United Health Products Inc (UEEC)

[jhersh]

United Health Products Provides Update on FDA PMA Application Process

MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the companys FDA Premarket Approval (PMA) application process.

Following the companys March 21 submission of its PMA application and as part of its substantive review, on June 18 the Food & Drug Administration issued a customary "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application.

Brian Thom, UHPs Chief Executive Officer, comments: "We are very pleased to have reached this milestone in the PMA process, and to understand the FDAs assessment of our application. We are confident we can address these deficiencies to the FDAs satisfaction. In the coming weeks the company will be engaging with the FDA review team directly to determine the most efficient path to providing our responses."

The FDAs 180-day application review period, of which approximately 90 days have elapsed, will be paused while the company develops its responses to the deficiencies that were identified, and will resume once all the responses have been submitted.

There can be no assurance that the companys PMA application will be approved.

About United Health Products -- UHP develops, manufactures and markets HemoStyp(TM), a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.