(BFM Bourse) – On the occasion of the publication of its half-year results, the company reiterated that it expects a resumption next month of the implantations of its Aeson heart prosthesis, suspended since December. The group also posted a stable loss over the first six months of the year.
The big deadline is approaching for Carmat. The company founded in 2008 was forced to suspend the implantations of its Aeson artificial heart last December, due to a quality problem detected on certain prostheses. Occurring only a few months after the first sale of the group, this blunder had dealt a serious blow to the action, the price of which has since been halved.
The company implemented corrective and preventive measures to remedy the problems noted at the end of December, integrating them into its production which resumed at the end of the first quarter.
The group now seems to see the end of the tunnel. On the occasion of the publication of its half-year results, Carmat confirmed on Thursday that it expects a resumption of establishments next month.
The company said it had submitted a “notification of change” in early August to Dekra, a notified body, that is to say, charged by the European Union with assessing the conformity of a product.
A smooth roadmap
“Given the usual review times and its discussions with Dekra, the company is reasonably confident in obtaining the regulatory approvals allowing it to resume in October the commercial establishments of Aeson in the European Union and in all countries recognizing the CE marking [une certification européenne permettant la commercialisation d’un produit, NDLR]“, announced the company.
Carmat also indicated that it had submitted at the beginning of the month to the National Agency for the Safety of Medicines and Health Products, ANSM, a request to resume its clinical trial EFICAS in France. She anticipates a green light next month.
In the United States, Carmat has submitted two files to the FDA (Food and Drug Administration, the American health authority) and intends to file a third this month, in order to resume implantations within the framework of the EFS clinical study. (feasibility study), first step in view of the potential commercialization of the prosthesis across the Atlantic. “After their review [de ces dossier, NDLR]the company anticipates submitting an ‘IDE Supplement’ to the FDA [une demande d’exemption, NDLR]which would allow the recruitment of the second cohort (7 patients) of this study which will include a total of 10 patients”, explained Carmat.
“The company’s roadmap seems to be proceeding as planned”, appreciates Degroof Petercam.
“Subject to regulatory approval, we anticipate implantations to resume in Europe this year, as the company expects. Our scenarios are based on a target of 7 implants this year, including 3 commercial implants and 4 implants in the part of the EFICAS study in France. In the United States, we think it will take a little longer, and we expect a recovery in early 2023″, develops the financial intermediary.
A peak in sales of 750 million euros
“We continue to believe that Aeson is by far the most advanced artificial heart in the world and that the product fills an important medical need, which should result in strong market adoption and robust sales (revenue maximum estimated at around 750 million euros)”, concludes Degroof Petercam.
These announcements satisfy the market since the Carmat title takes off on the Paris Stock Exchange, taking 11%, to 14.32 euros around 10:30 a.m.
In terms of its financial results for the first half, the group did not record any turnover due to the suspension of its establishments. Carmat benefited from 1.9 million euros in financial income under the research tax credit, posting a total loss for the half-year of 26 million euros against 26.4 million euros a year earlier.
As of June 30, its cash amounted to 47.7 million euros against 39.2 million euros at the end of December. The company has confirmed that its resources should allow it to operate until March 2023.
Julien Marion – ©2022 BFM Bourse
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