United Health Products Provides Regulatory Application Update
MT. LAUREL, NJ - June 6, 2025 ( NEWMEDIAWIRE ) - United Health Products, Inc. (OTCQB: UEEC) today provided a status update on its discussion with the Food & Drug Administration. As previously disclosed, the review by FDA's Office of Product Evaluation and Quality of its Investigational Device Exemption (IDE) application to conduct the follow-on clinical study of 27 patients undergoing organ space procedures found no deficiencies but stated that the company must address the findings set forth in the assessment of the Bioresearch Monitoring (BIMO) audit of its initial 2019 clinical study. The assessment was issued by the Division of Clinical Policy and Quality on March 24, 2025, and the company submitted its detailed response addressing all findings on April 14. As of the current date, the FDA states that its review of the company's response is ongoing.
Pending the resolution of the BIMO Audit assessment, the company has completed all study tasks that can be accomplished prior to the IDE approval so that patient enrollment can begin as soon as possible thereafter.
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 [email protected].
The company can also be reached by phone or text message at 475.755.1005.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words 'believes,' 'expects,' 'anticipates' or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
View the original release on www.newmediawire.com
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