IceCure Reports 2025 Full Year Financial & Operational Results
Rhea-AI Summary
IceCure (Nasdaq: ICCM) reported record fourth-quarter sales of $1.3M and full-year 2025 revenue of $3.379M, driven by U.S. FDA clearance for ProSense® in low-risk breast cancer, new ASBrS guideline support, and expansion plans including a 30-site ChoICE post-marketing study.
Financials show gross profit $1.226M and narrowed net loss of $15.057M; cash and equivalents rose to $8.897M. Health Canada expansion application pending; patient enrollment for ChoICE expected H2 2026.
Positive
- FDA cleared ProSense® for low-risk breast cancer in 2025
- ASBrS 2026 guideline recommends cryoablation for selected patients
- ChoICE post-marketing study: 400 patients in 36 months across 30 sites
- Record Q4 sales of $1.3M and FY 2025 revenue of $3.379M
- Cash and equivalents increased to $8.897M (+17.7% YoY)
- Sales and marketing expenses declined 30.8% YoY
Negative
- Gross profit declined to $1.226M (down ~15% YoY)
- Gross margin fell to 36% from 44% in 2024
- General & administrative expenses rose to $4.529M (+20.6% YoY)
- Cost of revenues increased due to raw materials and subcontractors
Key Figures
Market Reality Check
Peers on Argus
ICCM is up 5.8% while key medical device peers show mixed moves: several names like LUNG, BDMD and TELA are down, and APYX is modestly higher. Combined with elevated ICCM volume, this points to a stock-specific reaction to its results and operational updates.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 19 | Nine-month results | Positive | -3.2% | Nine-month 2025 results plus landmark FDA marketing authorization and rollout plans. |
| Aug 13 | Half-year results | Neutral | +2.4% | H1 2025 results with lower revenue, rights offering, and ongoing clinical progress. |
| Jul 03 | Prelim Q2/H1 | Neutral | +4.5% | Preliminary Q2 and H1 2025 sales with shipment delays but stable order flow. |
| May 28 | Q1 2025 results | Negative | -8.8% | Q1 2025 results with narrowed loss but continued cash burn and financing steps. |
| Mar 27 | 2024 annual results | Neutral | -3.1% | 2024 results showing slight revenue growth, higher losses and pending FDA decision. |
On past earnings-type announcements, ICCM often saw modest moves, with one notable selloff and mostly smaller gains or declines; today’s positive reaction contrasts with the slightly negative average move.
Over the past year, ICCM’s earnings updates have traced its transition from awaiting FDA decisions to commercial rollout. On Mar 27, 2025, 2024 results showed modest revenue growth and a $15.32M net loss. Subsequent 2025 updates on May 28, Jul 3, and Aug 13 highlighted fluctuating revenue, ongoing net losses, and financing steps. By Nov 19, 2025, results incorporated landmark FDA marketing authorization and plans for a ~400‑patient post-market study. Today’s full-year 2025 results extend that narrative with record sales and continued commercial ramp.
Historical Comparison
In the past year ICCM had 5 earnings updates averaging a -1.65% move. Today’s +5.8% reaction to record 2025 results and breast-cancer adoption is a notably stronger response.
Earnings events show a progression from awaiting breast cancer clearance and building data to securing FDA marketing authorization and now reporting record 2025 sales as commercial rollout advances.
Regulatory & Risk Context
An active Form F-3/A shelf, amended on Mar 16, 2026, allows IceCure to offer securities "from time to time" after effectiveness. The recent amendment only updated the auditor consent, with no usage to date and the registration not yet effective.
Market Pulse Summary
This announcement combines record 2025 revenue of $3.38M with continued net losses of $15.06M and compressed 36% gross margins. Operationally, it underscores ASBrS guidance, FDA-cleared low-risk breast cancer use, and plans for a 400‑patient post-marketing study. Investors may track commercialization progress at 30 planned U.S. sites, potential reimbursement upgrades, cash levels of $8.90M, and use of the active F-3 shelf when assessing execution risk.
Key Terms
cryoablation medical
cpt iii code regulatory
AI-generated analysis. Not financial advice.
Record 4th quarter and full year sales of
Strong commercial momentum for ProSense® in the
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
Conference call to be held today at 11:00 am Eastern Time
Three significant events are expected to drive commercial adoption of ProSense®:
- The American Society of Breast Surgeons' ("ASBrS") updated 2026 "Resource Guide on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast" recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer. The updated guidance represents an important step toward broader clinical adoption of IceCure's ProSense® cryoablation system.
- The
U.S. Food and Drug Administration ("FDA") approved the study design for IceCure's post-marketing study for ProSense® in the treatment of low-risk breast cancer. Patient enrollment for the "ChoICE" study is expected to commence by the second half of 2026, with at least 80 patients enrolled in the first year of the study. The ChoICE study is expected to enroll and treat 400 patients within 36 months across 30 clinical sites in theU.S. which can be used commercially. - On March 16, 2026, the Company submitted a Class III amendment application to Health Canada seeking to expand its current regulatory approval to include the use of the ProSense® cryoablation system for the treatment of early-stage, low-risk invasive breast cancer in patients aged 60 years and older. The application is supported by data from IceCure's ICE3 clinical study, the largest study of its kind, which served as the basis for the FDA's marketing clearance of ProSense® in the treatment of low-risk breast cancer. Under the proposed indication in
Canada , up to 7,130 number of women would be eligible for breast cancer cryoablation. A decision is expected during the second half of 2026, subject to the agency's standard review procedures and potential follow-up questions.
"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
Upcoming Catalysts
- Further commercial momentum and conversion of sales pipeline into signed contracts and installed systems expected in
North America and globally.
- Organic demand from patients and doctors is further advanced by positive word-of-mouth and media coverage, as seen in a recent news segment featuring a new ProSense® installation at Thomas Hospital inAlabama .
- Physician-focused outreach at the leadingU.S. -based breast cancer conferences in April 2026—the ASBrS Annual Meeting and the Society of Breast Imaging Symposium—is expected to result in a more immediate response from doctors, due to FDA clearance and medical society recommendations. - Expected to on-board 30 hybrid commercial-clinical sites across the
U.S. are expected to open following the FDA's recent approval of IceCure's ChoICE post-marketing study protocol. These 30 planned sites, while treating study participants, will also be active commercial sites where any appropriate patient seeking treatment with ProSense® cryoablation may be treated. Both clinical study and commercial procedures will be eligible for CPT III reimbursement. Several potential customers in IceCure'sU.S. pipeline have indicated they would move forward with purchase and installations upon the FDA's approval of the post-marketing study protocol. - Expanded reimbursement coverage is expected for low-risk breast cancer procedures following FDA marketing clearance and the new ASBrS guidelines which recommend cryoablation for select patients. ProSense® currently has reimbursement under the CPT III code which covers
~ of facility costs, and this may increase by up to an additional$4,000 $900 in early 2027 if the Company's submission for Transitional Pass-Through ("TPT") payment is approved later this year. IceCure also plans to submit for CPT I code reimbursement in the second quarter of this year, and expects a response by early 2027, with CPT I expected to go effective in early 2028. - More regulatory submissions are expected. IceCure's distributor in
Japan , Terumo Corporation, is expected to file for regulatory approval for ProSense® in the treatment of breast cancer in the first half of 2026.
Additional Recent Operational and Clinical Highlights
- 2025 marked an all-time sales record in
Europe , reflecting strong demand and expanded market presence - The FDA's marketing clearance in theU.S. for low-risk breast cancer had a direct positive influence on European markets, as expected. Regulatory validation in theU.S. increased confidence and adoption internationally, especially inEurope . In markets where IceCure already had activity, the Company saw expanded usage including new clinical applications, particularly in breast cancer, beyond interventional oncology. - Recent installations of ProSense® in the
U.S. range from small clinics, to mid-sized hospitals, to a globally recognized prestigious hospitals network– A hospital network that is widely regarded as the leading hospital in theU.S. and one of the top in the world now has ProSense® installations at two of its larger sites and is expected to purchase additional ProSense® systems. A major university teaching hospital in the southernU.S. recently purchased ProSense®. These are two examples representing the profile of potential customers in IceCure's pipeline. - Thomas Hospital of Infirmary Health, the largest not-for-profit, non-governmental healthcare system in
Alabama , purchased and installed ProSense® - The first breast cancer cryoablation procedures in the state ofAlabama were performed at Thomas Hospital with ProSense®. A local CBS news affiliate station aired an engaging news segment regarding a 90 year-old patient who was treated for low-risk breast cancer with ProSense® and walked out 30 minutes later to continue her active day. See the segment HERE. The hospital's purchase was made possible by the Thomas Hospital Foundation, a nonprofit organization dedicated to supporting Thomas Hospital to access state-of-the-art medical technology to offer innovative and compassionate care for their patients. IceCure is currently in talks with numerous regional hospitals across theU.S. with a profile similar to Thomas Hospital. - Shero Imaging, a
St. Louis, Missouri based privately owned and operated clinic, is the first clinic in the state to offer breast cancer cryoablation with ProSense® - Shero Imaging is an example of how an advanced breast imaging center can grow beyond diagnostics into treatment with ProSense®. IceCure estimates that there are approximately 8,700 breast imaging facilities in theU.S. , with 3,000 to 4,000 of them being privately owned and 800 – 1,500 dedicated women's breast imaging centers, similar to Shero. - During 2025, ProSense® was featured in a record number of peer-reviewed publications and conference presentations - 16 principal investigators presented at 10 conferences across the globe including the
U.S. ,Europe , andAsia , covering indications including breast, musculoskeletal and kidney cancer. - An independent study published in Clinical Breast Cancer reports ProSense® cryoablation produces excellent outcomes including reduced anxiety and improved quality of life – this single-center prospective study conducted at the Breast Diagnostic Unit of Careggi University Hospital in
Italy reports ProSense® is a safe and effective treatment for early-stage breast cancer, demonstrating a positive impact on patient quality of life (QoL), including reduced pain (VAS score), reduced anxiety, and improved overall well-being with the largest improvements seen in physical wellbeing - In an independent study using ProSense® resulted in
92.9% volume reduction of fibroadenoma one-year post-cryoablation - The investigator-initiated study titled "Cryoablation for fibroadenoma with liquid nitrogen-based system: A retrospective analysis of prospectively collected data" was published in the peer-reviewed journal PLOS One. ProSense® cryoablation has FDA-clearance for fibroadenomas. The study, which is believed to be the first to evaluate larger lesions and use multiple cryoprobe relocations, may impact treatment guidelines issued by medical societies for large non-cancerous breast tumors. - Several independent international studies underway are increasing global exposure to ProSense® among patients and physicians - The SIX study led by Dr. Vanessa Sanvido, a leading breast surgeon in
Brazil , and the PRECICE study inItaly , led by Prof. Franco Orsi, an interventional radiologist and key opinion leader, are heavily promoting their studies on social media to recruit patients. This is expected to lead not only to valuable clinical data, but also to increased patient awareness of cryoablation as a minimally invasive treatment option for low-risk breast cancer.
Financial Results for the Twelve Months Ended December 31, 2025
Revenue for the twelve months ended December 31, 2025, increased to
Gross profit for the twelve months ended December 31, 2025, was
Research and development expenses for the twelve months ended December 31, 2025 were
Sales and marketing expenses for the twelve months ended December 31, 2025 were
Total operating expenses for the twelve months ended December 31, 2025 declined to
Net loss narrowed for the twelve months ended December 31, 2025, to
As of December 31, 2025, cash and cash equivalents, including short-term deposits, totaled
Conference call & webcast info:
Tuesday, March 17, 2026, at 11:00 am EST
US: 1-888-407-2553
A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors
A 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
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
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IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
ICECURE MEDICAL LTD. | ||||||||
As of | As of | |||||||
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 and | ||||||||
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. | ||||||||
Year ended | ||||||||
2025 | 2024 | |||||||
| ||||||||
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 and | 63,579,251 | 50,876,790 | ||||||
ICECURE MEDICAL LTD. | ||||||||
Year ended | ||||||||
2025 | 2024 | |||||||
| ||||||||
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 of | 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 A NON-GAAP RECONCILIATIONS
| ||||||||
Year ended | ||||||||
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 | % | ||||
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SOURCE IceCure Medical
FAQ
What did IceCure (ICCM) report for full-year 2025 revenue and Q4 sales?
What regulatory and clinical milestones did ICCM announce on March 17, 2026?
What are the details of the ChoICE post-marketing study for ICCM's ProSense®?
How did IceCure's profitability and cash position change in 2025 (ICCM)?
What is IceCure's regulatory progress in Canada and Japan for ProSense® (ICCM)?
How might reimbursement evolve for ProSense® procedures and ICCM's timeline?
