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 September 2026
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
September 10, 2026, IceCure Medical Ltd. (the “Company”) issued a press release titled “IceCure Medical Receives Regulatory
Approval to Market ProSense® in China”, a copy of which is furnished as Exhibit 99.1 to this Report of Foreign Private Issuer
on Form 6-K.
This Report of Foreign Private
Issuer on Form 6-K (excluding the third paragraph of the press release included as Exhibit 99.1 hereto) is incorporated by reference
into the Company’s Registration Statements on Form F-3 (File Nos. 333-297030, 333-290046 and 333-258660)
and Form S-8 (333-298361, 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Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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
| Exhibit No. |
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| 99.1 |
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Press Release issued by IceCure Medical Ltd., dated September 10, 2026, titled “IceCure Medical Receives Regulatory Approval to Market ProSense® in China” |
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.
| |
IceCure Medical Ltd. |
| |
|
|
| Date: September 10, 2026 |
By: |
/s/ Eyal
Shamir |
| |
|
Name: |
Eyal Shamir |
| |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
IceCure Medical Receives Regulatory Approval
to Market ProSense® in China
CAESAREA, Israel, September 10, 2026 /PRNewswire/
-- IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure,” “IceCure Medical” or the “Company”), developer
of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced
that it has received approval, as a Class III medical device, from China’s National Medical Products Administration (“NMPA”)
for its ProSense® system and associated cryoprobes.
The NMPA approval represents an important regulatory
milestone for IceCure and enables ProSense®, IceCure’s flagship cryoablation system, to be marketed in China in
accordance with the approved registration.
“We are pleased to receive NMPA approval
for ProSense® in China, marking an important step in expanding access to IceCure’s minimally invasive cryoablation
technology,” said Eyal Shamir, Chief Executive Officer of IceCure Medical. “The approval further strengthens our global regulatory
position and expands the markets in which ProSense® may be commercialized.”
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to 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 Asia.
Forward Looking Statements
This press release contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements,
which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the
use of forward-looking terms such as “believe,” “expect,” “may,” “should,” “could,”
“seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or
other comparable terms. For example, the Company is using forward-looking statements when it discusses: the Company’s potential
future regulatory position and its long-term growth strategy and objectives. 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,
2025 filed with the Securities and Exchange Commission (“SEC”) on March 17, 2026, 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.
Investor Contact:
Meir Peleg, CFO
investors@icecure-medical.com
+1-888-902-5716
