United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to sponsor a new clinical study of the company's CelluSTAT Hemostatic Gauze. The partnership follows the FDA's approval in March of UHP's proposal to have a non-affiliated party oversee the study, which aims to address an outstanding Warning Letter.
Under the agreement, NAMSA will initially seek an Investigational Device Exemption (IDE) to organize and conduct a study of UHP's neutralized cellulose hemostat technology. Upon completion, UHP will hold an exclusive right of reference to all study data for use in a revised Premarket Approval (PMA) application. This arrangement allows the study to proceed while UHP works with the FDA to resolve regulatory issues.
NAMSA brings extensive experience in clinical trial management for Class III hemostatic agents and has former FDA Center for Devices and Radiological Health staff. Brian Thom, UHP's CEO, expressed confidence in NAMSA's ability to efficiently sponsor a human study that validates the safety and effectiveness of CelluSTAT, noting their long-standing partnership in preclinical testing.
The CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent and is seeking approval to enter the human surgical market. The company's new website is www.uhpcorp.com.
This collaboration marks a critical step toward clinical validation and potential FDA clearance, which could open significant market opportunities for UHP in surgical hemostasis.
