MT. LAUREL, NJ - July 31, 2025 (NEWMEDIAWIRE) - United Health Products, Inc. (OTCQB: UEEC) today provided a status update on its discussions with the Food & Drug Administration. As previously disclosed, the Company’s Investigational Device Exemption (IDE) application was disallowed pending resolution of the FDA Warning Letter issued on March 25, 2015, identifying certain violations of required clinical procedures that occurred during the 2019 clinical trial. On April 14, 2025, the Company submitted a response to the FDA that addresses the violations. As of the current date, the FDA has not responded to the company’s submission.
The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of its IDE application, UHP has engaged with the FDA’s IDE review team (which functions separately from the group that issued the Warning Letter) to seek a path to timely approval of a new IDE and commencement of the clinical study irrespective of the Warning Letter status. UHP has retained a regulatory attorney to support its efforts in this regard and is discussing with the FDA various solutions including, among other options, identifying an alternative sponsor acceptable to the FDA to oversee the new clinical study on the Company’s behalf. In such an arrangement, UHP would retain full and exclusive rights to the data and analysis contained in a Clinical Trial Report and incorporate these into a revised PMA application. The Company will make further announcements as FDA discussions progress.
About United Health Products -- UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. UHP is seeking approval to access the human surgical market.
For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
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