Monitor for IDE approval and study commencement as the next catalyst. The outstanding Warning Letter remains a risk to the PMA timeline. No revenue is expected until PMA approval, which is likely years away.
Price Chart
Executive Summary
United Health Products (UEEC) announced an agreement with NAMSA, a global MedTech CRO, to serve as regulatory sponsor for a new clinical study of its CelluSTAT Hemostatic Gauze, supporting the company's FDA Premarket Approval (PMA) application. The FDA approved the company's proposal in March 2026 for a non-affiliated party to oversee the study. NAMSA will initially seek an Investigational Device Exemption (IDE) to conduct the study, while UHP continues to work with the FDA to resolve an outstanding Warning Letter.
Key Facts
- NAMSA, a global MedTech CRO, will serve as sponsor of a new clinical study of CelluSTAT Hemostatic Gauze.
- FDA approved UHP's proposal in March 2026 for a non-affiliated party to oversee the study.
- NAMSA will initially seek an IDE to organize and conduct the study.
- UHP retains exclusive right of reference to all study data for a revised PMA application.
- UHP continues to work with FDA to resolve an outstanding Warning Letter.
- No financial terms or expected study costs were disclosed.
Financial Impact
No direct financial impact disclosed; clinical study costs and potential revenue from PMA approval are not quantified.
Risk Factors
- IDE may not be granted by the FDA.
- Outstanding Warning Letter may delay or prevent PMA approval.
- Clinical study may fail to demonstrate safety and effectiveness.
- Pre-revenue company with no current product sales; relies on equity financing.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001477932-26-004244 |
| Document: ueec_ex991.htm | 0001477932-26-004244 |
| Document: 0001477932-26-004244-index-headers.html | 0001477932-26-004244 |
| Document: 0001477932-26-004244-index.html | 0001477932-26-004244 |
| Document: 0001477932-26-004244.txt | 0001477932-26-004244 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jul 10, 2026 15w ago | 8-K | $0.0500 $0.0300 | ▼ −40.00% | ▼ −42.89% | $0.0374 (−25.20%) |
May 15, 2026 23w ago | EFFECT | $0.0650 $0.0425 | ▼ −34.62% | ▼ −39.13% | $0.0374 (−42.46%) |
US Market Status
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