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IceCure Medical (ICCM) Moves to Buy: Rationale Behind the Upgrade
ZACKS· 2024-06-04 17:01
IceCure Medical Ltd. (ICCM) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. Since a chan ...
FDA to Convene Advisory Panel for Review of IceCure's De Novo Marketing Clearance Request for ProSense®, Decision Expected Early 2025; Aligns with Commercial Readiness Plan
Prnewswire· 2024-06-04 12:30
Demonstrates public health importance of assessing ProSense®'s potential to offer optimal treatment that benefits women with early-stage breast cancer Patients, patient advocacy groups, doctors, and the general public will be welcome to participate and comment in the open public hearing IceCure welcomes a transparent public forum to share ICE3 study results and show how ProSense® cryoablation could potentially offer a minimally invasive alternative treatment to women diagnosed with early-stage breast cancer ...
IceCure(ICCM) - 2024 Q1 - Earnings Call Transcript
2024-05-28 21:06
IceCure Medical Ltd (NASDAQ:ICCM) Q1 2024 Earnings Conference Call May 28, 2024 11:00 AM ET Company Participants Michael Polyviou - Investor Relations Eyal Shamir - Chief Executive Officer Tlalit Bussi Tel-Tzure - VP, Business Development & Global Marketing Ronen Tsimerman - Chief Financial Officer & Chief Operating Officer Conference Call Participants Kemp Dolliver - Brookline Capital Markets Anthony Vendetti - Maxim Group Ben Haynor - Lake Street Capital Markets Yi Chen - H.C. Wainwright Operator Good mor ...
IceCure(ICCM) - 2024 Q1 - Quarterly Report
2024-05-28 12:45
Exhibit 99.1 IceCure Medical Maintains Positive Momentum and Reports Sales Growth for Cryoablation System in First Quarter of 2024 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, ...
IceCure Medical Maintains Positive Momentum and Reports Sales Growth for Cryoablation System in First Quarter of 2024
prnewswire.com· 2024-05-28 12:30
30% sales growth reflects continued adoption of ProSense® in the U.S. and other global markets Major milestones achieved: - Completion of landmark ICE3 trial for breast cancer - Positive final ICE3 trial data Awaiting FDA Decision 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 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceC ...
IceCure Medical to Report First Quarter 2024 Financial & Operational Results on May 28, 2024
prnewswire.com· 2024-05-21 12:53
About IceCure Medical CAESAREA, Israel, May 21, 2024 /PRNewswire/ -- 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, announced today that it will issue a press release containing its financial and operational results as of and for the three months ended March 31, 2024 before the Nasdaq Stock Market opens on Tuesday, May 28, 2024. The ...
IceCure Medical (ICCM) Submits Final Cryoablation Data to FDA
Zacks Investment Research· 2024-04-18 16:10
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’ ...
IceCure(ICCM) - 2023 Q4 - Annual Report
2024-04-03 12:40
[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% |
IceCure(ICCM) - 2023 Q4 - Annual Report
2024-04-03 12:15
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 ...
IceCure(ICCM) - 2023 Q2 - Quarterly Report
2023-08-14 12:17
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 ...