Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
25 Novembre 2024 - 2:50PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of: November 2024 (Report No. 2)
Commission File Number: 001-40753
ICECURE MEDICAL LTD.
(Translation of registrant’s name into
English)
7 Ha’Eshel St., PO Box 3163
Caesarea, 3079504 Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F
☐ Form 40-F
CONTENTS
On November 25, 2024, IceCure Medical Ltd. (the
“Company”) issued a press release titled “IceCure’s Next-Generation Multiprobe Cryoablation Technology Issued
Notice of Allowance from Japan’s Patent Office,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign
Private Issuer on Form 6-K.
The first two paragraphs
and the section titled “Forward Looking Statements” in the press release attached herewith as Exhibit 99.1 are incorporated
by reference into the Company’s Registration Statements on Form F-3 (Registration Nos. 333-258660 and 333-267272) and Form S-8
(Registration Nos. 333-270982, 333-264578, 333-262620 and 333-281587), filed with the Securities and Exchange Commission, to be a part
thereof from the date on which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents
or reports subsequently filed or furnished.
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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ICECURE MEDICAL LTD. |
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Date: November 25, 2024 |
By: |
/s/ Eyal Shamir |
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Name: |
Eyal Shamir |
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Title: |
Chief Executive Officer |
Exhibit 99.1
IceCure’s Next-Generation Multiprobe Cryoablation
Technology Issued Notice of Allowance from Japan’s Patent Office
Invention facilitates treatment of larger
tumors and is a significant leap forward in the field of cryoablation
CAESAREA, Israel, November 25, 2024 –
IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of
minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced
it has received a Notice of Allowance from the Japan Patent Office for its invention titled “Cryogenic System with Multiple Submerged
Pumps”.
The patent addresses a cryogenic system featuring
multiple submerged pumps that enable IceCure to introduce a groundbreaking next-generation multiprobe system. This advanced technology
allows for high-end capabilities to independently control and maintain the performance of each cryoprobe, facilitating the treatment of
large tumors.
“As a core technology for our next-generation
MSense™ multiprobe cryoablation system, we believe that our latest innovation not only expands our intellectual property and product
portfolio, but also represents a significant leap forward in the field of cryoablation procedures,” stated IceCure’s Chief
Executive Officer, Eyal Shamir. “Japan is a market in which we are active through our partner, Terumo Corporation, which plans to
file for regulatory approval of ProSense® for breast cancer in 2025.”
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems for the treatment of tumors (benign and cancerous) by freezing, with the primary
focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital
surgical tumor removal that is easily performed in a relatively short procedure. The Company’s flagship ProSense® system is marketed
and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and China.
Forward Looking Statements
This press release contains forward-looking statements
within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal
securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,”
“seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking
statements. For example, IceCure is using forward looking statements in this press release when it discusses: the potential use of the
patent; the belief that this patent represents a significant leap forward in the field of cryoablation technology; and that Terumo Corporation
plans to file for regulatory approval of ProSense® for breast cancer in 2025. Historical results of scientific research and clinical
and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions.
Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in
these forward-looking statements include, among others: the Company’s planned level of revenues and capital expenditures; the Company’s
available cash and its ability to obtain additional funding; the Company’s ability to market and sell its products; legal and regulatory
developments in the United States and other countries; the Company’s ability to maintain its relationships with suppliers, distributors
and other partners; the Company’s ability to maintain or protect the validity of its patents and other intellectual property; the Company’s
ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East,
specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company’s Annual Report on Form 20-F for
the year ended December 31, 2023 filed with the SEC on April 3, 2024, and other documents filed with or furnished to the SEC which are
available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes
after the date of this release, except as required by law.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
IceCure Medical (NASDAQ:ICCM)
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