United Health Products, Inc.

What they do

United Health Products develops, manufactures, and markets a patented hemostatic gauze called CelluSTAT, derived from cotton, designed to absorb exudate and help control bleeding from superficial wounds. The company is seeking U.S. Class III Premarket Approval (PMA) and European CE Mark certification to sell the product in human surgical markets. Currently, the company generates no revenue and is focused on addressing FDA requirements from a 2025 Warning Letter related to clinical study violations.

Revenue drivers

• CelluSTAT in U.S. surgical market — The company's sole product, CelluSTAT, is designed for hemostasis; revenue potential depends on FDA PMA approval for Class III surgical use, but no revenue has been generated to date.
• CelluSTAT in European surgical market — The company is also seeking CE Mark certification to sell CelluSTAT in Europe, but this market has not yet been entered and no revenue is reported.
• Wound care applications — The product is also intended for superficial wound care, but the company has not reported any sales in this segment during the reported periods.

Recent performance

For the year ended December 31, 2025, the company reported $0 revenue and a net loss of $2,669,348, compared to $0 revenue and a net loss of $2,001,733 in 2024. Operating expenses increased to $2,255,474 in 2025 from $2,007,572 in 2024, driven by a $745,125 increase in stock-based compensation, partially offset by a $494,750 decrease in professional expenses. Other expenses rose by $419,713 due to a $242,000 loss on fraud, higher interest expense, and a decrease in debt settlement gains. As of March 31, 2026, the company had cash and equivalents of $1,029, total assets of $248,825, total liabilities of $4.4 million, and shareholder equity of negative $4.2 million.

Strategy

The company's stated strategy is to secure FDA PMA approval for CelluSTAT to enter the U.S. Class III surgical market and CE Mark certification for Europe. Management believes the Class III surgical market is the most attractive due to limited competition. To address FDA concerns, the company has proposed a supplemental clinical study in intestinal and thoracic organ space, and has submitted Corrective and Preventative Actions (CAPAs) and a proposal for a third-party monitor of FDA communications. The company is relying on funding from a Common Stock Purchase Agreement with White Lion to finance its operations.

Risks

• FDA approval uncertainty — The FDA issued a Warning Letter in March 2025 for five clinical study violations, and the company has not yet received PMA approval; no assurance exists that approval will ever be granted.
• Going concern risk — The company's independent auditors expressed substantial doubt about its ability to continue as a going concern, with negative working capital of $3,837,757 as of December 31, 2025.
• Liquidity and financing risk — With only $1,029 in cash as of March 31, 2026, the company depends on future financing, such as the White Lion purchase agreement, which may not be available on favorable terms.
• Operational and regulatory compliance risk — The company must correct clinical trial violations and conduct an audit of processes and personnel to ensure good clinical practices, and any failure could delay or prevent regulatory approval.

Outlook

Management continues to pursue FDA PMA approval, having submitted revised CAPAs on January 5, 2026, and a report on IRB communications on February 16, 2026. The company has proposed a supplemental study in the intestinal and thoracic organ space to address FDA concerns. There are no assurances that adequate financing will be available to fund operations or that the company will achieve commercial operations in the foreseeable future.