December 7th 2022
CARMAT launches a global offering for an amount of
c. €30 million that has received subscription commitments totaling €5.5 million
Paris, December 7, 2022 – 5.45 pm (CET)
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative to people suffering from end-stage biventricular heart failure (the “Company”), today announces the launch of a c. €30 million global offering via the issuance of new shares at a fixed price of €10.50 per share aimed at specialized and strategic investors, as defined below, and retail investors (via the PrimaryBid platform) (the “Global Offering”).
The Company is planning to use the funds raised through this Global Offering to support the development of its activities, and particularly its production ramp-up, the resumption and uptake of Aeson® sales and the initiation of the EFICAS clinical study in France.
In this respect, CARMAT reminds that at the end of October it obtained all the necessary regulatory authorisations to resume commercial implants[1] of Aeson® and initiate the EFICAS[2] study in France. Subsequently, in mid-November, a first patient was implanted in a German hospital in a commercial setting and several French centres are in an active screening phase for the upcoming start of the EFICAS study. The Company confirms that it now intends to gradually develop its implants, depending in particular on the rebuilding of its inventory of implantable prostheses. With regard to the feasibility study in the United States (EFS)[3], discussions with the FDA are continuing and the Company is currently anticipating the recruitment of the second cohort of 7 patients in 2023. Finally, CARMAT also aims to carry out, in 2023, 3 additional implants in its European PIVOTAL study[4], which would bring the total number of implants in this study to 20.
Stéphane Piat, Chief Executive Officer of CARMAT, commented: “This new funding happens at a pivotal time for CARMAT as we are preparing for a first full year of sales in the history of the company. The continued support from several of our core shareholders and other investors will notably enable us to progressively rebuild our inventory of implantable prostheses, initiate the EFICAS clinical study in France shortly, and very importantly develop our sales in Europe. We are also pleased that retail investors will again be able to take part in this financing round via the PrimaryBid platform. We have never been so close to making Aeson® successful commercially, and thus giving a large number of patients, access to our unique therapy that saves lives”.
[1] In December 2020, CARMAT obtained the CE marking allowing it to market its Aeson® artificial heart in the “bridge-to-transplant” (BTT) indication in the European Union and other countries recognising the CE marking.
[2] The EFICAS study will enroll 52 patients eligible for heart transplant in France and will provide CARMAT with additional data on the efficacy and safety of its artificial heart, as well as medico-economic data to support the value proposition and reimbursement of the device, particularly in France. As a reminder, CARMAT has obtained €13 million in funding from the French National Innovation Fund to partially finance the EFICAS study; this funding will be perceived as patients are progressively enrolled in the study.
[3] The Early Feasibility Study (EFS) in the US will involve a total of 10 patients in two successive cohorts; a first cohort of 3 patients completed in the second half of 2021, followed by a second cohort of 7 patients which requires the go-ahead from the Food & Drug Administration (FDA) to start.
[4] The PIVOTAL study was initiated in 2016 with an initial enrollment target of 20 patients, a number that could be adjusted up or down during the course of the study. The interim results of this study, for which there was no pre-determined quantitative success threshold, enabled CARMAT to obtain CE marking in December 2020. The latest published results for 15 patients included show a success rate of 73%, with a total of 11 patients achieving the primary objective of the study (7 patients achieving at least 6 months of survival with the prosthesis, and 4 successfully transplanted within 6 months following Aeson® implant).