United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to serve as the sponsor of a new clinical study of the company's CelluSTAT Hemostatic Gauze. The collaboration follows the FDA's approval in March of UHP's proposal to have a non-affiliated party oversee the study.
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 approach allows the study to proceed, subject to IDE granting, while UHP continues to work with the FDA to resolve an outstanding Warning Letter.
NAMSA brings extensive experience in clinical trial management for Class III hemostatic agents and familiarity with the FDA Center for Devices and Radiological Health. Brian Thom, UHP's CEO, stated, '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.' He added that NAMSA's expertise in clinical studies and FDA approval processes gives confidence in gaining approval for and efficiently sponsoring a human study that will validate the safety and effectiveness of CelluSTAT Hemostatic Gauze.
The clinical study represents a critical step for UHP as it seeks approval to access the human surgical market with its all-natural hemostatic agent designed to control mild to moderate bleeding. The company's patented Neutralized Regenerated Cellulose technology underpins the product. For more information, visit https://www.uhpcorp.com.
This announcement underscores the importance of independent clinical validation in navigating regulatory pathways and addressing FDA concerns. The outcome of the study could determine the market potential for CelluSTAT and influence UHP's strategic direction.
