PARIS--(BUSINESS WIRE)--Regulatory News:
CARMAT (Paris:ALCAR) (FR0010907956, 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, announces the first implantation of its bioprosthetic artificial heart in Denmark.
The implant procedure was performed by the team of Dr. Peter Skov Olsen, cardio-thoracic surgeon at the Heart Center of Rigshospitalet in Copenhagen. It is the first Danish hospital to implant the CARMAT total artificial heart and the third international medical center contributing to the PIVOTAL study, together with the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic, and the National Research Center for Cardiac Surgery in Nur-Sultan, Kazakhstan.
Finn Gustafsson, MD, PhD, Professor of Advanced Heart Failure and Transplantation at the Heart Center and principal investigator of the study, comments: “We are excited to gain clinical experience with the CARMAT artificial heart and to contribute to the PIVOTAL study. With its hemocompatibility, autoregulation and silent operation, the CARMAT TAH could become a real alternative treatment to heart transplantation for patients suffering from end-stage heart-failure.”
Stéphane Piat, Chief Executive Officer of CARMAT, adds: “Rigshospitalet has developed a strong expertise in treating advanced heart failure and has participated in front-line clinical studies with innovative medical therapies and devices in this field. I am delighted that such an internationally recognized site becomes the third international center to implant our device. With the recent release of certain COVID-19 pandemic-related restrictions, CARMAT’s teams and proctors were able to prepare and participate in the surgical procedure and early post-operative follow up. To date, 13 patients have received our device in the PIVOTAL study and, subject to the progressive ramp-up in recruitments across our three active study centers, we estimate that 4-5 months are needed to complete enrollment and reach the total of 20 patients.”
In accordance with good clinical practice and subject to regulatory obligations or specific circumstances, CARMAT will not provide individual updates on patients’ implantations or their health condition. However, it is planning to communicate when major milestones in the PIVOTAL study are reached, such as the opening of new centers and the overall progression of patient recruitment.
About CARMAT: the world’s most advanced total artificial heart project
A credible response to end-stage heart failure: CARMAT aims to eventually provide a response to a major public health issue associated with heart disease, the world’s leading cause of death: chronic and acute heart failure. By pursuing the development of its total artificial heart, composed of the implantable bioprosthesis and its portable external power supply system to which it is 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 physiological artificial heart: given its size, the use of highly biocompatible materials, its unique self-regulation system and its pulsatile nature, the CARMAT total artificial heart could, assuming the clinical trials are successful, potentially save the lives of thousands of patients each year with no risk of rejection and with a good quality of life.
A project leader acknowledged at a European level: with the backing of the European Commission, CARMAT has been granted the largest subsidy ever given to an SME by Bpifrance; a total of €33 million.
Strongly committed, prestigious founders and shareholders: Matra Défense SAS (subsidiary of the Airbus Group), Professor Alain Carpentier, the Centre Chirurgical Marie Lannelongue, Truffle Capital, a leading European venture capital firm, ALIAD (Air Liquide’s venture capital investor), CorNovum (an investment holding company held 50-50 by Bpifrance and the French State), the family offices of Pierre Bastid (Lohas), of Dr. Antonino Ligresti (Santé Holdings S.R.L.), of the Gaspard family (Corely Belgium SPRL and Bratya SPRL) and of M. Pierre-Edouard Stérin (BAD 21 SPRL), Groupe Therabel as well as the thousands of institutional and individual shareholders who have placed their trust in CARMAT.
For more information: www.carmatsa.com
ISIN code: FR0010907956
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 March 13, 2020 under number D.20-0126 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 the ANSM, enroll patients, obtain satisfactory clinical results, perform the clinical trials and tests required for CE marking and to obtain the CE mark. CARMAT products are currently exclusively used within the framework of clinical trials.