MOUNT LAUREL, NJ - 
(NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval (PMA) application process.
Following the company’s March 21 submission of its PMA application and as part of its substantive review, on June 18 the Food & Drug Administration issued a customary “Deficiencies Letter” to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application.
Brian Thom, UHP’s Chief Executive Officer, comments: “We are very pleased to have reached this milestone in the PMA process, and to understand the FDA’s assessment of our application. We are confident we can address these deficiencies to the FDA’s satisfaction. In the coming weeks the company will be engaging with the FDA review team directly to determine the most efficient path to providing our responses.”
The FDA’s 180-day application review period, of which approximately 90 days have elapsed, will be paused while the company develops its responses to the deficiencies that were identified, and will resume once all the responses have been submitted.
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.
For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
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.
