---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-084013"
form_type: "8-K"
ticker: "NMTC"
cik: "0001500198"
company_name: "NEUROONE MEDICAL TECHNOLOGIES Corp"
filed_at: "2023-11-07T23:59:59+00:00"
generated_at: "2026-06-08T14:45:23.890936+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.45
calibrated_materiality_score: 0.45
confidence: "high"
source: SEC EDGAR
---

# NeuroOne responds to FDA questions on OneRF Ablation System 510(k); expects feedback in 30 days

## Summary
- Company responded to FDA questions on its 510(k) submission for the OneRF Ablation System.
- FDA feedback expected within 30 days; commercialization targeted for H1 2024 pending clearance.
- OneRF would be first sEEG-guided RF ablation system with real-time temperature control.
- NeuroOne estimates worldwide brain ablation market at $100M+ with rapid growth potential.
- CEO Dave Rosa cites potential to reduce hospital stays, procedures, and complications.

## SEC filing metadata
- accession: 0001213900-23-084013
- form_type: 8-K
- ticker: NMTC
- cik: 0001500198
- company_name: NEUROONE MEDICAL TECHNOLOGIES Corp
- filed_at: 2023-11-07T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.45
- calibrated_materiality_score: 0.45
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1500198/000121390023084013/0001213900-23-084013-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1500198/000121390023084013/ea187820-8k_neuroone.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-084013
- JSON: https://secwatch.observer/filing/0001213900-23-084013.json
- Plain text: https://secwatch.observer/filing/0001213900-23-084013.txt

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