IceCure Medical (ICCM) recently announced that the company had submitted final data to the FDA requesting market authorization for its ProSense System.ProSense is designed to provide cryoablation, an outpatient technique that treats breast cancer in 20–40 minutes. It requests FDA approval to use cryoablation and adjuvant hormone therapy in the treatment of individuals with early-stage T1 invasive breast cancer.Price PerformanceIn the past six months, ICCM shares have gained 41.8% compared with the industry’ ...

[Overview & Key Highlights](index=1&type=section&id=Overview%20%26%20Key%20Highlights) IceCure Medical reported **26%** global ProSense® sales growth in FY2023, marking its commercial transition and completing the ICE3 breast cancer study - The company is transitioning from a research and development focus to a commercial phase, highlighted by a **significant increase in product sales**[1](index=1&type=chunk) - The most significant milestone achieved is the completion of the ICE3 breast cancer study, with full results set for FDA submission in April 2024, potentially boosting commercial demand[3](index=3&type=chunk)[6](index=6&type=chunk) 2023 Key Financial Highlights | Metric | Value/Status | | :--- | :--- | | Global Product Sales Growth | 26% Increase | | U.S. Product Sales Growth | 24% Increase | | Cash and Cash Equivalents (Dec 31, 2023) | $11.1 million | | Q1 2024 Capital Raise (ATM) | $3 million (gross proceeds) | | Cash and Cash Equivalents (Mar 31, 2024) | Approx. $11 million | [2023 and Recent Significant Operating, Clinical, Regulatory & Commercial Highlights](index=2&type=section&id=2023%20and%20Recent%20Significant%20Operating%2C%20Clinical%2C%20Regulatory%20%26%20Commercial%20Highlights) In 2023, IceCure completed its ICE3 breast cancer study, expanded global regulatory approvals and distribution, and advanced its technology pipeline - The ICE3 breast cancer study successfully completed, demonstrating a **96.39% local recurrence-free rate** with no significant device-related adverse events, with full results set for FDA submission in April 2024[5](index=5&type=chunk)[6](index=6&type=chunk) - Regulatory approvals for ProSense® were secured in Brazil, Canada, and China, expanding the total to **15 countries** with various indications[8](index=8&type=chunk) - Global commercial rollout is gaining momentum with new distribution agreements and system installations in Portugal, India, and Brazil[9](index=9&type=chunk) - The company is advancing its technology pipeline, filing a 510(k) submission with the FDA for its next-generation single probe XSense™ System and cryoprobes[11](index=11&type=chunk) [Financial Results for the Twelve Months Ended December 31, 2023](index=3&type=section&id=Financial%20Results%20for%20the%20Twelve%20Months%20Ended%20December%2031%2C%202023) FY2023 revenues increased to **$3.2 million** with **26%** ProSense® sales growth, and net loss improved **14%** to **$14.7 million** from expense reductions FY 2023 vs FY 2022 Financial Performance (in millions) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $3.2M | $3.1M | +3.2% | | ProSense® & Disposables Sales | $3.0M | $2.3M | +26% | | Gross Profit | $1.3M | $1.4M | -7.1% | | Operating Expenses | $16.9M | $18.2M | -7.1% | | Net Loss | ($14.7M) | ($17.0M) | +14% (improvement) | | Net Loss Per Share | ($0.32) | ($0.46) | +30.4% (improvement) | - Operating expenses decreased due to reductions in R&D (down to **$8.3 million** from **$9.1 million**) and G&A (down **30%** to **$4.2 million**), partially offset by increased Sales and Marketing expenses (up to **$4.4 million** from **$3.2 million**) to support commercialization[14](index=14&type=chunk)[15](index=15&type=chunk)[16](index=16&type=chunk) - Cash and cash equivalents stood at **$11.1 million** as of December 31, 2023, down from **$23.7 million** at the end of 2022, with an expense reduction plan implemented for 2024[18](index=18&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The 2023 consolidated financial statements reflect reduced assets, a narrowed net loss, and significant cash usage [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, total assets decreased to **$16.4 million** from **$30.2 million**, primarily due to reduced cash, with equity at **$12.2 million** Consolidated Balance Sheet Summary (U.S. dollars in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | **14,184** | **28,130** | | *Cash and cash equivalents* | *10,533* | *23,659* | | **Total Assets** | **16,410** | **30,188** | | **Total Current Liabilities** | **3,871** | **4,336** | | **Total Liabilities** | **4,247** | **4,766** | | **Total Shareholders' Equity** | **12,163** | **25,422** | [Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) For FY2023, revenues increased to **$3.23 million**, while expense management reduced operating loss to **$15.6 million** and net loss to **$14.7 million** Consolidated Statement of Comprehensive Loss Summary (U.S. dollars in thousands) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenues | 3,229 | 3,085 | | Gross profit | 1,300 | 1,445 | | Operating loss | (15,576) | (16,739) | | Net loss | (14,652) | (16,978) | | Basic and diluted net loss per share | (0.32) | (0.46) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2023, the company used **$12.5 million** in cash for operations, resulting in a net decrease of **$13.2 million** and a year-end cash balance of **$10.5 million** Consolidated Statement of Cash Flows Summary (U.S. dollars in thousands) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2122 | | :--- | :--- | :--- | | Net cash used in operating activities | (12,521) | (14,292) | | Net cash provided by (used in) investing activities | (713) | (891) | | Net cash provided by financing activities | 83 | 13,577 | | Increase (decrease) in cash and cash equivalents | (13,151) | (1,606) | | Cash and cash equivalents end of the year | 10,533 | 23,659 | [Reconciliation of US GAAP to Non-US GAAP Financial Measures](index=4&type=section&id=Reconciliation%20of%20US%20GAAP%20to%20Non-US%20GAAP%20Financial%20Measures) IceCure uses non-GAAP measures to assess core business performance, with non-GAAP gross profit from system and disposable sales increasing **47%** to **$1.03 million** in 2023, and non-GAAP gross margin improving to **35%** - The company uses non-GAAP financial measures to better assess the commercial performance of its business by isolating gross profit and margin from system and disposable sales[20](index=20&type=chunk) GAAP to Non-GAAP Reconciliation (U.S. dollars in thousands) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | **GAAP Gross Profit** | **$1,300** | **$1,445** | | GAAP Gross Margin % | 40% | 47% | | Revenues from sales of systems and disposables | $2,955 | $2,338 | | **Non-GAAP Gross Profit** | **$1,026** | **$698** | | Non-GAAP Gross Margin % | 35% | 30% |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANTTO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...

Exhibit 99.1 ICECURE MEDICAL LTD. UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET (U.S. dollars in thousands, except share data and per share data) | | As of | As of | | --- | --- | --- | | | June 30, | December 31, | | | 2023 | 2022 | | ASSETS | | | | CURRENT ASSETS | | | | Cash and cash equivalents | 3,031 | 23,659 | | Deposit | 13,648 | - | | Restricted deposit | 296 | 296 | | Trade accounts receivable | 118 | 78 | | Inventory | 2,751 | 2,857 | | Prepaid expenses and other receivables | 589 | 1,24 ...

IceCure Medical Ltd (NASDAQ:ICCM) Q4 2023 Earnings Conference Call March 29, 2023 10:00 AM ET Company Participants Eyal Shamir - CEO Ronen Tsimerman - CFO & COO Todd Kehrli - EVC Group, IR Conference Call Participants Kemp Dolliver - Brookline Capital Markets Ben Haynor - Alliance Global Partners Chaitanya G. - H.C. Wainwright Operator Good morning, and thank you for standing by. [Operator instructions]. I would now like to turn the conference over to Todd Kehrli. Please go ahead. Todd Kehrli Thank you, Ope ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANTTO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...

Exhibit 99.1 IceCure Medical Reports 2022 Full Year Financial Results & Recent Corporate Developments; Milestone Achievements Expected to Drive Revenue Growth in 2023 ● Rising Awareness and Utilization of ProSense System: System and disposables sales in the U.S. represented 20% of 2022 revenues, up from 11% in 2021, as increased utilization of systems generated a 28% year-over-year increase in U.S. sales. Worldwide, disposable sales accounted for 43% of 2022 revenue, up from 29% in 2021. ● Filed for FDA Mar ...

IceCure Medical Ltd (NASDAQ:ICCM) Q3 2022 Results Conference Call December 2, 2022 8:00 AM ET Company Participants Eyal Shamir - Chief Executive Officer Ronen Tsimerman - Chief Financial Officer Hania Bednarski - Oncoplastic Breast Surgeon and Cryoablation Specialist Conference Call Participants Ben Haynor - Alliance Global Partners Anthony Vendetti - Maxim Group Kemp Dolliver - Brookline Capital Markets Operator Welcome to IceCureÂ's Conference Call on the Financial Results for the Nine Months Ended Septem ...

Exhibit 99.1 "We have edged closer to commercialization of ProSense for breast cancer in the U.S. with our recent FDA filing for marketing approval, and the assignment of a Medicare CPT III reimbursement code. IceCure has taken a leadership role in the industry based on our vast ICE 3 breast cancer cryoablation clinical data and by receiving the CMS's first payment assignment for cryoablation of breast cancer," stated IceCure's CEO Eyal Shamir. "While our quarterly revenues may continue to fluctuate in the ...

Financial Statements This section presents the company's unaudited interim condensed consolidated financial statements, including the balance sheet, statements of comprehensive loss, changes in shareholders' equity, cash flows, and accompanying notes [Unaudited Interim Condensed Consolidated Balance Sheet](index=1&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Balance%20Sheet) As of June 30, 2022, IceCure Medical's total assets decreased to **$23.8 million** from **$32.3 million**, primarily due to a reduction in cash and cash equivalents, leading to a decline in total shareholders' equity from **$27.0 million** to **$18.9 million** Balance Sheet Summary | Financial Metric | June 30, 2022 ($ thousands) | December 31, 2021 ($ thousands) | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | 13,468 | 25,621 | -47.4% | | Total current assets | 21,563 | 30,322 | -28.9% | | Total Assets | 23,813 | 32,281 | -26.2% | | Total Liabilities | 4,937 | 5,323 | -7.2% | | Total Shareholders' Equity | 18,876 | 26,958 | -30.0% | - The company's cash position more than halved in the first six months of 2022, decreasing from **$25.6 million to $13.5 million**[3](index=3&type=chunk) - The accumulated deficit increased from **$58.4 million to $67.4 million** during the first half of 2022, contributing to the decline in shareholders' equity[3](index=3&type=chunk) [Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) For the six months ended June 30, 2022, the company reported a net loss of **$9.0 million**, a significant increase from **$3.8 million** in 2021, driven by a **27% revenue decrease** and substantial rises in R&D and S&M expenses Statements of Comprehensive Loss Summary | Metric | Six months ended June 30, 2022 ($ thousands) | Six months ended June 30, 2021 ($ thousands) | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Revenues | 1,512 | 2,073 | -27.1% | | Gross Profit | 818 | 1,193 | -31.4% | | Research and development expenses | 4,649 | 2,730 | +70.3% | | Sales and marketing expenses | 1,533 | 625 | +145.3% | | Operating loss | 8,706 | 3,746 | +132.4% | | Net loss | 8,968 | 3,847 | +133.1% | | Basic and diluted net loss per share | $0.244 | $0.156 | +56.4% | [Unaudited Interim Condensed Consolidated Statements of Changes in Shareholders' Equity](index=3&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased by **$8.1 million** to **$18.9 million** by June 30, 2022, primarily due to a **$9.0 million net loss**, partially offset by **$0.9 million** in share-based compensation Statements of Changes in Shareholders' Equity Summary | Description | Amount ($ thousands) | | :--- | :--- | | Balance as of January 1, 2022 | 26,958 | | Share-based compensation | 885 | | Pre-funded warrants exercised | 1 | | Net loss for the period | (8,968) | | **Balance as of June 30, 2022** | **18,876** | [Unaudited Interim Condensed Consolidated Statements of Cash Flows](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents decreased by **$12.1 million** to **$13.5 million** in H1 2022, driven by **$6.8 million** used in operating activities and **$4.8 million** in investing activities, contrasting with a **$15.2 million** increase in H1 2021 Statements of Cash Flows Summary | Cash Flow Activity ($ thousands) | Six months ended June 30, 2022 | Six months ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | (6,845) | (3,561) | | Net cash provided by (used in) investing activities | (4,770) | 4,079 | | Net cash provided by financing activities | 1 | 14,642 | | **Increase (decrease) in cash and cash equivalents** | **(11,614)** | **15,160** | - Cash used in operations nearly doubled year-over-year, reflecting the larger net loss and changes in working capital[10](index=10&type=chunk) - Financing activities provided virtually no cash in H1 2022, compared to **$14.6 million** raised from share issuance in H1 2021[10](index=10&type=chunk) [Notes to the Unaudited Interim Condensed Consolidated Financial Statements](index=5&type=section&id=Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) This section provides supplemental details on the company's operations, accounting policies, financial condition, including its cryoablation business, going concern assessment, revenue breakdown, and subsequent events [Note 1 - General](index=5&type=section&id=Note%201%20-%20General) This note describes IceCure Medical's business as a developer of cryoablation devices, its global operations, and management's assessment of its going concern status - IceCure Medical is an Israeli company, listed on NASDAQ and the Tel Aviv Stock Exchange, that develops and commercializes minimally invasive cryoablation devices for freezing tumors[12](index=12&type=chunk)[13](index=13&type=chunk)[14](index=14&type=chunk) - The company has subsidiaries and operations in the United States, Hong Kong, and China to manage business development, clinical trials, and regulatory approvals in those regions[14](index=14&type=chunk)[15](index=15&type=chunk) - Regarding its 'Going Concern' status, the company has an accumulated deficit of **$67.4 million** and generated a loss of **$9.0 million** in H1 2022; however, management expects its cash reserves of **$15.4 million** as of August 31, 2022, to be sufficient for the next 12 months of operations[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk) [Note 2 - Summary of Significant Accounting Policies](index=6&type=section&id=Note%202%20-%20Summary%20of%20Significant%20Accounting%20Policies) This note confirms that the interim financial statements adhere to U.S. GAAP and apply accounting policies consistent with the latest annual statements - The unaudited interim financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP)[22](index=22&type=chunk) - The significant accounting policies applied are identical to those used in the company's latest annual financial statements[24](index=24&type=chunk) [Note 4 - Revenues](index=7&type=section&id=Note%204%20-%20Revenues) This note details the company's revenue sources, primarily from the sale of consoles, disposables, and exclusive distribution agreements - The company's revenues are primarily derived from the sale of consoles, disposables, and exclusive distribution agreements[29](index=29&type=chunk) Revenue Sources | Revenue Source ($ thousands) | Six months ended June 30, 2022 | Six months ended June 30, 2021 | | :--- | :--- | :--- | | Consoles | 361 | 695 | | Disposables | 667 | 556 | | Exclusive distribution agreement | 484 | 822 | | **Total** | **1,512** | **2,073** | [Note 5 - Subsequent Events](index=7&type=section&id=Note%205%20-%20Subsequent%20Events) This note outlines significant events occurring after the reporting period, including the granting of options and issuance of restricted shares to consultants - On July 4, 2022, the company granted **55,222 options** to a consultant at an exercise price of approximately **$1.76 per share**[32](index=32&type=chunk) - On July 18, 2022, the company issued **21,000 restricted ordinary shares** to a consultant, which are restricted from sale for 12 months[32](index=32&type=chunk)