---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-039652"
form_type: "8-K"
ticker: "BFRI"
cik: "0001858685"
company_name: "Biofrontera Inc."
filed_at: "2024-10-07T23:59:59+00:00"
generated_at: "2026-05-30T19:36:20.089647+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA approves Biofrontera's sNDA for up to 3 tubes of Ameluz per treatment

## Summary
- FDA increased max dosage from 1 to 3 tubes of Ameluz per PDT treatment for actinic keratosis.
- Approval supported by two Phase 1 safety studies (116 patients) showing equivalent safety profile.
- CEO notes work with Medicare and commercial payers to obtain reimbursement for label update.
- AK affects ~58M people in US; ~13M treatments annually; up to 60% of SCCs start as untreated AK.

## SEC filing metadata
- accession: 0001493152-24-039652
- form_type: 8-K
- ticker: BFRI
- cik: 0001858685
- company_name: Biofrontera Inc.
- filed_at: 2024-10-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858685/000149315224039652/0001493152-24-039652-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858685/000149315224039652/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-039652
- JSON: https://secwatch.observer/filing/0001493152-24-039652.json
- Plain text: https://secwatch.observer/filing/0001493152-24-039652.txt

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