United Health Products, Inc. (OTCQB: UEEC) announced a collaboration with NAMSA, a global MedTech contract research organization, to conduct a new clinical study of its CelluSTAT Hemostatic Gauze. NAMSA will serve as the Sponsor, initially seeking an Investigational Device Exemption (IDE) to organize and study UHP's neutralized cellulose hemostat technology. This move aligns with the company's FDA-approved proposal from March 2026 to have a non-affiliated party oversee the study.
The agreement comes after the FDA approved UHP’s plan to use a third-party sponsor, allowing the study to proceed while UHP addresses the outstanding Warning Letter. Upon study completion, UHP will hold an exclusive right of reference to all data, which will be used in a revised Premarket Approval (PMA) application. NAMSA, with expertise in Class III hemostatic agents and FDA processes, will manage the clinical trial.
Brian Thom, UHP’s CEO, expressed confidence in NAMSA’s capabilities, citing their experience in clinical study management and FDA approval processes. “NAMSA has been a great partner for several years in preclinical testing, and their deep experience gives me confidence that they can gain IDE approval and efficiently sponsor a human study validating the safety and effectiveness of our CelluSTAT Hemostatic Gauze,” Thom said.
UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent, with CelluSTAT designed to control mild to moderate bleeding. The company is seeking approval to enter the human surgical market. For more information, visit the company’s website at www.uhpcorp.com. The original press release is available at www.newmediawire.com.
This collaboration marks a significant step for UHP in advancing its hemostatic technology through clinical validation, potentially paving the way for FDA approval and market entry. The study’s outcome could impact the availability of new hemostatic options for surgical settings.
