Clinical TrialJul 10, 2026, 12:26 PM
United Health Products Partners with NAMSA for CelluSTAT Clinical Study
AI Summary
United Health Products, Inc. announced an agreement with NAMSA, a global MedTech contract research organization, to serve as the regulatory sponsor for a new clinical study of UHP's CelluSTAT Hemostatic Gauze. This collaboration aims to support UHP's FDA Premarket Approval (PMA) application and address an outstanding FDA Warning Letter. NAMSA will initially seek an Investigational Device Exemption (IDE) and UHP will have exclusive rights to the study data for its revised PMA application.
Key Highlights
- United Health Products partnered with NAMSA for a new clinical study.
- NAMSA will serve as regulatory sponsor for CelluSTAT Hemostatic Gauze.
- The study supports UHP's FDA Premarket Approval (PMA) application.
- NAMSA will initially seek an Investigational Device Exemption (IDE).
- UHP will have exclusive rights to study data for a revised PMA application.
- The collaboration aims to resolve an outstanding FDA Warning Letter.
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