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.
As previously noted in the company’s Form 10-K, the U.S. Food & Drug Administration (FDA) requested in late January 2022 that (i) responses submitted by UHP to previous FDA questions be incorporated into its complete Premarket Approval (PMA) application and ii) that the application be reformatted to conform to the FDA’s online “eSubmitter” format. On April 20, 2022, the UHP completed these tasks and there are currently no outstanding applications from the FDA. As usual, 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 is no guarantee that the PMA request will be approved.
Support for Ukraine
In an effort to support the people of Ukraine and those defending the country against Russian invasion, UHP is donating 10,000 units of its HemoStyp haemostatic gauze to help with much-needed civilian and military medical care. UHP, through donations from some of its existing shareholders, has partnered with a US-based charitable relief organization and will deliver 4,000 initial units in the coming days and the remainder once the packaging and sterilization process is complete. . UHP is proud to be able to bring comfort and relief to the victims of Russia’s brutal aggression, and continues to seek commercial avenues to deliver its HemoStyp hemostatic products to this region.
About United Health Products — United Health Products develops, manufactures and markets HemoStyp™, a patented hemostatic agent based on neutralized oxidized regenerated cellulose (NORC). 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 clearance to enter the human surgery market.
For more information on UHP, visit: www.unitedhealthproductsinc.com or contact the company at firstname.lastname@example.org.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press 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. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements.