IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer

Rhea-AI Summary

IceCure (NASDAQ: ICCM) expects record fourth quarter North American sales driven by increased orders and installations of its ProSense® cryoablation system following the FDA marketing authorization in October 2025 for local treatment of low-risk breast cancer in women aged 70 and above. The company reports rapid interest from hospitals, breast surgeons and radiologists, including orders from a highly ranked U.S. hospital network, and says ProSense® is receiving broad media and conference visibility. IceCure plans preliminary top-line revenue disclosure in January 2026 and its full Form 20-F in April 2026.

Positive

• FDA marketing authorization for ProSense in October 2025
• Expected record Q4 North American sales versus prior year
• New installations at highly regarded U.S. medical institutions

Negative

• Q4 sales figures are preliminary and subject to revision at the January 2026 report

Key Figures

Eligible patient age 70 years and above FDA marketing authorization population for low-risk breast cancer (Oct 2025)

Preliminary results timing January 2026 Planned release of preliminary top-line revenue results

Full report timing April 2026 Planned filing of full annual report on Form 20-F

Market Reality Check

$0.6749 Last Close

Volume Volume 383,769 is roughly in line with 20-day average 380,085 (rel. 1.01x). normal

Technical Price $0.6257 trades below 200-day MA $0.99, ~62% under 52-week high and ~6% above 52-week low.

Peers on Argus 2 Up

ICCM was down 2.23% pre-news while close peers were mixed: TELA up 4.42%, VNRX up 0.71%, APYX down 3.88%, LUNG down 2.36%, BDMD up 0.74%. Momentum scanner only flagged VNRX and WOK moving up, suggesting stock-specific factors rather than a broad medical device move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 10	Clinical data update	Positive	+3.1%	RSNA 2025 data showing strong ProSense® performance across 263 breast cancer patients.
Dec 09	Conference update	Positive	+1.5%	CIRSE 2025 presentations and training highlighting ProSense® cryoablation use in multiple cohorts.
Dec 05	IP/patent news	Positive	+0.4%	China Notice of Allowance for cryogen flow control patent supporting next‑gen XSense system.
Nov 19	Earnings & ops update	Neutral	-3.2%	Nine‑month 2025 results with $2.1M revenue, 30% margin, $10.8M net loss and FDA authorization highlight.
Nov 18	Regulatory approval	Positive	+2.0%	Swissmedic approval for ProSense® across breast, lung, liver, kidney and bone indications.

Pattern Detected

Recent operational and regulatory updates have generally aligned with modestly positive price reactions, while the latest mixed financial report saw a small decline.

Recent Company History

Over the past month, IceCure reported several milestones tied to its ProSense® cryoablation platform. On Nov 18, 2025, Swissmedic approved ProSense® for multiple cancer indications, followed by nine‑month financials on Nov 19 with revenue of $2.1M, 30% gross margin, and a net loss of $10.8M alongside an October FDA marketing authorization. Subsequent news highlighted a China patent allowance and clinical data at CIRSE and RSNA. Today’s expectation of record Q4 North American sales fits this trajectory of commercialization and post‑approval adoption updates.

Market Pulse Summary

The stock moved +8.7% in the session following this news. A strong positive reaction aligns with the company’s recent stream of operational and regulatory milestones, including the October FDA marketing authorization and international approvals. The announcement that North America is expected to deliver record fourth-quarter sales underscores post-approval adoption momentum. However, prior financials showed a net loss and modest revenue base, so investors would have needed to monitor execution, future revenue mix, and any capacity or reimbursement constraints when assessing how sustainable a sharp move might have been.

Key Terms

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.

marketing authorization regulatory

"following the U.S. Food and Drug Administration's ("FDA") marketing authorization of ProSense®"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

form 20-f regulatory

"followed by its full annual report on Form 20-F in April 2026."

Form 20-F is the standardized annual disclosure that non-U.S. companies must file with the U.S. securities regulator when their shares are traded in the U.S.; it contains audited financial statements, a plain-language description of the business, management discussion, governance details and key risk factors. It matters to investors because it provides a consistent, comparable company “report card” and rulebook, helping buyers assess financial health, governance and risks before investing.

AI-generated analysis. Not financial advice.

ProSense® systems are being sold and installed at new locations across North America, including some of the most highly regarded medical institutions in the United States

CAESAREA, Israel, Dec. 17, 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, is expecting to report a significant increase in fourth quarter sales in North America compared to the same period last year. Based on currently available preliminary information, the increase in sales would represent record North American sales levels for the Company. The Company is experiencing a surge of interest for the ProSense® console and its disposable cryoprobes following the U.S. Food and Drug Administration's ("FDA") marketing authorization of ProSense® for the local treatment of low-risk breast cancer in women aged 70 and above in October 2025.

"We are highly encouraged by the strong and rapid interest from doctors and medical institutions just two months after the FDA's marketing authorization for ProSense® in low-risk breast cancer," said Eyal Shamir, IceCure's Chief Executive Officer. "We believe several factors correlated with the FDA's recent favorable decision are driving demand, such as ProSense®'s high visibility at medical conferences including hands-on training sessions, our engagement with breast-focused medical societies, the growing body of independent studies and peer reviewed data, and patient-driven demand supported by increasing media coverage and awareness of our non-surgical option."

Shad Good, Vice President of Sales North America, commented, "Our sales team is engaged with a growing number of hospitals, clinics, breast surgeons and radiologists nationwide who are evaluating ProSense® and placing orders. As expected, the FDA's marketing authorization is a major catalyst in the growth of our sales pipeline. Patients in the U.S. now have a minimally invasive option and providers want to offer this choice to their patients. We are very pleased that one of our most recent orders is from a hospital network that is ranked one of the top in the world, with multiple locations in the U.S. We believe orders from these kinds of highly influential institutions may further drive demand from the broader market."

IceCure plans to report preliminary top-line revenue results in January 2026 followed by its full annual report on Form 20-F in April 2026.

ProSense® for the treatment of low-risk breast cancer is featured in a growing number of mainstream media outlets, women's magazines, healthcare industry trade publications, and consumer healthcare news including: Essense, Cancer Health, Authority Magazine, Arizona Family, Fierce Biotech, Medscape, KFF Health News, MedPage Today, and Medical Device Network.

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 expectation of a significant increase in fourth quarter North American sales; its belief that such increases would represent record sales levels for the Company; anticipated continued demand for the ProSense® system following FDA marketing authorization; its belief that various factors are driving and will continue to drive adoption; the growth of its U.S. sales pipeline; and its belief that orders from highly influential hospital networks may further drive broader market demand. 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

 

View original content:https://www.prnewswire.com/news-releases/icecure-expected-to-report-record-fourth-quarter-sales-in-north-america-driven-by-recent-fda-clearance-of-prosense-cryoablation-for-low-risk-breast-cancer-302644619.html

SOURCE IceCure Medical

FAQ

What did IceCure announce about Q4 2025 North American sales for ICCM?

IceCure said it expects record Q4 2025 North American sales compared with the same period last year based on preliminary information.

How did the FDA decision in October 2025 affect IceCure (ICCM)?

The FDA marketing authorization in October 2025 for ProSense in low-risk breast cancer has driven increased orders and interest from hospitals and clinicians.

When will IceCure (ICCM) release the preliminary revenue figures for Q4 2025?

IceCure plans to report preliminary top-line revenue results in January 2026.

Who is eligible for ProSense treatment under the FDA authorization mentioned by ICCM?

The authorization covers ProSense for local treatment of low-risk breast cancer in women aged 70 and above.

Are ProSense systems being adopted by major U.S. medical centers for ICCM?

IceCure reports ProSense systems are being sold and installed at new locations including highly regarded U.S. medical institutions.

What should investors watch for after IceCure's sales announcement for ICCM?

Investors should watch the January 2026 preliminary revenue release and the April 2026 Form 20-F for final figures and disclosures.