United Health Products Provides Business Update on Its Regulatory Approval Application Process
October 07, 2021 at 04:30 pm IST
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United Health Products, Inc. provided an update on its regulatory approval application process and other business activities. As part of its substantive review process to evaluate UHP's PMA application, the FDA has requested details on certain elements of the HemoStyp manufacturing process. In keeping with industry best practices, UHP recently completed the implementation of an industry-standard Good Manufacturing Practices software tool and will be submitting a response to the FDA's request later this month. Separately, UHP's registration statement was declared effective by the SEC on Sept. 29, which permitted it to proceed towards closing of its previously announced stock purchase agreement with Triton Funds, which has agreed to invest between $4 million and $6 million in UHP's common stock in one or more closings as may be requested by UHP from time to time. The registration statement registers shares purchased by Triton Funds for resale. These funds will enable the advancement of R&D, regulatory and commercial initiatives to bring a broad portfolio of HemoStyp formats to several geographic markets. As part of its ongoing R&D effort, UHP recently produced a prototype form of HemoStyp material that is designed for trauma and surgical applications where its existing HemoStyp gauze material may not be suitable. Further in-vitro and animal testing is planned to advance potential FDA and other regulatory applications for use of this format.
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. 
