United Health Products, Inc. (OTCQB: UEEC) announced an agreement with NAMSA, a global leader in MedTech contract research, to serve as Sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze. This collaboration follows the FDA's approval of UHP's proposal to have a non-affiliated party oversee the study, granted 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 data from the study to use in 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 specializes in medical device and in vitro diagnostic technologies, with decades of 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. 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.”
United Health Products 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. This clinical study is a critical step toward FDA clearance, as it will provide the necessary data to support a PMA application and address regulatory concerns.
For more information on UHP, visit the company’s new website at www.uhpcorp.com. The original release can be viewed at www.newmediawire.com.
