United Health Products Advances FDA Resolution Process and Reports Positive Pre-Clinical Study Results

United Health Products, Inc. has provided an update on its ongoing discussions with the Food & Drug Administration regarding a Warning Letter issued in March 2025 that identified violations during the company's 2019 clinical trial. The company submitted a response to the FDA on April 14, 2025, addressing the violations, followed by post-audit and validation of certain clinical trial data. On December 10, the FDA issued an evaluation of UHP's response containing conclusions about the company's oversight of the 2019 study, requests for additional information, and comments on UHP's plan to complete an additional clinical study.

The company disputes certain FDA findings and has scheduled a conference with the regulatory agency before year-end with the objective of discussing and resolving these disputed findings. UHP believes this process will ultimately result in the ability to commence a new study early in 2026. This regulatory progress is crucial for the company's path toward potential approval of its medical products for human surgical use.

Concurrently, UHP has completed two long-term pre-clinical studies required for its planned Premarket Approval resubmission. One study compared the rates of absorption and tissue reactivity of UHP's CelluSTAT Hemostatic Gauze against the current standard of care product. Investigators subcutaneously implanted gauze samples into animal models and monitored implantation sites over several months. The study showed no evidence of any CelluSTAT material two weeks post-implantation and no tissue reaction at any time.

This contrasts with standard of care gauze material, which remained present at the implantation site for over eight weeks and showed evidence of tissue reactivity at three months, measured by the presence of macrophages and giant cells. These results confirm prior findings and suggest that use of UHP's CelluSTAT Hemostatic Gauze carries less risk of post-surgical complications such as mass formation, imaging mimicry, and chronic inflammation. The implications for patient outcomes could be significant if these results translate to human surgical applications.

Looking ahead, the company is organizing a study to potentially expand the indications for use of CelluSTAT, assuming approval for use in human surgical procedures. UHP has scheduled an animal model study to examine and confirm the usability of CelluSTAT in a variety of the most common laparoscopic procedures, which represent a growing majority of surgeries in the U.S. market today. The results of this planned study will be submitted as part of a supplemental FDA PMA application. For more information, visit the company's website at https://www.uhpcorp.com.