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 2023
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 2, 2023, IceCure
Medical Ltd. (the “Company”) issued a press release titled: “Independent Study Validates IceCure’s ProSense Cryoablation
is Safe & Effective Outpatient Procedure for Breast Cancer with 96.8% Success Rate,” a copy of which is furnished as Exhibit
99.1 with this Report of Foreign Private Issuer on Form 6-K (the “Report”).
The first four paragraphs
and the section titled “Forward Looking Statements” in the press release furnished herewith 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, and 333-262620), filed with the Securities and Exchange Commission, to be a part thereof from the date on
which this Report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
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.
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IceCure Medical Ltd. |
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Date: October 2, 2023 |
By: |
/s/ Eyal Shamir |
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Name: |
Eyal Shamir |
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Title: |
Chief Executive Officer |
2
Exhibit 99.1
Independent Study Validates IceCure’s
ProSense Cryoablation is Safe & Effective Outpatient
Procedure for Breast Cancer with
96.8% Success Rate
| ● | Study
was conducted in Spain with women who declined standard of care surgery |
| ● | ProSense
is approved for the treatment of breast cancer throughout the European Union |
CAESAREA,
Israel, October 2, 2023 -- IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”), developer of
the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical
tumor removal, today announced that new data was presented at the European Society of Breast Imaging (“EUSOBI”) Scientific
Meeting in Valencia, Spain by Lucía Graña-López, MD, PhD, principal investigator of the independent, non-sponsored
study.
In a poster titled “Cryoablation for the
treatment of early-stage breast cancer in patients who decline surgery” Dr. Graña-López presented the findings of
her study conducted at University Hospital Lucus Augusti in Lugo, Spain which used ProSense for cryoablation treatment of 31 patients
with early-stage breast cancer who declined surgery, the standard of care. Dr. Graña-López, a radiologist who specializes
in breast and women’s imaging, is Head of the Breast Unit at University Hospital Lucus Augusti.
All patients were diagnosed with biopsy-proven
early breast cancer (cT1-2cN0-1cM0) with a median tumor size of 24 mm, ranging between 6 to 45 mm. Patients were followed by mammography
and ultrasound every 6 months for 2 years and annually thereafter. The median follow-up was 10 months, with a range of 0 to 40 months.
Cancer progression was observed in 1 patient (1/31, 3.2%). No major complications were seen and the procedure was well tolerated by all
patients.
The study concluded that cryoablation could be
an alternative treatment to surgery for breast cancer in patients who reject surgery. Underscoring the need for such an alternative, the
poster presented that breast cancer is the most commonly diagnosed malignant neoplasm worldwide and that while surgery is the standard
of care for early-stage breast cancer, some patients, most of them elderly, decline standard of care surgery and prefer a less invasive
option.
Dr. Graña-López commented, “I’ve
been effectively using ProSense for cryoablation in women who decline surgery with very good results. I think that soon, cryoablation
will be a real alternative to surgery in early-stage breast cancer in post-menopausal women. Beyond breast cancer, I believe ProSense
can have an impact on the way cancers of the kidney, lung, and thyroid gland are treated.”
“Doctors around the world are using ProSense
with women who want an alternative to surgery for early- stage breast cancer, and it’s highly encouraging to see these physicians
publish and share their results with the medical community,” stated IceCure’s CEO, Eyal Shamir. “These data are very
much in line with the interim results of our ICE3 study, the largest of its kind in the U.S., which is expected to conclude in the first
quarter of 2024.”
About IceCure
Medical
IceCure Medical (Nasdaq: ICCM)
develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy 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 system is marketed
and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, 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 and Israeli 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 statement in this press release when it discusses:
the expected conclusion of its ICE3 study in the first quarter of 2024; and that, according to Dr. Graña-López, soon cryoablation
will be a real alternative to surgery in early-stage breast cancer in post-menopausal women. Historic
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. Because such statements deal with future events and are based on IceCure’s
current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure
could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained
or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the Company, including
those set forth in the Risk Factors section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022 filed with
the SEC on March 29, 2023, 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
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