United Health Products, Inc. (OTCQB: UEEC) has announced an agreement with NAMSA, a global MedTech contract research organization, to serve as sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze. The collaboration follows the company’s proposal to the FDA for a non-affiliated party to oversee the study, which the FDA approved in March 2026.
Under the terms of 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 of the study, UHP will hold an exclusive right of reference to all study data, which will be used in a revised Premarket Approval (PMA) application. This approach allows the study to proceed once the IDE is granted, while UHP continues to work with the FDA to resolve an outstanding Warning Letter.
The clinical study is a critical step for UHP as it seeks to access the human surgical market. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. The company has developed and patented a Neutralized Regenerated Cellulose hemostatic agent.
NAMSA, which is 100% focused on medical device and in vitro diagnostic technologies, has decades of experience in clinical trial management for Class III hemostatic agents and experience working with the FDA Center for Devices and Radiological Health. Brian Thom, UHP’s CEO, expressed confidence in the partnership, citing NAMSA’s deep experience in clinical study of new medical devices and FDA approval processes.
The implications of this announcement are significant for UHP. If the study validates the safety and effectiveness of CelluSTAT, it could pave the way for FDA approval and entry into the surgical market. The partnership with NAMSA, a well-regarded CRO, may also help address the FDA’s concerns underlying the Warning Letter. For the broader medical device industry, this collaboration highlights the importance of independent oversight in clinical studies to ensure regulatory compliance and robust data.
UHP’s new website at www.uhpcorp.com provides more information about the company and its products. The original press release is available on www.newmediawire.com.
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