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, 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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Disclosures from H.C. Wainwright & Co., Carmat SA, Initiating Coverage, August 27, 2021
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Carmat SA (including, without limitation, any option, right, warrant, future, long or short position).
As of July 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Carmat SA.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from Carmat SA for non-investment banking services in the previous 12 months..
The Firm or its affiliates did receive compensation from Carmat SA for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Carmat SA during the past 12 months.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.