United Health Products Advances FDA Approval and Market Listing for Hemostatic Gauze

March 28th, 2025 3:11 PM
By: Newsworthy Staff

United Health Products has submitted additional safety test results to the FDA for its CelluSTAT Hemostatic Gauze and provided updates on its OTCQB market listing application, moving closer to potential market entry for its medical device.

United Health Products Advances FDA Approval and Market Listing for Hemostatic Gauze

United Health Products has made significant progress in its regulatory and market expansion efforts for its innovative hemostatic medical device, CelluSTAT Hemostatic Gauze. The company recently completed crucial safety testing required by the FDA and submitted additional documentation to support its Investigational Device Exemption (IDE) application.

The sterilization and biotoxicity tests conducted by the company confirmed that the CelluSTAT Hemostatic Gauze meets the stringent safety requirements for a Class III, absorbable medical device. These results represent a critical milestone in the company's strategy to gain approval for accessing the human surgical market.

Simultaneously, United Health Products has been working to advance its market visibility by pursuing an uplisting to the OTCQB market. The company has responded to additional information requests from OTC Markets, potentially paving the way for improved trading visibility and investor accessibility.

While the company acknowledges that neither the FDA Premarket Approval nor the OTCQB uplisting is guaranteed, these developments signal meaningful progress in bringing their all-natural hemostatic agent to market. The CelluSTAT product, designed to control mild to moderate bleeding, could represent an important innovation in surgical wound management.

The ongoing regulatory process underscores the rigorous standards medical device manufacturers must meet to introduce new products. For United Health Products, each successfully completed step brings the company closer to potentially providing healthcare professionals with a novel hemostatic solution that could improve surgical outcomes.

Source Statement

This news article relied primarily on a press release disributed by NewMediaWire. You can read the source press release here,

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