What Does Breast Cancer Cryoablation (ProSense®) Cost?

Capital equipment, disposables, reimbursement, and total cost of care—organized by procurement scenarios

The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above , with FDA approval announced in October 2025 . Hospitals and ASCs evaluating this system need to factor capital equipment cost, per-procedure consumables, installation, training, service contracts, and the reimbursement landscape—which remains uneven. MedSource currently has limited aggregate quote data for ProSense; this article reflects publicly available pricing and will be updated as purchasing data accumulates.

What the typical range is

Retail prices for cryoablation devices vary from US$35,000 to US$125,000 and depreciate according to a standard schedule . Probe prices range from US$1000 to US$1500 each . Because ProSense is newly cleared and IceCure has not published an official list price, institutional quotes will be your only reliable source. Assume $50,000–$90,000 as a conservative opening range for the ProSense capital system pending direct vendor quotes.

Liquid nitrogen is inexpensive, with a cost of less than US$1/L, and is easy to obtain through a specialty gas provider , making ongoing consumable costs substantially lower than argon-based competitors. Per-case cryoprobe cost is typically $1,000–$1,500 per procedure; cryoprobes are sold exclusively by IceCure , ensuring margin control but limiting competition on supplies.

What pushes price up — features, certifications, support tier

Single-probe efficiency: ProSense's single cryoprobe system is more efficient and as effective in treating the same tumor as three cryoprobes in a multiprobe system, designed uniquely as a single cryoprobe system . This reduces per-case supply consumption but does not change capital cost.

FDA Class II with special controls: ProSense Cryoablation System can be classified in class II with the establishment of special controls . The FDA requires the company to conduct post-market clinical validation performance testing of the ProSense Cryoablation System in patients to assess long-term tumor recurrence and other serious adverse events . This post-market obligation may influence manufacturer pricing strategy but does not directly change institutional purchase cost.

Liquid nitrogen infrastructure advantage: ProSense eliminates the need for specific safety rooms for large and hazardous high-pressure cylinder tanks of argon-based systems to allow for office-based or radiology rooms . Facilities already equipped for standard cryogenic storage avoid expensive room modifications. Newly built programs may see modest reductions in facilities cost vs. argon systems.

Training and credentialing tiers: Manufacturers typically offer tiered training packages (basic, advanced, multi-site). Expect $5,000–$15,000 per institution for initial physician credentialing and staff training.

What pushes price down — refurbished, older generation, lease, GPO contracts

Lease vs. purchase: Cryoablation devices may be purchased, leased, or obtained through participation in a research trial . Generally, the study sponsor will cover the associated treatment costs for patients in clinical trials based on the negotiated contract. In these cases, any costs associated with off-trial use will be covered by the institution . Leasing spreads capital expense over 3–5 years and transfers maintenance risk; expect 20–30% higher lifetime cost but improved cash flow predictability.

Group Purchasing Organization (GPO) contracts: IceCure has not yet published GSA or major GPO contracts. As adoption accelerates post-FDA clearance, GPO participation should emerge within 12–18 months, potentially yielding 10–20% volume discounts.

Research trial participation: The FDA-approved postmarket ChoICE study targets approximately 400 patients across 30 U.S. sites within 36 months. 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 . Trial sites receive systems at reduced or zero capital cost; equipment reverts to sponsor at study end.

Refurbished or demo units: As early adopters upgrade or trials close, used ProSense systems may enter the secondary market. Expect 25–35% discounts from new retail; verify service history and remaining shelf-life (5-year sterilization expiry applies).

Hidden costs — install, training, calibration, service contracts

Installation and validation (not always included in quoted price): $3,000–$7,000. Includes site survey, utility/cryogen delivery setup, equipment positioning, software configuration, and biomedical engineering validation. IceCure and facility teams must coordinate liquid nitrogen dewar placement and refill logistics.

Physician training and credentialing: $5,000–$15,000 depending on scope (single physician vs. multi-provider team). Clinical trial participation or manufacturer partnerships may subsidize this.

Maintenance and service contracts: Not yet publicly documented for ProSense, but industry standard for cryoablation: $2,500–$5,000/year for parts, preventive service, and emergency support. Warranty typically 1 year; extended contracts cover years 2–5.

Liquid nitrogen supply contracts: Ongoing cost. Liquid nitrogen is inexpensive, with a cost of less than US$1/L ; estimate $500–$1,500/year depending on case volume (assumes 50–100 cases annually).

Consumables per case:

• Cryoprobe: $1,000–$1,500
• Ultrasound gel, drapes, anesthetic (miscellaneous): ~$200–$400
• Total per-case variable cost: $1,200–$1,900

How to negotiate — concrete tactics

Request full pricing tiers: Ask IceCure for itemized quotes separating capital equipment, software licensing, training, service tiers, and probe pricing. Do not accept bundled quotes without line-item clarity.

Benchmark against argon systems: Even though ProSense is the only FDA-cleared breast-specific system, comparable liquid-nitrogen cryoablation devices exist for other organs (kidney, liver). Obtain competitive quotes from Boston Scientific or Galil Medical to establish range.

Volume commitments: Negotiate probe pricing on case-volume thresholds. A 50-case/year commitment should yield better unit pricing than per-order purchasing.

Service contract scope: Lock in annual maintenance fees before purchase, including travel time, parts, and 24-hour response windows. Clarify whether software updates and regulatory compliance (post-market surveillance) are manufacturer or facility responsibility.

Financing terms: Negotiate payment schedules (capital upfront vs. phased). Lease-to-own or equipment-as-a-service (not yet standard in this category) may emerge as vendor competition increases.

Post-market surveillance cost-sharing: The study targets about 400 patients across 30 U.S. sites within 36 months. A key feature is that sites will simultaneously function as commercial centers, treating study participants and additional patients with ProSense® cryoablation using cryoprobes sold exclusively by IceCure . Clarify whether participation subsidizes capital cost or defrays supply costs during the trial.

When the price feels off — red flags

Vague reimbursement promises: 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 . However, the provider fee is set to "C," which indicates that the provider fee is set at the discretion of the local Medicare administrative contractor . Vendors claiming guaranteed reimbursement rates are overselling. Physician fees remain undefined by CMS.

No mention of post-market study costs: The FDA has determined that you must collect and report post-market surveillance data acquired under anticipated conditions of use to demonstrate that the device performs as intended when used to treat the intended patient population. Specifically, you must conduct post-market clinical validation performance testing of the ProSense Cryoablation System in patients to assess long-term tumor recurrence and other serious adverse events . These data-collection, documentation, and reporting costs fall on the facility; budget $10,000–$25,000/year depending on case volume.

Equipment tied to exclusive supply agreements: Confirm that cryoprobes cannot be sourced from third parties. Cryoprobes are sold exclusively by IceCure , limiting supply negotiation. Ask for multi-year probe pricing locked in at purchase to avoid margin erosion.

No upfront clarity on liquid nitrogen sourcing: Ask whether your facility can select any medical-grade supplier or if IceCure has a preferred vendor. Centralized sourcing may increase cost.

Lack of depreciation schedule transparency: Obtain written confirmation of the 5-year shelf-life and sterilization expiry. Used or borderline-expiration units should be priced proportionally lower.

Sources

• FDA De Novo Classification, DEN220077 (ProSense Cryoablation System, Class II with special controls; March 2026)
• IceCure Medical Ltd., Press Release: "ProSense® Cryoablation Granted FDA Marketing Authorization" (October 3, 2025)
• IceCure Medical Ltd., Press Release: "FDA Approves IceCure's Post-Marketing ChoICE Study" (March 11, 2026)
• Fine RE, et al., "Cryoablation without excision for early-stage breast cancer: ICE3 trial 5-year follow-up on ipsilateral breast tumor recurrence," Annals of Surgical Oncology, 31(7273–7283) (2024)
• American Journal of Roentgenology (AJR), "Breast Cryoablation: From the AJR How We Do It Special Series" (2025)—includes device cost ranges and operational budgeting
• Boston Scientific, "Cryoablation 2025 Billing and Coding Guide" (CPT codes 0581T, 19105; facility status J1, provider status C)

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Article Status: This article reflects published ProSense specifications, FDA clearance documents, and general cryoablation market data current as of May 2026. IceCure has not released official list prices. MedSource will update pricing ranges and add aggregate institutional quotes as they become available.