UHP provides update on FDA PMA application, White Lion agreement

United Health Products, UHP, provided an update on the company’s FDA Premarket Approval, PMA, application process and the amendment of its Agreement with White Lion Capital. UHP continues to advance its Premarket Approval application with the Food and Drug Administration. Last December, a batch lot of HemoStyp gauze produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company’s human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the company’s manufacturing process, which results will be included in its final PMA application. There can be no assurance that the company’s PMA application will be approved. Separately, in September 2022 the company entered into a Common Stock Purchase Agreement with White Lion Capital, LLC under which the company has the right to sell shares of its common stock to White Lion at a price equal to 93% of the five-day volume weighted average trading price. The company has successfully raised over $350,000 to fund its operations under the Agreement. The Agreement contains a condition that the company share price must be above $0.25 per share in order to issue a share purchase notice, which White Lion can waive at its discretion. On January 25, 2023, the company and White Lion amended the Agreement such that if the company issues a purchase notice when its shares are trading below the Floor Price and White Lion waives the Floor Price condition, White Lion’s purchase price per share in that transaction will be 90% of the five-day volume weighted average trading price rather than 93%. All other terms of the Agreement remain unchanged