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 2024
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 8, 2024, IceCure
Medical Ltd. (the “Company”) issued a press release titled “FDA Advisory Panel Votes in Favor of IceCure’s ProSense®
Cryoablation Benefit-Risk Profile in Early-Stage 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 first, third and fourth
paragraphs and the section titled “Forward Looking Statements” in the press release attached herewith as Exhibit 99.1 are
incorporated by reference into the Company’s Registration Statements on Form F-3 (Registration Nos. 333-258660 and 333-267272)
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a part thereof from the date on which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded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
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 8, 2024 |
By: |
/s/ Eyal Shamir |
|
|
Name: |
Eyal Shamir |
|
|
Title: |
Chief Executive Officer |
2
Exhibit 99.1
FDA Advisory Panel Votes in Favor of IceCure’s
ProSense®
Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
FDA decision on marketing authorization expected
in the first quarter of 2025
CAESAREA, Israel, November 8, 2024 –
IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of
minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced the
U.S. Food and Drug Administration’s (“FDA”) Medical Device Advisory Committee Panel’s (the “Advisory Panel”)
favorable recommendation with 9 panelists voting in favor and 5 voting against the benefit-risk profile of IceCure’s ProSense®.
The majority of panelists voted that the benefits of IceCure’s ProSense® System outweigh the risks when used according to the
proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine
therapy. Among those that voted “no”, there were three who stated that if the FDA applied adequate special controls, this
would have swayed their opinion in favor.
“This is a significant milestone on the
path towards the marketing authorization of ProSense® cryoablation in the U.S. for early-stage low risk breast cancer and I believe
a critically important development for women seeking an alternative to lumpectomy,” stated IceCure’s Chief Executive Officer,
Eyal Shamir. “We expect the FDA’s decision, based on the Advisory Panel’s recommendation, in the first quarter of 2025.
Our U.S. sales and distribution team is ready to support doctors and patients in the event of a successful marketing authorization for
ProSense® in breast cancer.”
The Advisory Panel’s favorable vote was
based on the comprehensive body of data available on ProSense® as a treatment for early-stage low risk breast cancer, including results
from the Company’s ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonies and input from
a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses
and researchers.
The purpose of the Advisory Panel was for the
FDA to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing
authorization of ProSense® for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine
therapy. The Advisory Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient,
consumer, and regulatory communities.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive
treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal
zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery,
reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens
that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems for the treatment of tumors (benign and cancerous) by freezing, with the primary
focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital
surgical tumor removal that is easily performed in a relatively short procedure. 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, India, Brazil and China.
Forward Looking Statements
This press release contains forward-looking statements
within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal
securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,”
“seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking
statements. For example, IceCure is using forward looking statements in this press release when it discusses: that this is a significant
milestone on the path towards the approval of ProSense® cryoablation in the U.S. for early-stage low risk breast cancer; the belief
that this approval is critically important development for women seeking an alternative to lumpectomy; that the Company expects to receive
news of the FDA’s decision in the first quarter of 2025; and that the Company’s U.S. sales and distribution team is ready
to support doctors and patients in the event of successful marketing authorization for ProSense® in breast cancer. Historical results
of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest
identical or even similar conclusions. 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, 2023 filed with the SEC on April 3, 2024, 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.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
IceCure Medical (NASDAQ:ICCM)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
IceCure Medical (NASDAQ:ICCM)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024