United Health Products names NAMSA as sponsor of CelluSTAT clinical study
United Health Products announced on July 7, 2026 that NAMSA, a global MedTech contract research organization, will serve as regulatory sponsor of a new clinical study of UHP's CelluSTAT Hemostatic Gauze in connection with the company's FDA Premarket Approval application. The arrangement follows FDA approval in March 2026 of UHP's proposal to have a non-affiliated party oversee the study. NAMSA will initially seek an Investigational Device Exemption to organize and conduct the study, with UHP holding exclusive right of reference to the study data for use in a revised PMA application.
- NAMSA will serve as Sponsor of clinical study of CelluSTAT Hemostatic Gauze
- FDA approved UHP's proposal for non-affiliated party to oversee study in March 2026
- NAMSA will seek Investigational Device Exemption (IDE) to organize and conduct study
- UHP will hold exclusive right of reference to all study data for revised PMA application
- Study is intended to proceed while UHP works with FDA to resolve outstanding Warning Letter
- Agreement announced July 7, 2026
The arrangement enables UHP to advance its hemostatic gauze toward FDA approval through a third-party clinical study while the company resolves a pending Warning Letter with the regulator.
Derived from 8-K filed 2026-07-10. Not investment advice. Figures are extracted from the filing; prose is AI-assisted. View the source filing on SEC.gov →