FDA clears IceCure Medical (ICCM) ProSense for low-risk breast cancer

Rhea-AI Filing Summary

IceCure Medical Ltd. reports that the U.S. FDA has granted marketing authorization for its ProSense® cryoablation system to treat low-risk breast cancer in women aged 70 and above. The company furnished two press releases on this authorization, highlighting it as a significant development in providing women with breast cancer a minimally invasive care option. Portions of these press releases are also incorporated by reference into several of IceCure's existing Form F-3 and Form S-8 registration statements.

Positive

• FDA marketing authorization for ProSense® cryoablation to treat low-risk breast cancer in women aged 70 and above represents a major regulatory milestone that can enable commercialization in this indication.

Negative

• None.

Insights

Healthcare regulatory and medtech analyst

FDA marketing authorization for ProSense in a defined breast cancer group is a clearly positive regulatory milestone for IceCure.

The disclosure centers on the U.S. FDA granting marketing authorization for ProSense® cryoablation to treat low-risk breast cancer in women aged 70 and above. This moves ProSense from development and evaluation into an approved, marketable use case in a specific patient population, which is a critical step for any medical device company.

The company characterizes the decision as a significant development in providing minimally invasive care for breast cancer, underscoring a potential clinical and commercial niche. The authorization is tied to “low-risk” disease and a defined age group, so future growth will depend on how widely physicians adopt this indication and any follow-on approvals or label expansions disclosed in later filings.

The press releases, with certain paragraphs excluded, are incorporated by reference into multiple Form F-3 and Form S-8 registration statements, indicating IceCure is formally embedding this regulatory milestone into its broader capital markets documentation. Subsequent company disclosures may detail commercial rollout, reimbursement dynamics, and any additional clinical data supporting this newly authorized use.

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”

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: October 3, 2025	By:	/s/ Eyal Shamir
		Name:	Eyal Shamir
		Title:	Chief Executive Officer

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FAQ

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

IceCure Medical reported that the U.S. FDA granted marketing authorization for its ProSense® cryoablation system to treat low-risk breast cancer in women aged 70 and above, and it furnished two related press releases.

What is ProSense cryoablation authorized to treat according to IceCure Medical?

ProSense® cryoablation is authorized by the FDA for the treatment of low-risk breast cancer in women aged 70 and above, as described in the October 3, 2025 press releases.

Why does IceCure call this FDA authorization a significant development?

IceCure describes the authorization as a significant development in giving women with breast cancer minimally invasive care, highlighting its potential impact on treatment options for this defined group.

How does this 6-K affect IceCure Medical's existing registration statements?

Portions of the attached press releases are incorporated by reference into IceCure’s Form F-3 registration statements (Nos. 333-258660, 333-267272, 333-290046) and Form S-8 registration statements (Nos. 333-270982, 333-264578, 333-262620, 333-281587).

On what date did IceCure Medical issue the FDA authorization press releases?

IceCure Medical issued both press releases on October 3, 2025, and furnished them as Exhibits 99.1 and 99.2 to this Form 6-K.

Which exhibits in the 6-K contain details on the FDA decision for IceCure?

Exhibit 99.1 is titled “IceCure Receives FDA Marketing Authorization for ProSense® Cryoablation for the Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above,” and Exhibit 99.2 provides a similar title emphasizing minimally invasive care.