United Health Products, Inc. — Cyborg Score 4/10

Mixed
Hemostatic wound care devices

Strategic Profile

The company's main product is a bio-compatible sterile gauze that produces hemostasis, or stops bleeding, when applied to a cut or open wound. The company has been pursuing FDA Premarket Approval (PMA) for its flagship HemoStyp product, with regulatory progress documented through 2024, though final approval status remains pending as of mid-2026.

Cyborg Score Rationale

UHP operates in the specialized hemostatic wound care market with differentiated proprietary technology (NORC). However, the company faces significant challenges including OTC trading status, extended FDA approval timelines (PMA process ongoing since at least 2021), and past SEC regulatory issues (settlement in June 2022). Revenue and market traction data are unavailable.

Top Insights

  • FDA Premarket Approval pursuit for HemoStyp since at least 2021; full PMA application submitted in March 2024, with substantive review ongoing as of August 2024
  • Product targets fragmented end-markets including surgical, wound care, emergency response, and veterinary applications with multiple distribution channels
  • Company settled SEC investigation in June 2022, indicating prior compliance issues that may affect institutional investor confidence
  • Limited financial disclosure and OTC trading suggest constrained capital access and minimal analyst coverage

Named Competitors

  • Advanced Hemostatic Solutions — Large diversified medical device and biopharmaceutical company
  • Surgical & Wound Care Products — Dental and specialty surgical equipment manufacturer
  • Hemostatic Technologies — Regenerative medicine and hemostatic device developer

Recent Developments

  • (December 2024) Provided update on planned clinical study
  • (August 2024) Updated FDA Premarket Approval application process status
  • (March 2024) Submitted full FDA PMA application for HemoStyp

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