Entire pr as follow......https://uhpcorp.com/united-health-products-es...cal-study/
United Health Products Establishes Collaboration to Conduct Clinical Study
July 7, 2026
Darien, Connecticut – July 7, 2026 – United Health Products, Inc. (OTCQB: UEEC) today announced an agreement with NAMSA, the global leader in MedTech contract research offering end-to-end development services, whereby NAMSA will serve as regulatory sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze.
Consistent with the company’s recent proposal to the FDA to have a non-affiliated party oversee a new clinical study, which the FDA approved in March of this year, NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct a study of UHP’s neutralized cellulose hemostat technology. Upon completion of the study, UHP will hold an exclusive right of reference to all data from the study to use in a revised Premarket Approval (PMA) application. This plan will allow a study to proceed (subject to granting of the IDE) while UHP works with the FDA to resolve the outstanding Warning Letter.
NAMSA is exclusively focused on medical device and in vitro diagnostic technologies. Its experts bring decades of experience in clinical trial management for Class III devices, including hemostatic agents, as well as experience working with the FDA Center for Devices and Radiological Health.
Brian Thom, UHP’s CEO commented, “NAMSA has been a great partner to UHP for several years in our preclinical testing efforts and I am delighted that we are expanding our relationship with such a well-regarded and capable CRO. NAMSA’s deep experience in the clinical study of new medical devices and in working through the FDA approval process give me confidence in their ability to efficiently sponsor and execute a rigorous human study evaluating the safety and effectiveness of our CelluSTAT Hemostatic Gauze.”
Go team go!
United Health Products Establishes Collaboration to Conduct Clinical Study
July 7, 2026
Darien, Connecticut – July 7, 2026 – United Health Products, Inc. (OTCQB: UEEC) today announced an agreement with NAMSA, the global leader in MedTech contract research offering end-to-end development services, whereby NAMSA will serve as regulatory sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze.
Consistent with the company’s recent proposal to the FDA to have a non-affiliated party oversee a new clinical study, which the FDA approved in March of this year, NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct a study of UHP’s neutralized cellulose hemostat technology. Upon completion of the study, UHP will hold an exclusive right of reference to all data from the study to use in a revised Premarket Approval (PMA) application. This plan will allow a study to proceed (subject to granting of the IDE) while UHP works with the FDA to resolve the outstanding Warning Letter.
NAMSA is exclusively focused on medical device and in vitro diagnostic technologies. Its experts bring decades of experience in clinical trial management for Class III devices, including hemostatic agents, as well as experience working with the FDA Center for Devices and Radiological Health.
Brian Thom, UHP’s CEO commented, “NAMSA has been a great partner to UHP for several years in our preclinical testing efforts and I am delighted that we are expanding our relationship with such a well-regarded and capable CRO. NAMSA’s deep experience in the clinical study of new medical devices and in working through the FDA approval process give me confidence in their ability to efficiently sponsor and execute a rigorous human study evaluating the safety and effectiveness of our CelluSTAT Hemostatic Gauze.”
Go team go!
