Carmat: Setting The Stage For Pivotal Heart Study
Edison | May 05, 2016 05:32AM ET
Carmat (PA:ALCAR) shareholders approved the terms of a €50m equity financing earlier this month. While the shares outstanding increased by 29.5%, we estimate funds on hand are sufficient to fund operations into H118, and likely through the completion of a pivotal study for the Carmat bioprosthetic heart. With the recent completion of the feasibility study, Carmat plans to start a CE mark enabling pivotal trial in H216, which could lead to commercialisation by H218. Our rNPV approach generates a valuation of €651m (up from €611m), or €116.92 per share after including an estimated mid-2016 net cash position of €41.3m.
75% in feasibility study survive beyond 30 days
Carmat completed the four-patient feasibility study in January 2016, after the death of the fourth patient to complications unrelated to the performance of the bioprosthetic heart itself. The other three patients (75%) met the company’s targeted success of a survival duration of at least 30 days post-implantation. This rate is comparable to statistics cited by the Agence de Biomédecine, which reported in 2013 that the 30-day survival rate in human heart transplants is approximately 80% for patients above age 60.
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