IceCure's Cryoablation Gains Steam as Non-Surgical Cancer Option

CAESAREA, Israel – December 10, 2025 – A significant shift may be underway in the fight against breast cancer, moving from the operating room to the outpatient clinic. At the world's largest radiology conference this month, a wave of new data highlighted the growing efficacy of a minimally invasive tumor-freezing technology, signaling a potential new standard of care for a specific and vulnerable patient population. The focus of this attention is IceCure Medical's (NASDAQ: ICCM) ProSense® system, a cryoablation technology that destroys tumors by encasing them in ice.

The recent Radiological Society of North America (RSNA) Annual Meeting in Chicago served as a powerful validation platform for the Israeli medtech company. Four independent studies featuring ProSense® were presented, adding to a mounting body of evidence that is critical for translating an innovative prototype into a commercially viable and widely adopted medical procedure. For the many women who are not suitable for surgery or who seek less invasive alternatives, this technology represents a significant step forward.

"The broad range of independent studies conducted, peer reviewed, published and presented by ProSense® users supports the widescale adoption of our cryoablation system and is highly encouraging for women who seek a non-surgical option," said Eyal Shamir, IceCure's Chief Executive Officer, in a statement accompanying the news.

A Wave of Clinical Validation

For any new medical device to cross the chasm from niche technology to mainstream adoption, it must be backed by robust, independent clinical evidence. The data presented at RSNA, which draws approximately 50,000 medical professionals from across the globe, provides exactly that. The findings from European researchers underscore the system's potential, particularly for elderly patients or those with comorbidities that make traditional surgery too risky.

One pivotal study from Spain involved 73 women, with a median age of 87, who were considered inoperable or elected not to undergo surgery. The results were striking: for patients with luminal breast cancer tumors—the most common type—up to 2.5 cm in size, the percutaneous cryoablation (PCA) procedure was 100% successful in destroying the tumor. The procedure was well tolerated, performed under local anesthesia, and had no major complications reported over a mean follow-up of nearly 20 months.

Another compelling study from Italy evaluated 111 surgery-ineligible patients to determine the most effective non-surgical approach. Researchers compared three groups: patients receiving cryoablation combined with hormonal therapy (HT), cryoablation alone, and hormonal therapy alone. The combination of ProSense® cryoablation with HT proved significantly superior, achieving an average tumor size reduction of 83.3%. This was nearly double the reduction seen in the HT-only group (42.1%). Furthermore, complete remission was observed in 74.4% of patients in the combination group, compared to just 36.1% in the HT-only group. The researchers concluded that the addition of cryoablation provides significant value over hormonal therapy alone.

Two other presentations focused on refining the post-procedure follow-up, demonstrating how advanced imaging like Contrast-Enhanced Mammography (CEM) can effectively assess treatment success without the need for an invasive biopsy, further enhancing the minimally invasive nature of the entire care pathway.

From Clinical Trial to Market Approval

While the RSNA presentations provide crucial momentum, the most significant commercialization milestone for IceCure came just two months prior. On October 3, 2025, the U.S. Food and Drug Administration (FDA) granted De Novo marketing authorization for ProSense®. This decision officially moved the technology from an investigational device to a commercially available treatment option in the United States, making it the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer.

The authorization is highly specific, targeting women aged 70 and older with biologically low-risk, early-stage (ER+, PR+, HER2-) breast cancer tumors measuring up to 1.5 cm. The indication is for use with adjuvant endocrine therapy, aligning with the findings of the Italian study. This regulatory green light was not granted lightly; it was supported by years of data from the landmark ICE3 clinical trial, the largest multi-center study ever completed for liquid-nitrogen-based cryoablation in this patient group. The ICE3 trial demonstrated a 96.3% local recurrence-free rate, proving the treatment's efficacy is comparable to surgical lumpectomy for this population.

This FDA authorization is a game-changer, creating a new treatment paradigm and providing IceCure with a formidable competitive advantage. The De Novo classification sets a high bar for competitors, who will now likely be required to submit five years of follow-up data to gain similar 510(k) marketing authorization.

Navigating the Path to Widespread Adoption

The journey from prototype to profit is paved with regulatory approvals but funded by reimbursement. Gaining FDA authorization is only half the battle; securing payment from insurers is the critical next step for widespread adoption. IceCure has been strategically laying this groundwork for years.

The procedure for breast cancer cryoablation is tracked under a Category III CPT code (0581T), which is designated for emerging technologies to allow for data collection and analysis. A pivotal moment occurred when the Centers for Medicare & Medicaid Services (CMS) assigned this code to an ambulatory payment classification, enabling healthcare facilities to bill for the procedure for Medicare patients, effective January 1, 2023.

However, challenges remain. Category III codes do not guarantee automatic reimbursement from private payers, who often require prior authorization and may deny claims based on their own coverage policies. This uncertainty can make providers hesitant to offer the procedure outside of a cash-pay model. Yet, the combination of a formal FDA marketing authorization and a growing mountain of positive clinical data, like that presented at RSNA, provides the necessary ammunition for providers to successfully appeal denials and for IceCure to lobby payers for more consistent coverage.

As part of its FDA authorization, IceCure is required to conduct a post-market surveillance study involving approximately 400 patients across 30 sites. This not only gathers more long-term data but also strategically transforms these study sites into active commercial centers, accelerating physician training and patient access across the country.

Redefining Patient Care and the Competitive Edge

Beyond the financials and regulatory mechanics, the rise of ProSense® speaks to a broader trend in oncology: a deliberate shift toward de-escalation of treatment and a greater focus on patient quality of life. For decades, the standard of care for early-stage breast cancer has been surgery. Cryoablation offers a profound alternative.

The procedure itself is remarkably less burdensome. Performed in an office or outpatient setting under local anesthesia, it involves inserting a thin probe into the tumor under ultrasound guidance. Liquid nitrogen is then circulated through the probe, creating an ice ball that engulfs and destroys the cancerous tissue. Patients can typically return to normal activities within a day, a stark contrast to the weeks of recovery often required after a lumpectomy.

This less-invasive approach preserves the cosmetic appearance of the breast and avoids the risks associated with anesthesia and surgery. Studies have shown that patients who undergo cryoablation report significantly higher satisfaction with their treatment outcomes compared to those undergoing traditional breast-conserving surgery. For an elderly patient, avoiding the physical trauma of surgery can be the determining factor in maintaining their independence and overall health.

The confluence of these factors—strong and consistent clinical validation, a landmark FDA approval creating a high regulatory barrier for competitors, a nascent but developing reimbursement pathway, and immense patient-centric benefits—is positioning IceCure Medical to turn its innovative technology into a true commercial success. ProSense® is no longer just a promising prototype; it is an authorized, validated, and increasingly accessible tool that is freezing out cancer and reshaping the future of breast cancer treatment.