United Health Products Advances FDA Discussions 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 letter identified violations of required clinical procedures during the company's 2019 clinical trial. The company submitted a response to the FDA on April 14, 2025, which included a 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. UHP believes resolving these disputed findings will ultimately allow it to commence a new study early in 2026. This regulatory progress is crucial for the company's efforts to gain approval for its medical products in the human surgical market.

In parallel with these regulatory discussions, 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 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. Tissue reactivity was 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. For more information about the company's technology and progress, visit https://www.uhpcorp.com.

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. The original press release containing this information can be viewed at https://www.newmediawire.com.

The company's progress in addressing FDA concerns while simultaneously advancing its product development through pre-clinical studies represents a significant step toward bringing its hemostatic technology to market. The positive study results suggesting reduced complication risks could have important implications for surgical outcomes if the product receives regulatory approval. These developments come at a time when the medical device industry faces increasing scrutiny over product safety and efficacy standards. The implications extend beyond UHP's specific regulatory pathway, potentially influencing how similar products are evaluated and what evidence is required to demonstrate safety advantages over existing treatments. The contrast between CelluSTAT's rapid absorption and the standard product's persistence highlights a tangible difference that could translate to clinical benefits, particularly in reducing long-term inflammatory responses that sometimes complicate surgical recovery. Success in these regulatory and scientific endeavors could position UHP's technology as a safer alternative in a competitive market where post-operative complications remain a significant concern for healthcare providers and patients alike.