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

NEUROONE MEDICAL TECHNOLOGIES Corp

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.

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