IceCure’s ProSense Breast Cancer Treatment Receives Landmark FDA Approval
5 October, 2025
The FDA approval makes ProSense the first cryoablation-based treatment authorized for breast cancer. IceCure gains at least a five-year competitive edge as it prepares for U.S. commercialization
Israel’s IceCure Medical, developer of a minimally invasive system that destroys cancerous tumors by freezing them with liquid nitrogen, announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for its ProSense cryoablation system to treat breast cancer. The indication covers women aged 70 and above diagnosed with early-stage, low-risk breast cancer. According to the company, approximately 36,000 women in the U.S. are diagnosed each year with this specific subtype of the disease.
The approval marks the most significant regulatory milestone in IceCure’s history and represents the first and only cryoablation-based treatment ever approved by the FDA for breast cancer. Following the announcement, the company’s shares surged more than 17% in after-hours trading on Nasdaq.
The FDA’s decision is based on results from IceCure’s ICE3 clinical trial, the largest study ever conducted to evaluate cryoablation for early-stage breast cancer. The five-year trial, held at 19 medical centers across the U.S., enrolled 206 women with low-risk tumors. The results showed a 96.3% rate of no local recurrence, no serious device-related adverse events, and high patient satisfaction, including excellent cosmetic outcomes. The findings were published in the Annals of Surgical Oncology and formed a key part of the FDA’s decision-making process.
A Five-Year Competitive Advantage
The approval followed a vote by a special FDA Advisory Panel convened specifically for this purpose. The panel determined that any competitor seeking to market a similar system will not be eligible for the FDA’s 510(k) clearance pathway, and will instead need to conduct its own clinical trial with supporting data. This effectively grants IceCure a competitive advantage of at least five years over potential rivals.
Following the approval, IceCure is establishing a U.S. sales team to support commercial rollout. As part of the FDA’s requirements, the company will conduct a Post-Market Study after product launch. IceCure considers this an advantage, as the study will be carried out in collaboration with leading medical institutions across the United States, accelerating adoption of the technology in clinical settings.
IceCure’s system already holds a CPT3 reimbursement code that provides initial insurance coverage for the procedure, a move expected to ease adoption among hospitals and physicians. The ProSense system is also CE-marked in Europe and approved by Israel’s Ministry of Health, but the company expects the FDA authorization to further drive adoption in existing markets and assist in securing regulatory approval in Japan, one of its key target markets.
In an interview with Techtime, IceCure CEO Eyal Shamir said:
“Our main focus in recent years has been breast cancer, as our system offers clear technological and economic advantages in this indication. This approval is a breakthrough not only for IceCure but for the entire field of breast cancer care. Now that we’ve achieved regulatory clearance, we are entering the execution phase and plan to accelerate commercialization in the U.S. Our treatment provides a non-surgical alternative for women over 70 diagnosed with early-stage breast cancer.”
Liquid Nitrogen Delivered Directly to the Tumor
Founded in 2006, IceCure developed a system based on cryoablation technology, which eradicates tumors through controlled freezing. The minimally invasive procedure involves inserting a thin, ultrasound-guided needle—protected by 11 patents—directly into the tumor. Once in position, liquid nitrogen is circulated through the tip, freezing and destroying the cancerous tissue while preserving the surrounding healthy tissue.
The procedure typically lasts 20 to 40 minutes, requires only local anesthesia, and does not need an operating room. Unlike competing cryoablation systems that rely on expensive noble gases such as argon or helium—with smaller freezing zones that require multiple probes—ProSense uses liquid nitrogen, allowing for a wider treatment area, fewer probes, and lower costs.
Cryoablation is particularly effective for early-stage tumors, making early diagnosis essential for treatment success. In recent years, IceCure has focused its business and clinical strategy on early-stage breast cancer, believing the company’s technology offers the strongest therapeutic and cosmetic advantages—achieving high recovery rates while eliminating the need for partial mastectomy and preserving the natural appearance of the breast.
Posted in tags: breast cancer , FDA , IceCure
