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.
|Want to be the first to know about interesting Medical Devices investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter.||Subscribe|
- Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
- This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
For additional disclosures, please click here.
Disclosures for H.C. Wainwright & Co., IceCure Medical Ltd., September 6, 2023
This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.
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
of the Firm, a substantial portion of which is derived from investment banking services.
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.
The Firm or its affiliates did not receive compensation from IceCure Medical Ltd for investment banking services within twelve
months before, but will seek compensation from the companies mentioned in this report for investment banking services within
three months following publication of the research report.
The Firm does not make a market in IceCure Medical Ltd as of the date of this research report.
The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment
objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational
purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction
where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to
any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.
No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional
information available upon request.
H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is
not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial
situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness
of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.
H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market
commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.
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.
The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being
accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security
discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of
this report and are subject to change without notice.
Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal
Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.