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. The company submitted a response to the FDA on April 14, 2025, addressing violations identified during its 2019 clinical trial, followed by a post-audit and validation of certain clinical trial data. On December 10, the FDA issued an evaluation of UHP's response containing conclusions on 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 significant for the company's path toward market approval for its medical products.

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 with the current "standard of care" product. Investigators subcutaneously implanted gauze samples into animal models and monitored the 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 surgical patients could be substantial if these results translate to human applications, potentially reducing recovery times and improving surgical outcomes.

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 https://www.uhpcorp.com.

The company's progress comes at a time when the medical device industry faces increasing regulatory scrutiny, making UHP's navigation of the FDA process particularly noteworthy. Successful resolution of the Warning Letter and advancement of CelluSTAT through the approval pipeline could position the company to access the substantial human surgical market. The positive pre-clinical data suggesting reduced tissue reactivity compared to current standard products indicates potential clinical advantages that could influence surgical practice if confirmed in human trials. View the original release on https://www.newmediawire.com.