United Health Products, Inc. has provided an update on its ongoing discussions with the Food and 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. Following a response submitted in April 2025 and subsequent post-audit validation, the FDA issued an evaluation on December 10, containing conclusions on the company's oversight, requests for additional information, and comments on plans for 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 points. United Health Products believes this process will ultimately enable it to commence a new study early in 2026. This regulatory progress is crucial for the company's pursuit of Premarket Approval for its CelluSTAT Hemostatic Gauze, which is designed to control mild to moderate bleeding in surgical settings.
Concurrently, United Health Products has completed two required long-term preclinical studies. One study compared the absorption rates and tissue reactivity of CelluSTAT Hemostatic Gauze against the current standard of care product. In animal models where gauze samples were subcutaneously implanted, investigators found no evidence of CelluSTAT material two weeks post-implantation and no tissue reaction at any time. In contrast, standard gauze material 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 findings confirm prior research and suggest that using CelluSTAT Hemostatic Gauze may carry less risk of post-surgical complications such as mass formation, imaging mimicry, and chronic inflammation. The implications for surgical patients could be significant, potentially reducing recovery times and improving outcomes following procedures where hemostatic agents are employed.
Looking forward, the company is organizing a study to potentially expand the indications for CelluSTAT's use, assuming it receives approval for human surgical procedures. United Health Products has scheduled an animal model study to examine and confirm the usability of CelluSTAT in various common laparoscopic procedures, which represent a growing majority of surgeries in the U.S. market. The results of this planned study will be submitted as part of a supplemental FDA Premarket Approval application.
For more information on United Health Products, visit the company's website at https://www.uhpcorp.com. The original release can be viewed at https://www.newmediawire.com. The company's progress through the FDA regulatory process and its preclinical findings represent important developments in the medical device sector, particularly for products aimed at improving surgical outcomes and patient safety.
