What does OneRF® Trigeminal Nerve Ablation System cost?

Price-estimate guide for a newly FDA-cleared, minimally invasive pain management platform entering limited commercial availability.

The OneRF® Trigeminal Nerve Ablation System received FDA 510(k) clearance in August 2025 , and completed limited market release in March 2026 . Manufacturer list pricing for this system is not publicly available. MedSource does not yet have aggregate quote data. Based on comparable radiofrequency (RF) generator platforms and the system's architectural design, this article estimates realistic acquisition ranges—but procurement officers should treat these projections as directional only pending first-generation pricing announcements.

What the typical range is

Publicly available pricing for OneRF Trigeminal is zero. However, context matters:

Standalone RF generators typically range between $10,000 and $15,000

• The OneRF Trigeminal is a disposable-probe system that leverages the same NeuroOne Radiofrequency Generator already used in epilepsy ablation procedures, allowing existing OneRF Ablation System customers to quickly add trigeminal neuralgia treatment without additional capital investment, with each procedure utilizing a disposable kit

Realistic expectation: If your facility already owns the OneRF brain ablation RF generator (estimated $15,000–$25,000), per-procedure kit cost likely falls in the $2,000–$5,000 range for disposable probes and accessories. If buying as a standalone system entry point, expect $20,000–$35,000 for generator plus initial probe inventory. These figures are not verified against published manufacturer pricing and will be updated as quotes accrue.

What pushes price up — features, certifications, support tier

Multi-contact probe architecture

The system includes a "first-of-its-kind" multi-contact RF probe that allows for both precise localization and tailored ablation of the pain-conducting nerve tissue – using the same RF probe, and under temperature-controlled conditions which enhance safety and accuracy . This design innovation reduces the number of probe repositionings required during a procedure. Hospitals performing high-volume trigeminal ablations may justify higher equipment costs through faster OR throughput.

FDA 510(k) Class II pathway

The system received FDA 510(k) clearance under K251243 . The predicate pathway likely kept development and regulatory costs lower than a de novo application would, but OEM may pass through compliance and validation labor to buyers.

Limited availability & distribution exclusivity

The company targets a limited commercial launch in the fourth quarter of calendar 2025 . First-mover facilities or exclusive regional arrangements may negotiate higher pricing; broader distribution may drive costs down as supply chains mature.

Training & credentialing bundles
NeuroOne is a small, specialized neurotech firm. Premium integration fees—including surgeon credentialing, nursing education, and case support—are likely factored into purchase agreements.

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

Existing generator ownership

The OneRF® Trigeminal Nerve Ablation Kit uses the same NeuroOne Radiofrequency Generator already used in epilepsy ablation procedures . Health systems with functional OneRF brain ablation systems pay only for the trigeminal-specific disposable kit and software license—potentially 40–60% lower than a greenfield purchase.

Used OneRF brain systems
Secondary markets for functional neurosurgery equipment exist, though sparse. If your facility can acquire a used OneRF brain generator in working condition, trigeminal capabilities may unlock at minimal incremental cost. Verify FDA compliance and remaining warranty.

Leasing vs. purchase
NeuroOne has not announced lease options; however, early-stage medical devices often test rental/revenue-share models to reduce adoption friction. Ask directly about trial or lease-to-own arrangements if capital budget is constrained.

GPO/Consortium pricing
NeuroOne is not a traditional GPO vendor (group purchasing organization agreements favor high-volume, commodity-like products). However, health systems in neurosurgery networks or regional pain consortiums should negotiate collective pricing. A group of 5–10 facilities may unlock 10–15% discounts.

Hidden costs — install, training, calibration, consumables, service contracts

Site preparation & installation
Fluoroscopy suite compatibility is essential. The procedure uses X-ray guidance to target the trigeminal (Gasserian) ganglion . If your OR lacks modern C-arm integration or requires electrical/network upgrades, budget $5,000–$15,000.

Operator training & credentialing
Surgeons and interventional neuro radiologists require hands-on training and case observation. Assume 2–3 surgeon-days off-site (travel, meals, per diem): $8,000–$12,000 per facility for initial credentialing. Additional nursing and technician staff training: $2,000–$4,000.

Disposable probe/kit cost per procedure
This is the recurring cost driver. Industry standards suggest RF ablation kits cost $1,500–$3,500 per use. At 20–30 procedures annually (realistic for a dedicated pain/neurosurgery center), annual consumables = $30,000–$105,000. Higher-volume centers may negotiate volume discounts.

Service contracts & maintenance
RF generators require annual calibration and preventive maintenance (~$2,000–$4,000/year). NeuroOne's support model is unclear at launch; premium service (4-hour response, parts included) likely costs $3,000–$6,000 annually.

Software/licensing updates
Expect modest annual licensing fees ($1,000–$2,000) for firmware updates and software features if NeuroOne moves to a subscription model (common in newer neurotech platforms).

How to negotiate — concrete tactics

1. Anchor on existing generator investment
If you own or can acquire a used OneRF brain ablation system, your BATNA (best alternative to negotiated agreement) is the incremental kit cost only. Lead with: "We already have the generator. What is your trigeminal kit price and annual support for facilities with existing hardware?" This typically yields 30–50% savings vs. bundled pricing.

2. Request volume commitments with discounts
Propose a 3-year contract with a defined patient volume (e.g., 25 cases/year = 75 cases total). Offer to co-market as an early-adopter site in exchange for 15% discount on kits and bundled training.

3. Negotiate pricing transparency for consumables
Do not accept cost-per-case quoting without disaggregation. Demand separate line items:

• Generator/one-time capital: $___
• Initial probe inventory (qty 5): $___ per unit
• Annual service contract: $___
• Operator training: $___
• Refresh kits (replacement probes after 1 year): $___

4. Push back on "limited availability" scarcity pricing
The device is clinically new. Use this leverage: "We are an early clinical site; we expect pioneer pricing, not scarcity markup. What is your roadmap for wider distribution, and how will pricing adjust?"

5. Explore regional/GPO partnerships
Engage your integrated delivery network (IDN) or state hospital association to coordinate multi-site negotiations. NeuroOne will likely offer better terms for 3–5 facility clusters than for single-site purchases.

6. Demand outcome-based tier-down
Propose: "Year 1 kit price is $X. If we perform fewer than 20 cases or patient satisfaction drops below 85%, the Year 2 kit price decreases 10%." This transfers risk from buyer to seller and is increasingly standard in specialty surgical tech.

When the price feels off — red flags

No published generator list price
If NeuroOne refuses to provide a list price (even with confidentiality agreement between you and their CFO), it signals bespoke pricing leverage. Ask why. Request a detailed cost-of-goods breakdown or a quote cap tied to inflation.

Consumable costs hidden until contract signature
Demand per-unit probe costs before signing equipment agreements. Hidden kit costs of $5,000+ per case will crater your ROI on low-volume use (<15 cases/year).

Exclusive distributor markup
If NeuroOne channels through regional distributors, verify that markup is <20%. Call the distributor's parent company to benchmark against other specialty neuro products (e.g., stereotactic frames, electrode arrays).

Trainer or support charged per-use
Some device vendors charge "per-procedure support" fees. This is a cash grab. Support should be annual/flat or included in kit cost. Reject any quote linking surgeon consulting fees to case volume.

No warranty on refurbished/used generators
If buying a used OneRF brain system, insist on 12-month hardware warranty and 6-month software support. If unavailable, assume $3,000–$5,000 repair budget annually.

Sources

NeuroOne Medical Technologies, FDA 510(k) clearance announcement, August 2025 (K251243)

NeuroOne, Limited Market Release completion, March 2026

NeuroOne, OneRF Trigeminal Nerve Ablation Kit technical specification: shared RF generator platform

Block Imaging, Radiofrequency Generator Price Cost Guide, January 2026

NeuroOne, Multi-contact RF probe technical specifications, FDA 510(k) submission, August 2025

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Update plan

This article will be updated quarterly as:

• First-generation manufacturer MSRPs are published
• Multi-site volume deals are negotiated (anonymized benchmarks added)
• Used/refurbished market inventory emerges
• Procedural case volumes from early-adopter sites inform actual consumable utilization and cost-per-case

Last updated: May 2026. MedSource is actively collecting quote and contract data. If you have pricing or lease terms to share confidentially, contact the procurement research team.