United Health Products Reiterates Guidance on FDA PMA Application Process
MESQUITE, NV, June 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.
As disclosed in a press release on March 29, 2023, UHP has produced additional batches of its HemoStyp hemostatic gauze to demonstrate consistency and uniformity of its manufacturing process as required for Class III medical devices. Testing of these additional batches has produced satisfactory results which have been incorporated into the company’s PMA application file.
Concurrently with this effort, packaged product testing in collaboration with the company’s U.S. based, FDA certified packaging partner is being conducted to confirm packaging integrity, effective sterilization and other criteria for Class III products. This testing process is advancing as expected and the company anticipates its completion during the month of June as previously stated. Upon completion, the results will also be incorporated into the PMA application and the full application will be submitted to the FDA.
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 475.755.1005
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.
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