United Health Products gets FDA approval for new CelluSTAT gauze clinical study plan with a partner sponsor and a GCP audit to resolve a 2025 Warning Letter. TheUnited Health Products gets FDA approval for new CelluSTAT gauze clinical study plan with a partner sponsor and a GCP audit to resolve a 2025 Warning Letter. The

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

2026/04/06 20:00
3 min di lettura
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United Health Products, Inc. has reached significant regulatory milestones with the Food and Drug Administration that could resolve compliance issues and advance its hemostatic gauze product toward market approval. The FDA has formally approved the company’s 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 allows UHP to hold an exclusive right of reference to all data from the study for use in a revised Premarket Approval application.

The regulatory breakthrough comes after 14 months of investigation and discussion with the FDA to address concerns over the company’s actions during its 2019 clinical trial. The Warning Letter issued on March 25, 2025, identified violations that occurred during that trial period. Under the newly approved plan, a study can proceed subject to granting of an Investigational Device Exemption while UHP continues working with the FDA to resolve the Warning Letter.

In addition to 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. This audit, recommended by the FDA, will be conducted in the coming months to assess and confirm the company’s ability to conduct its own clinical trial in accordance with all applicable FDA regulations. The company views this audit, along with other corrective actions it has proposed, as key to resolving and lifting the Warning Letter.

Bran Thom, UHP’s CEO, stated that these milestones provide a clear path to demonstrating the safety and effectiveness of CelluSTAT gauze through a new IDE study. 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. For more information about the company and its developments, visit their website at https://www.uhpcorp.com.

The regulatory progress represents a critical juncture for UHP as it seeks approval to access the human surgical market with its patented Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT Hemostatic Gauze is designed as an all-natural product to control mild to moderate bleeding. The company’s ability to navigate the FDA’s regulatory requirements and address previous compliance issues will determine its future market prospects and potential impact on surgical hemostasis products.

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