United Health Products Receives FDA Approval for Clinical Study Plan to Address Warning Letter

The Food and Drug Administration has formally approved United Health Products' proposal to collaborate with another U.S. manufacturer and distributor of hemostatic products, where the partner will serve as Sponsor of a new clinical study of UHP's CelluSTAT Hemostatic Gauze. This arrangement grants the company an exclusive right of reference to all data from the study for use in a revised Premarket Approval application, allowing research to proceed while UHP works with regulators to resolve the Warning Letter issued on March 25, 2025, which identified violations during the company's 2019 clinical trial.

In addition to approving the clinical study arrangement, the FDA has approved the external audit firm that will conduct a Good Clinical Practices audit of UHP's protocols, procedures, and personnel as recommended by the agency. This audit, scheduled for the coming months, aims to assess and confirm the company's ability to conduct its own clinical trials in accordance with all applicable FDA regulations. CEO Bran Thom stated these milestones result from fourteen months of investigation and discussion with the FDA to address concerns over the company's actions in 2018-2019, providing a clear path to demonstrating the safety and effectiveness of CelluSTAT gauze through a new Investigational Device Exemption study.

The regulatory developments carry significant implications for United Health Products' ability to advance its hemostatic technology toward market approval. The Warning Letter had created substantial uncertainty about the company's regulatory standing and ability to conduct clinical research necessary for FDA clearance. By securing FDA approval for both the collaborative study model and external audit process, UHP has established a structured framework to address regulatory deficiencies while maintaining momentum toward potential product commercialization. The company's ability to reference study data from the partner-sponsored trial represents a strategic advantage, allowing continued progress toward PMA submission despite the ongoing Warning Letter resolution process.

United Health Products is currently in discussions with several established medical device companies regarding the substitute sponsor plan and anticipates entering a formal collaboration agreement soon. The parallel GCP audit, along with other corrective actions proposed by the company, is expected to resolve and lift the Warning Letter. These regulatory advancements are particularly important for UHP's goal of accessing the human surgical market with its patented Neutralized Regenerated Cellulose hemostatic agent, CelluSTAT Hemostatic Gauze, an all-natural product designed to control mild to moderate bleeding. For more information, visit https://www.uhpcorp.com or view the original release on https://www.newmediawire.com.