IceCure Medical (ICCM) secures Israel approval for XSense breast cancer system

Rhea-AI Filing Summary

IceCure Medical Ltd. furnished a report noting it has received regulatory approval in Israel for its next-generation XSense™ cryoablation system for breast cancer and other indications, as described in a press release dated September 15, 2025. The press release is included as Exhibit 99.1 to this report.

The first, second and fifth paragraphs of that press release, along with its forward-looking statements section, are incorporated by reference into IceCure’s existing registration statements on Form F-3 and Form S-8, so they become part of those offering documents from the date of this submission.

Positive

• Regulatory approval achieved in Israel for IceCure’s next-generation XSense™ cryoablation system for breast cancer and other indications, marking a key milestone for that platform.

Negative

• None.

Insights

Healthcare regulatory analyst

IceCure reports Israeli regulatory approval for its next‑generation XSense cryoablation system.

IceCure Medical discloses that it has received regulatory approval in Israel for its next-generation XSense™ cryoablation system for breast cancer and other indications, based on the title of the attached September 15, 2025 press release. Regulatory clearance for a new medical system in the company’s home market is typically a key step toward clinical use.

The company also incorporates specific paragraphs and the forward-looking statements section of that press release into multiple effective Form F-3 and Form S-8 registration statements. This means the new information about XSense and related forward-looking statements are now legally part of those offering documents, aligning investor disclosures with the latest regulatory development.

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 2025 (Report No. 3)

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 15, 2025, IceCure Medical Ltd. (the “Company”) issued a press release titled “IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign Private Issuer on Form 6-K. 

The first, second and fifth paragraphs and the section titled “Forward Looking Statements” in the press release attached herewith as Exhibit 99.1 is 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.

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EXHIBIT INDEX

Exhibit No.
99.1		Press release dated September 15, 2025 titled “IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications”

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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 15, 2025	By:	/s/ Eyal Shamir
		Name:	Eyal Shamir
		Title:	Chief Executive Officer

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FAQ

What did IceCure Medical (ICCM) announce in this Form 6-K?

IceCure Medical reported that it issued a press release titled “IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications” dated September 15, 2025, which is attached as Exhibit 99.1.

Which product received regulatory approval according to IceCure Medical’s filing?

The filing states that IceCure received regulatory approval in Israel for its next-generation XSense™ cryoablation system intended for breast cancer and other indications, as described in the attached press release.

In which country did IceCure Medical receive regulatory approval for XSense?

According to the press release title referenced in the Form 6-K, IceCure received regulatory approval in Israel for its next-generation XSense™ cryoablation system.

How does this Form 6-K affect IceCure Medical’s registration statements?

The first, second and fifth paragraphs of the press release and the “Forward Looking Statements” section are incorporated by reference into IceCure’s registration statements on Form F-3 (Nos. 333-258660, 333-267272 and 333-290046) and Form S-8 (Nos. 333-270982, 333-264578, 333-262620 and 333-281587).

Who signed IceCure Medical’s September 15, 2025 Form 6-K?

The Form 6-K was signed on behalf of IceCure Medical Ltd. by Eyal Shamir, who is identified as the company’s Chief Executive Officer.

What exhibit is attached to IceCure Medical’s September 2025 Form 6-K?

The filing includes Exhibit 99.1, which is a press release dated September 15, 2025 titled “IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications”.