United Health Products Provides Regulatory and Business Update
United Health Products (OTCPK: UEEC) announced progress in its FDA regulatory review, having submitted a revised Premarket Approval (PMA) application. Completed on April 20, 2022, this application now meets FDA formatting requirements, with no outstanding requests. Additionally, UEEC is supporting Ukraine by donating 10,000 units of its HemoStyp hemostatic gauze, aimed at aiding medical care amidst the ongoing conflict. The company emphasizes its commitment to both regulatory compliance and humanitarian efforts.
- Completion of FDA PMA application tasks.
- No outstanding requests from the FDA.
- Donation of 10,000 units of HemoStyp to support Ukraine.
- Uncertainty regarding PMA application approval.
Henderson, NV, April 27, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on its FDA regulatory process and other matters.
Regulatory Review
As previously disclosed in the company’s Form 10-K, the U.S. Food & Drug Administration (FDA) requested in late January 2022 that i) the responses submitted by UHP to previous FDA questions be incorporated into its full Premarket Approval (PMA) application and ii) that the application be reformatted to conform to the FDA’s “eSubmitter” online format. On April 20, 2022, UHP completed these tasks and there are currently no requests outstanding from the FDA. As is customary, the company and its regulatory consultant have requested a meeting within the next 30 days with the committee responsible for reviewing its PMA application. There can be no assurance that the PMA application will be approved.
Support for Ukraine
In an effort to support the people of Ukraine and those working to defend the country against the Russian invasion, UHP is donating 10,000 units of its HemoStyp hemostatic gauze to aid with much needed civilian and military medical care. UHP, with donations from certain of its existing shareholders, has partnered with a U.S. based charitable relief organization and will deliver an initial 4,000 units in the coming days and the remainder as the packaging and sterilization process is complete. UHP is proud to be able to bring some measure of comfort and relief to the victims of Russia’s brutal aggression, and continues to pursue commercial avenues to deliver its HemoStyp hemostatic products to this region.
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
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