MT. LAUREL, NJ - December 15, 2025 (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 certain violations of required clinical procedures that occurred during the company’s 2019 clinical trial.
On April 14, 2025, the company submitted a response to FDA that addressed the violations, followed by a post-audit and validation of certain clinical trial data. On December 10, FDA issued an evaluation of UHP’s response to the Warning Letter containing conclusions on UHP’s oversight of the 2019 study, requests for additional information and comments on the UHP’s plan to complete an additional clinical study. The company disputes certain of FDA’s findings and has scheduled a conference with FDA before yearend with the objective of discussing and resolving the disputed findings, which it believes will ultimately result in the ability to commence a new study early in 2026.
Company Update
UHP has also recently completed two long-term, pre-clinical studies that are required for its planned Premarket Approval resubmission. One of these studies compares the rates of absorption and tissue reactivity of UHP’s CelluSTAT Hemostic Gauze and the current “standard of care” product. In the study, investigators subcutaneously implanted gauze samples into animal models and monitored the implantation sites over several months. Among other positive findings the study showed no evidence of any CelluSTAT material two weeks post-implantation and no tissue reaction at any time. This is compared to standard of care gauze material, which remained present at the implantation site for over eight weeks and showed evidence of tissue reactivity (measured by the presence of macrophages and giant cells) at three months. 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.
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.
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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