---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-094562"
form_type: "8-K"
ticker: "NMTC"
cik: "0001500198"
company_name: "NEUROONE MEDICAL TECHNOLOGIES Corp"
filed_at: "2023-12-11T23:59:59+00:00"
generated_at: "2026-06-07T14:49:34.543757+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# NeuroOne receives FDA 510(k) clearance for OneRF Ablation System; plans H1 2024 launch

## Summary
- FDA 510(k) clearance for OneRF Ablation System to create RF lesions in nervous tissue for functional neurosurgical procedures.
- First FDA-cleared thin-film, sEEG-guided RF system combining recording and ablation with temperature control; third FDA-cleared device.
- Company targets commercial launch in first half of 2024, either directly or through a strategic partner.
- Estimated worldwide brain ablation market at least $100M and growing rapidly, with potential for multifold growth.
- Potential for patients to need only one surgery for both diagnostic and therapeutic procedures, reducing hospital stays and adverse events.

## SEC filing metadata
- accession: 0001213900-23-094562
- form_type: 8-K
- ticker: NMTC
- cik: 0001500198
- company_name: NEUROONE MEDICAL TECHNOLOGIES Corp
- filed_at: 2023-12-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1500198/000121390023094562/0001213900-23-094562-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1500198/000121390023094562/ea189752-8k_neuroone.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-094562
- JSON: https://secwatch.observer/filing/0001213900-23-094562.json
- Plain text: https://secwatch.observer/filing/0001213900-23-094562.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.