IceCure Participates in Society of Breast Imaging Symposium 2026 as U.S. ProSense® Revenue Increases by 30%+ in First Quarter of 2026 Compared to First Quarter of 2025

Rhea-AI Summary

IceCure (Nasdaq: ICCM) reported that preliminary, unaudited U.S. revenue for ProSense® systems and cryoprobes rose more than 30% in Q1 2026 vs Q1 2025.

The company highlighted commercial momentum after the FDA clearance in October 2025 for treating low-risk breast cancer in women aged 70+, participation and hands-on training at SBI 2026 (April 16–19, 2026), and an award-winning Massachusetts General Hospital cost study showing >50% cost reduction versus lumpectomy.

Positive

• U.S. revenue +30%+ in Q1 2026 (preliminary, unaudited)
• Massachusetts General Hospital study: >50% cost reduction vs lumpectomy
• FDA clearance Oct 2025 for ProSense in women aged 70+
• Growing installed base at leading academic and research hospitals

Negative

• Q1 figures are preliminary, unaudited and may change after closing procedures
• FDA clearance limited to women aged 70+, constraining immediate addressable U.S. market
• Revenue increase reported without final GAAP verification or detailed regional breakdown

News Market Reaction – ICCM

-3.34%

2 alerts

-3.34% Session close to close

$30.96M Market Cap

0.0x Rel. Volume

In the Apr 21 session, ICCM declined 3.34%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores stronger early U.S. commercialization for ProSense®, with preliminary ...

Analysis

This announcement underscores stronger early U.S. commercialization for ProSense®, with preliminary first-quarter 2026 U.S. revenue up more than 30% year over year and independent data suggesting over 50% cost savings versus surgery. It builds on prior milestones such as FDA clearance and the planned ChoICE post‑market study targeting 400 patients across 30 sites. Investors may track final Q1 results on May 14, 2026, adoption trends at leading hospitals, and the pace of new system placements.

Key Figures

U.S. ProSense revenue growth: more than 30% Cost reduction vs lumpectomy: 50% reduction Cost reduction vs surgery: more than 50% +5 more

8 metrics

U.S. ProSense revenue growth more than 30% Q1 2026 vs Q1 2025 preliminary, unaudited

Cost reduction vs lumpectomy 50% reduction Cryoablation cost analysis at Massachusetts General Hospital

Cost reduction vs surgery more than 50% Cryoablation vs breast-conserving surgery cost analysis

Planned ChoICE enrollment 400 patients ChoICE post-market study target enrollment

ChoICE study sites 30 U.S. sites Planned study locations over enrollment period

ChoICE study duration 36 months Planned enrollment timeline

Year-one enrollment target 80 patients Minimum patients in first year of ChoICE trial

Patient age indication 70 and above FDA-cleared low-risk breast cancer population for ProSense

Historical Context

5 past events · Latest: Mar 26 (Negative)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 26	Dilutive financing	Negative	-33.7%	Registered direct offering and private placement raising about $4M with new warrants.
Mar 25	Clinical data update	Positive	-3.4%	Positive 5-year ICESECRET kidney cancer cryoablation results with strong recurrence-free rates.
Mar 24	Management changes	Positive	-4.5%	Appointment of new CFO and planned Medical Director amid noted commercial momentum.
Mar 17	Full-year earnings	Positive	-8.9%	Record Q4 sales, higher 2025 revenue, narrowed net loss, and higher cash balance.
Mar 11	FDA study approval	Positive	+8.9%	FDA approval of ChoICE post-market study design for low-risk breast cancer cryoablation.

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

Pattern Detected

ICCM has often sold off on positive operational and clinical updates, while financing and FDA study approval have seen moves more in line with expectations.

Recent Company History

Over the last months, IceCure reported FDA approval for its ChoICE post‑market study on Mar 11 2026, which coincided with a +8.87% move, and record 2025 revenue of $3.379M with narrowed net loss of $15.057M on Mar 17 2026, yet the stock fell 8.9%. Positive kidney cancer trial data and management changes in late March also saw negative reactions. A $4.0M registered direct offering and private placement on Mar 26 2026 led to a -33.66% drop, underscoring sensitivity to dilution alongside a pattern of weakness even after good news.

Key Terms

cryoablation, lumpectomy, breast-conserving surgery, percutaneous cryoablation, +2 more

6 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.

lumpectomy medical

"Cryoablation cost analysis study ... demonstrated 50% reduction in cost 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.

breast-conserving surgery medical

"cryoablation may reduce total treatment costs by more than 50% compared to breast-conserving surgery"

A surgical procedure that removes a cancerous lump and a small margin of surrounding tissue while keeping most of the breast intact, similar to cutting away a rotten spot from an apple while preserving the rest. It matters to investors because its prevalence, outcomes and reimbursement influence demand for surgical devices, radiation and imaging services, hospital stays and follow-up care, which affect revenue and regulatory risk across healthcare companies.

percutaneous cryoablation medical

"titled "Cost Analysis of Percutaneous Cryoablation versus Breast Conserving Surgery""

Percutaneous cryoablation is a minimally invasive medical procedure that inserts a thin probe through the skin to freeze and destroy targeted tissue, commonly tumors. For investors, it matters because adoption and effectiveness influence demand for specialized devices, hospital procedure volumes, reimbursement decisions and regulatory approvals — think of it as a targeted “local freezing” alternative to open surgery that can reshape market share and revenues in relevant medical device and healthcare services sectors.

post-market surveillance study regulatory

"upcoming post-market surveillance study, the ChoICE trial, reviewed procedural techniques"

A post-market surveillance study is a research program that tracks a medical product's safety and performance after it has been approved and sold, collecting real-world data on rare side effects, long-term outcomes, and how the product is actually used. Investors care because the study can reveal new risks or benefits that affect sales, regulatory status, recalls, liability and future costs—similar to ongoing inspections that show whether a car model holds up over time.

CPT Category III reimbursement regulatory

"procedures are eligible for CPT Category III reimbursement (about $4,000 facility fee)."

CPT Category III reimbursement refers to whether insurers pay for medical services or technologies that have been assigned temporary Category III billing codes used for emerging, experimental or investigational procedures. Think of it as a temporary barcode for a new product: getting reimbursed means hospitals and doctors can bill insurers and receive payment, which affects how quickly a new procedure is adopted and how much revenue developers and providers can expect.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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The Company's participation at the Society of Breast Imaging Symposium and other upcoming medical conferences are timely as commercial momentum accelerates

Cryoablation cost analysis study from Massachusetts General Hospital featuring ProSense® demonstrated 50% reduction in cost vs. lumpectomy won SBI 2026 Abstract Award

CAESAREA, Israel, April 21, 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 announced that it expects to report U.S. revenue of ProSense® systems and cryoprobes increased more than 30% in the first quarter of 2026 compared the same period last year, based on preliminary, unaudited estimates.

 

The performance in the U.S. represents the adoption of ProSense® immediately following the U.S. Food and Drug Administration's ("FDA") clearance of ProSense® for the local treatment of low-risk breast cancer in women aged 70 and above in October 2025. The Company experienced this rising enthusiasm at the Society of Breast Imaging ("SBI") 2026 Symposium ("SBI 2026"), which was held in Seattle, Washington from April 16 to 19, 2026. IceCure exhibited ProSense® cryoablation technology and participated in a hands-on physician training workshop.

Following the FDA's clearance of ProSense® for early-stage breast cancer, IceCure continues to expand its installed base of ProSense® systems in the U.S., including placements at leading academic and research hospitals, supported by a robust and expanding pipeline of prospective customers, which the Company expects to close with new system sales in the second quarter of 2026.

"IceCure is seeing a meaningful shift in the treatment landscape for early-stage breast cancer, with cryoablation gaining increasing attention from physicians, healthcare systems, and patients," said Eyal Shamir, Chief Executive Officer of IceCure. "We believe this growing momentum is reflected in our strong commercial performance in the U.S., as well as in the expanding number of systems installed at some of the most prestigious teaching and research hospitals in the U.S. Additionally, we believe the high level of engagement at SBI 2026, combined with independent, award-winning data demonstrating the significant cost benefits of cryoablation, further supports our view that this technology is advancing toward becoming a standard-of-care option for indicated patients."

Award Winning Abstract

At SBI 2026, an award-winning abstract titled "Cost Analysis of Percutaneous Cryoablation versus Breast Conserving Surgery for the Treatment of Breast Cancer: Implication for Cost Efficacy-based Treatment Strategy" was presented by Matt Hoyer, M.D., of Massachusetts General Hospital. The study received the Wendell Scott Research Award, which recognizes the most outstanding abstract submitted by a breast imaging fellow. The analysis, which evaluated ProSense® as one of two liquid nitrogen-based cryoablation systems, demonstrated that cryoablation may reduce total treatment costs by more than 50% compared to breast-conserving surgery. The findings also highlighted cryoablation as a viable alternative for well-selected, low-risk early-stage breast cancer patients, building on promising treatment outcomes demonstrated in prior studies, including IceCure's ICE3 trial. In addition to highlighting optimized outpatient treatment, faster recovery, and improved patient quality of life, the abstract emphasized cryoablation's alignment with value-based low cost care and its potential to expand the role of radiologists in multidisciplinary cancer treatment.

How-To Cryoablation Workshop 
Part of SBI 2026's scientific programming included the workshop, "How I Do It – Cryoablation: Working It Up and Freezing it Out," led by Luz A. Venta, M.D., FACR, FSBI, of Weill Cornell Medical College, and Robert C. Ward, M.D., of the Warren Alpert Medical School of Brown University. The session provided practical, real-world guidance on integrating cryoablation into clinical practice. Dr. Venta's portion focused on optimizing diagnostic imaging workups prior to cryoablation, including protocols for evaluating masses, calcifications, asymmetries, and associated findings. Dr. Ward, who will be the co-primary investigator of IceCure's upcoming post-market surveillance study, the ChoICE trial, reviewed procedural techniques, clinical indications, and supporting data for cryoablation, as well as strategies to maximize benefits while minimizing risks and addressing potential barriers to broader adoption. The session concluded with an interactive Q&A, offering attendees deeper insight into implementation and best practices.

The Company expects to report its full operating and financial results for the first quarter of 2026 on Thursday, May 14, 2026.  Details for the conference call and webcast will be provided in a separate press release in early May. The preliminary financial information above regarding an increase in the Company's U.S. revenue of ProSense ® systems and cryoprobes for the first quarter of 2026 has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, management and is based upon Company estimates and remains subject to, among other things, the completion of IceCure's quarterly financial closing procedures and final adjustments, which may impact the results and expectations set forth above.

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: the expected increase in U.S. revenue of ProSense® systems and cryoprobes in the first quarter of 2026 compared to the first quarter of 2025, which are subject to, among other things, the completion of IceCure's quarterly financial closing procedures and final adjustments, which may impact the results and expectations set forth above; the Company's expectations regarding closing new system sales in the second quarter of 2026; the Company's belief that commercial momentum reflects a meaningful shift in the treatment landscape for early-stage breast cancer; the potential for cryoablation to become a standard-of-care option for indicated patients; and the Company's expectations regarding the timing of reporting its full operating and financial results for the first quarter of 2026. 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:

E-mail: investors@icecure-medical.com

Michael Polyviou

Phone: 732-232-6914

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SOURCE IceCure Medical

FAQ

How much did IceCure (ICCM) say U.S. ProSense revenue grew in Q1 2026?

IceCure reported a preliminary, unaudited increase of more than 30% in U.S. ProSense revenue for Q1 2026 versus Q1 2025. According to the company, this reflects early commercial uptake after FDA clearance in October 2025.

What FDA clearance did IceCure (ICCM) receive for ProSense and when?

ProSense received FDA clearance in October 2025 for local treatment of low-risk breast cancer in women aged 70 and above. According to the company, this clearance supported U.S. commercial adoption in early 2026.

What did the Massachusetts General Hospital study presented at SBI 2026 find about ProSense cost?

The study showed cryoablation may reduce total treatment costs by more than 50% versus breast-conserving surgery. According to the company, the abstract won the Wendell Scott Research Award at SBI 2026.

Will IceCure report final Q1 2026 financial results and when?

IceCure expects to release full Q1 2026 operating and financial results on May 14, 2026. According to the company, conference call and webcast details will follow in early May.

How did IceCure participate at SBI 2026 and what was covered?

IceCure exhibited ProSense and ran a hands-on physician training workshop at SBI 2026 (April 16–19, 2026). According to the company, sessions covered procedural technique, diagnostics, and implementation best practices.

Are the reported Q1 2026 ProSense revenue figures final and audited for ICCM?

No, the company describes the Q1 2026 U.S. revenue figures as preliminary and unaudited and subject to final closing adjustments. According to the company, final results may change after quarterly close procedures.