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 September 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 September 5, 2023, IceCure
Medical Ltd. (the “Company”) issued a press release titled: “IceCure Medical’s ProSense Cryoablation System Receives
Regulatory Approval in Brazil,” 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, second, third and fifth 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extent not superseded by documents or reports subsequently filed or furnished.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: September 5, 2023 |
By: |
/s/
Eyal Shamir |
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Name: |
Eyal Shamir |
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Title: |
Chief Executive Officer |
2
Exhibit 99.1
IceCure Medical’s ProSense Cryoablation
System Receives Regulatory Approval in Brazil
| ● | $6.6
million in sales expected in Brazilian market over the next five years per distribution agreement
guarantees |
| ● | High
level of early interest in ProSense in South America’s largest market |
CAESAREA, Israel, September 5, 2023 --
IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”), developer of minimally-invasive cryoablation
technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that
its ProSense System has received regulatory approval as a Class III device from the Brazilian Health Regulatory Agency (“ANVISA”).
ProSense’s disposable cryoprobes and introducers, were previously registered as Class II devices by ANVISA. Applications for both
the ProSense System and its disposable cryoprobes and introducers were submitted to ANVISA by IceCure’s distributor in Brazil,
Ktrfios Importação e Exportação
LTDA (“Ktrfios”).
ProSense’s indications approved by ANVISA
are oncology, which includes the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal,
and skin tissue, as well as for palliative intervention and other indications.
Healthcare providers are cleared to conduct procedures
with ProSense, its introducers and disposable probes, and Ktrfios is cleared to both market and sell ProSense’s introducers and
disposable probes. ANVISA has assessed that the probes, which were initially registered as a Class II device under ANVISA rules, are to
be transitioned to a Class III device and aligned with the Brazilian regulatory system classification for the same class as ProSense.
Therefore, ANVISA has requested that the probes also be submitted by Ktfrios for regulatory approval as a Class III device. The introducers
remain a Class II device and do not require an additional regulatory submission. Class III device clearance for the probes is expected
to be finalized by the end of the first quarter of 2024.
“We are very pleased that ProSense has received
regulatory approval in Brazil. We expect this to translate into near-term revenues. Early indications of market interest point to strong
demand in the largest market in South America where cost-effective, minimally invasive, safe, and effective cryoablation procedures can
offer great benefits compared to traditional surgical interventions,” stated IceCure Chief Executive Officer, Eyal Shamir.
With a total population of over 200 million people,
more than 500,000 new cancer cases and more than 250,000 deaths attributed to cancer each year according to the World Health Organization’s
Cancer Tomorrow | IARC project, Brazil has an urgent need for minimally invasive cancer treatments.
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 ProSense 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 statements in this press release
when it discusses: the expected Class III device clearance for the probes by the end of the first quarter of 2024; the expected near-term
revenues as a result of regulatory approval of ProSense in Brazil; and the potential of ProSense to offer great benefits compared to traditional
surgical interventions. 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
IceCure Medical (NASDAQ:ICCM)
過去 株価チャート
から 10 2024 まで 11 2024
IceCure Medical (NASDAQ:ICCM)
過去 株価チャート
から 11 2023 まで 11 2024