United Health Products has reported significant progress in its regulatory and market expansion efforts, focusing on obtaining FDA approval for its CelluSTAT Hemostatic Gauze and improving its market visibility.
The medical device company has successfully completed additional sterilization and biotoxicity tests requested by the FDA for its Investigational Device Exemption (IDE) application. These test results confirm that the CelluSTAT Hemostatic Gauze meets safety requirements for a Class III, absorbable medical device. The submission of these results represents a critical step toward potential FDA approval and market entry.
Simultaneously, the company is pursuing an uplisting of its common shares to the OTCQB market. OTC Markets has requested and received additional information from United Health Products, enabling the completion of their review process.
The CelluSTAT Hemostatic Gauze, an all-natural product designed to control mild to moderate bleeding, could represent a significant advancement in surgical hemostasis technology. While FDA approval is not guaranteed, the company's systematic approach to meeting regulatory requirements demonstrates its commitment to bringing a potentially innovative medical solution to market.
Investors and healthcare professionals will likely be monitoring the company's progress, as successful FDA approval could open substantial market opportunities for United Health Products in the surgical medical device sector.
