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 2026 (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
October 13, 2026, IceCure Medical Ltd. (the “Company”) issued a press release titled “IceCure Highlights Clinical Data
and Strong Physician Engagement for ProSense® Breast Cancer Cryoablation at EUSOBI 2026”, a copy of which is furnished as Exhibit
99.1 to this Report of Foreign Private Issuer on Form 6-K.
This Report of Foreign Private
Issuer on Form 6-K (excluding the sixth paragraph of the press release included as Exhibit 99.1 hereto) is incorporated by reference
into the Company’s Registration Statements on Form F-3 (File Nos. 333-297030, 333-290046 and 333-258660)
and Form S-8 (333-298361, 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Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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. |
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|
| 99.1 |
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Press
Release issued by IceCure Medical Ltd., dated October 13, 2026, titled “IceCure Highlights Clinical Data and Strong Physician Engagement
for ProSense® Breast Cancer Cryoablation at EUSOBI 2026” |
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 13, 2026 |
By: |
/s/
Eyal Shamir |
| |
|
Name: |
Eyal Shamir |
| |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
IceCure Highlights Clinical Data and Strong
Physician Engagement for ProSense® Breast Cancer Cryoablation at EUSOBI 2026
Scientific presentations, research posters
and clinical workshops featured ProSense® breast cancer cryoablation and highlighted strong physician engagement across Europe
CAESAREA, Israel, October 13, 2026 /PRNewswire/
-- IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure,” “IceCure Medical” or the “Company”), developer of minimally-invasive
cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, announced today that ProSense® breast
cancer cryoablation was featured in multiple scientific presentations, research posters and physician workshops at the European Society
of Breast Imaging (“EUSOBI”) Annual Scientific Meeting 2026, held in Maastricht, the Netherlands. Featured presentations included
12-month clinical data reporting objective response rates of 97.5% among 40 patients treated with cryoablation plus endocrine therapy
and 91.7% among 24 patients treated with cryoablation alone.
ProSense® was featured during two key scientific
sessions at EUSOBI, reflecting clinical interest in breast cancer cryoablation in Europe. Dr. Lucía Graña-López (Lugo,
Spain) presented the clinical potential of cryoablation during her presentation “Beyond Biopsy: Image-Guided Therapy in Practice”
during the session “From Target to Treatment: Breast Interventions.” Dr. Francesca Pugliese (Florence, Italy) shared her findings
from “Local Tumor Control in Elderly Breast Cancer Patients Ineligible for Surgery: Cryoablation Alone or Combined with Hormonal
Therapy” during the session on “Advances in Image-Guided Breast Intervention and Minimally Invasive Therapy.”
The Company also hosted two well-attended clinical
workshops, led by Dr. Lucía Graña-López (Lugo, Spain) and Dr. Federica Di Naro (Florence, Italy): “From Freeze
to Future: Cryoablation as a New Frontier in De-Escalated Breast Cancer Care” and “Reading the Freeze: Practical Imaging Interpretation
After Breast Cancer Cryoablation”. Each workshop attracted nearly 70 participants.
Two scientific posters by ProSense® users
were presented: “From Initial Experience to One-Year Outcomes: Single-Center Efficacy and Safety of Percutaneous Cryoablation for
Breast Lesions in Romania” by Dr. Georgiana-Cristiana Camen (Romania) and “When Enhancement Disappears: The Role of Negative
CEM (Contrast Enhancement Mammography) in Predicting Histological Response After Breast Cryoablation” by Dr. Francesca Pugliese
(Florence, Italy).
EUSOBI is a leading European organization dedicated
to breast imaging and education, bringing together breast radiologists and other specialists from across Europe and internationally. The
Annual Scientific Meeting provides a platform for the exchange of clinical knowledge, research and advances in breast imaging and treatment.
“We are thrilled by the tremendous enthusiasm
and engagement ProSense® generated throughout EUSOBI,” said Eyal Shamir, Chief Executive Officer of IceCure Medical. “From
live demonstrations and two key scientific sessions to two workshops attended by nearly 70 participants each, the response was outstanding.
The inclusion of ProSense® in scientific posters and the presentation of encouraging 12-month clinical results further demonstrate
the growing momentum behind breast cancer cryoablation and the expanding role of ProSense® in advancing minimally invasive care across
Europe.”
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, as a safe
and effective minimally invasive option to surgical tumor removal, with the primary focus areas being breast, kidney, bone and lung cancer.
The Company’s flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including
in the U.S., Europe, and Asia.
ProSense® cryoablation became the first-and-only
medical device cleared by the FDA for the local treatment of breast cancer in patients aged 70 years and older with biologically low-risk
tumors ≤1.5 cm in size who are treated with adjuvant endocrine therapy, including patients who are not eligible for surgery.
Investor Relations:
Meir Peleg, CFO
investors@icecure-medical.com
+1-888-902-5716
Forward Looking Statements
This press release contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements,
which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the
use of forward-looking terms such as “believe,” “expect,” “may,” “should,” “could,”
“seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable
terms. For example, the Company is using forward-looking statements when it discusses: the potential for increased physician interest
in, adoption of, and use of ProSense® and breast cancer cryoablation, including in Europe; the potential of expansion of ProSense®’s
role in minimally invasive breast cancer care; and the potential for broader commercial adoption of ProSense®. Important factors that
could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements
include, among others: the Company’s planned level of revenues and capital expenditures; the Company’s available cash and its ability
to obtain additional funding; the Company’s ability to market and sell its products; legal and regulatory developments in the United States
and other countries; the Company’s ability to maintain its relationships with suppliers, distributors and other partners; the Company’s
ability to maintain or protect the validity of its patents and other intellectual property; the Company’s ability to expose and educate
medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as
well as those factors set forth in the Risk Factors section of the Company’s Annual Report on Form 20-F for the year ended December 31,
2025 filed with the SEC on March 17, 2026, and other documents filed with or furnished to the SEC which are available on the SEC’s website, www.sec.gov.
The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required
by law.
