United Health Products, Inc. (OTCQB: UEEC) has provided an update on its regulatory status with the Food & Drug Administration, a development that could significantly influence its future in the human surgical market. The company's Investigational Device Exemption (IDE) application was previously disallowed due to a FDA Warning Letter issued in 2015, citing violations during a 2019 clinical trial. In response, UHP submitted a detailed addressal of these violations on April 14, 2025, but awaits the FDA's feedback.
The resolution timeline remains uncertain, prompting UHP to engage with the FDA's IDE review team separately from the group that issued the Warning Letter. The company aims to secure approval for a new IDE and commence clinical studies, irrespective of the Warning Letter's status. To bolster these efforts, UHP has enlisted a regulatory attorney and is exploring solutions such as identifying an alternative sponsor acceptable to the FDA to oversee the new clinical study. This arrangement would allow UHP to retain exclusive rights to the data and analysis for a revised Premarket Approval (PMA) application.
UHP's product, CelluSTAT Hemostatic Gauze, represents a potential advancement in controlling mild to moderate bleeding with its all-natural, patented Neutralized Regenerated Cellulose hemostatic agent. The ongoing discussions with the FDA are crucial for UHP's ambition to penetrate the human surgical market. Further updates will be provided as discussions progress. For more information, visit https://www.uhpcorp.com.
