secwatch.observer — SEC 8-K summary
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Issuer:     United Health Products, Inc. (UEEC)
CIK:        0001096938
Form:       8-K
Filed at:   2024-11-06T23:59:59+00:00
Accession:  0001477932-24-006902
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1096938/000147793224006902/0001477932-24-006902-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1096938/000147793224006902/ueec_8k.htm
  HTML page:      https://secwatch.observer/filing/0001477932-24-006902

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer