In an Aug. 27 research note, H.C. Wainwright & Co. analyst Yi Chen reported that the third implant of Carmat SA's (ALCAR:PA; CKMTF:OTCMKTS) Aeson bioprosthetic artificial heart, intended to be a bridge to transplant, was just carried out.
The implant recipient had severe end-stage biventricular heart failure and qualified for an urgent heart transplant, Chen noted. The patient is recovering well post procedure.
This third commercial Aeson implantation was performed at the Department of Cardiovascular Surgery at the University Medical Center Schleswig-Holstein, one of Germany's premier heart centers. The second Aeson also had been implanted in Germany, at the Hannover Medical School, whereas the first had been done in Italy.
"Observations thus far validate Aeson's clinical utility and bode well for the commercial prospects in the European Union," commented Chen. "We expect to see additional implants of Aeson as a bridge to transplant in Germany in the coming months."
In other Aeson news, out of the U.S., the second center implanted the artificial heart as part an early feasibility study being conducted in the States, Chen indicated. The procedure was carried out at University of Louisville Health–Jewish Hospital in Kentucky. The first had been done at Duke University Hospital in North Carolina in July 2021.
For the U.S. feasibility study, a total of 10 patients will be enrolled. Per the protocol, a report on the first three implanted patients must be generated after 60 days post implantation and before enrollment of the remaining seven patients. The study's primary endpoint is survival 180 days after implant or a successful heart transplant within 180 days post implant. Topline data are expected in mid-2022.
Chen highlighted that Aeson could save many patients who otherwise would die while waiting for a rare available heart and transplant.
"Aeson's differentiated features, including hemocompatibility, pulsatility, autoregulation and
silent operation, have the potential to enable a genuine physiologic heart replacement therapy for critically ill patients suffering from end-stage biventricular heart failure [and] who have few options," Chen wrote.
H.C. Wainwright & Co. has a Buy rating and a €38 per share price target on France-based Carmat. Its current share price is about €27.25.
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