United Health Products, Inc. (OTCQB: UEEC) provided a regulatory update on its efforts to resolve the Warning Letter issued by the Food and Drug Administration (FDA) on March 25, 2025, which identified violations during the company’s 2019 clinical trial. The FDA has formally approved the company’s proposal to collaborate with another U.S. manufacturer and distributor of hemostatic products, whereby the partner will serve as Sponsor of a new clinical study of UHP’s CelluSTAT Hemostatic Gauze. Under this arrangement, UHP will hold an exclusive right of reference to all data from the study for use in a revised Premarket Approval (PMA) application. This plan allows the study to proceed, subject to granting of an Investigational Device Exemption (IDE), while UHP works with the FDA to resolve the Warning Letter.
In addition, the FDA has approved the external audit firm that will conduct a Good Clinical Practices (GCP) audit of UHP’s protocols, procedures, and personnel, as recommended by the FDA. The audit, scheduled for the coming months, aims to assess and confirm the company’s ability to conduct its own clinical trial in accordance with all applicable FDA regulations. Bran Thom, UHP’s CEO, stated, “These important milestones are the result of the past 14 months of investigation and discussion with the FDA to address their concerns over the company’s actions in 2018-19. We are pleased to now have a clear path to demonstrating, through a new IDE study, the safety and effectiveness of our CelluSTAT gauze.”
The company is currently in discussions with several established medical device companies regarding the substitute sponsor plan and hopes to enter into a formal collaboration agreement soon. Parallel to this effort, UHP looks forward to the GCP audit, which, along with other proposed corrective actions, is expected to resolve and lift the Warning Letter. 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, and UHP is seeking approval to access the human surgical market. For more information, visit the company’s website at www.uhpcorp.com.
This regulatory progress is significant for United Health Products as it lays out a concrete path to resolve the FDA’s concerns and potentially bring CelluSTAT to market. The approval of the partner-sponsored study and the GCP audit are critical steps that could lead to lifting the Warning Letter and ultimately obtaining PMA approval, which would allow the company to enter the surgical hemostatic market. The outcome of these efforts will be closely watched by investors and the medical device industry.
