United Health Products has successfully completed additional sterilization and biotoxicity tests for its medical device, CelluSTAT Hemostatic Gauze, marking a significant step forward in its FDA approval process. The company submitted comprehensive test results confirming the product meets safety requirements for a Class III, absorbable medical device.
The FDA previously requested supplemental tests as part of the Investigational Device Exemption (IDE) application, a critical precursor to initiating a clinical study involving 27 patients. By providing these detailed test results, United Health Products has demonstrated the sterility and biocompatibility of its hemostatic product.
Simultaneously, the company is pursuing an uplisting of its common shares to the OTCQB market. OTC Markets has requested additional information, which United Health Products has now provided, enabling the market to complete its review of the application.
The CelluSTAT Hemostatic Gauze, an all-natural product designed to control mild to moderate bleeding, represents a potential innovation in surgical wound management. The company’s ongoing efforts to gain regulatory approval could position it to access the human surgical market with a unique hemostatic solution.
While the company has made significant progress, it acknowledges that neither the FDA Premarket Approval nor the OTCQB uplisting are guaranteed outcomes. The ongoing regulatory and market processes will ultimately determine the future trajectory of United Health Products’ medical device.
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