United Health Products provides update on PMA application

United Health Products provided an update on the company’s FDA Premarket Approval application. UHP continues to advance its Premarket Approval application with the Food and Drug Administration. The company has received and reviewed external laboratory test results on HemoStyp hemostatic gauze produced under its new manufacturing arrangements. The measured physical and chemical characteristics of the new product were shown to be effectively identical to those of the HemoStyp gauze product utilized in the company’s human trial, a key step toward demonstrating a supply of equivalent product for planned commercial production. The company will now incorporate these laboratory results and other data into its PMA application for submission as soon as possible. Concurrently with these final steps for completion of its application, UHP continues to engage with the FDA on various technical aspects of its review process. There can be no assurance that the company’s PMA application will be approved.