The Food and Drug Administration has formally approved United Health Products' proposal to collaborate with another U.S. manufacturer and distributor of hemostatic products to conduct a new clinical study of the company's CelluSTAT Hemostatic Gauze. This regulatory development represents a critical step toward resolving the Warning Letter issued to the company on March 25, 2025, which identified violations that occurred during UHP's 2019 clinical trial.
Under the approved arrangement, the partner company will serve as Sponsor of the new clinical study, while United Health Products will hold an exclusive right of reference to all data from the study for use in a revised Premarket Approval application. This plan allows a study to proceed subject to the granting of an Investigational Device Exemption while UHP continues working with the FDA to resolve the Warning Letter. The company is currently in discussions with several established medical device companies regarding this substitute sponsor plan and hopes to enter into a formal collaboration agreement soon.
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 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 audit represents a parallel effort to the clinical study collaboration that will help resolve and lift the Warning Letter.
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. The company now has a clear path to demonstrating the safety and effectiveness of its CelluSTAT gauze through a new IDE study. 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.
This regulatory progress matters because it potentially clears a significant hurdle for a medical device seeking market approval. The resolution of the Warning Letter through FDA-approved mechanisms demonstrates regulatory pathways available to companies facing compliance challenges. For the medical device industry, this case illustrates how collaboration between companies and regulatory oversight can create solutions that maintain safety standards while allowing product development to continue. The successful resolution could eventually bring a new hemostatic product to market, potentially offering healthcare providers additional options for controlling surgical bleeding. For more information on UHP, visit the company's website at https://www.uhpcorp.com. The original release can be viewed on https://www.newmediawire.com.
