IceCure Medical Ltd.'s (ICCM:NASDAQ) ProSense system, used to deliver precise and targeted cryoablation treatments, was approved in Brazil as a Class III device for oncological conditions, reported H.C. Wainwright & Co. analyst Dr. Yi Chen in a September 6 research note.
"The cost-effective and minimally invasive cryoablation procedure should drive physician and patient adoption compared to traditional surgical intervention," Chen commented.
Notable Return Potential
On this news, H.C. Wainwright reiterated its US$3 per share target price on the Israeli medical device firm, now trading at about US$1.12 per share, noted Chen.
The difference between the current and target prices reflects a potential return on investment that is significant: 168%.
IceCure is a Buy.
Regulatory Approval Specifics
The Brazilian Health Regulatory Agency, Anvisa, approved IceCure's ProSense for the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal system, and skin. With the approval, Ktrfios, IceCure's distributor in Brazil, may market and sell ProSense along with the disposable probes and introducers needed for its use.
Chen highlighted that IceCure's management expects to generate US$6.6 million in ProSense-related sales in Brazil over the next five years based on guarantees outlined in the distribution agreement.
As part of the recent approval, Anvisa requested the ProSense probes be transitioned to a Class III device, as is the overall system. Ktrfios will apply for Class III approval of these, which it expects to obtain by the end of Q1/24. The introducers, however, will remain a Class II device.
Further Approval Pending
In other news, IceCure used interim data from the ICE3 clinical trial to support a de novo application of ProSense in the U.S. for the indication of early-stage, low-risk breast cancer in patients deemed unsuitable for surgical alternatives, Chen reported.
Five-year results of the ICE3 study, still in progress, are due out in H1/24. H.C. Wainwright expects them to be positive.
"If approved, the U.S. would have the company's largest commercial footprint for ProSense," Chen added.
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Disclosures for H.C. Wainwright & Co., IceCure Medical Ltd., September 6, 2023
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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. 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 IceCure Medical Ltd (including, without limitation, any option, right, warrant, future, long or short position).
As of August 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of IceCure Medical Ltd. 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
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Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics
Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent
protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr.
Selvaraju's position with Relief when reading this research report.
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