U.S. FDA Approves IceCure's Post-Marketing "ChoICE" Study for ProSense® Cryoablation in the Local Treatment of Low-Risk Breast Cancer

Rhea-AI Summary

IceCure (Nasdaq: ICCM) announced that the U.S. FDA approved the study design for the ChoICE Trial Post-Market Study of ProSense® cryoablation for low-risk breast cancer.

Key points: FDA marketing authorization was granted in October 2025 for patients ≥70 with tumors ≤1.5 cm; enrollment is expected to start in H2 2026, targeting ~400 patients across 30 U.S. sites within 36 months, with at least 80 patients in year one. The Study will use IceCure-exclusive cryoprobes and sites may treat non-study patients commercially; procedures are eligible for CPT Category III reimbursement (about $4,000 facility fee).

Positive

• FDA marketing authorization granted in Oct 2025 for ProSense® in defined low-risk patients
• FDA approved the ChoICE post-market study design enabling U.S. commercialization data collection
• Study scale: ~400 patients across 30 U.S. sites within 36 months
• Study model allows participating sites to provide commercial cryoablation to non-study patients
• Procedures eligible for CPT Category III reimbursement, approximately $4,000 facility fee

Negative

• Regulatory indication limited to patients aged 70+ with tumors ≤1.5 cm
• Full study enrollment stretched over 36 months, which may delay broader real-world evidence
• Initial commercial exposure relies on use of cryoprobes sold exclusively by IceCure

News Market Reaction – ICCM

+8.87%

5 alerts

+8.87% News Effect

+8.6% Peak in 1 min

+$4M Valuation Impact

$49M Market Cap

0.6x Rel. Volume

On the day this news was published, ICCM gained 8.87%, reflecting a notable positive market reaction. Argus tracked a peak move of +8.6% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $4M to the company's valuation, bringing the market cap to $49M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Year 1 enrollment: 80 patients Total study size: 400 patients Clinical sites: 30 sites +5 more

8 metrics

Year 1 enrollment 80 patients Expected to be enrolled in first year of ChoICE Study

Total study size 400 patients Planned enrollment across U.S. clinical sites within 36 months

Clinical sites 30 sites U.S. locations participating in the post‑market ChoICE Study

Study duration 36 months Timeline to enroll and treat patients in the ChoICE Study

Approved age group 70+ years Patients eligible under prior FDA marketing authorization

Tumor size limit ≤1.5 cm Biologically low-risk tumors treated under FDA authorization

Facility reimbursement $4,000 facility fee CPT Category III code reimbursement for study procedures

CPT code type CPT Category III Reimbursement designation available to participating facilities

Market Reality Check

Price: $0.6900 Vol: Volume 84,843 is 0.54x th...

low vol

$0.6900 Last Close

Volume Volume 84,843 is 0.54x the 20-day average of 155,741, indicating relatively light pre-news trading. low

Technical Price at 0.6145 is below the 200-day MA of 0.83 and about 59.84% under the 52-week high.

Peers on Argus

Momentum scanner shows 5 healthcare/medical peers moving, with 3 up and 2 down (...

3 Up 2 Down

Momentum scanner shows 5 healthcare/medical peers moving, with 3 up and 2 down (sector summary notes median move -5.2%). Names like APYX and LUNG appear in momentum, suggesting broader sector dynamics rather than a purely isolated move.

Previous Fda approval Reports

5 past events · Latest: May 06 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
May 06	ASBrS interest update	Positive	+0.9%	Surgeon interest at ASBrS 2025 after positive FDA developments and ICE3 recognition.
Apr 30	FDA path update	Positive	-0.8%	Progress with FDA on De Novo path and planned 400-patient post-market study.
Mar 20	Timeline extension	Positive	-15.5%	Update on extended FDA decision timeline despite prior favorable advisory vote.
Feb 04	SIO meeting data	Positive	+1.6%	Strong independent data and awards for ProSense® as FDA decision anticipated.
Nov 08	FDA panel vote	Positive	-11.7%	Advisory panel 9–5 vote in favor of ProSense® benefit‑risk profile.

Pattern Detected

FDA-related headlines have often been positive but followed by mixed-to-negative next-day moves, with 3 of 5 such events trading down despite constructive regulatory progress.

Recent Company History

Over the past year, ICCM’s key milestones around FDA engagement for ProSense® have included an advisory panel vote in November 2024, timeline updates in March 2025, and subsequent positive interactions outlining a post-market study of 400 patients across 25 sites. Later 2025 updates at ASBrS highlighted strong physician interest. Today’s FDA-approved post‑marketing "ChoICE" study design continues this regulatory progression for low‑risk breast cancer treatment.

Historical Comparison

-5.1% avg move · FDA-approval-related headlines for ICCM have averaged a -5.1% next-day move, even when updates were ...

fda approval

-5.1%

Average Historical Move fda approval

FDA-approval-related headlines for ICCM have averaged a -5.1% next-day move, even when updates were positive. The ChoICE post‑marketing study approval fits this ongoing regulatory and post‑market evidence-building arc.

FDA engagement progressed from advisory panel support to defined De Novo pathway, then to commitments for a 400-patient post‑market study. The newly approved ChoICE post‑marketing protocol marks execution of that plan for low‑risk breast cancer.

Market Pulse Summary

The stock moved +8.9% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +8.9% in the session following this news. A strong positive reaction aligns with the strategic significance of FDA-approved post‑marketing evidence generation. The ChoICE Study targets 400 patients across 30 sites over 36 months, all using company-supplied cryoprobes under a reimbursed CPT Category III pathway. Historically, FDA-related headlines averaged about -5.1%, so any large upside move would contrast prior mixed reactions.

Key Terms

cryoablation, post-market study, post-market surveillance study, adjuvant endocrine therapy, +4 more

8 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.

post-market study regulatory

"participate in the post-market study with the FDA-cleared ProSense"

A post-market study is research conducted after a medical product or device has been approved and is being sold, designed to track how it performs in everyday use, monitor side effects, and gather longer-term safety or effectiveness data. For investors, these studies function like follow-up reports that can confirm a product’s real-world value or reveal problems that affect sales, regulatory standing, and future revenue—think of it as a customer satisfaction and safety check that can change a company’s financial outlook.

post-market surveillance study regulatory

"the FDA requested that IceCure conduct a post-market surveillance study"

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.

adjuvant endocrine therapy medical

"tumors ≤1.5 cm in size who are treated with adjuvant endocrine therapy"

A course of hormone-blocking medication given after initial cancer treatment (surgery, radiation or chemotherapy) to lower the chance the tumor will return in cancers that grow in response to hormones such as estrogen or progesterone. It matters to investors because these therapies are taken long-term like an insurance policy against recurrence, so changes in guidelines, patent status, or safety data can materially affect drug sales, market size and reimbursement.

CPT Category III regulatory

"facilities will be able to use CPT Category III reimbursement code"

CPT Category III codes are temporary billing labels used to identify and track new or experimental medical procedures, services, or technologies while evidence about their safety, usefulness, and cost is being collected. For investors, these codes matter because they help measure real-world adoption and outcomes—similar to a temporary product barcode that lets payers and hospitals gather data before deciding on permanent coverage and reimbursement, which can influence revenue prospects for healthcare companies.

Centers for Medicaid and Medicare Services regulatory

"under the established Centers for Medicaid and Medicare Services CPT Category III code"

The Centers for Medicare & Medicaid Services is the U.S. federal agency that runs the country’s major public health insurance programs and sets rules for how providers, drug makers, and insurers get paid. Think of it as a large payer and rule-maker: its coverage decisions, reimbursement rates and regulatory guidance directly affect healthcare companies’ revenues, pricing and market access, so investors watch CMS actions for potential impact on profits and growth.

facility fee financial

"CPT Category III code, which provides approximately $4,000 for the facility fee alone"

A facility fee is a charge billed by a hospital or clinic for use of its buildings, equipment and support services when a patient receives care, separate from the fee paid to the treating doctor. For investors, it matters because these charges are a steady revenue stream that can boost margins and cash flow, but they are also sensitive to changes in insurance reimbursement rules and regulatory scrutiny—think of it as a venue rental fee separate from the performer’s paycheck.

minimally invasive medical

"minimally invasive treatment option for eligible breast cancer patients"

Medical procedures described as minimally invasive use small cuts, flexible tubes or tiny cameras to treat or diagnose problems with far less cutting than traditional surgery — like using a keyhole instead of tearing down a wall. Investors care because these approaches can shorten hospital stays, lower complication rates and change equipment and reimbursement needs, which can speed adoption and reshape market demand for devices, supplies and services.

AI-generated analysis. Not financial advice.

IceCure is engaged with leading medical institutions throughout the U.S. looking to participate in the post-market study with the FDA-cleared ProSense®

Clinical study sites may offer ProSense® cryoablation to additional patients not enrolled in the study, supporting its potential broader commercial adoption

Post-market study will be conducted using cryoprobes sold exclusively by IceCure and facilities will be able to use CPT Category III reimbursement code

CAESAREA, Israel, March 11, 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 the U.S. Food and Drug Administration ("FDA") has approved the study design for the "ChoICE Trial Post-Market Study," the Company's post-marketing study for ProSense® in the treatment of low-risk breast cancer (the "Study"). Patient enrollment is expected to commence in the second half of 2026, with at least 80 patients expected to be enrolled in the first year of the Study.

The FDA previously granted marketing authorization in October 2025 for ProSense® for the treatment of patients aged 70 years and older with biologically low-risk tumors ≤1.5 cm in size who are treated with adjuvant endocrine therapy. In connection with its grant of marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study to generate additional real-world data regarding the use of ProSense® in this indication.

The Study is expected to enroll and treat approximately 400 patients across 30 clinical sites in the U.S. within 36 months. IceCure has already received interest and engagement from leading medical institutions across the country seeking to participate in the Study. Under the approved study design, participating sites will treat enrolled patients while also serving as active commercial sites, providing cryoablation to patients outside of the study, thereby supporting the Company's commercial expansion. The Study will be conducted using cryoprobes sold exclusively by IceCure and facilities will be able to use an established CPT Category III reimbursement code.

"We believe the combination of FDA marketing authorization, this FDA-approved post-market study with 30 clinical sites across the country, supportive American Society of Breast Surgeons ('ASBrS') guidelines, an established reimbursement code, and strong physician engagement positions us to meaningfully expand access to ProSense® as a minimally invasive treatment option for eligible breast cancer patients across the U.S.," stated Eyal Shamir, Chief Executive Officer of IceCure. "We are also very pleased to work with two leading thought leaders in breast cancer treatment, Dr. Robert Ward and Dr. Nathalie Johnson, who will be Co-Principal Investigators of the Study."

Robert C. Ward, M.D., is a specialist in women's imaging and breast tumor cryoablation. Dr. Ward is an experienced clinical investigator who has authored and co-authored several publications on breast cancer cryoablation and is a skilled ProSense® user. He is Assistant Professor of Diagnostic Imaging and Program Director for the Breast Imaging Fellowship at the Warren Alpert Medical School at Brown University, and Associate Chief of Diagnostic Imaging at Women & Infants Hospital of Rhode Island.

Nathalie McDowell Johnson, M.D., FACS, is Senior Medical Director of the Legacy Health Systems Cancer Institute and Legacy Breast Health Centers in Portland, Oregon. Dr. Johnson is the former President of the ASBrS and is an avid supporter of expanding minimally invasive treatment options for breast cancer patients.

Study procedures are eligible for reimbursement under the established Centers for Medicaid and Medicare Services CPT Category III code, which provides approximately $4,000 for the facility fee alone. IceCure believes the existing reimbursement framework may support reimbursement claims for study procedures, and that additional reimbursement pathways may develop over time, particularly in light of the recent FDA marketing authorization and inclusion of cryoablation for breast cancer in the updated ASBrS resource guide.

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 commencement of patient enrollment in the Study in the second half of 2026; the anticipated enrollment of at least 80 patients in the first year of the study and approximately 400 patients across 30 clinical sites within 36 months; the belief that the combination of FDA marketing authorization, the post-market study, ASBrS guidelines, established reimbursement codes, and physician engagement may support broader access to ProSense® as a minimally invasive treatment option for eligible breast cancer patients; the expectation that participating clinical sites will serve as active commercial sites supporting the Company's commercial expansion; the belief that the existing CPT Category III reimbursement framework may support reimbursement claims for study procedures; and the expectation that additional reimbursement pathways may develop over time in light of the FDA marketing authorization and updated ASBrS resource guide. 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.

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

IR Contact:
Michael Polyviou 
investors@icecure-medical.com
732-232-6914

View original content:https://www.prnewswire.com/news-releases/us-fda-approves-icecures-post-marketing-choice-study-for-prosense-cryoablation-in-the-local-treatment-of-low-risk-breast-cancer-302710919.html

SOURCE IceCure Medical

FAQ

What did IceCure (ICCM) announce about the FDA-approved ChoICE post-market study?

The company announced FDA approval of the ChoICE Trial post-market study design for ProSense®. According to IceCure, the Study plans to enroll about 400 patients at 30 U.S. sites over 36 months, with enrollment starting in the second half of 2026.

When will patient enrollment for IceCure's (ICCM) ChoICE Trial begin and how many in year one?

Enrollment is expected to begin in the second half of 2026. According to IceCure, the company expects at least 80 patients to be enrolled in the first year of the Study as sites activate.

What population is ProSense® approved for under IceCure's FDA authorization (ICCM)?

ProSense® has FDA marketing authorization for patients aged 70 and older with biologically low-risk tumors ≤1.5 cm. According to IceCure, this is the specific patient population covered by the October 2025 authorization.

How will reimbursement work for ProSense® procedures in the IceCure (ICCM) Study?

Study procedures are eligible under an established CPT Category III code with facility reimbursement. According to IceCure, the CPT Category III code provides about $4,000 for the facility fee alone.

Will participating sites in IceCure's (ICCM) ChoICE Trial be allowed to treat non-study patients?

Yes. Participating clinical sites may offer ProSense® to patients outside the Study as active commercial sites. According to IceCure, this dual role is intended to support commercial expansion alongside study enrollment.

What is the scale and timeline of IceCure's (ICCM) ChoICE post-market study?

The Study targets roughly 400 patients across 30 U.S. sites over a 36-month period. According to IceCure, this timeline reflects the expected duration to enroll and treat the planned patient cohort.