United Health Products Provides Regulatory Status Update
December 22, 2021 at 07:30 pm IST
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United Health Products, Inc. provided an update on the status of its application to the Food & Drug Administration (FDA) for Pre-market Approval (PMA) of its HemoStyp™ hemostatic gauze. On Dec. 21, the FDA informed UHP that its review of the PMA application is ongoing and at this time there were no additional information requests to UHP. The FDA reserves the right under its review process to request additional information at any time. As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market its HemoStyp products for human surgical procedures in the United States. There can be no assurance that a PMA will be granted by the FDA.
United Health Products, Inc. develops, manufactures, and markets a hemostatic gauze for the healthcare and wound care sectors. Its gauze product, HemoStyp, is derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. HemoStyp hemostatic gauze is a flexible, silk-like material that is applied by placing the gauze onto the bleeding tissue. The supple material can be easily folded and manipulated as needed to fit the size of the wound or incision. In surface bleeding and surgical situations, the product quickly converts to a translucent gel that allows the physician or surgeon to monitor the coagulation process. In superficial bleeding situations, HemoStyp can be bonded to an adhesive plastic bandage or integrated into a traditional gauze component to address a range of needs, including traumatic bleeding injuries and prolonged bleeding following hemodialysis. Its customer base includes hospitals, surgery centers, clinics and others.
UNITED HEALTH PRODUCTS, INC. 
