Sun, 24 Jan 2021

Carmat (ALCAR): CE Mark Achieved, Launching in Q2

11 Jan 2021, 18:55 GMT+10

LONDON, UK / ACCESSWIRE / January 11, 2021 / Carmat announced that it has received a CE Mark for its physiologic heart replacement therapy (PHRT) and that the product will be launched in Q221 under the brand name Aeson. The approved indication is a bridge to transplantation therapy (BTT), although over time we expect approval for Aeson as a destination therapy (DT), which will enable commercialisation to a larger number of patients. The initial commercial focus will be on France and Germany, which Carmat estimates to account for 55% of the EU mechanical circulatory support market.

We have increased our valuation to €747m or €58.83 per share from €679m or €53.88 per share. This is mostly due to our increase in the probability of commercial success for Aeson in the EU to 35% from 30% following receipt of the CE Mark. This was partially offset by more conservative near-term estimates as the launch will occur later in 2021 than expected and is also more focused. We assume a financing requirement of €40m for 2021 to fund US clinical development and the commercial launch.

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