IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas

Rhea-AI Summary

IceCure Medical (Nasdaq: ICCM) announced publication in PLOS One of an independent study showing ProSense® cryoablation is safe and effective for breast fibroadenomas.

The study reported a median volume reduction of 80.6% at ~6 months and 92.9% at one year, evaluated larger lesions using up to three cryoprobe relocations, and notes ProSense® has FDA clearance for fibroadenomas.

Positive

• Median volume reduction 92.9% at one year
• Median volume reduction 80.6% at ~6 months
• Study evaluates larger lesions with multiple cryoprobe relocations
• ProSense has FDA clearance for fibroadenomas
• Estimated U.S. addressable cases: ~63,000 excisions annually

Negative

• Study is a retrospective analysis, limiting evidence strength
• Single-center data from Hungary may limit global generalizability
• No randomized control arm reported in the study

Key Figures

Volume reduction at 1 year: 92.9% Volume reduction ~6 months: 80.6% Fibroadenoma prevalence: Up to 10% of women +3 more

6 metrics

Volume reduction at 1 year 92.9% Fibroadenoma volume reduction one-year post-cryoablation with ProSense

Volume reduction ~6 months 80.6% Median fibroadenoma volume reduction at approximately six months

Fibroadenoma prevalence Up to 10% of women Women expected to have a fibroadenoma during their lives

Addressable cases 63,000 cases Estimated annual U.S. fibroadenoma excision cases addressable by cryoablation

Lesion size in prior studies 4 centimeters Upper lesion size limit often used in prior fibroadenoma cryoablation studies

Cryoprobe relocations Up to three times Maximum ProSense cryoprobe relocations per patient per procedure

Market Reality Check

Price: $0.5778 Vol: Volume 219,598 vs 20-day ...

normal vol

$0.5778 Last Close

Volume Volume 219,598 vs 20-day average 171,018 (relative volume 1.28x). normal

Technical Shares at 0.5778 are trading below the 200-day MA of 0.85, and 62.24% below the 52-week high.

Peers on Argus

Peer momentum data flags a non-sector move: scanner shows only WOK moving, down ...

1 Down

Peer momentum data flags a non-sector move: scanner shows only WOK moving, down 11.94%. Within healthcare device peers, moves are mixed: LUNG -1.25%, VNRX -11.25%, APYX -4.66% versus BDMD +32.89% and TELA +8.3%, suggesting stock-specific factors around this cryoablation study.

Historical Context

5 past events · Latest: Feb 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 23	Kidney trial update	Positive	+0.1%	Completed five-year follow-up in ICESECRET kidney cancer cryoablation study.
Feb 19	New site adoption	Positive	-0.1%	Thomas Hospital in Alabama installed ProSense for breast cancer cryoablation.
Feb 11	New site adoption	Positive	-1.8%	Shero Imaging became first Missouri provider for ProSense breast cryoablation.
Feb 09	CFO transition	Neutral	+1.8%	Planned departure of long‑tenured CFO with succession search underway.
Jan 28	Guideline inclusion	Positive	+0.0%	ASBrS draft guidelines proposed cryoablation for select low‑risk breast cancer.

Pattern Detected

ICCM often shows muted or negative next-day moves even on positive clinical and commercial updates, with several recent supportive ProSense news items followed by flat or negative price reactions.

Recent Company History

Over recent months, ICCM news has focused on expanding clinical evidence and adoption of ProSense®. On Jan 28, inclusion of cryoablation in proposed ASBrS guidelines highlighted growing acceptance. Subsequent releases in February detailed new breast cancer sites in Alabama and Missouri and a five-year kidney cancer follow-up, all reinforcing safety and efficacy. A CFO transition was also announced. Today’s fibroadenoma study adds further peer‑reviewed support to this accumulating clinical and commercial narrative.

Market Pulse Summary

This announcement highlights independent, peer‑reviewed evidence that ProSense® cryoablation achieve...

Analysis

This announcement highlights independent, peer‑reviewed evidence that ProSense® cryoablation achieved a 92.9% fibroadenoma volume reduction at one year and 80.6% at six months, addressing an estimated 63,000 U.S. excision cases annually. It reinforces a broader clinical evidence base across benign breast disease. In evaluating the impact, investors may track future guideline updates, additional investigator‑initiated studies, and how effectively IceCure converts growing scientific support into commercial installations and procedure volumes.

Key Terms

cryoablation, fibroadenomas, core needle biopsy, benign breast lesion

4 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.

fibroadenomas medical

"ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas"

Fibroadenomas are common, non-cancerous lumps in breast tissue made of gland and fibrous tissue; they feel like a firm, movable knot under the skin, similar to finding a harmless bump in fabric. They matter to investors because their prevalence and management influence demand for diagnostic imaging, biopsy tools, surgical procedures and follow-up care, and can affect clinical trial design, regulatory attention and revenue for companies selling breast-health products.

core needle biopsy medical

"Fibroadenoma is the most common benign breast lesion identified through core needle biopsy."

A core needle biopsy is a medical procedure that uses a hollow needle to remove a small, cylinder-shaped sample of tissue from an organ or suspicious lump so doctors can examine it under a microscope. Think of it like taking a small core sample of soil to learn what's below the surface. For investors, results and usage affect diagnostic accuracy, treatment decisions, demand for biopsy devices and lab services, clinical trial enrollment, and potential reimbursement and regulatory outcomes.

benign breast lesion medical

"Fibroadenoma is the most common benign breast lesion identified through core needle biopsy."

A benign breast lesion is a non‑cancerous change or growth in breast tissue—similar to a harmless lump or skin mole—that does not invade surrounding tissue or spread elsewhere. It matters to investors because its diagnosis and management drive demand for imaging, biopsy services, pathology, and follow‑up care, and can affect healthcare costs, reimbursement, product sales and the pipeline for diagnostic or treatment technologies.

AI-generated analysis. Not financial advice.

Treatment with ProSense® resulted in 92.9% volume reduction of fibroadenoma one-year post-cryoablation

Findings may impact treatment guidelines issued by medical societies for large non-cancerous breast tumors; study is believed to be the first to evaluate larger lesions and use multiple cryoprobe relocations

ProSense® Cryoablation has FDA-clearance for fibroadenomas

CAESAREA, Israel, March 2, 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 the publication of an independent, investigator-initiated study evaluating ProSense® for the treatment of non-cancerous breast tumors,  or fibroadenomas. The study, titled "Cryoablation for fibroadenoma with liquid nitrogen-based system: A retrospective analysis of prospectively collected data," was published in the peer-reviewed journal PLOS One.

Fibroadenoma is the most common benign breast lesion identified through core needle biopsy. Up to 10% of women will have a fibroadenoma at some point in their lives, according to the Cleveland Clinic. Surgical excision is currently the standard of care for many fibroadenomas, particularly for larger lesions or those causing discomfort. IceCure estimates that cryoablation could address approximately 63,000 cases of fibroadenoma excision in the U.S. annually.  

"We believe this publication is very significant because it reinforces the safety and effectiveness of ProSense® cryoablation for fibroadenomas and may contribute to updates in treatment guidelines for non-cancerous breast tumors issued by medical societies in key markets where ProSense® is used, including the American Society of Breast Surgeons," said Eyal Shamir, IceCure's Chief Executive Officer. "Previous studies supporting cryoablation for fibroadenomas were often limited to lesions 4 centimeters or smaller, and many were published more than a decade ago. This study is unique in that it includes a large patient cohort and evaluates larger lesions using multiple cryoprobe relocations. We are grateful to the study's investigators for their pursuit of improved outcomes for patients and their use of ProSense® for their study."

The study was conducted at the Premier Med Healthcare, Training, and Research Institute in Hungary and led by Dr. Teodora Filipov and Dr. Pál Ákos Deák. The investigators concluded that cryoablation with a liquid nitrogen system, specifically ProSense®, proved safe and effective, demonstrating a median volume reduction of 80.6% at approximately six months and 92.9% at one-year post-treatment. The study further found that sequential cryoprobe relocations preserve safety and efficacy. ProSense® cryoprobes can be relocated up to three times per patient, per procedure enabling physicians to fully treat large or multifocal lesions through complete ablation coverage.

IceCure believes these findings further support the growing clinical adoption of minimally invasive cryoablation as an alternative to surgical excision for benign breast tumors, particularly for women seeking minimal scarring and short procedure times.

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 United States, 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 number of cases of fibroadenoma excision that cryoablation could address in the U.S. annually; the potential impact of the study's findings on future treatment guidelines for non-cancerous breast tumors; the possibility that the results may contribute to updates by medical societies such as the American Society of Breast Surgeons; and the expectation that these findings will further support the growing clinical adoption of ProSense as an alternative to surgical excision for benign breast tumors. 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 U.S. Securities and Exchange Commission ("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

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SOURCE IceCure Medical

FAQ

What did IceCure (ICCM) report about ProSense cryoablation on March 2, 2026?

IceCure reported publication of an independent PLOS One study showing ProSense cryoablation is safe and effective for fibroadenomas, with median volume reductions of 80.6% at ~6 months and 92.9% at one year, according to the company.

How effective was ProSense cryoablation for fibroadenomas in the PLOS One study (ICCM)?

The study found median volume reduction of 92.9% at one year and 80.6% at ~6 months, indicating substantial lesion shrinkage; according to the company, results came from a large cohort using multiple probe relocations.

Does ProSense have regulatory clearance for treating fibroadenomas (ICCM)?

Yes. ProSense cryoablation has FDA clearance for fibroadenomas, and the company said the published study supports its safety and effectiveness for non-cancerous breast tumors in clinical use.

What is unique about the PLOS One fibroadenoma study using ProSense (ICCM)?

The study evaluated larger lesions and used up to three sequential cryoprobe relocations per procedure, which the investigators said preserved safety and efficacy, according to the company.

How many U.S. fibroadenoma excisions could cryoablation address according to IceCure (ICCM)?

IceCure estimates cryoablation could address approximately 63,000 U.S. fibroadenoma excisions annually, suggesting a sizable addressable procedure volume if adopted more widely, according to the company.