Mesquite, Nevada – January 19, 2024 – United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.
The company reports today on the receipt and review of final reports on product sterilization and stability testing for its hemostatic gauze. As previously disclosed, UHP has been working with external packaging and sterilization service providers to complete various required tests for its Premarket Approval application. The reported data received this week on the efficacy of the proposed radiation sterilization protocol were well within acceptable bioburden levels for Class III products. UHP will now compile these data and proceed with final drafting of the PMA documentation to be submitted via the eSTAR platform for FDA and Health Canada review.
There can be no assurance that the company’s PMA or Health Canada applications will be approved.
About United Health Products — UHP develops, manufactures and markets HemoStyp™, 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.
The company can also be reached by phone or text message at 475.755.1005
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