Carmat (PA:ALCAR) resumed the EU pivotal trial of its artificial heart after addressing regulator concerns. We anticipate that the study could be completed in mid-2019, leading to a potential EU launch in 2020. The Carmat device could potentially fill a significant need among those waiting for human transplants and/or with terminal heart failure (HF) or acute myocardial infarction (MI). Our valuation is €627m, down from €747m previously.
Carmat heart intends to replicate human function
The Carmat heart is the first biocompatible, biventricular mechanical heart, and is designed to act like a human heart as closely as possible, by applying technology involving self-regulatory mechanisms and biocompatible materials. The Carmat heart aims to provide a permanent solution to patients suffering from advanced biventricular HF or potentially terminal acute MI, for whom no human transplant is available and who have exhausted all remaining treatment possibilities.
French regulator allows resumption of EU pivotal trial
Carmat began a 20- to 25-patient EU pivotal trial in July 2016, but recruitment was suspended by ANSM (the French health regulator) in Q416 following the death of the study’s first enrolled patient. ANSM permitted resumption of the trial in Q217. We expect the study to be completed in mid-2019, which could lead to potential EU launch in 2020 (vs our previous estimate of H218).
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