PARIS–(BUSINESS WIRE)–Regulatory news:
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 with end-stage biventricular heart failure, announces the publication of 3 articles in peer-reviewed scientific journals. The articles present the results of studies on patients implanted with the Aeson® artificial heart and confirm its hemocompatibility and the absence of inflammation induced by the device.
The article titled “The bioprosthetic total artificial heart in self-regulated mode is biologically hemocompatible: overview of von Willebrand factor multimersin the April 2022 issue of Arteriosclerosis, Thrombosis and Vascular Biology, a peer-reviewed publication of American Heart Association, demonstrates that the Aeson® Total Artificial Heart (TAH) induces minimal shear stress on blood cells compared to existing mechanical circulatory assist (MCS) devices. Therefore, Aeson® does not induce blood cell damage (haemolysis) or the so-called acquired von Willebrand syndrome, which has been associated with gastrointestinal bleeding seen in patients treated with other MCS devices.
The publication “Prophylactic mid-dose anticoagulation with low molecular weight heparin is safe after implantation of a bioprosthetic artificial heartin the September 2022 issue of Journal of Heart and Lung Transplantationa peer-reviewed publication of International Society of Heart and Lung Transplantation, provides data demonstrating that an intermediate dose of anticoagulation with low molecular weight heparin in combination with low dose aspirin is feasible without evidence of increased thrombotic complications or activation of the coagulation. For other MCS devices, a much higher amount of anticoagulation is required, with the associated risk of bleeding complications. The authors conclude that, thanks to the hemocompatibility of Aeson®, the anticoagulation approach used for patients cared for with the device represents a significant advance in the management of the MCS system aimed at reducing adverse events related to the hemocompatibility.
The online publication entitled “Bioprosthetic total artificial heart implantation does not induce chronic inflammation” in October 2022 ASAIO Journala peer-reviewed publication of American Society for Artificial Internal Organs, evaluated the inflammatory status in 9 patients treated with Aeson® TAH up to 12 months. Inflammation markers such as white blood cells and cytokines (tumor necrosis factor, interleukins) were not significantly altered after Aeson® implantation and circulating immune cell subpopulations (lymphocytes) n did not show significant modulation during follow-up. Impaired cellular immunity has been described in patients treated with other MCS devices and is a risk factor for bleeding, thrombotic complications and infection.
Stéphane Piat, Managing Director of CARMAT, declared: “These scientific publications based on data from our PIVOT study confirm one of the key concepts of the Aeson® artificial heart, which is the hemocompatibility of the device. The absence of significant stress on the blood cells circulating in the device and the absence of chronic inflammation as assessed by biomarkers allows a low dose of anticoagulant treatment invisible in mechanical circulatory support. The combination of these factors is unique to the Aeson® artificial heart and may contribute to a favorable safety profile for patients supported by the device while awaiting a donor heart. This key advantage will help us on a larger scale once we resume and accelerate implants in both clinical and commercial settings.
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).
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 that relate to the objectives and prospects of the Company. Such a front–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 rate of development of CARMAT’s production and sales, the rate and results of 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. 22-0332. 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).