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, addressing the violations, 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 agency before year-end to discuss and resolve these disputed findings. UHP believes this process will ultimately result in the ability to commence a new study early in 2026.
Concurrently, UHP has completed two long-term preclinical 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 sites over several months.
The study showed no evidence of any CelluSTAT material two weeks post-implantation and no tissue reaction at any time. In contrast, standard of care gauze material 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 CelluSTAT carries less risk of post-surgical complications such as mass formation, imaging mimicry, and chronic inflammation.
Looking ahead, UHP is organizing a study to potentially expand the indications for use of CelluSTAT, assuming approval for use in human surgical procedures. The company 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 business and technology leaders monitoring the medical device sector, UHP's progress represents both regulatory and technological developments. The resolution of FDA compliance issues could enable the company to advance its product to market, while the preclinical data suggests potential clinical advantages over existing hemostatic products. The planned expansion into laparoscopic procedures aligns with surgical trends toward minimally invasive techniques. More information about the company is available at https://www.uhpcorp.com. The original release can be viewed at https://www.newmediawire.com.
