Full Press Release Details
Record 4thquarter and full year sales of $1.3 million and $3.4 million, respectively
Strong commercial momentum for ProSense® in the U.S. and globally following FDA clearance in low-risk breast cancer and medical society recommendations
30 hybrid commercial-clinical sites to be added for FDA approved post-marketing study in addition to growing pipeline of potential commercial customers
IceCure Applies to Expand Regulatory Approval in Canada for ProSense® Cryoablation to Include the Treatment of Low-Risk Breast Cancer
Conference call to be held today at 11:00 am Eastern Time
CAESAREA, Israel,March 17, 2026/PRNewswire/ --IceCure Medical Ltd.(Nasdaq:ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today reported record sales as of and for the twelve months ended December 31, 2025 as well as recent commercial and clinical updates.
Three significant events are expected to drive commercial adoption of ProSense®:
"2025 was a pivotal year for IceCure. Following the FDA's clearance for cryoablation of low-risk breast cancer in October, we had record sales in the fourth quarter and fiscal year, which were driven by growing global adoption of ProSense®. We believe we are just at the beginning of this favorable trend," stated Eyal Shamir, Chief Executive Officer of IceCure. " The recent ASBrS recommendation issued in March 2026, supports cryoablation as a treatment option and represents powerful validation of our technology and its role in modern breast cancer care. We are seeing increasing interest from physicians, hospitals, and patients around the world, and we believe these milestones position IceCure to accelerate adoption, expand installations, and continue advancing our mission of providing a minimally invasive alternative that improves outcomes and patient quality of life."
Shad Good, IceCure's VP of Sales North America, added, "Momentum in the U.S. market continues to build as three important factors have converged: FDA clearance of ProSense®, reimbursement, and new professional society guidelines supporting cryoablation for selected breast cancer patients. We are seeing a clear uptick in engagement from hospitals and clinics, increased cryoprobe orders from existing customers, and a growing pipeline of new sites evaluating the system. With plans to expand our commercial infrastructure and launch our post-marketing study across 30 clinical sites, we believe we are well positioned to significantly broaden access to ProSense® and drive meaningful commercial growth in North America."
Upcoming Catalysts
Additional Recent Operational and Clinical Highlights
Financial Results for the Twelve Months Ended December 31, 2025
Revenue for the twelve months ended December 31, 2025, increased to $3,379,000 from $3,291,000 for the twelve months ended December 31, 2024, which included the recognition of $100,000 from a distribution agreement and other services in Japan. The increase in sales was due to an increase in sales in Europe, Latin America, North America and China, partially offset by a decrease in sales in Japan.
Gross profit for the twelve months ended December 31, 2025, was $1,226,000 compared to $1,451,000 for the twelve months ended December 31, 2024. Gross margin was 36% in the twelve months ended December 31, 2025, compared to 44%in the twelve months ended December 31, 2024. Non-GAAP gross profit for the twelve months ended December 31, 2025 was $1,226,000 compared to $1,351,000 for the twelve months ended December 31, 2024. Non-GAAP gross margin for the twelve months ended December 31, 2025 was 36% compared to 42% for the twelve months ended December 31, 2024. The changes in non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from the exclusive distribution agreements and other services in Japan, was mostly attributable to the decrease in revenue from the exclusive distribution agreements and other services in Japan, an increase in our cost of revenues in 2025, mostly in raw materials, subcontractors, auxiliary material costs, and an increase in payroll and related benefits and other costs. 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 twelve months ended December 31, 2025 were $7,433,000 compared to $7,096,000 in the twelve months ended December 31, 2024, primarily reflecting an increase in clinical trials and payroll and related benefits which were partially offset by a reduction in our development expenses for the XSense system .
Sales and marketing expenses for the twelve months ended December 31, 2025 were $4,358,000, compared to $6,296,000 for the twelve months ended December 31, 2024 primarily reflecting mainly a reduction in costs associated with consultants and professional services related to our De Novo classification approval case with the FDA and the associated convening of the Advisory Panel, a decrease in travel and a decrease in payroll and related benefits expenses. The Company expects sales and marketing expenses to increase in 2026 as IceCure enhances its market penetration efforts in the U.S. following FDA clearance for low-risk breast cancer at the end of 2025. General and administrative expenses for the twelve months ended December 31, 2025 were $4,529,000, compared to $3,755,000 for the twelve months ended December 31, 2024 reflecting an increase primarily in payroll and related benefits mostly attributed to increase in share-based compensation expenses and the depreciation of the USD against the NIS.
Total operating expenses for the twelve months ended December 31, 2025 declined to $16,320,000 from $17,147,000 for the twelve months ended December 31, 2024. The decrease in operating expenses was attributable to the decrease in sales and marketing expenses, partially offset by the decrease in gross profit and the increase in research and development and general and administrative expenses.
Net loss narrowed for the twelve months ended December 31, 2025, to $15,057,000, or $0.24 per share, compared to a net loss of $15,318,000, or $0.30 per share, for the twelve months ended December 31, 2024.
As of December 31, 2025, cash and cash equivalents, including short-term deposits, totaled $8,897,000, compared to $7,564,000 as of December 31, 2024.
Conference call & webcast info:
Tuesday, March 17, 2026, at 11:00 am ESTUS: 1-888-407-2553Israel/International: +972-3-918-0696A live webcast will be available at:https://www.veidan-conferencing.com/icecure-investorsA recording of the webcast will be available at:ir.icecure-medical.com.
About IceCure Medical
IceCure Medical (Nasdaq:ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction 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 option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia.
Forward Looking Statement
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 strong commercial momentum for ProSense; updated ASBrS guidance representing an important step toward broader clinical adoption of ProSense; the expected timing and patient enrollment and treatment for the ChoICE post-marketing study; growing global adoption of ProSense and increasing interest from physicians, hospitals and patients; plans to expand the Company's sales team and broaden access to ProSense to drive meaning commercial growth in North America; expectations to increases to CPT code reimbursement and coverage; a decision by Health Canada on the Company's Class III amendment application is expected during the second half of 2026; that more regulatory submissions are expected, including by Terumo Corporation which is expected to file for regulatory approval for ProSense in Japan in the treatment of breast cancer in the first half of 2026; hospitals and clinics expected to purchase additional ProSense systems; that several studies are underway which are expected to lead to valuable clinical data and increased patient awareness of cryoablation as a minimally invasive treatment option for low-risk breast cancer; and that the Company expects sales and marketing expenses to increase in 2026 as IceCure enhances its market penetration efforts in the U.S. 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, 2024 filed with the SEC on March 27, 2025, 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:[email protected]Michael PolyviouPhone: 732-232-6914
SOURCE IceCure Medical
| ICECURE MEDICAL LTD.CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||||
| As ofDecember 31,2025 | As ofDecember 31,2024 | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 8,897 | 7,564 | ||||||
| Trade receivables | 331 | 221 | ||||||
| Inventory | 2,625 | 1,988 | ||||||
| Prepaid expenses and other receivables | 752 | 981 | ||||||
| Total current assets | 12,605 | 10,754 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Right-of-use assets | 239 | 524 | ||||||
| Property and equipment, net | 993 | 1,252 | ||||||
| Long-term restricted deposits | 51 | 46 | ||||||
| Total non-current assets | 1,283 | 1,822 | ||||||
| TOTAL ASSETS | 13,888 | 12,576 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade payables | 863 | 1,232 | ||||||
| Lease liabilities | 204 | 298 | ||||||
| Employees and employees related benefits | 2,659 | 2,757 | ||||||
| Other current liabilities | 1,098 | 1,227 | ||||||
| Total current liabilities | 4,824 | 5,514 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term lease liabilities | 13 | 161 | ||||||
| Total non-current liabilities | 13 | 161 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued andoutstanding: 73,122,293 shares and 56,568,999 shares as of December 31, 2025and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | 129,487 | 112,280 | ||||||
| Accumulated deficit | (120,436) | (105,379) | ||||||
| Total shareholders' equity | 9,051 | 6,901 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 13,888 | 12,576 |
| ICECURE MEDICAL LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| Year endedDecember 31, | ||||||||
| 2025 | 2024 | |||||||
| U.S. dollars in thousands(except per share data) | ||||||||
| Revenues | 3,379 | 3,291 | ||||||
| Cost of revenues | 2,153 | 1,840 | ||||||
| Gross profit | 1,226 | 1,451 | ||||||
| Research and development expenses | 7,433 | 7,096 | ||||||
| Sales and marketing expenses | 4,358 | 6,296 | ||||||
| General and administrative expenses | 4,529 | 3,755 | ||||||
| Operating loss | 15,094 | 15,696 | ||||||
| Finance income, net | (37) | (378) | ||||||
| Net loss and comprehensive loss | 15,057 | 15,318 | ||||||
| Basic and diluted net loss per share | 0.24 | 0.30 | ||||||
| Weighted average number of shares outstanding used in computing basic anddiluted loss per share | 63,579,251 | 50,876,790 |
| ICECURE MEDICAL LTD.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| Year endedDecember 31, | ||||||||
| 2025 | 2024 | |||||||
| U.S. dollars inthousands | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (15,057) | (15,318) | ||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 295 | 332 | ||||||
| Share-based compensation | 1,373 | 869 | ||||||
| Exchange rate changes in cash and cash equivalents and long-term restricted deposits | (114) | 39 | ||||||
| Changes in assets and liabilities: | ||||||||
| Increase in trade receivables | (110) | (118) | ||||||
| Decrease (increase) in prepaid expenses and other receivables | 229 | (237) | ||||||
| Decrease (increase) in inventory | (637) | 287 | ||||||
| Decrease in right of use assets | 327 | 271 | ||||||
| Increase (decrease) in trade payables | (369) | 730 | ||||||
| Decrease in lease liabilities | (284) | (256) | ||||||
| Increase (decrease) in employees and employees related liabilities | (98) | 764 | ||||||
| Increase (decrease) in other current liabilities | (129) | 74 | ||||||
| Net cash used in operating activities | (14,574) | (12,563) | ||||||
| Cash flows from investing activities | ||||||||
| Investment in short-term deposits | (5,000) | (1,373) | ||||||
| Withdrawal of short-term deposits | 5,000 | 1,902 | ||||||
| Withdrawal of (investment in) restricted deposits | - | (12) | ||||||
| Purchase of property and equipment | (36) | (71) | ||||||
| Net cash provided by (used in) investing activities | (36) | 446 | ||||||
| Cash flows from financing activities: | ||||||||
| Loan from related party | 2,000 | - | ||||||
| Repayment of loan from relate party | (2,000) | - | ||||||
| Proceeds from issuance of ordinary shares, warrants and pre-funded warrants, net ofissuance costs | 15,539 | 9,187 | ||||||
| Proceeds from warrants and pre-funded warrants exercise | 295 | - | ||||||
| Net cash provided by financing activities | 15,834 | 9,187 | ||||||
| Increase (decrease) in cash and cash equivalents | 1,224 | (2,930) | ||||||
| Cash and cash equivalents at beginning of the year | 7,564 | 10,533 | ||||||
| Effect of exchange rate fluctuations on balances of cash and cash equivalents | 109 | (39) | ||||||
| Cash and cash equivalents at end of period | 8,897 | 7,564 | ||||||
| Non-cash activities | ||||||||
| Obtaining a right-of-use asset in exchange for a lease liability | 41 | 116 |
| APPENDIX ANON-GAAP RECONCILIATIONS | ||||||||
| Year endedDecember 31, | ||||||||
| U.S. dollars in thousands | 2025 | 2024 | ||||||
| GAAP gross profit | $ | 1,226 | $ | 1,451 | ||||
| Revenue from Exclusive Distribution Agreement and other services | - | (100) | ||||||
| Non-GAAP gross profit | $ | 1,226 | $ | 1,351 | ||||
| Sales of systems and disposables | 3,379 | 3,191 | ||||||
| Non-GAAP gross profit | $ | 1,226 | $ | 1,351 | ||||
| Non-GAAP gross margin % | 36 | % | 42 | % |