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: October 2025
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 October 3, 2025, IceCure Medical Ltd. (the “Company”)
issued a press release titled “IceCure Receives FDA Marketing Authorization for ProSense® Cryoablation for the Treatment of
Low-Risk Breast Cancer in Women Aged 70 and Above,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign Private
Issuer on Form 6-K.
On October 3, 2025, the Company also issued a press
release titled “IceCure Medical's ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast
Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care,” a copy of
which is furnished as Exhibit 99.2 with this Report of Foreign Private Issuer on Form 6-K.
The press release attached
herewith as Exhibit 99.1 (excluding the second, third, sixth and eighth paragraphs thereof) and the press release attached herewith as
Exhibit 99.2 (excluding the second, seventh and fifteenth paragraphs thereof) are incorporated by reference into the Company’s Registration
Statements on Form F-3 (Registration Nos. 333-258660, 333-267272 and 333-290046) 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of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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
| Exhibit No. |
|
|
| 99.1 |
|
Press release dated October 3, 2025 titled “IceCure Receives FDA Marketing Authorization for ProSense® Cryoablation for the Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above” |
| 99.2 |
|
Press release dated October 3, 2025 titled “IceCure Medical's ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care” |
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: October 3, 2025 |
By: |
/s/ Eyal Shamir |
| |
|
Name: |
Eyal Shamir |
| |
|
Title: |
Chief Executive Officer |
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