---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-072044"
form_type: "8-K"
ticker: "ELUT"
cik: "0001708527"
company_name: "ELUTIA INC."
filed_at: "2024-06-17T23:59:59+00:00"
generated_at: "2026-06-01T04:08:11.440492+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Elutia receives FDA clearance for antibiotic-eluting bioenvelope EluPro for cardiac and neuromodulation devices

## Summary
- FDA cleared EluPro, first antibiotic-eluting bioenvelope, for pacemakers, defibrillators, neurostimulators, and neuromodulators.
- Targets $600M US implantable electronic device protection market; no other biologic competitor currently.
- Delivers rifampin and minocycline embedded in extracellular matrix to reduce infection, migration, and erosion complications.
- Additional indications expand addressable market to neurostimulation/modulation, estimated at $8B worldwide.
- Elutia plans national CIED launch in H2 2024; adjacent neuro markets prioritized for expansion.

## SEC filing metadata
- accession: 0001104659-24-072044
- form_type: 8-K
- ticker: ELUT
- cik: 0001708527
- company_name: ELUTIA INC.
- filed_at: 2024-06-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1708527/000110465924072044/0001104659-24-072044-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1708527/000110465924072044/tm2417396d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-072044
- JSON: https://secwatch.observer/filing/0001104659-24-072044.json
- Plain text: https://secwatch.observer/filing/0001104659-24-072044.txt

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