United Health Products Provides Regulatory Update

Rhea-AI Summary

United Health Products (OTCPK: UEEC) announced an update regarding its FDA regulatory review process on May 18, 2022. The company submitted a supplemented Premarket Approval (PMA) response for its hemostatic gauze, HemoStyp™, to the FDA on April 20, 2022. UHP has scheduled a meeting with the review committee for July 6, 2022, where it anticipates receiving feedback on its application. However, the outcome of the PMA application remains uncertain, as approval cannot be guaranteed.

Positive

• None.

Negative

• Uncertainty surrounding the approval of the PMA application for HemoStyp™.
• No assurance that the ongoing engagement with the FDA will result in a positive outcome.

Henderson, NV, May 18, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on its FDA regulatory process.  

Regulatory Review
As previously disclosed, on April 20, 2022, UHP delivered to the U.S. Food & Drug Administration (FDA) a supplemented and e-formatted Premarket Approval (PMA) response for its HemoStyp™ hemostatic gauze and, as is customary, requested a meeting with the committee responsible for reviewing its PMA application. UHP has accepted the FDA’s offer to meet on July 6, 2022, and anticipates receiving feedback on its latest response in advance of this meeting. The company will continue to engage with members of the review committee to address any remaining requests and to ensure a productive interaction in July.  There can be no assurance that the PMA application will be approved.

Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com

About United Health Products -- United Health Products 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 consumer markets, and is focused on gaining approval to access the human surgical market. 

For more information on UHP visit: www.unitedhealthproductsinc.com or contact the Company at info@unitedhealthproductsinc.com

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 from United Health Products (UEEC) regarding FDA approval?

On May 18, 2022, United Health Products provided an update stating they submitted a supplemented PMA response to the FDA on April 20, 2022.

When is United Health Products' meeting with the FDA regarding its PMA application?

United Health Products has scheduled a meeting with the FDA review committee for July 6, 2022.

What product is United Health Products seeking FDA approval for?

United Health Products is seeking FDA approval for its hemostatic gauze, HemoStyp™.

Is FDA approval guaranteed for United Health Products' HemoStyp™?

No, there is no assurance that the FDA will approve the PMA application for HemoStyp™.