MT. LAUREL, NJ - April 6, 2026 (NEWMEDIAWIRE) - United Health Products, Inc. (OTCQB: UEEC) today provided a status update on its discussions with the Food & Drug Administration (FDA) to resolve the Warning Letter issued on March 25, 2025, identifying violations that occurred during the company’s 2019 clinical trial.
Following recent discussions, the FDA earlier this month 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, and where the company will hold an exclusive right of reference to all data from the study to use in a revised Premarket Approval (PMA) application. This plan will allow a study to proceed (subject to granting of an Investigational Device Exemption) while UHP works with the FDA to resolve the Warning Letter.
In addition to its agreement with this clinical study arrangement, the FDA has approved the external audit firm that will conduct a Good Clinical Practices (GCP) audit of UHP’s protocols, procedures and personnel that was recommended by the FDA. The goal of this audit, which will be conducted in the coming months, is 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, commented, “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. We are currently in discussions with several established medical device companies regarding our substitute sponsor plan and hope to enter into a formal collaboration agreement soon. In parallel with this effort, we look forward to the GCP audit which, along with other corrective actions we have proposed, will resolve and lift the Warning Letter.”
About United Health Products -- UHP 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. UHP is seeking approval to access the human surgical market.
For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
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