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 2023 (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 November 28, 2023, IceCure Medical Ltd. (the
“Company”) issued a press release titled: “IceCure System Successfully Treated Kidney Cancer Tumor with 92% Disease-Free
Survival Rate and 100% Secondary Local Control Rate,” a copy of which is furnished as Exhibit 99.1 with this Report of Foreign Private
Issuer on Form 6-K (the “Report”).
On November 29, 2023, IceCure Medical Ltd. (the “Company”) issued a press release titled: “IceCure’s ProSense®
Deepens Regulatory Approval in India,” a copy of which is furnished as Exhibit 99.2 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 Exhibit 99.1 and the first two paragraphs
and the section titled “Forward Looking Statements” in Exhibit 99.2 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which this Report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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.
|
IceCure Medical Ltd. |
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|
|
Date: November 29, 2023 |
By: |
/s/ Eyal Shamir |
|
|
Name: |
Eyal Shamir |
|
|
Title: |
Chief Executive Officer |
2
Exhibit 99.1
IceCure System Successfully Treated Kidney Cancer
Tumor with 92% Disease-Free Survival Rate and 100% Secondary Local Control Rate
| ● | Independent
study concluded: |
| o | IceCure system offers significant advantage in ability
to re-treat tumors that are initially resistant, achieving a subsequent local control rate of 100% |
| o | 92.4% of patients (N= 24) were discharged the day after
cyroablation |
| o | The technology’s ability to preserve renal function
post-treatment is paramount for patients’ quality of life |
| o | Findings serve as a guide for medical professionals
in choosing efficient, cost-effective, and patient-friendly treatment options, thereby benefiting society at large by optimizing kidney
tumor management |
| ● | Success
across multiple indications supports ProSense®’s commercialization, particularly in facilities that can use one device across
multiple specialties |
CAESAREA, Israel, November 28, 2023 --
IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys
tumors by freezing as an alternative to surgical tumor removal, today announced the latest release of a study (the “Study”)
in a series of independent studies of ProSense® published in peer-reviewed journals demonstrating safety and efficacy. The Study,
titled “Single-Probe Percutaneous Cryoablation with Liquid Nitrogen for the Treatment of T1a Renal Tumors”, published in Cancers,
demonstrated the safety and efficacy of ProSense® in treating malignant small renal masses. The Study was authored by eight physicians
in France, including interventional radiologists and urologists from Curie Institute, Paris, Nîmes
University Hospital (University of Montpellier), Nîmes, and Carémeau University
Hospital, Nîmes.
ProSense® is approved for the treatment of
benign and malignant kidney tumors in the U.S., Europe, and numerous other countries.
Caption: 85-year-old man with 3 cm biopsy-proven clear cell renal carcinoma
(image left, white arrow)). RENAL nephrometry score calculated as 6. The central image shows the CT scan obtained with the patient in
a prone position and the cryoprobe placed in the tumor with the final ice ball (end of the second freezing cycle). The right image shows
the MRI during follow-up at 1 month, demonstrating complete local response with no evidence of tumor enhancement (white arrow head). |
The objective of this retrospective Study was
to address the challenges of managing small renal masses, including recurrence rates, by exploring the safety and efficiency of single-probe
percutaneous cryoablation as a potential solution. The causes of partial tumor response and persistent tumor residue after a T1a renal
cryoablation procedure were assessed. A total of 25 patients underwent cryoablation for 26 T1a renal tumors with a median tumor size of
25.3 mm (20 to 30.7 mm) and a median RENAL nephrometry score, indicating tumor complexity, of 7 (5 to 9).
Main findings of the Study:
| ● | Disease-free
survival rate was 92% (23 out of 25) at a median follow-up of 26 and a half months |
| ● | Recurrent
lesions were treated again using cryoablation, achieving a secondary local control rate of 100% |
| ● | No
major complications arose |
| ● | 92.4%
of patients (N= 24) were discharged the day after surgery |
One of the Study’s authors, Professor Julien
Frandon, Director of the Interventional Radiology Department at Nîmes University Hospital
commented, “In our recent publication, we evaluated the safety and efficacy of IceCure’s cryoablation technology for the treatment
of renal T1a tumors. This innovative approach has demonstrated remarkable safety profiles, even for challenging and unfavorably located
small renal masses. One of the study’s crucial findings is the technology’s ability to preserve renal function post-treatment, which is
paramount for patients’ quality of life. This technology stands out as a forward-thinking solution in oncological treatment, providing
a combination of patient safety, procedural efficiency, and cost-effectiveness.”
“We appreciate the diligent work of Professor
Frandon and his colleagues in conducting this Study and we congratulate them on its publication in Cancers, a prestigious European
medical journal,” stated IceCure’s Chief Executive Officer Eyal Shamir. “The authors’ findings are similar to
the interim results from our own ICESECRET study in small renal masses which demonstrated an 89.5% recurrence-free rate. We expect ICESECRET’s
five-year patient follow-up to be completed in 2026, with topline results available shortly afterwards.”
About ProSense®
ProSense® cryoablation is a minimally invasive,
non-surgical, outpatient 40-minute, cost affective treatment option that destroys tumors by freezing them. ProSense® has been investigated
and proven effective in various clinical applications, including breast tumors, kidney cancer, lung cancer, and in palliative care. Independent
and company-sponsored clinical studies of ProSense® have shown strong results, with high rates of tumor destruction, and patient and
physician satisfaction.
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 potential of ProSense® to be an effective and viable option for treating small renal masses; and the expectation
that the five-year patient follow-up for the ICESECRET study is to be completed in 2026, with topline results available shortly afterwards.
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. 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, 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
3
Exhibit 99.2
IceCure’s ProSense® Deepens Regulatory
Approval in India
| ● | ProSense® is already marketed and sold in India based on previous
regulatory requirements and now has been re-classified due to new regulations |
| ● | Breast cancer cryoablation is already performed in India with ProSense®
|
CAESAREA, Israel, November 29, 2023 --
IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” 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 the Central Drugs Standard Control Organization (“CDSCO”) in India has granted approval
for the ProSense® system based on the CDSCO’s updated regulatory requirements. This is in addition to existing approvals, including
disposables and cryoprobes, already approved for indications covering general surgery and oncology for tissues of the breast, lung, bone,
kidney, liver and more. ProSense® was previously marketed and sold in India in accordance with prior regulatory requirements. This
latest approval, granted in November 2023, confirms that ProSense® meets all updated regulatory requirements in India.
ProSense® is marketed and sold in India through
IceCure’s distributor, Novomed. The first breast cancer cryoablation procedure in India was conducted using ProSense® in June
of 2023, at the Kovai Medical Center and Hospital in Coimbatore. Along with Novomed, IceCure recently presented ProSense® at the 10th
Annual Conference of the Breast Imaging Society of India, where the cryoablation system was enthusiastically received by doctors, who
attended a presentation of the ICE3 clinical study results and participated in hands-on demonstrations.
“India is a very important market for us
because we see the potential for significant growth with safe, effective, and cost-efficient technologies rapidly adopted. We have a highly
productive partnership with our in-country distributor, Novomed, and anticipate increasing market traction,” stated IceCure’s
Chief Executive Officer, Eyal Shamir. “Obtaining and maintaining regulatory approvals across the world supports our continued commercial
traction worldwide.”
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 potential for significant growth and increasing market traction in India; and that obtaining and maintaining regulatory
approvals supports the Company’s continued commercial traction worldwide. 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, 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
IceCure Medical (NASDAQ:ICCM)
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