---
schema_version: "secwatch.filing_event.v1"
accession: "0001477932-24-006902"
form_type: "8-K"
ticker: "UEEC"
cik: "0001096938"
company_name: "United Health Products, Inc."
filed_at: "2024-11-06T23:59:59+00:00"
generated_at: "2026-05-30T04:18:40.213034+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# UHP FDA PMA update: supplemental study needed for organ space, 6-7 month delay

## Summary
- FDA requires additional clinical data for CelluSTAT (HemoStyp) use in intestinal/thoracic procedures.
- Pivotal study (232 patients, 118 treated) showed non-inferiority and superiority for time to hemostasis.
- Company will enroll limited number of human subjects in multi-site supplemental study, taking ~6-7 months.
- FDA review period remains paused until all deficiencies addressed; ~90 of 180 days elapsed.
- Additional biocompatibility and sterility testing agreed with FDA; BIMO site inspections completed.

## SEC filing metadata
- accession: 0001477932-24-006902
- form_type: 8-K
- ticker: UEEC
- cik: 0001096938
- company_name: United Health Products, Inc.
- filed_at: 2024-11-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- 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/1096938/000147793224006902/0001477932-24-006902-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1096938/000147793224006902/ueec_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001477932-24-006902
- JSON: https://secwatch.observer/filing/0001477932-24-006902.json
- Plain text: https://secwatch.observer/filing/0001477932-24-006902.txt

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