United Health Products Provides Update on FDA PMA Application

Rhea-AI Summary

United Health Products (OTCPK: UEEC) has provided an update on its FDA Premarket Approval application for HemoStyp, a hemostatic agent. The company has completed its review of Standard Operating Procedures and is waiting for the results of external laboratory tests on samples produced under a new manufacturing agreement. The submission of the full PMA application is anticipated shortly, although approval is not guaranteed. UHP aims to secure access to the human surgical market, building on its existing offerings in dental, veterinary, and emergency medicine.

Positive

• Advancing FDA Premarket Approval application for HemoStyp.
• Completion of Standard Operating Procedures for manufacturing.
• Anticipation of submitting full PMA application soon.

Negative

• No assurance that the PMA application will be approved.
• Awaiting external test results may delay the application process.

Mesquite, NV, Nov. 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provides an update on the company’s FDA Premarket Approval application.  

UHP continues to advance its Premarket Approval application with the Food and Drug Administration. As described in its October 31 press release, the company has completed its review and documentation of manufacturing and packaging related Standard Operating Procedures (SOPs) and is now awaiting external laboratory test results on HemoStyp samples produced under its new manufacturing arrangement. Upon receipt and review of the sample analysis, the company expects to submit its full PMA application within a few days. 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 status of United Health Products' FDA application?

United Health Products is awaiting external laboratory test results before submitting its full Premarket Approval application for HemoStyp.

What is HemoStyp developed by United Health Products?

HemoStyp is a patented, all-natural hemostatic agent designed to control bleeding.

When does United Health Products expect to submit its PMA application?

The company expects to submit its PMA application shortly after receiving the laboratory test results.

What markets does United Health Products target with HemoStyp?

UHP targets the dental, veterinary, and emergency medicine markets, with plans to access the human surgical market.

What risks are associated with United Health Products' FDA approval process?

There is no guarantee that the PMA application will be approved, which poses a risk for UHP.