United Health Products Reports on FDA Application Status

Rhea-AI Summary

United Health Products (UEEC) reports positive results from product sterilization and stability testing for its hemostatic gauze, meeting acceptable bioburden levels for Class III products. The company will proceed with final drafting of the PMA documentation to be submitted for FDA and Health Canada review.

Positive

• Positive results from product sterilization and stability testing
• Meeting acceptable bioburden levels for Class III products

Negative

• No assurance that the company’s PMA or Health Canada applications will be approved

MESQUITE, NV, Jan. 19, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products (UEEC) 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. 

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.

FAQ

What did United Health Products (UEEC) report on?

United Health Products (UEEC) reported on the receipt and review of final reports on product sterilization and stability testing for its hemostatic gauze.

What were the results of the reported data on the efficacy of the proposed radiation sterilization protocol?

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.

What will United Health Products (UEEC) do next after receiving the reported data?

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.

Will the company's PMA or Health Canada applications be approved?

There can be no assurance that the company’s PMA or Health Canada applications will be approved.