United Health Products, Inc. has reached significant regulatory milestones with the Food & Drug Administration that could resolve a Warning Letter issued in March 2025 and advance its medical device 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 plan enables a study to proceed subject to granting of an Investigational Device Exemption while UHP continues working with the FDA to resolve the Warning Letter, which identified violations that occurred 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. This audit, recommended by the FDA, will assess and confirm the company's ability to conduct its own clinical trial in accordance with all applicable FDA regulations. The audit is scheduled to be conducted in the coming months.
Bran Thom, UHP's CEO, stated that these milestones result from 14 months of investigation and discussion with the FDA to address 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," Thom commented. 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.
The regulatory developments are important because they represent a potential pathway for UHP to address FDA compliance issues while advancing its medical device toward market approval. 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. The resolution of the Warning Letter and successful completion of the new clinical study could position the company to enter a significant medical device market segment.
For investors and industry observers, these developments indicate progress in resolving regulatory challenges that have affected the company since the 2025 Warning Letter. The collaborative approach with an established medical device partner could provide additional validation and resources for advancing the product through the regulatory process. More information about the company is available on its website at https://www.uhpcorp.com.
The original release containing this information was published on https://www.newmediawire.com. The regulatory progress comes as UHP continues developing its patented Neutralized Regenerated Cellulose hemostatic agent, with the company working toward demonstrating compliance with FDA requirements while advancing its product through the approval process.
