United Health Products Provides Update on Manufacturing and FDA PMA Application

Rhea-AI Summary

United Health Products (OTCPK: UEEC) has provided an update on its FDA Premarket Approval (PMA) application. The company confirmed that external lab tests on its HemoStyp hemostatic gauze showed the product's characteristics closely match those used in human trials. This is a significant step towards ensuring an equivalent product for commercial production. UHP plans to integrate these results into its PMA application for submission soon while continuing discussions with the FDA on technical aspects. However, there is no guarantee that the PMA application will be approved.

Positive

• External lab tests confirm HemoStyp gauze characteristics match those used in human trials.
• Advancement in PMA application process is underway with incorporation of lab results.

Negative

• No guarantee of PMA application approval.

MESQUITE, NV, Dec. 19, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the company’s FDA Premarket Approval application.

UHP continues to advance its Premarket Approval application with the Food and Drug Administration. The company has received and reviewed external laboratory test results on HemoStyp hemostatic gauze produced under its new manufacturing arrangements. The measured physical and chemical characteristics of the new product were shown to be effectively identical to those of the HemoStyp gauze product utilized in the company’s human trial, a key step toward demonstrating a supply of equivalent product for planned commercial production. The company will now incorporate these laboratory results and other data into its PMA application for submission as soon as possible. Concurrently with these final steps for completion of its application, UHP continues to engage with the FDA on various technical aspects of its review process.

There can be no assurance that the company’s PMA application will be approved.

About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Oxidized Regenerated Cellulose (NORC) 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 focused on gaining 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 is the latest update on United Health Products' PMA application?

United Health Products has made progress on its FDA PMA application, confirming that the characteristics of its HemoStyp gauze are consistent with those used in human trials.

What does the recent lab testing reveal about HemoStyp?

Lab tests indicate HemoStyp hemostatic gauze has physical and chemical characteristics effectively identical to those used in past human trials.

Is there any assurance on the approval of UEEC's PMA application?

There is no assurance that United Health Products' PMA application will receive FDA approval.