United Health Products Advances Regulatory Pathway for Surgical Hemostatic Agent

United Health Products is making strategic moves to advance its medical device approval process for CelluSTAT, an all-natural hemostatic agent designed to control mild to moderate bleeding. The company has submitted multiple critical applications to support its goal of entering the human surgical market.

The medical technology firm recently filed an Investigational Device Exemption (IDE) application with the FDA, which has requested additional sterilization and biotoxicity tests. UHP expects to complete and submit these final tests by the end of March, positioning the company for potential FDA review and approval.

To support its clinical study requirements, UHP has successfully raised over $500,000 through private placement transactions with existing and new investors. The company anticipates generating sufficient capital through similar private investments to fund the remaining clinical study and complete its Premarket Approval (PMA) application.

Simultaneously, UHP has negotiated a Clinical Trial Agreement with a national hospital and surgical center operator. The agreement includes three facilities prepared to conduct the 27 surgical procedures requested by the FDA, demonstrating the company's proactive approach to meeting regulatory requirements.

The company has also submitted an application to OTC Markets to have its common shares quoted on the OTCQB market. This strategic move aims to increase potential investor base and improve trading liquidity for the company's stock.

Despite potential workforce changes at the FDA during the Trump Administration, UHP reports that the agency's response times remain consistent with previous interactions. The company remains focused on its regulatory objectives while navigating the complex medical device approval landscape.

UHP's CelluSTAT represents a potentially significant advancement in surgical hemostasis, offering an all-natural solution for controlling bleeding during medical procedures. The company's methodical approach to regulatory compliance and clinical validation underscores its commitment to introducing an innovative medical technology to the market.