United Health Products teams with NAMSA on CelluSTAT hemostatic gauze study
UEEC•NAMSA to sponsor new clinical study
United Health Products said it signed an agreement with NAMSA to sponsor a new clinical study of CelluSTAT Hemostatic Gauze. NAMSA will seek an Investigational Device Exemption to organize the human study of the company’s neutralized cellulose hemostat technology.
Study data to support revised FDA filing
UHP said it will receive an exclusive right of reference to the study data for use in a revised Premarket Approval application. The company said the study is intended to proceed while it works with the FDA to resolve an outstanding Warning Letter.
