United Health Products, Inc.

United Health Products, Inc. (UHP) develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. The company's gauze product, CelluSTAT®, is made from cotton and designed to absorb fluid from superficial wounds and help control bleeding. UHP is currently seeking regulatory approval to sell its hemostatic gauze product line in the U.S. Class III and European CE Mark human surgical markets. As part of its business strategy, UHP is pursuing FDA Premarket Approval (PMA) for its CelluSTAT Hemostatic Gauze products. In March 2024, the company submitted a full PMA application to the FDA. The FDA responded in June 2024 with a "Deficiencies Letter" containing approximately 40 specific comments and requests for additional information regarding the device description, sterility and shelf life, clinical and performance testing, and biocompatibility sections of the application. From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of UHP's records and procedures related to its 2019 clinical study, subsequently issuing Inspectional Observations on Form 483. In October 2024, UHP and the FDA held a virtual meeting to discuss the Deficiencies Letter. During this discussion, UHP highlighted the results of its 2019 clinical trial, which involved 232 patients (118 treated with its hemostatic gauze). This study demonstrated statistically superior performance in time to hemostasis for CelluSTAT compared to Ethicon's Surgicel Original, the standard of care. The study also indicated no heterogeneity of results across procedure categories, surgeons, or clinical sites, suggesting the results are both poolable and generalizable. Furthermore, none of the adverse events during the study were attributed to UHP's hemostatic gauze product.