United Health Products, Inc. 8K

United Health Products engaged NAMSA to sponsor and conduct an FDA IDE-based clinical study of its CelluSTAT Hemostatic Gauze, providing data for a revised PMA application.

United Health Products, Inc. announced that it has entered into an agreement with NAMSA, a MedTech contract research organization, under which NAMSA will act as sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze, including seeking an Investigational Device Exemption from the FDA to organize and conduct the study of UHP’s neutralized cellulose hemostat technology, with UHP retaining an exclusive right of reference to the resulting data for use in a revised Premarket Approval application while it continues to work with the FDA to resolve an outstanding Warning Letter.

Filing Facts

CIK

1096938

Ticker

-

Form

8K

Source Type

sec

Accession

0001477932-26-004244

Alert Tier

6