Henderson, Nevada – April 1, 2022 – United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on its regulatory process, business condition, and other matters.
Following the submission in October, 2021 of a response to the FDA’s questions and comments on its Premarket Approval (PMA) application, UHP and the FDA held a meeting in late January 2022 in which the FDA requested that i) the information submitted in October be incorporated into the full PMA application and ii) that the application be reformatted to conform to the FDA’s “eSubmitter” online format. The company and its regulatory consultant have been working to accomplish these tasks and have also taken this opportunity to revise certain elements of the PMA application to reflect current FDA conventions for presentation of data within the application. UHP expects to complete these tasks before the end of April. There can be no assurance that the FDA will approve the company’s PMA application.
In parallel with the PMA application process, UHP is well advanced in the application process for a CE Mark certificate under the Medical Devices Regulation (MDR) framework. The process for European registration requires the engagement of a Notified Body (NB) that will provide the centralized communication between UHP and the members of the European Union. With the support of its regulatory consultant, UHP has identified certain suitable NB candidates and is in the process of engaging with them to advance the application and review process.
Commercial Operations and Financial Results
As described in the company’s annual report filed with the SEC today on Form 10-K, UHP has re-engaged with several potential customers and distribution partners in the 510k market with the objective of generating revenues from its HemoStyp™ products. This effort may provide a source of revenue and cash flow while the FDA PMA review process proceeds.
As also described in the 10-K the company, in consultation with its auditors, has written off the value of its production equipment and certain work-in-progress inventory due to the extended period of inactivity, consistent with accounting standards. The company notes that its manufacturing equipment remains in good operational condition and is on location at the premises of our FDA-approved contract manufacturing partner. The equipment is ready to become operational in anticipation of an FDA inspection and/or the need to produce HemoStyp material for commercial orders.
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 2,000 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.
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.
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