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 found 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 its detailed response to the FDA on April 14, 2025, and awaits further feedback.
The significance of this update lies in the potential of United Health Products' CelluSTAT Hemostatic Gauze, an all-natural product designed to control mild to moderate bleeding, to enter the human surgical market. FDA approval is a critical step in making this innovative treatment available to patients, which could have a substantial impact on surgical procedures and patient care worldwide. The company has completed all necessary study tasks in anticipation of IDE approval, aiming to commence patient enrollment promptly upon receiving the green light from the FDA.
This development is crucial for the medical and surgical industries, as it represents progress in the quest for safer and more effective hemostatic agents. The outcome of the FDA's review could pave the way for new standards in bleeding control during surgical procedures, benefiting both healthcare providers and patients. The ongoing review process underscores the importance of regulatory compliance and the rigorous standards required for medical device approval, ensuring patient safety and efficacy of new treatments.
