by the forward-looking statements, which are subject to inherent risks, including those described in the Universal registration document filed with the Autorité des Marchés Financiers on February 24, 2021 under number D.21-0076 as well as changes in economic conditions, the financial markets or the markets in which CARMAT operates. In particular, no guarantee can be given concerning the Company’s ability to finalize the development, validation and industrialization of the prosthesis and the equipment required for its use, to manufacture the prostheses, satisfy the requirements of competent authorities, enroll patients, obtain satisfactory clinical results, perform the clinical trials and achieve commercial objectives.

Aeson® is an active implantable medical device commercially available in Europe ONLY, CARMAT SA., CE0344. The Aeson® TAH is intended to replace ventricles of 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 LVAD and are likely to undergo heart transplant in the 180 days following device implantation. The decision to implant and the surgical procedure must be executed by Health Care professionals trained by the manufacturer. Carefully read the documentation (clinician manual, patient manual & alarm booklet) for characteristics and information necessary for patient selection and good use (contraindications, precautions, side effects).

In the USA, Aeson® is currently exclusively available within the framework of clinical trials.