PARIS--(BUSINESS WIRE)--Regulatory News:
CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world's most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today confirms the announcement by the National Research Center for Cardiac Surgery (Astana, Kazakhstan) on the successful transplant of a donor heart in the first international patient implanted with the CARMAT heart in October 2017.
The surgery, consisting in the explant of the CARMAT bioprosthesis followed by the transplant of a heart graft, was successfully performed by the team headed by Dr. Yuriy Pya, CEO of the National Research Center for Cardiac Surgery, following 8 months of excellent support provided by the CARMAT total artificial heart (TAH).
The end stage heart failure patient was initially not eligible to heart transplant as he suffered from pulmonary hypertension. The implant of the CARMAT device was performed in October 2017 as a bridge to transplant within the framework of the PIVOTAL study.
The patient’s health condition improved considerably during the 8-month period thanks to the support of the CARMAT device allowing the patient to efficiently recover from pulmonary hypertension, become eligible for transplantation, and ultimately successfully receive a donor heart in June.
The primary objective of the PIVOTAL study was largely met for this patient, as the study protocol calls for a 180-day (i.e. 6 months) post-implant survival or a successful heart transplantation replacing the device, within the 180-day timeframe.
Dr. Yuriy Pya, CEO of the National Research Center for Cardiac Surgery, comments: “This patient, who was not initially eligible for a heart transplant due to pre-existing pulmonary hypertension, was supported by the CARMAT TAH for 8 months. During this time, our team was able to monitor the improvement of the pulmonary hypertension assisted by the hemodynamic data which are continuously provided by the CARMAT TAH. The patient was in excellent condition before the transplant procedure and was only on light anticoagulant medication. The explant of the device left a natural space for the donor heart, which was then implanted according to our standard procedure. The patient is going well and we look forward to further contributing to the success of the clinical study of this exciting new therapeutic option for patients suffering from end-stage heart failure.”
Stéphane Piat, CEO of CARMAT, adds: “We congratulate the team at the National Research Center for Cardiac Surgery on this first donor transplantation in a patient who was supported by the CARMAT TAH. The outstanding follow up provided by Dr. Pya’s team to this patient underline the CARMAT strategy to work with centers of excellence for our international PIVOTAL study, which provides for inclusion of both patients eligible and not eligible to heart transplant. The excellent functioning of the prosthesis during 8 months together with the considerable improvement of the patient’s health condition reinforces our confidence in the potential of the CARMAT heart to efficiently treat end stage heart failure.”
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, 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.
Imitating the natural heart: given its size, the choice of structural materials and its innovative physiological functions, CARMAT’s total artificial heart could, assuming the necessary clinical trials are successful, potentially benefit the lives of thousands of patients a 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: Airbus Group (Matra Défense), 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 (Babalia) and of Dr. Antonino Ligresti (Santé Holdings S.R.L.), 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 Document de Référence registration document filed with the Autorité des Marchés Financiers under number D.18-0169 on March 22, 2018, 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.