Carmat outlines commercial and development plan for its total artificial heart
- Addressable market in the bridge-to-transplant indication of more than 2,000 patients a year in Europe
- Company prepares for commercial launch in Q2 2021, with initial focus on Germany and France
- Robust clinical plan to support adoption and sales development
- Virtual conference with Stéphane Piat today at 5 pm CET
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today outlines the commercial and development plan for its total artificial heart. The Company holds a virtual conference in English today at 5 pm CET, for which you can register on this link.
2020, a defining year for CARMAT
In 2020, despite the COVID-19 situation, CARMAT has delivered on key objectives including:
- obtaining from the US Food & Drug Administration (FDA) the full approval to start an Early Feasibility Study (EFS) in the US, and successful training of three US centers in Q4 2020 in order to start implants in Q1 2021;
- securing a funding of €13m from the French state to start a new clinical trial (“EFICAS” study) in France in Q2 2021;
- receiving the CE Marking which allows CARMAT to market its total artificial heart as a bridge-to-transplant in a large number of countries, including all European Union countries;
- resuming the PIVOTAL study in France, with 2 patients treated in December.
Commercial readiness, positioning and branding
Ahead of getting the CE marking, CARMAT had taken the necessary steps to be prepared to start selling its artificial heart from Q2 2021. This involves:
- accelerating the ramp-up of manufacturing activities;
- proactive customer targeting and early support to hospitals for reimbursement;
- product positioning and branding.
The Carmat artificial heart will be marketed under the Aeson® brand name.
In view of the 3 unique features of the product – pulsatility, autoregulation2 and hemocompatibility – CARMAT creates a new product category: the Physiologic Heart Replacement Therapy (PHRT).
Commercial opportunity and plan
Significant market opportunity
The CE marking for the CARMAT heart as a bridge-to-transplant (BTT) represents a very significant market opportunity with a minimum of 2,000 patients currently on waiting lists for a heart transplant in five major European countries.
Initial focus on Germany and France
In 2021, the Company’s plan is to focus on Germany and France, which together account for 55% of the mechanical circulatory support (MCS) market in the European Union:
- Aeson® will be commercially launched in Germany in Q2 2021,
- the French market will initially be addressed through the EFICAS study.
In addition, the company might seize further sales opportunities in other countries recognizing the CE marking.
Strong market development approach
In parallel, CARMAT will continue to implement a very robust clinical plan which includes the EFICAS Study in France (52 patients), the completion of the ongoing PIVOTAL study (target of 20 patients), along with a large post-market clinical follow-up which will include the first 95 patients treated in commercial setting, in order to generate further safety, performance and health-economics data. These data are expected to drive product adoption and support Aeson®’s value proposition (notably to obtain reimbursement of the product in France), and ultimately the obtention of the destination therapy (DT) indication for the product. While the BTT indication allows for temporary support by the device, this additional DT indication would allow CARMAT to target the patients who are not eligible to heart transplant who would remain under CARMAT’s device support in the longer term.
CARMAT confirms that its available resources enable the company to fund its activities through to Q3 2021. The company is considering different options to finance its future development.
Stéphane Piat, Chief Executive Officer of CARMAT, says: “2020 was a defining year for the company, culminating with the obtention of the CE Marking just before Christmas. Despite a very challenging environment, marked by the COVID-19, CARMAT has delivered on the vast majority of its objectives, and I would like to thank again the entire CARMAT team and all stakeholders who have made this possible. The bridge-to-transplant indication that we got as part of the CE Marking represents hope for patients and a very sizable market opportunity for the Company, as at least 2,000 patients are currently on waiting lists for a heart transplant in Europe, but only a fraction of them is fortunate enough to benefit from a donor graft. In 2021, our intention is to focus our efforts on Germany and France, which account for more than half of these patients. We might also address other countries recognizing the CE marking in a more opportunistic way. I am happy to confirm that we will be ready to start selling our product as early as Q2 2021. We will also continue to execute our strong clinical plan, in particular the EFICAS study that should start in Q2 2021, but also a post-market clinical follow-up of 95 implanted patients, which will have a significant impact on the adoption momentum of our prosthesis. Given its unique features demonstrated in clinical trials to date, Aeson® introduces a new way of treating end-stage heart failure, the Physiologic Heart Replacement Therapy, which aims to provide patients with significantly improved quality of life.”
 The CE marking was granted on December 22, 2020, to CARMAT’s total artificial heart system as a bridge-to-transplant (BTT) in patients suffering from end-stage biventricular heart failure (Intermacs Classes 1-4) who are not amenable to maximal medical therapy or the LVAD (Left Ventricular Assist Device) and who are likely to undergo heart transplant in the 180 days following implantation.
 Bizouarn P et al.; Effects of pre-load variations on hemodynamic parameters with a pulsatile autoregulated artificial heart during the early post-operative period. J Heart Lung Transplant. 2018;37(1):161-3
 JACC 2017 Smadja, Bioprosthetic total artificial heart induces a profile of acquired hemocompatibility with membranes recellularization, July 2017:403-9
 The “PHRT” category has been created by CARMAT and differentiates form the “TAH” (total artificial heart) category by its unique combination of 3 features: pulsatility, autoregulation and hemocompatibility. The physiological heart replacement therapy can be either temporary (BTT – bridge to transplant) or for the long run (DT – destination therapy). The physiological nature of Aeson® is documented in the following publication: Richez U et al.; Hemocompatibility and safety of the CARMAT Total Artifical Heart hybrid membrane. Heliyon. 2019 Dec; 5(12): e02914. Published online 2019 Dec 8. doi: 10.1016/j.heliyon.2019.e02914
 GlobalData: EU5 Cardiac Assist Devices Market Outlook To 2025 – Intra-Aortic Balloon Pumps, Mechanical Circulatory Support Devices And Short-Term Circulatory Support Devices (Report GDMECR1561DB)
 The initial inclusion target for this study was 20 patients, a figure that can be adjusted up or down during the course of the study. To date, 15 patients have been enrolled in the study.
 Including cash on-hand, €10m of ‘PGE’ Loan (loan guaranteed by the French State) drawn in November 2020, the last tranche (€10m) of the European Investment Bank Loan which can be drawn at any time until December 2021 (as drawdown criteria has already been met), and the non-dilutive financing of €13m granted by the French state to fund the EFICAS study (this amount will be perceived over the duration of the study); excluding the balance of the Kepler-Cheuvreux equity line, which can be used until September 27, 2021.