---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-019186"
form_type: "8-K"
ticker: "NRXS"
cik: "0001933567"
company_name: "Neuraxis, INC"
filed_at: "2025-10-24T23:59:59+00:00"
generated_at: "2026-05-17T02:22:38.414766+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Neuraxis gets FDA 510(k) clearance for PENFS to treat functional dyspepsia in ages 8+

## Summary
- FDA cleared Neuraxis' PENFS for functional abdominal pain associated with functional dyspepsia and nausea in patients 8 years and older.
- This is the first FDA clearance or approval specifically addressing functional dyspepsia in adults.
- Clearance based on RCTs and real-world evidence; FDA extrapolated pediatric data to adults.
- Company increased ATM offering from $3.3M to $6.27M; no shares sold under prior agreement.

## SEC filing metadata
- accession: 0001493152-25-019186
- form_type: 8-K
- ticker: NRXS
- cik: 0001933567
- company_name: Neuraxis, INC
- filed_at: 2025-10-24T23:59:59+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/1933567/000149315225019186/0001493152-25-019186-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933567/000149315225019186/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-019186
- JSON: https://secwatch.observer/filing/0001493152-25-019186.json
- Plain text: https://secwatch.observer/filing/0001493152-25-019186.txt

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