United Health Products, Inc. (OTCQB: UEEC) has provided an update on its regulatory discussions with the Food & Drug Administration (FDA), highlighting the uncertainty surrounding the resolution of a Warning Letter issued in 2015. The letter cited violations during a 2019 clinical trial, leading to the disallowance of the company's Investigational Device Exemption (IDE) application. On April 14, 2025, the company submitted a response addressing these violations, but the FDA has yet to respond.
The company is actively engaging with the FDA's IDE review team to explore avenues for the approval of a new IDE and the initiation of a clinical study, regardless of the Warning Letter's status. United Health Products has enlisted a regulatory attorney to aid in these efforts and is considering various solutions, including the possibility of an alternative sponsor to oversee the new study. This arrangement would allow the company to retain exclusive rights to the data and analysis for incorporation into a revised Premarket Approval (PMA) application.
United Health Products is focused on advancing its Neutralized Regenerated Cellulose hemostatic agent, CelluSTAT Hemostatic Gauze, designed for controlling mild to moderate bleeding. The company aims to secure approval for the human surgical market. For more information, visit https://www.uhpcorp.com.
The resolution of the FDA Warning Letter and the approval of the IDE application are critical steps for United Health Products to proceed with its clinical study and ultimately bring its innovative product to market. The outcome of these discussions could have significant implications for the medical device industry and patients in need of effective hemostatic solutions.
