[6-K] IceCure Medical Ltd. Current Report (Foreign Issuer)

Rhea-AI Filing Summary

IceCure Medical Ltd. reported that it issued a press release announcing that its ProSense^® cryoablation system received regulatory approval in Switzerland for use in treating breast, lung, liver, and kidney cancer. The press release, dated November 18, 2025, is furnished as an exhibit to this report. Most of the press release (excluding its second paragraph) is also incorporated by reference into IceCure’s existing shelf and employee equity compensation registration statements on Forms F-3 and S-8, making the Swiss approval disclosure part of those offering documents.

Positive

• Swiss multi-indication regulatory approval: ProSense^® cryoablation system received regulatory approval in Switzerland for cancer indications including breast, lung, liver, and kidney, broadening potential market access.

Negative

• None.

Insights

Medical devices & biotech markets analyst

Swiss regulatory approval broadens ProSense’s potential market and is integrated into key U.S. registration statements.

The report highlights that IceCure Medical has obtained regulatory approval in Switzerland for its ProSense^® cryoablation system for multiple cancer indications, including breast, lung, liver, and kidney. Approval in a new jurisdiction can expand where the system may be marketed and used, especially given the broad set of organ indications listed.

The company also makes this regulatory milestone part of its existing Forms F-3 and S-8 by incorporating most of the press release by reference. This means investors relying on those shelf and employee plan registration statements will see the Swiss approval reflected in the company’s described business developments, though the filing does not quantify commercial impact.

Overall, the development is favorable in strategic terms because it adds a European regulatory clearance for a multi-indication cancer therapy platform and formally updates the company’s U.S. securities registration documents with this information.

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 2025 (Report No. 4)

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 18, 2025, IceCure Medical Ltd. (the “Company”) issued a press release titled “IceCure’s ProSense® Cryoablation System Receives Regulatory Approval in Switzerland for Indications Including Breast, Lung, Liver, and Kidney Cancer,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign Private Issuer on Form 6-K. 

The press release attached herewith as Exhibit 99.1 (excluding the second paragraph thereof) 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 November 18, 2025 titled “IceCure’s ProSense® Cryoablation System Receives Regulatory Approval in Switzerland for Indications Including Breast, Lung, Liver, and Kidney Cancer”.

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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: November 18, 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 stating its ProSense^® cryoablation system received regulatory approval in Switzerland for indications including breast, lung, liver, and kidney cancer.

Which IceCure Medical product received regulatory approval in Switzerland?

The ProSense^® cryoablation system received regulatory approval in Switzerland for use in treating cancer in organs including the breast, lung, liver, and kidney.

Does this 6-K affect IceCure Medical’s existing registration statements?

Yes. Most of the press release (excluding its second paragraph) is incorporated by reference into IceCure Medical’s Registration Statements on Form F-3 and Form S-8, updating those offering documents with the Swiss approval information.

Which specific registration statements does IceCure update with this 6-K?

The press release is incorporated by reference into 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.

Does the filing describe financial impacts from the Swiss approval for ICCM?

No. The report only notes the fact of regulatory approval in Switzerland and the incorporation of the related press release into existing registration statements; it does not provide financial figures.

What is the purpose of filing this IceCure Medical press release on Form 6-K?

The Form 6-K formally furnishes the press release about the Swiss regulatory approval to the U.S. market and incorporates most of its content into IceCure’s existing shelf and employee equity plan registration statements.