regulatory
confidence high
sentiment neutral
materiality 0.60
United Health Products partners with NAMSA to sponsor clinical study of CelluSTAT for FDA PMA
United Health Products, Inc.
- NAMSA will serve as regulatory sponsor, seeking an IDE to conduct a clinical study of CelluSTAT Hemostatic Gauze.
- UHP will hold exclusive right of reference to all study data for use in a revised PMA application.
- The study is part of efforts to resolve the outstanding FDA Warning Letter.
- NAMSA has decades of experience in clinical trial management for Class III hemostatic agents and FDA CDRH.
- CEO Brian Thom expressed confidence in NAMSA's ability to gain IDE approval and efficiently sponsor the study.