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PRESS RELEASE
By: NewMediaWire
January 31, 2025

United Health Products Provides Update on FDA PMA Application Process

MT. LAUREL, NJ - January 31, 2025 (NEWMEDIAWIRE) - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s regulatory and capital markets activities.  

As previously disclosed, UHP submitted to the FDA an Investigational Device Exemption application (IDE) last November, the approval of which is a precondition to enroll patients in the planned study. The company held discussions with the FDA prior to year end and again on January 28th regarding the FDA’s comments on its application, which resolved certain concerns regarding preclinical testing protocols. With these matters resolved, the company expects to submit to the FDA its additional responses addressing all preclinical and clinical comments, in early February.

Concurrently with its IDE application process and in coordination with its contract research organization, UHP has identified surgical sites operated by a large, multi-state healthcare services provider that are suitable for conducting the organ space surgical procedures consistent with the study protocol. Contract negotiations with the site operator and a Central IRB are in process.  In addition, the Company is engaged with a digital media partner to develop investigator training materials necessary to conduct the study. It is anticipated that these activities will be completed prior to March 15 which will allow the company to complete its clinical study report by mid-summer as previously stated. There can be no assurance that the PMA application will be approved.

To fund the clinical study and other activities UHP has successfully raised over $400,000 through private placement transactions with longtime existing shareholders and is in discussions to secure additional funds under a similar strategy. To boost investor interest and demand for its securities, the company has applied to OTC Markets for an uplisting of its shares to trade on the OTCQB exchange from the current OTCPK platform. OTC Markets is reviewing the application materials and there can be no assurance that this application will be approved. The company does not currently anticipate drawing upon its existing stock purchase agreement with White Lion Capital.

About United Health Products -- UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT 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.

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.

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