IceCure Reports Financial & Operational Results for the Nine Months Ended September 30, 2025

Momentum building in the U.S. and rising interest globally following landmark FDA marketingauthorization for local cryoablation treatment of low-risk breast cancer

Demand for ProSense® systems expected to accelerate in 2026

Total U.S. population of approximately 200,000 patients, includes women aged 70+, thosenot suitable for surgery and benign breast tumors

Conference call to be held today, November 19, 2025 at 10:00 am Eastern Time

CAESAREA, Israel,Nov. 19, 2025/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 nine months ended September 30, 2025.

In October 2025, the U.S. Food and Drug Administration ("FDA") granted marketing authorization to IceCure's De Novo application for the ProSense® cryoablation system for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy.

"This was a landmark quarter for IceCure and the patients we aim to serve," said Eyal Shamir, Chief Executive Officer of IceCure Medical. "The FDA's marketing authorization for ProSense® in low-risk breast cancer in women aged 70 and over marks a historic milestone and validates years of rigorous clinical research, positioning IceCure at the forefront of minimally invasive breast cancer care. In addition to the 46,000 patients that are 70+, we believe there are an additional 88,000 patients not suitable for or willing to go through surgery and approximately 63,000 patients with benign breast tumors who can also benefit from cryoablation."

"The immediate response to the FDA's decision has been overwhelming and we are getting interest in the U.S. and globally from new potential users including breast surgeons, interventional and breast radiologists who are asking for demonstrations and installations," added Mr. Shamir. "Over the past few months, we've seen an uptick in probe sales to our installed base of existing ProSense® users in the U.S. and internationally. Further expanding ProSense®'s availability, we recently received regulatory approval in Switzerland for indications including breast cancer."

"Our U.S. sales team is hard at work. We expect ProSense® installations and procedure volume to increase and are very optimistic about our commercial traction," Shamir concluded.

Upcoming Catalysts

Third Quarter 2025 and Recent Operational and Clinical Highlights

Financial Results for the Nine Months Ended September 30, 2025

Revenue for the nine months ended September 30, 2025, was $2,100,000 compared to $2,416,000 for the nine months ended September 30, 2024, which included the recognition of $100,000 from a distribution agreement and other services in Japan. With the FDA's marketing clearance for ProSense® in low-risk breast cancer granted in October of 2025, the Company expects continued fluctuations in quarterly revenues as commercial activities ramp up in the U.S. and globally. The $316,000 decline in sales was due to a decrease in sales in Japan, other territories in Asia, and North America, and was partially offset by an increase in sales in Latin America.

Gross profit for the nine months ended September 30, 2025, was $626,000, compared to $1,034,000 for the nine months ended September 30, 2024. Gross margin was 30% in the nine months ended September 30, 2025, compared to 43%in the nine months ended September 30, 2024. Non-GAAP gross profit for the nine months ended September 30, 2025 was $626,000 compared to $934,000 for the nine months ended September 30, 2024. Non-GAAP gross margin for the nine months ended September 30, 2025 was 30% compared to 40% for the nine months ended September 30, 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 of 9% in revenue from sales of ProSense® systems and disposables probes. 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 nine months ended September 30, 2025 were $5,137,000, compared to $5,401,000 in the nine months ended September 30, 2024, primarily reflecting a reduction in service providers and consultants and clinical trials costs as the Company concluded its ICE3 study in 2024.

Sales and marketing expenses for the nine months ended September 30, 2025 were $3,061,000, compared to $4,041,000 for the nine months ended September 30, 2024, primarily reflecting a reduction in service providers and consultants. General and administrative expenses for the nine months ended September 30, 2025 were $3,306,000, compared to $2,763,000 nine months ended September 30, 2024, reflecting an increase primarily in service providers, consultants and share based compensation.

Total operating expenses for the nine months ended September 30, 2025 declined to $11,504,000 from $12,205,000 for the nine months ended September 30, 2024. The decrease in operating expenses was attributable to reductions in research and development, and sales and marketing expenses, and partially offset by increases in general and administrative expenses.

Net loss for the nine months ended September 30, 2025, was $10,811,000, or $0.18 per share, relatively unchanged compared to a net loss of $10,839,000, or $0.22 per share, for the same period last year.

As of September 30, 2025, the Company had cash, cash equivalents, including short-term deposits, of approximately $10.0 million, compared to $7.6 million as of December 31, 2024. In July 2025, the Company successfully completed a rights offering, which was approximately two times oversubscribed, raising $10 million in gross proceeds to support commercialization of ProSense® and of the next-generation XSense™ system.

During the first ten months of 2025, the Company raised $5.87 million in net proceeds from the sale of 5,425,806 ordinary shares under its at-the-market offering facility bringing its cash balance as of October 31, 2025 to $11.8 million.

Use of Non-U.S. GAAP Measures

In addition to disclosing financial results prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP), this press release contains certain financial measures which may be defined as "non-GAAP financial measures" by the SEC. The Company defines non-GAAP gross profit as gross profit less revenue from exclusive distribution agreements and other services. The Company has provided non-GAAP gross profit in this press release because it is a key measure used by management and the board of directors as an indication of our gross profit from sales of our systems and disposables and management believes that it is useful to investors' understanding and assessment of the Company's gross profit without the impact of revenue recorded from the Company's exclusive distribution agreements and other services. The Company has provided a reconciliation below of non-GAAP gross profit and non-GAAP gross margin to the most directly comparable financial measure calculated and presented in accordance with U.S. GAAP. The non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with U.S. GAAP and the financial results calculated in accordance with U.S. GAAP and reconciliations to those financial results should be carefully evaluated.

Conference call & webcast info:Wednesday, November 19, 2025, at 10:00 am ESTUS: 1-888-407-2553Israel/International: +972-3-918-0696A live webcast will be available at:https://www.veidan-conferenceing.com/icecureA 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 potential and expected benefits of the FDA's marking authorization for ProSense®; anticipated U.S. and global commercial traction; the planned rollout of ProSense® to clinical and commercial sites pending FDA review and agreement with post-market study plans; potential reimbursement coverage and code updates; the timing and outcome of Terumo Corporation's planned regulatory submission in Japan; the expected design, timing, and impact of the post-market study; the Company's expectations regarding procedure volume, installations, and sales momentum; and future regulatory, clinical, and commercial developments for ProSense® and XSense™. 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

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SOURCE IceCure Medical