United Health Products, Inc. (OTCQB: UEEC) announced today an agreement with NAMSA, a global leader in MedTech contract research, to serve as Sponsor of a new clinical study of the company's CelluSTAT Hemostatic Gauze. The collaboration marks a strategic step toward addressing the FDA's outstanding Warning Letter and advancing the product toward market approval.
Under the terms of the agreement, NAMSA will initially seek an Investigational Device Exemption (IDE) from the FDA to organize and conduct a study of UHP's neutralized cellulose hemostat technology. The FDA approved the company's proposal in March 2026 to have a non-affiliated party oversee the study. Upon completion, UHP will hold an exclusive right of reference to all data from the study, which it intends to use in a revised Premarket Approval (PMA) application. This approach allows the study to move forward while UHP works with the FDA to resolve the outstanding Warning Letter.
NAMSA brings extensive expertise to the project. The organization is 100% focused on medical device and in vitro diagnostic technologies, and its experts have decades of experience in clinical trial management for Class III hemostatic agents. Additionally, NAMSA team members have experience working for the FDA Center for Devices and Radiological Health, which could facilitate smoother navigation of the regulatory process.
Brian Thom, UHP's CEO, expressed confidence in the partnership. "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," Thom said. "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 clinical study is a critical milestone for UHP, as it seeks to access the human surgical market with its all-natural product designed to control mild to moderate bleeding. The CelluSTAT Hemostatic Gauze is based on Neutralized Regenerated Cellulose hemostatic technology, which UHP has developed and patented. Success in the study could pave the way for FDA approval and commercialization, potentially offering a new option for surgeons and patients.
The implications of this announcement extend beyond UHP. For the medical device industry, the collaboration demonstrates a pathway for smaller companies to leverage experienced contract research organizations to manage complex regulatory hurdles. For investors, the progress toward resolving the FDA Warning Letter and the initiation of human trials could signal a de-risking of the company's prospects. For healthcare providers and patients, the product could eventually provide an additional tool for bleeding control in surgical settings.
More information about UHP can be found on the company's website at www.uhpcorp.com. The original press release is available at www.newmediawire.com.
