Mesquite, Nevada – June 27, 2023 – United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.
As previously disclosed, UHP is conducting FDA required testing on its packaged products in collaboration with the company’s U.S. based, FDA certified packaging partner. The test protocol is designed to ensure that products shipped to customers are sterile and are not damaged nor contaminated during transport from the packaging facility. The protocol involves a sequential process by three external vendors including sterilization, agitation and liquid immersion followed by physical inspection and bio contamination testing. Due to capacity constraints at certain vendors the company now expects the full results may not be available until mid-July rather than the end of June as previously stated. UHP will issue a statement upon completion of this process. The results will be incorporated into the PMA application, which is otherwise complete, and the full application will be submitted to the FDA. The company has notified the FDA of its intention to file this revised PMA submission as soon as possible.
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 Regenerated Cellulose 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 seeking approval to access the human surgical market.
The company can also be reached by phone or text message at 475.755.1005Safe 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.