IceCure Reports First Quarter 2026 Financial Results: ProSense® Sales Increase Substantially in the U.S. and North America

Rhea-AI Summary

IceCure (Nasdaq: ICCM) reported Q1 2026 revenue of $911,000, up 26% year-over-year, driven by North America sales (+84%) and U.S. growth (+31%). Gross profit rose 35% to $295,000 with 32% margin.

Active U.S. ProSense® accounts increased 46% to 19, alongside positive breast and kidney cryoablation clinical data.

Positive

• Q1 2026 revenue up 26% year-over-year to $911,000
• North America sales increased 84%; U.S. sales grew 31%
• Gross profit up 35% to $295,000; margin improved to 32%
• Active U.S. ProSense accounts rose 46% to 19 post-FDA clearance
• Five-year ICESECRET kidney cancer study showed 89.4% and 83.9% recurrence-free rates
• Cost analysis showed 50% cost reduction vs lumpectomy using ProSense

Negative

• Q1 2026 net loss widened to $4,274,000 from $3,588,000
• Total operating expenses increased to $4,542,000 from $3,875,000
• Research and development expenses rose to $2,211,000 from $1,664,000
• General and administrative expenses increased to $1,263,000 from $922,000
• Cash and cash equivalents declined to $8,115,000 from $8,897,000
• Revenue growth was partially offset by decreased sales in Asia

Market Context

This announcement highlights early commercialization leverage after FDA clearance, with Q1 2026 reve...

Analysis

This announcement highlights early commercialization leverage after FDA clearance, with Q1 2026 revenue of $911,000 (up 26%), gross margin improving to 32%, and cash of $8.115M. It also underscores expanding clinical validation, including an 89.4% recurrence-free rate in kidney cancer and cost data suggesting a 50% reduction versus lumpectomy. Historically, earnings releases have seen cautious market responses despite similar operational progress.

Key Figures

Q1 2026 revenue: $911,000 Q1 2025 revenue: $725,000 Revenue growth: 26% +5 more

8 metrics

Q1 2026 revenue $911,000 Three months ended March 31, 2026

Q1 2025 revenue $725,000 Three months ended March 31, 2025

Revenue growth 26% Q1 2026 vs Q1 2025 global revenue increase

Gross profit $295,000 Q1 2026 gross profit, up from $218,000 in Q1 2025

Gross margin 32% Q1 2026 gross margin vs 30% in Q1 2025

Net loss $4,274,000 Q1 2026 net loss ($0.06 per share)

Cash & equivalents $8,115,000 Balance as of March 31, 2026

Recurrence-free rate 89.4% ICESECRET kidney cancer study subgroup recurrence-free result

Previous Earnings Reports

5 past events · Latest: Mar 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 17	Full-year 2025 results	Positive	-8.9%	Reported record Q4 sales and higher 2025 revenue with narrowed net loss.
Nov 19	Nine-month 2025 results	Positive	-3.2%	Highlighted nine‑month results and landmark FDA marketing authorization for ProSense®.
Aug 13	H1 2025 results	Neutral	+2.4%	Reported H1 2025 revenue, rights offering proceeds, and clinical data progress.
Jul 03	Prelim Q2/H1 2025	Neutral	+4.5%	Released preliminary Q2 and H1 2025 sales and shipment delay details.
May 28	Q1 2025 results	Neutral	-8.8%	Announced Q1 2025 revenue, gross profit, narrowed net loss, and financing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings-related announcements for ICCM have often been followed by modestly negative next-day moves, with an average move of about -2.81%, even when operational updates sounded constructive.

Recent Company History

Over the past year, IceCure’s earnings releases have tracked its transition from pre‑authorization development to commercial ramp after U.S. FDA clearance for ProSense®. Prior updates highlighted rising revenues, evolving reimbursement, and narrowing net losses, yet share reactions were frequently negative. Today’s Q1 2026 results—showing higher revenue, gross profit, and margins—fit the trajectory of gradual commercialization and clinical validation already outlined in prior earnings communications.

Key Terms

cryoablation, post-marketing study, recurrence-free, lumpectomy, +2 more

6 terms

cryoablation medical

"cryoablation technology that destroys tumors by freezing as an option"

A medical treatment that uses extreme cold to freeze and destroy unwanted tissue, such as small tumors or heart tissue causing irregular rhythms; think of it like applying a focused freezer to stop a problem spot without cutting it out. It matters to investors because devices, tools, and drugs tied to cryoablation, plus clinical results, approval status and insurance coverage, can drive sales, shape market adoption and affect the financial outlook of healthcare companies.

post-marketing study medical

"ChoICE post-marketing study, which will have 30 clinical/commercial hybrid sites"

A post-marketing study is research conducted after a drug or medical device is approved and sold to check how it performs in everyday use, tracking long-term safety, side effects, and effectiveness. For investors it matters because results can change sales forecasts, trigger label updates or warnings, lead to additional costs or legal exposure, or open new markets — like a car recall study revealing issues that affect a maker’s reputation and future earnings.

recurrence-free medical

"five-year top-line results from the ICESECRET kidney cancer study, demonstrating recurrence-free rates"

Recurrence-free describes a period after treatment during which a disease, usually cancer or another condition, has not returned. For investors, it signals the durability of a therapy or intervention—longer recurrence-free time can mean stronger clinical benefit, greater market potential, and lower likelihood of additional costly treatments or regulatory setbacks, much like a repaired roof that stays leak-free longer increases a home’s value and reduces future expenses.

lumpectomy medical

"cost analysis study from Massachusetts General Hospital ... 50% cost reduction vs. lumpectomy"

A lumpectomy is a surgical procedure that removes a breast tumor along with a small ring of surrounding tissue, preserving most of the breast like cutting a stain out of a shirt rather than replacing the whole garment. Investors watch lumpectomy rates and related technology because they affect demand for surgical tools, hospital services, follow-up therapies and reimbursement patterns, which in turn influence revenue and cost projections for medical device makers, hospitals and insurers.

net loss financial

"Net loss for the three months ended March 31, 2026, was $4,274,000"

Net loss is the amount by which a company’s total costs and expenses exceed its total income during a reporting period, after taking into account taxes and one‑time items. It matters to investors because repeated or large net losses can shrink a company’s cash and owner value, reducing its ability to pay dividends, invest for growth or borrow money — like a household spending more than it earns and dipping into savings to cover the shortfall.

gross margin financial

"Gross margin increased to 32% in the three months ended March 31, 2026"

Gross margin is the difference between how much money a company makes from selling its products and how much it costs to produce them, expressed as a percentage of sales. It shows how efficiently a company is turning sales into profit before other expenses like marketing or salaries. Higher gross margin means the company keeps more money from each sale, which is a good sign of financial health.

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Pent-up demand immediately following FDA clearance generates 46% increase in active customer accounts using ProSense® as of the end of the first quarter 2026, compared with prior to FDA clearance

Accelerating adoption of ProSense® driven by several growth catalysts, including FDA clearance, expanding reimbursement framework, media coverage, growing body of clinical data and recommendation of cryoablation for breast cancer in leading clinical guidelines

Conference call to be held today at 11:00 am Eastern Time

CAESAREA, Israel, May 12, 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 financial results as of and for the three months ended March 31, 2026 as well as recent commercial and clinical updates. Revenues, gross profits and gross margins all increased during the first quarter of 2026 compared to the first quarter of 2025 including:

• Global revenue rose 26%
• Sales in North America increased 84%
• Sales in the U.S. grew 31%

"We are off to an incredibly strong start to 2026 and we are highly encouraged by the growing momentum we are experiencing in the U.S. for ProSense® in early-stage breast cancer, which has been building over time through our clinical data, physician engagement, and regulatory milestones," said Eyal Shamir, Chief Executive Officer of IceCure. "Our commercial team is building a strong pipeline of hospitals and clinics, many of which are progressing through their internal purchasing processes, and we are now seeing that pipeline converting into revenue. Demonstrating the rising momentum, an account that purchased a ProSense® system before U.S. Food and Drug Administration ("FDA") approval recently purchased an additional system for a second site, and we believe there is an opportunity to expand even further throughout this hospital network, which is one of the most prominent names in healthcare globally."

"We plan to leverage this rising interest and expand our U.S. sales footprint this year to eight regions, supporting the increasing demand from our marketing efforts and heightened positive response to our presence at key recent industry conferences, including the Society of Breast Imaging and the American Society of Breast Surgeons annual meetings. ProSense® integrates seamlessly into existing clinical workflows without requiring additional infrastructure, so we believe we are well positioned to scale. We also expect our ChoICE post-marketing study, which will include 30 U.S. sites and where both commercial and clinical procedures will be performed, will further accelerate adoption and broaden access to ProSense® across the United States."

Commercial and Clinical Highlights:

• Continued growth in U.S. ProSense® systems and disposable probes revenue, driven by increasing new installations and procedure volumes at new and existing customers. The Company had 13 active accounts prior to FDA approval, many of which had multiple systems installed across their respective healthcare systems. Following FDA approval, active accounts in the U.S. increased by 46% as a result of onboarding new accounts and reactivating some that previously had systems but were awaiting FDA clearance before actively using the systems. The 19 active accounts as of the end of the first quarter of 2026 alone represent a vast opportunity to penetrate deeper into these hospital networks with additional system sales.
• Immediately expanded U.S. commercial footprint following FDA clearance with new system installations, including Thomas Hospital of Infirmary Health, the first hospital in Alabama to offer breast cancer cryoablation, and SHERO Imaging, the first provider in Missouri to offer the procedure
• Continued to advance a growing pipeline of hospitals and clinics progressing through purchasing processes, with increasing conversion expected due to FDA clearance and updated clinical guidelines
• Post-marketing ChoICE study, which will have 30 clinical/commercial hybrid sites in the United States, expected to support broader adoption and reimbursement; the study protocol received FDA approval during the first quarter of 2026
• American Society of Breast Surgeons updated its resource guide to recommend cryoablation as a local treatment option for low-risk breast cancer, marking a significant milestone in clinical acceptance
• Showcased ProSense® Cryoablation at American Society of Breast Surgeons 2026 Annual Meeting where IceCure sponsored a symposium titled "Unlocking De-Escalation: Cryoablation for Breast Cancer" featuring prominent breast physicians from leading medical institutions including Cleveland Clinic, University of Michigan, West Cancer Center, and the Warren Alpert Medical School of Brown University
• Participated in the 2026 Society of Breast Imaging ("SBI") Symposium, highlighting growing physician awareness and adoption of ProSense® for breast cancer treatment
• Reported positive five-year top-line results from the ICESECRET kidney cancer study, demonstrating recurrence-free rates of 89.4% and 83.9%, reinforcing long-term efficacy of cryoablation
• Independent fibroadenoma study published in PLOS ONE demonstrated that ProSense® is safe and effective in the treatment of breast fibroadenomas, further supporting its clinical utility
• Cryoablation cost analysis study from Massachusetts General Hospital featuring ProSense® demonstrated 50% cost reduction vs. lumpectomy, and the study won the Wendell Scot Research Award at the 2026 SBI Symposium

Financial Results for the Three Ended March 31, 2026

Revenues for the three months ended March 31, 2026 grew to $911,000, from $725,000 in the three months ended March 31, 2025, an increase of approximately 26%. Growth was driven by increased sales in the U.S., Canada, and Mexico, partially offset by a decrease in sales in Asia.

Gross profit increased by 35% to $295,000 for the first quarter of 2026, compared to $218,000 in the same period last year. Gross margin increased to 32% in the three months ended March 31, 2026, compared to 30% in the three months ended March 31, 2025.

Research and development expenses for the three months ended March 31, 2026 were $2,211,000 compared to $1,664,000 in the three months ended March 31, 2025, primarily reflecting activities related to the CHoICE study.

Sales and marketing expenses for the three months ended March 31, 2026 were $1,068,000, compared to $1,289,000 for the three months ended March 31, 2025. The decrease is mostly due to a decrease in consulting fees associated with regulatory submissions. The Company expects sales and marketing expenses to increase for the balance of 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 three months ended March 31, 2026 were $1,263,000, compared to $922,000 for the three months ended March 31, 2025, reflecting primarily an increase in salary expenses, mainly due to fluctuations in the exchange rate between the U.S. dollar and Israeli shekel.

Total operating expenses for the three months ended March 31, 2026 were $4,542,000 compared to $3,875,000 for the three months ended March 31, 2025. The increase was attributable to the increase in research and development and general and administrative expenses, partially offset by a decrease in sales and marketing expenses.

Net loss for the three months ended March 31, 2026, was $4,274,000, or $0.06 per share, compared to a net loss of $3,588,000, or $0.06 per share, for the three months ended March 31, 2025.

As of March 31, 2026, cash and cash equivalents totaled $8,115,000, compared to $8,897,000 as of December 31, 2025.

Conference call & webcast info:

Tuesday, May 12, 2026, at 11:00 am EDT

US: 1-888-407-2553

Israel/International: +972-3-918-0696

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 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 growing momentum in the U.S. for ProSense® in early-stage breast cancer; building a strong pipeline of hospitals and clinics and converting that pipeline into revenue due to, among other things, FDA clearance and updated clinical guidelines; the Company's plan to expand its U.S. sales footprint this year to eight regions; the ChoICE post-marketing study and the expectation that it will further accelerate adoption and broaden access to ProSense® across the United States; and the opportunity to penetrate deeper into existing hospital networks with additional system sales. 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, 2025 filed with the SEC on March 17, 2026, 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

 

ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
		As of March 31, 2026				As of December 31, 2025
		(Unaudited)
		U.S. dollars in thousands
ASSETS
CURRENT ASSETS
Cash and cash equivalents			8,115				8,897
Trade receivables			274				331
Inventory			2,646				2,625
Prepaid expenses and other receivables			1,089				752
Total current assets			12,124				12,605
NON-CURRENT ASSETS
Right-of-use assets			152				239
Property and equipment, net			975				993
Long-term restricted deposits			52				51
Total non-current assets			1,179				1,283
TOTAL ASSETS			13,303				13,888
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Trade payables			988				863
Lease liabilities			134				204
Employees and employees related benefits			2,895				2,659
Other current liabilities			787				1,098
Total current liabilities			4,804				4,824
NON-CURRENT LIABILITIES
Long-term lease liabilities			5				13
Total non-current liabilities			5				13
SHAREHOLDERS' EQUITY
Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and      outstanding: 81,180,045 shares and 73,122,293 shares as of March 31, 2026      and December 31, 2025, respectively
Additional paid-in capital			133,204				129,487
Accumulated deficit			(124,710)				(120,436)
Total shareholders' equity			8,494				9,051
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY			13,303				13,888

 

ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
		Three months ended March 31,
		2026				2025
		U.S. dollars in thousands (except per share data)
Revenues			911				725
Cost of revenues			616				507
Gross profit			295				218
Research and development expenses			2,211				1,664
Sales and marketing expenses			1,068				1,289
General and administrative expenses			1,263				922
Operating loss			4,247				3,657
Finance expense (income), net			27				(69)
Net loss and comprehensive loss			4,274				3,588
Basic and diluted net loss per share			0.06				0.06
Weighted average number of shares outstanding used in computing basic and diluted loss per share			73,573,265				57,639,679

 

ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
		Three months ended March 31,
		2026				2025
		U.S. dollars in thousands
Cash flows from operating activities
Net loss		(4,274)				(3,588)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			69				89
Share-based compensation			180				125
Exchange rate changes in cash and cash equivalents and long-term restricted deposits			(4)				43
Changes in assets and liabilities:
Decrease (increase) in trade receivables			57				(79)
Increase in prepaid expenses and other receivables			(337)				(84)
Increase in inventory			(21)				(48)
Decrease in right of use assets			87				101
Increase (decrease) in trade payables			125				(279)
Decrease in lease liabilities			(78)				(105)
Increase in employees and employees related liabilities			236				123
Decrease in other current liabilities			(311)				(336)
Net cash used in operating activities			(4,271)				(4,038)
Cash flows from investing activities
Purchase of property and equipment			(51)				(6)
Net cash provided by (used in) investing activities			(51)				(6)
Cash flows from financing activities:
Proceeds from issuance of ordinary shares and warrants, net of issuance costs			3,537				2,562
Net cash provided by financing activities			3,537				2,562
Decrease in cash and cash equivalents			(785)				(1,482)
Cash and cash equivalents at beginning of the year			8,897				7,564
Effect of exchange rate fluctuations on balances of cash and cash equivalents			3				(42)
Cash and cash equivalents at end of period			8,115				6,040
Non-cash activities
Obtaining a right-of-use asset in exchange for a lease liability			-				26

 

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SOURCE IceCure Medical

FAQ

How did IceCure (Nasdaq: ICCM) perform financially in Q1 2026?

IceCure reported Q1 2026 revenue of $911,000, a 26% year-over-year increase. According to IceCure, gross profit rose 35% to $295,000 with gross margin improving to 32%, while net loss widened to $4,274,000, or $0.06 per share.

What drove ProSense sales growth in the U.S. and North America in Q1 2026 for ICCM?

ProSense sales growth was driven by FDA clearance, new installations, and higher procedure volumes. According to IceCure, North America sales rose 84%, U.S. sales grew 31%, and active U.S. customer accounts using ProSense increased 46% to 19 by quarter-end.

How many active ProSense customer accounts did IceCure have in the U.S. after FDA clearance?

IceCure had 19 active U.S. ProSense accounts as of Q1 2026. According to IceCure, this reflects a 46% increase from 13 active accounts prior to FDA approval, driven by onboarding new customers and reactivating prior system owners.

What were IceCure’s Q1 2026 net loss and cash position (ICCM)?

IceCure recorded a Q1 2026 net loss of $4,274,000 and cash of $8,115,000. According to IceCure, the loss increased from $3,588,000 year-over-year, while cash and cash equivalents declined from $8,897,000 at December 31, 2025.

What new clinical data on ProSense and cryoablation did IceCure highlight in May 2026?

IceCure highlighted five-year ICESECRET kidney cancer data and breast-related studies supporting ProSense. According to IceCure, kidney cryoablation showed recurrence-free rates of 89.4% and 83.9%, while other studies demonstrated safety, effectiveness, and a 50% cost reduction versus lumpectomy.

How is IceCure’s ChoICE post-marketing study expected to impact ProSense adoption in the U.S.?

The ChoICE study is expected to support broader ProSense adoption and reimbursement in the U.S. According to IceCure, the FDA-approved protocol covers 30 hybrid clinical/commercial sites where both commercial and clinical procedures will be performed, potentially accelerating hospital and clinic uptake.

What happened to IceCure’s operating expenses in Q1 2026 and what drove the changes?

Operating expenses increased to $4,542,000 in Q1 2026 from $3,875,000. According to IceCure, higher research and development spending, mainly for the ChoICE study, and increased general and administrative expenses were partially offset by lower sales and marketing costs.