United Health Products Partners with NAMSA to Advance Clinical Study of CelluSTAT Hemostatic Gauze

United Health Products, Inc. (OTCQB: UEEC) has announced a collaboration with NAMSA, a global leader in MedTech contract research, to conduct a new clinical study of its CelluSTAT Hemostatic Gauze. Under the agreement, NAMSA will serve as the sponsor of the study, initially seeking an Investigational Device Exemption (IDE) from the FDA to organize and conduct a trial of UHP's neutralized cellulose hemostat technology. This move aligns with a proposal UHP made to the FDA earlier this year, which the agency approved in March, to have a non-affiliated party oversee the study.

Upon completion of the study, UHP will hold an exclusive right of reference to all data generated, which will be used to support a revised Premarket Approval (PMA) application. This approach allows the study to proceed while UHP works with the FDA to resolve the outstanding Warning Letter. NAMSA, which focuses exclusively on medical device and in vitro diagnostic technologies, brings decades of experience in clinical trial management for Class III hemostatic agents and familiarity with the FDA's Center for Devices and Radiological Health.

Brian Thom, UHP’s CEO, expressed confidence in the partnership, stating, “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 that they can gain approval for, and efficiently sponsor a human study that will validate the safety and effectiveness of our CelluSTAT Hemostatic Gauze.”

The CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding, utilizing UHP's patented Neutralized Regenerated Cellulose hemostatic agent. The company is seeking FDA approval to access the human surgical market. For more information, visit the company’s website at www.uhpcorp.com.

This collaboration marks a significant step for UHP as it navigates regulatory hurdles and works towards bringing its hemostatic technology to market. The clinical study, if approved, could provide critical data to support the safety and efficacy of CelluSTAT, potentially impacting surgical practices and patient outcomes. For the medical device industry, this partnership underscores the importance of experienced CROs in facilitating FDA approvals for innovative hemostatic agents.