IceCure (NASDAQ: ICCM) sees record Q4 North America sales after FDA clearance

Rhea-AI Filing Summary

IceCure Medical Ltd. furnished a report stating it issued a press release titled “IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer.” The title indicates the company expects record fourth quarter sales in North America and directly links this to the recent FDA clearance of its ProSense cryoablation system for treating low-risk breast cancer.

The company is also incorporating most of this press release by reference into several existing Form F-3 and Form S-8 registration statements, so the same information becomes part of those offering documents from the date of this report.

Positive

• Recent FDA clearance and record sales expectations: IceCure links a recent FDA clearance of its ProSense® cryoablation for low-risk breast cancer with expected record fourth quarter sales in North America.

Negative

• None.

Insights

Healthcare & biotech analyst

FDA clearance tied to record Q4 North America sales expectations is a clearly positive signal for IceCure’s ProSense platform.

The disclosure highlights that IceCure Medical expects record fourth quarter sales in North America and explicitly connects this expectation to recent FDA clearance of its ProSense® cryoablation system for low-risk breast cancer. That pairing underscores both a new regulatory milestone and stronger commercial activity in the same region.

The report also states that most of this press release is incorporated by reference into multiple existing Form F-3 and Form S-8 registration statements. This makes the information about record sales expectations and the recent FDA clearance part of those securities documents, which is typically associated with developments the company views as important for current and potential shareholders.

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: December 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 December 17, 2025, IceCure Medical Ltd. (the “Company”) issued a press release titled  “IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast 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 and third paragraphs thereof) is incorporated by reference into the Company’s Registration Statements on Form F-3 (File 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 December 17, 2025 titled “IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer ”.

1

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: December 17, 2025	By:	/s/ Eyal Shamir
		Name:	Eyal Shamir
		Title:	Chief Executive Officer

2

FAQ

What did IceCure Medical Ltd. (ICCM) disclose in this Form 6-K?

IceCure Medical Ltd. reported that it issued a press release titled “IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer,” and furnished that press release as an exhibit.

What sales performance does IceCure Medical (ICCM) highlight for the fourth quarter?

The press release title states that IceCure is expected to report record fourth quarter sales in North America, indicating the highest quarterly sales in that region so far.

How is FDA clearance related to IceCure Medical’s expected record sales?

According to the press release title, the expected record fourth quarter North America sales are driven by recent FDA clearance of ProSense® cryoablation for low-risk breast cancer, directly linking the sales outlook to this regulatory event.

Which SEC registration statements now incorporate this IceCure press release?

The company states that the press release (excluding its second and third paragraphs) is incorporated by reference into its Form F-3 registration statements and Form S-8 registration statements identified in the report.

Does the IceCure press release become part of existing offering documents?

Yes. The report states that, from the date this Form 6-K is submitted, most of the press release is deemed to be part of the specified Form F-3 and Form S-8 registration statements, unless later superseded.

What product is mentioned in connection with FDA clearance for IceCure Medical (ICCM)?

The product is ProSense® cryoablation, which the company describes in the press release title as having received recent FDA clearance for treating low-risk breast cancer.