United Health Products has made significant strides in its regulatory journey, completing crucial safety tests for its CelluSTAT Hemostatic Gauze and submitting comprehensive documentation to both the Food and Drug Administration (FDA) and OTC Markets.
The medical device company has successfully addressed the FDA's request for additional sterilization and biotoxicity tests, confirming the sterility and biocompatibility of its hemostatic gauze. These test results are essential for obtaining an Investigational Device Exemption (IDE), a prerequisite for initiating a 27-patient clinical study.
The completed tests validate the product's safety standards for a Class III, absorbable medical device. This milestone represents a critical step toward potential market approval for a product designed to control mild to moderate bleeding using an all-natural approach.
Simultaneously, United Health Products has responded to OTC Markets' information requests related to its application for uplisting to the OTCQB market. By providing the requested documentation, the company has enabled OTC Markets to proceed with its review of the application.
While the company emphasizes that neither the FDA Premarket Approval nor the OTCQB uplisting is guaranteed, these developments signal meaningful progress in the company's strategic objectives. The potential approval would provide United Health Products access to the human surgical market and enhance its market visibility.
The CelluSTAT Hemostatic Gauze, a patented neutralized regenerated cellulose hemostatic agent, represents an innovative solution in wound management. Its all-natural composition could potentially offer healthcare providers and patients an alternative hemostatic product with unique characteristics.
These regulatory advancements demonstrate United Health Products' commitment to rigorous safety standards and strategic market expansion, positioning the company for potential future growth in the medical device sector.
