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: May 2024 (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 May 28, 2024, IceCure Medical
Ltd. (the “Company”) issued a press release titled “IceCure Medical Maintains Positive Momentum and Reports Sales Growth
for Cryoablation System in First Quarter of 2024”, a copy of which is furnished as Exhibit 99.1 with this Report of Foreign Private
Issuer on Form 6-K.
The press release furnished
herewith, excluding the second and third paragraphs thereof, is 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 of Foreign
Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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. |
| |
|
|
| Date: May 28, 2024 |
By: |
/s/ Eyal Shamir |
| |
|
Name |
Eyal Shamir |
| |
|
Title: |
Chief Executive Officer |
Exhibit
99.1
IceCure
Medical Maintains Positive Momentum and Reports Sales Growth for Cryoablation System in First Quarter of 2024
| ● | 30%
sales growth reflects continued adoption of ProSense® in the U.S. and other global markets |
| ● | Major
milestones achieved: |
| O | Completion
of landmark ICE3 trial for breast cancer |
| O | Positive
final ICE3 trial data |
| ● | Independent
studies performed globally continue to demonstrate ProSense®’s efficacy and safety
across numerous indications |
| ● | Conference
call to be held today at 11:00 am Eastern Time |
CAESAREA,
Israel, May 28, 2024 – 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 reported financial results as of and for the three months ended March 31, 2024. During the quarter,
the Company completed its landmark ICE3 trial and recently achieved several objectives, including: publishing and submitting the full
data set of its ICE3 trial results to the U.S. Food and Drug Administration (“FDA”); and requesting marketing authorization
for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone
therapy.
“Having
completed ICE3, the largest study of its kind in cryoablation in the U.S., we are now awaiting the FDA’s marketing clearance decision,”
stated IceCure’s CEO, Eyal Shamir. “ProSense® is already cleared and is being used to treat early-stage breast cancer
in numerous countries with great results. Since the U.S. is one of the largest markets in the world, we believe that delivering alternative
surgery-free options to women in the U.S., while establishing ProSense® as a gold-standard globally, will have a significant impact
on treating patients with breast cancer.”
“During
the first quarter, we also continued to experience an upward trend in sales in the U.S. We successfully managed to lower our operating
expenses in non-revenue generating activities by exercising prudent cash management.”
First
Quarter 2024 and Recent Significant Operating, Clinical, Regulatory & Commercial Highlights:
Reported
and Submitted Full ICE3 Breast Cancer Study Data to FDA: IceCure completed the largest controlled multicenter clinical trial ever
performed for liquid nitrogen (LN2) based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up
evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to
be free from local recurrence. 100% patient and physician satisfaction was reported. IceCure submitted the final ICE3 data, along with
other analyses and data, to the FDA requesting marketing authorization of ProSense® for the indication of treating patients with
early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. Full ICE3 study results were presented at the American
Society of Breast Surgeons’ (“ASBrS”) annual meeting by ICE3 investigators, including Dr. Richard Fine who delivered
an oral presentation titled “Cryoablation Without Excision for Early-Stage Breast Cancer; ICE3 Trial 5-year follow-up on Ipsilateral
Breast Tumor Recurrence,” which won the ABSrS Scientific Impact Award.
Zero
(0%) Breast Cancer Local Recurrence 5 Years After Treatment with ProSense®: An independent study performed in Japan was published
in an article titled “Percutaneous ultrasound–guided cryoablation for early–stage primary breast cancer: a follow–up
study in Japan,” in the journal Breast Cancer. In addition to no cancer recurrence 5 years following treatment with ProSense®,
researchers also reported excellent cosmetic outcomes, a high degree of patient satisfaction, and improved quality of life post-cryoablation.
Treatment
with ProSense® Resulted in 100% Tumor Reduction in Early-Stage Breast Cancer: An independent study in women deemed inoperable
for breast cancer reported median tumor reduction of 100% at 6 and 12 months following cryoablation. The study was conducted by ProSense®
user, Dr. Federica di Naro, of Azienda Ospedaliero-Universitaria Careggi in Florence, Italy.
ProSense®
Found to be Promising Alternative Treatment for Extra-Pelvis Endometriosis: An investigator-initiated single-site study of women
with endometriosis in the abdominal wall and para-diaphragmatic areas found that treatment with ProSense® for about 30 minutes resulted
in the disappearance of hemorrhagic signals and development of necrotic changes, as well as pain reduction from a median of 7 on a scale
of 0 - 10 to a median of 1, with some patients reporting 0. The independent study was conducted at University Hospital, Nîmes,
France, and data were shared at the European Congress of Radiology 2024 in Vienna, Austria in a presentation titled “BEYOND PAIN:
Cryoablation of endometriotic nodules using liquid nitrogen”.
ProSense®
Boosts Immune Response Against Cancer by Enhancing CD8+ T Cell Response: An independent study, conducted at Case Western Reserve
University in Cleveland, Ohio and published in OncoImmunology, demonstrated that ProSense® can activate the body’s natural
immune response by enhancing CD8+ T cells, which are an important arm of immune response. The data support previous studies and suggest
ProSense® may produce anti-cancer benefits in humans beyond tumor destruction during a cryoablation procedure.
Commercial
and Medical Community Interest Continues to Grow with ProSense® Featured at Conferences in the U.S., India and Japan: In the
U.S., in addition to ICE3 data being presented at ASBrS, cryoablation gained prominence at the Society of Interventional Oncology (SIO)
Annual Scientific Meeting where the technology was featured in the first breast cryoablation master class at SIO. ICE3 trial data were
cited prominently in the master class given by several ProSense® users, including Dr. Kenneth Tomkovich, ICE3’s co-principal investigator,
and Dr. Fine. In India, ProSense® users and key opinion leaders highlighted the benefits of cryoablation at the Indian Society of
Vascular and Interventional Radiology Conference and the Fourth Breast Imaging & Interventional Techniques conference. ProSense®
was featured in a number of sessions, including one titled “Minimal access imaging guided therapies: cryoablative therapies in breast
pathologies”. Underscoring global adoption and use of ProSense®, Dr. Eisuke Fukuma, PhD, who has performed over 600 breast cryoablation
procedures with ProSense®, hosted two events in Japan at the 30th Japan Breast Disease Society and the 8th International Oncoplastic
Breast Surgery Symposium.
Received
Patent Allowance in Japan for a Novel Cryogen Flow Control to Optimize Patient Outcomes: IceCure received a Notice of Allowance from
the Japan Patent Office for its patent application titled “Cryogen Flow Control” for a technology that enhances the efficacy
and precision of cryoablation procedures.
Submitted
Application for FDA Clearance of Next-Generation XSense™ System and Cryoprobes: Demonstrating its global leadership in minimally
invasive cryoablation technologies, IceCure submitted a 510(k) filing for its single probe XSense™ system and cryoprobes to the
FDA for regulatory clearance in all the indications for which ProSense® has already received the requisite FDA clearance.
Financial
Results for the Three Months Ended March 31, 2024
Revenues
for the three months ended March 31, 2024 were $743,000 compared to $710,000 for the three months ended March 31, 2023, an
increase of 5%, due to an increase in the sales, which was offset by the end of revenue recognition from the exclusive distribution rights
agreement with Terumo Corporation in Japan for which no revenue was recognized in the three months ended March 31, 2024. For the three
months ended March 31, 2024, the Company reported ProSense® systems and disposable probes sales of $743,000 compared to $573,000
for the three months ended March 31, 2023, an increase of 30%, driven primarily by higher sales in the U.S. and Japan.
Gross
profit for the three months ended March 31, 2024 was $269,000 compared to $320,000 for the three months ended March
31, 2023. Gross margin for the three months ended March 31, 2024 was 36%, compared to 45% for the three months ended March 31, 2023.
Non-GAAP gross profit for the three months ended March 31, 2024 was $269,000, compared to $183,000 for the three months ended March 31,
2023, an increase of $86,000 or 47%. Non-GAAP gross margin for the three months ended March 31, 2024 was 36% compared to 32% for the
three months ended March 31, 2023. The increase in non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from the exclusive
distribution agreements, was attributable to the increase of 30% in revenue from sales of ProSense® systems and probes while the
increase in cost of revenues was 22%. Non-GAAP gross profit and non-GAAP gross margin are financial measures that may be defined as “non-GAAP
financial measures” by the U.S. Securities and Exchange Commission (“SEC”). For a reconciliation of these non-GAAP
financial measures to the nearest comparable GAAP measure, see Appendix A to this press release.
Research
and development expenses for the three months ended March 31, 2024, were $1,951,000 compared to $2,111,000 for the three
months ended March 31, 2023. The decrease was primarily due to a reduction in development expenses for the XSense™ System, and
a decrease in clinical and regulatory costs.
Sales
and marketing expenses for the three months ended March 31, 2024 were $1,038,000, compared to $1,075,000 for the three months
ended March 31, 2023. General and administrative expenses for the three months ended March 31, 2024 were $930,000, compared to $1,091,000
for the three months ended March 31, 2023. The decrease was due, in part, to a decrease in directors and officers insurance costs and
the depreciation of NIS against USD on NIS-denominated expenses such as payroll and related benefits.
Total
operating expenses for the three months ended March 31, 2024 were $3,919,000, compared to $4,277,000 for the three months ended
March 31, 2023. The decrease in operating expenses was attributable to reductions in research and development, general and administrative
expenses, and sales and marketing expenses.
Net
loss for the three months ended March 31, 2024 was $3,609,000, or $0.08 per share, compared to a net loss of $3,768,000,
or $0.08 per share, for the same period last year.
As
of March 31, 2024, the Company had cash and cash equivalents, including short-term deposits, of approximately $11 million,
compared to $11 million as of December 31, 2023. As of May 28, 2024, the Company had cash and cash equivalents of approximately
$10.8 million.
During
the first quarter of 2024, the Company raised $2.98 million in net proceeds from the sale of 2,210,057 ordinary shares under its at-the-market
(“ATM”) offering facility, and the compensation paid by the Company with respect to sales of the ordinary shares pursuant
to this ATM facility was $76,000.
Use of
Non-U.S. GAAP Measures
In
addition to disclosing financial results prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP),
this press release contains certain financial measures which may be defined as “non-GAAP financial measures” by the SEC.
The
Company defines non-GAAP gross profit as gross profit less revenue from exclusive distribution agreements as an indication of our gross
profit from sales of our systems and disposables. The Company has provided non-GAAP gross profit in this press release because it is
a key measure used by management and the board of directors as an indication of our gross profit from sales of our systems and disposables
and management believes that it is useful to investors’ understanding and assessment of the Company’s gross profit without
the impact of revenue recorded from the Company’s exclusive distribution agreements. The Company defines non-GAAP gross margin
as a percentage of non-GAAP gross profit from sales of our systems and disposables. The Company has provided non-GAAP gross margin in
this press release because it is a key measure used by management and the board of directors as an indication of the Company’s
profitability without the impact of revenue from the Company’s exclusive distribution agreements. We have provided a reconciliation
below of non-GAAP gross profit and non-GAAP gross margin to the most directly comparable financial measure calculated and presented in
accordance with U.S. GAAP. The non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute
for, or superior to, financial measures calculated in accordance with U.S. GAAP and the financial results calculated in accordance with
U.S. GAAP and reconciliations to those financial results should be carefully evaluated.
Conference
call & webcast info:
Tuesday,
May 28, 2024, at 11:00 am EDT
US:
1-888-407-2553
Israel/International:
+972-3-9180696
A
live webcast will be available at: https://veidan.activetrail.biz/IcecureQ1-2024
A
recording of the webcast will be available at: ir.icecure-medical.com/
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 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 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 pending FDA marketing clearance decision for ProSense®, the belief that delivering alternative surgery-free options
to women in the U.S., while establishing ProSense® as a gold standard globally, will have a significant impact, and the pending FDA
510(k) regulatory clearance application for the single probe XSense™ system and cryoprobes. 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 LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| | |
As of
March 31,
2024 | | |
As of December 31,
2023 | |
| | |
(Unaudited) | | |
(Audited) | |
| | |
U.S. dollars in thousands | |
| | |
| | |
| |
| ASSETS | |
| | |
| |
| | |
| | |
| |
| CURRENT ASSETS | |
| | |
| |
| Cash and cash equivalents | |
| 10,966 | | |
| 10,533 | |
| Deposits | |
| - | | |
| 529 | |
| Trade accounts receivables | |
| 157 | | |
| 103 | |
| Inventory | |
| 2,111 | | |
| 2,275 | |
| Prepaid expenses and other receivables | |
| 692 | | |
| 744 | |
| Total current assets | |
| 13,926 | | |
| 14,184 | |
| | |
| | | |
| | |
| NON-CURRENT ASSETS | |
| | | |
| | |
| Prepaid expenses and other long-term assets | |
| 44 | | |
| 34 | |
| Right-of-use assets | |
| 627 | | |
| 679 | |
| Property and equipment, net | |
| 1,456 | | |
| 1,513 | |
| Total non-current assets | |
| 2,127 | | |
| 2,226 | |
| TOTAL ASSETS | |
| 16,053 | | |
| 16,410 | |
| | |
| | | |
| | |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| | |
| | | |
| | |
| CURRENT LIABILITIES | |
| | | |
| | |
| Trade accounts payable | |
| 658 | | |
| 502 | |
| Lease liabilities | |
| 237 | | |
| 223 | |
| Other current liabilities | |
| 3,210 | | |
| 3,146 | |
| Total current liabilities | |
| 4,105 | | |
| 3,871 | |
| | |
| | | |
| | |
| NON-CURRENT LIABILITIES | |
| | | |
| | |
| Long-term lease liabilities | |
| 312 | | |
| 376 | |
| Total non-current liabilities | |
| 312 | | |
| 376 | |
| | |
| | | |
| | |
| SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 47,939,194 shares and 45,729,684 shares as of March 31, 2024 and December 31, 2023, respectively | |
| | | |
| | |
| Additional paid-in capital | |
| 105,306 | | |
| 102,224 | |
| Accumulated deficit | |
| (93,670 | ) | |
| (90,061 | ) |
| Total shareholders’ equity | |
| 11,636 | | |
| 12,163 | |
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| 16,053 | | |
| 16,410 | |
ICECURE
MEDICAL LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| | |
Three months ended
March 31, | |
| | |
2024 | | |
2023 | |
| | |
U.S. dollars in thousands
(except per share data) | |
| Revenues | |
| 743 | | |
| 710 | |
| Cost of revenues | |
| 474 | | |
| 390 | |
| Gross profit | |
| 269 | | |
| 320 | |
| Research and development expenses | |
| 1,951 | | |
| 2,111 | |
| Sales and marketing expenses | |
| 1,038 | | |
| 1,075 | |
| General and administrative expenses | |
| 930 | | |
| 1,091 | |
| Operating loss | |
| 3,650 | | |
| 3,957 | |
| Finance expenses (income), net | |
| (41 | ) | |
| (189 | ) |
| | |
| | | |
| | |
| Net loss and comprehensive loss | |
| 3,609 | | |
| 3,768 | |
| Basic and diluted net loss per share | |
| 0.08 | | |
| 0.08 | |
| Weighted average number of shares outstanding used in computing basic and diluted loss per share | |
| 46,736,034 | | |
| 45,623,434 | |
ICECURE
MEDICAL LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
| | |
Three months ended March 31, | |
| | |
2024 | | |
2023 | |
| | |
U.S. dollars in thousands | |
| Cash flows from operating activities | |
| | |
| |
| Net loss | |
| (3,609 | ) | |
| (3,768 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
| Depreciation | |
| 85 | | |
| 79 | |
| Share-based compensation | |
| 245 | | |
| 356 | |
| Exchange rate changes in cash and cash equivalents and short time deposits | |
| 43 | | |
| 8 | |
| Changes in assets and liabilities: | |
| | | |
| | |
| Decrease (increase) in trade accounts receivables | |
| (54 | ) | |
| (65 | ) |
| Decrease in prepaid expenses and other receivables | |
| 52 | | |
| 374 | |
| Decrease (increase) in inventory | |
| 164 | | |
| (71 | ) |
| Decrease in right of use assets | |
| 75 | | |
| 48 | |
| Increase (decrease) in trade accounts payable | |
| 156 | | |
| (29 | ) |
| Decrease in lease liabilities | |
| (73 | ) | |
| (57 | ) |
| Increase in other current liabilities | |
| 64 | | |
| 188 | |
| Net cash used in operating activities | |
| (2,852 | ) | |
| (2,937 | ) |
| | |
| | | |
| | |
| Cash flows from investing activities | |
| | | |
| | |
| Withdrawal of (investment in) short-term deposits | |
| 529 | | |
| (14,870 | ) |
| Investment in restricted long term deposits | |
| (10 | ) | |
| - | |
| Purchase of property and equipment | |
| (28 | ) | |
| (250 | ) |
| Net cash provided by (used in) investing activities | |
| 491 | | |
| (15,120 | ) |
| | |
| | | |
| | |
| Cash flows from financing activities: | |
| | | |
| | |
| Issuance of ordinary shares, net of issuance costs | |
| 2,837 | | |
| - | |
| Net cash provided by financing activities | |
| 2,837 | | |
| - | |
| | |
| | | |
| | |
| Increase (decrease) in cash and cash equivalents | |
| 476 | | |
| (18,057 | ) |
| Cash and cash equivalents at beginning of the year | |
| 10,533 | | |
| 23,659 | |
| Effect of exchange rate fluctuations on balances of cash and cash equivalents | |
| (43 | ) | |
| (8 | ) |
| Cash and cash equivalents at end of period | |
| 10,966 | | |
| 5,594 | |
| | |
| | | |
| | |
| Non-cash activities | |
| | | |
| | |
| Obtaining a right-of-use asset in exchange for a lease liability | |
| 23 | | |
| - | |
APPENDIX
A
NON-GAAP
RECONCILIATIONS (Unaudited)
| | |
Three Months ended
March 31, | |
| U.S. dollars in thousands | |
2024 | | |
2023 | |
| GAAP gross profit | |
$ | 269 | | |
$ | 320 | |
| Revenue from Exclusive Distribution Agreement | |
| - | | |
| (137 | ) |
| Non-GAAP gross profit | |
$ | 269 | | |
$ | 183 | |
| GAAP gross margin % | |
| 36 | % | |
| 45 | % |
| | |
| | | |
| | |
| Sales of systems and disposables | |
| 743 | | |
| 543 | |
| Non-GAAP gross profit | |
$ | 269 | | |
$ | 183 | |
| Non-GAAP gross margin % | |
| 36 | % | |
| 32 | % |
9
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