United Health Products Awaits FDA Decision on Hemostatic Gauze Clinical Study
United Health Products, Inc. is in the process of addressing FDA findings related to a BIMO audit for its hemostatic gauze product, CelluSTAT, aiming to expedite patient enrollment upon approval.
United Health Products, Inc. (OTCQB: UEEC) has provided an update on its ongoing discussions with the Food & Drug Administration (FDA) regarding its Investigational Device Exemption (IDE) application. The application seeks approval for a follow-on clinical study involving 27 patients undergoing organ space procedures. The FDA's Office of Product Evaluation and Quality has identified no deficiencies in the IDE application but has requested the company address findings from a Bioresearch Monitoring (BIMO) audit of its initial 2019 clinical study.
The company submitted a detailed response to the FDA's assessment on April 14, 2025, and the FDA's review of this response is currently ongoing. United Health Products has completed all preparatory study tasks pending the IDE approval, positioning the company to begin patient enrollment promptly upon receiving the green light from the FDA.
This development is significant as it represents a critical step toward bringing CelluSTAT Hemostatic Gauze to the human surgical market. CelluSTAT, an all-natural product designed to control mild to moderate bleeding, could offer a safer, more effective option for surgical teams and patients alike. The outcome of the FDA's review could have substantial implications for the medical device industry, particularly in the realm of surgical hemostasis, and potentially improve patient outcomes in surgeries requiring bleeding control.