IceCure CEO Issues Letter to Shareholders: Reports Record Fourth Quarter and Full Year 2025 ProSense® Sales

Rhea-AI Summary

IceCure (Nasdaq: ICCM) reported record 2025 ProSense® sales of approximately $3.4 million and cash and cash equivalents of approximately $8.9 million as of December 31, 2025, based on preliminary unaudited estimates. In October 2025 the company received FDA marketing authorization for ProSense® for local treatment of low-risk breast cancer in women aged 70+ with endocrine therapy, making it the first and only device with that FDA authorization. The company reported record European sales, expanded scientific publications and presentations, four new U.S. and China patents, and reimbursement under CPT III at $4,049 effective January 2026.

Positive

• FDA marketing authorization granted for low-risk breast cancer in women aged 70+ (first/only device)
• Record ProSense® sales ~$3.4M for year ended Dec 31, 2025 (preliminary, unaudited)
• Cash and cash equivalents ~$8.9M as of Dec 31, 2025 (preliminary)
• Record scientific visibility: 16 principal investigators presenting at 10 conferences
• Four new patents granted in the U.S. and China covering next-gen cryoablation tech
• CPT III reimbursement increased to $4,049 effective January 2026

Negative

• Financial figures are preliminary and unaudited and may change after closing procedures
• FDA authorization is limited to women aged 70+ with endocrine therapy, restricting initial U.S. label scope
• Reported $3.4M annual product sales indicate an early-stage commercial revenue base

News Market Reaction

-5.46%

1 alert

-5.46% News Effect

-6.1% Trough Tracked

-$3M Valuation Impact

$51M Market Cap

0.5x Rel. Volume

On the day this news was published, ICCM declined 5.46%, reflecting a notable negative market reaction. Argus tracked a trough of -6.1% from its starting point during tracking. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $51M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

2025 ProSense sales: $3.4 million Cash balance: $8.9 million Procedure reimbursement: $4,049 +5 more

8 metrics

2025 ProSense sales $3.4 million Preliminary, unaudited ProSense® sales for year ended Dec 31, 2025

Cash balance $8.9 million Cash and cash equivalents as of Dec 31, 2025 (preliminary)

Procedure reimbursement $4,049 CPT III code reimbursement for ProSense® effective January 2026

Addressable U.S. patients 200,000 women annually U.S. breast cryoablation market potential for ProSense®

NSCLC survival rate 92% 5-year disease-specific survival Non-small cell lung cancer treated with cryoablation plus radiation

Scientific contributors 16 principal investigators, 10 conferences Record peer-reviewed publications and presentations in 2025

New patents 4 patents granted/allowed U.S. and China patents for cryoablation and cryogenic technologies

Breast cancer subgroup 46,400 patients Early-stage, low-risk breast cancer patients aged 70+ in U.S.

Market Reality Check

Price: $0.6800 Vol: Volume 250,370 is below t...

low vol

$0.6800 Last Close

Volume Volume 250,370 is below the 20-day average of 375,394, suggesting muted pre-news positioning. low

Technical Shares at $0.7103 are trading below the 200-day MA of $0.93 and 57.21% under the 52-week high.

Peers on Argus

ICCM was up 1.18% while key peers showed mixed moves: APYX up 2.05%, LUNG down 2...

1 Up 2 Down

ICCM was up 1.18% while key peers showed mixed moves: APYX up 2.05%, LUNG down 2.86%, VNRX down 1.51%, BDMD down 2.27%, TELA down 0.91%. Momentum data also show one peer up and two down, indicating stock-specific drivers rather than a uniform sector rotation.

Common Catalyst Some medical device peers, such as APYX, also issued preliminary 2025 revenue updates, pointing to an earnings-preseason information cycle.

Historical Context

5 past events · Latest: Dec 17 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 17	Sales/FDA update	Positive	+8.7%	Expected record Q4 North America sales tied to October FDA authorization.
Dec 10	Clinical data update	Positive	+3.1%	RSNA 2025 breast studies showing strong ProSense® efficacy metrics.
Dec 09	Conference data	Positive	+1.5%	CIRSE 2025 data and training highlighting ProSense® performance and pain reduction.
Dec 05	Patent allowance	Positive	+0.4%	China patent allowance for cryogen flow control in next‑gen XSense system.
Nov 19	Earnings update	Neutral	-3.2%	Nine‑month 2025 financials with revenue growth but a <b>$10.8M</b> net loss.

Pattern Detected

ICCM has typically reacted positively to clinical, regulatory, and commercial updates, with 4 of the last 5 news events followed by gains and only the mixed financial update drawing a negative reaction.

Recent Company History

Over the past few months, ICCM highlighted a series of milestones. An Oct 2025 FDA marketing authorization for ProSense® in low-risk breast cancer underpinned expectations for record Q4 North America sales and stronger 2026 visibility. Multiple conferences in Nov–Dec 2025 showcased positive breast and cryoablation data, while a China patent allowance reinforced the company’s IP estate. The Nov 19, 2025 nine‑month results mixed revenue growth with a $10.8M net loss. Today’s record 2025 ProSense® sales update builds directly on those commercial and regulatory steps.

Market Pulse Summary

The stock moved -5.5% in the session following this news. A negative reaction despite upbeat comment...

Analysis

The stock moved -5.5% in the session following this news. A negative reaction despite upbeat commentary would contrast with prior responses, where four of the last five positive updates saw gains. The letter cites record 2025 ProSense® sales of about $3.4 million, a cash balance near $8.9 million, and expanding clinical evidence, but the stock had been trading well below its $0.93 200-day MA and 57.21% under the 52-week high. That backdrop, together with past losses, could lead investors to focus on valuation and funding risks.

Key Terms

fda marketing authorization, cryoablation, non-small cell lung cancer, nsclc, +4 more

8 terms

fda marketing authorization regulatory

"we were granted the U.S. Food and Drug Administration's ("FDA") marketing authorization for ProSense®"

Permission from the U.S. Food and Drug Administration that allows a medical product—such as a drug, device, or biologic—to be legally sold and promoted after the agency reviews data showing it meets safety and effectiveness standards. For investors this milestone matters because it clears the main regulatory hurdle to generate sales, reduces uncertainty about future revenue, and can materially change a company’s market value, similar to obtaining a license that lets a business open to customers.

cryoablation medical

"developer of minimally-invasive cryoablation technology that destroys tumors by freezing"

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.

non-small cell lung cancer medical

"successfully treated non-small cell lung cancer ("NSCLC"), demonstrating 92% disease-specific 5-year survival"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

nsclc medical

"successfully treated non-small cell lung cancer ("NSCLC"), demonstrating 92% disease-specific 5-year survival"

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

endometriosis medical

"studies also demonstrated that ProSense® substantially reduced abdominal wall endometriosis pain"

Endometriosis is a chronic condition where tissue similar to the lining of the uterus grows outside the uterus, often causing pain and fertility problems. It can impact a person's health and quality of life, potentially leading to increased healthcare costs and affecting workforce productivity. For investors, understanding conditions like endometriosis highlights the importance of healthcare innovations and markets related to women's health.

cpt iii code regulatory

"ProSense® currently has reimbursement under the CPT III code which increased to $4,049"

Category III CPT codes are temporary billing codes used to track new and experimental medical procedures, technologies, and tests while they gather evidence and usage data. For investors, these codes signal when a procedure is entering the formal payment system — like a product prototype getting a barcode — because assignment of a stable billing code can speed reimbursement, wider adoption, and potential revenue growth for companies behind the innovation.

pharmaceuticals and medical devices agency regulatory

"submit a request for breast cancer clearance to Japan's Pharmaceuticals and Medical Devices Agency"

A pharmaceuticals and medical devices agency is a government or independent regulator that reviews, approves and monitors medicines and medical devices to ensure they are safe, work as intended and meet quality standards. Investors care because its decisions control whether and when products can be sold, affect development costs, timelines and legal risk, and therefore have a direct impact on a company’s future revenue and valuation—much like a building inspector who must sign off before occupancy.

disease-specific 5-year survival medical

"NSCLC ("NSCLC"), demonstrating 92% disease-specific 5-year survival"

Disease-specific 5-year survival is the share of patients who are still alive five years after diagnosis or treatment when counting only deaths caused by that particular disease. Think of it like tracking how many items from a product line still function after five years, but excluding failures from unrelated causes. Investors care because higher disease-specific survival indicates a therapy or diagnosis is more effective, which can drive regulatory approval, pricing, patient demand, and revenue forecasts.

AI-generated analysis. Not financial advice.

Company experiencing strong demand in the U.S. following FDA marketing authorization of ProSense® as the only on-label minimally invasive solution for the local treatment of low-risk breast cancer, addressing a market opportunity of approximately 200,000 patients

Record European sales, driven by positive effects of U.S. clearance and continued growing adoption of ProSense® cryoablation for breast cancer in key markets

Record number of peer-reviewed publications and presentations at global conferences demonstrates growing clinical evidence for cryoablation of breast, musculoskeletal, and kidney cancers with ProSense®

CAESAREA, Israel, Jan. 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 issued the following letter to shareholders from its Chief Executive Officer, Eyal Shamir.

 

Dear shareholders,

2025 was a pivotal year for IceCure – we were granted the U.S. Food and Drug Administration's ("FDA") marketing authorization for ProSense® cryoablation for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above, including those who are not candidates for breast cancer surgery. This achievement has strengthened our belief that ProSense® can expand patient choice, enhance care, and offer improved healthcare economics through a minimally invasive approach. This milestone marks a meaningful step toward establishing cryoablation as a new standard of care for eligible women in the United States seeking effective care without surgical removal of breast tissue.

Following the FDA marketing authorization in October 2025, we have experienced and continue to experience an overwhelmingly positive response and interest in ProSense® consoles and disposable cryoprobes. This has contributed to record fourth quarter results in 2025 in North America. We are particularly enthused to see systems being placed at highly regarded institutions in the United States, which we believe can further accelerate broader adoption of ProSense®. Our sales team is engaged with leading hospitals, clinics, breast surgeons, and interventional radiologists currently evaluating ProSense® in the U.S.

Based on preliminary, unaudited estimates, IceCure delivered a record ProSense® sales of approximately $3.4 million for the year ended December 31, 2025, driven by growing demand in the U.S. and record sales in Europe as we continue to execute our global commercial strategy. Our cash and cash equivalents balance as of December 31, 2025 was approximately $8.9 million. This preliminary financial information has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, management. This preliminary financial information is based upon our estimates and remains subject to, among other things, the completion of IceCure's financial closing procedures and final adjustments, which may impact the results and expectations set forth above.

We also saw continued advancement in the large body of data supporting ProSense® for other indications. In 2025, independent investigators produced a record number of peer-reviewed publications and presentations regarding the use of ProSense® for breast, musculoskeletal, and kidney cancers. We believe this expanding body of evidence is critical to long-term adoption and to supporting expanded clinical use around the world.

2025 Key Achievements

FDA Marketing Authorization for Low-Risk Breast Cancer in Women Aged 70 and Above: The FDA granted marketing authorization for ProSense® for the local treatment of low-risk breast cancer in women aged 70 and above with endocrine therapy, establishing ProSense® as the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer.

Significant Addressable U.S. Patient Population: ProSense® addresses a U.S. patient population for breast cryoablation of approximately 200,000 women annually. This population includes approximately 46,400 early-stage, low-risk breast cancer patients aged 70 and over, 88,500 patients who are not candidates for breast cancer surgery, and 63,000 patients with fibroadenomas who opt for excision.

Commercial Expansion Across North America: ProSense® systems were sold and installed at new locations across North America, including at one of the most highly regarded medical institutions in the United States, reflecting strong clinical interest following the FDA marketing authorization.

Record Scientific Visibility and Independent Validation: IceCure achieved a record number of peer-reviewed publications and conference presentations by 16 principal investigators at 10 conferences across the globe including the U.S., Europe, and Asia, covering indications including breast, musculoskeletal and kidney cancer. These independent third-party studies continue to demonstrate ProSense® efficacy and safety in breast cancer and its potential for other indications.

Clinical Validation in Lung Cancer and Endometriosis: While a large body of evidence in ProSense®'s treatment of breast cancer continues to accumulate, independent studies demonstrated that IceCure's cryoablation system, combined with radiation therapy, successfully treated non-small cell lung cancer ("NSCLC"), demonstrating 92% disease-specific 5-year survival. Additional independent studies also demonstrated that ProSense® substantially reduced abdominal wall endometriosis pain with high procedural efficacy.

Regulatory Achievements: ProSense® received regulatory approval in Switzerland for indications including breast, lung, liver, and kidney cancer, while the next-generation XSense™ received regulatory approval in Israel.

Intellectual Property Estate Continued to Grow: IceCure was granted and allowed four new patents in the U.S. and China covering our latest innovations, including next-generation multi-probe cryoablation system, cryogenic pump, and cryogenic flow control technology.

2026 Objectives

• We believe the commercial sales momentum in the U.S. and wider utilization in Europe is expected to generate higher ProSense® system and cryoprobe sales in 2026.
• We expect additional reimbursement coverage may potentially become available for ProSense® procedures in 2026 and beyond based on factors including the FDA's marketing authorization in low-risk breast cancer, post-market activity, and recommendations from professional medical associations. ProSense® currently has reimbursement under the CPT III code which increased to $4,049 effective January 2026.
• Terumo, our distributor in Japan, is expected to submit a request for breast cancer clearance to Japan's Pharmaceuticals and Medical Devices Agency in the first half of 2026.
• More peer-reviewed publications are expected from ongoing independent studies of ProSense® worldwide.
• We expect continued progress toward regulatory approvals for ProSense® in additional global markets.
• We continue to explore opportunities for strategic cooperation and partnership, supported by recent clinical, regulatory, and commercial progress.

We wish you all a peaceful, healthy, and prosperous 2026.

Sincerely,
Eyal Shamir, CEO

About ProSense®

The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.

ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.

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: its preliminary unaudited estimates for certain 2025 financial performance, which are subject to, among other things, the completion of IceCure's financial closing procedures and final adjustments, which may impact the results and expectations set forth above; expectations that the FDA marketing authorization will accelerate broader adoption of ProSense® and support its establishment as a new standard of care in the United States; beliefs that commercial sales in the U.S. and increased utilization in Europe are expected to generate higher ProSense® system and cryoprobe sales in 2026; expectations that additional reimbursement coverage may potentially become available in 2026 and beyond; anticipated regulatory submissions and approvals in additional global markets, including a planned submission for breast cancer clearance in Japan; and expectations regarding future peer-reviewed publications, strategic collaborations, and continued clinical, regulatory, and commercial progress. 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: investors@icecure-medical.com 

Michael Polyviou

Phone: 732-232-6914

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

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SOURCE IceCure Medical

FAQ

What did IceCure (ICCM) report for ProSense® sales in 2025?

IceCure reported preliminary, unaudited ProSense® sales of approximately $3.4 million for the year ended December 31, 2025.

What FDA authorization did IceCure (ICCM) receive in October 2025?

The FDA granted marketing authorization for ProSense® for the local treatment of low-risk breast cancer in women aged 70 and above with endocrine therapy.

How large is the addressable U.S. patient population for ProSense® according to IceCure (ICCM)?

IceCure cites an approximate U.S. addressable population of 200,000 patients annually for breast cryoablation, including ~46,400 early-stage low-risk women aged 70+.

What reimbursement code and rate applies to ProSense® procedures in 2026 for ICCM?

ProSense® currently has reimbursement under CPT III, which increased to $4,049 effective January 2026.

How strong is the clinical evidence supporting ProSense® as reported by IceCure (ICCM)?

IceCure reported a record number of independent peer-reviewed publications and presentations in 2025, including studies across breast, musculoskeletal, and kidney indications and an independent NSCLC study showing 92% disease-specific 5-year survival when combined with radiation.

What are IceCure's near-term commercial objectives for 2026 (ICCM)?

IceCure expects higher ProSense® sales from U.S. momentum and wider European utilization, potential additional reimbursement coverage, continued peer-reviewed publications, and progress toward further global regulatory approvals.