United Health Products, Inc. (OTCQB: UEEC) has entered into 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. This collaboration aligns with the company’s recent proposal to the FDA to have a non-affiliated party oversee the study, which received FDA approval in March 2026.
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, which will be used in a revised Premarket Approval (PMA) application. This approach allows the study to proceed—subject to IDE approval—while UHP works with the FDA to resolve the outstanding Warning Letter.
NAMSA is dedicated exclusively to medical device and in vitro diagnostic technologies, with decades of experience in clinical trial management for Class III hemostatic agents. The organization also has expertise from working within the FDA Center for Devices and Radiological Health, providing regulatory insight critical for navigating the approval process.
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.”
UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. The company is seeking approval to access the human surgical market. For more information, visit the company’s website at www.uhpcorp.com.
This announcement underscores UHP’s commitment to advancing its hemostatic technology through rigorous clinical evaluation, potentially bringing a novel bleeding control solution to surgical settings.
