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

United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global MedTech contract research organization, to sponsor a new clinical study of the company's CelluSTAT Hemostatic Gauze. NAMSA will initially seek an Investigational Device Exemption (IDE) from the FDA to organize and conduct the study, which evaluates 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 while UHP addresses the FDA's outstanding Warning Letter.

The collaboration is significant because it follows the FDA's approval in March of UHP's proposal to have a non-affiliated party oversee a new clinical study. NAMSA, with decades of experience in clinical trial management for Class III hemostatic agents and familiarity with the FDA Center for Devices and Radiological Health, is well-positioned to navigate the regulatory process. Brian Thom, UHP's CEO, expressed confidence in NAMSA's ability to gain IDE approval and efficiently sponsor a human study that validates the safety and effectiveness of CelluSTAT.

For UHP, which has developed and patented a Neutralized Regenerated Cellulose hemostatic agent, this study is a critical step toward accessing the human surgical market. CelluSTAT is an all-natural product designed to control mild to moderate bleeding. Success in the clinical study could lead to FDA clearance and commercialization, addressing a significant unmet need in surgical hemostasis. The partnership with NAMSA underscores UHP's commitment to rigorous clinical validation and regulatory compliance.

More information about UHP is available on the company's website: www.uhpcorp.com. The original press release can be viewed at www.newmediawire.com.