United Health Products (OTCPK: UEEC) is making significant progress in its regulatory and capital market strategies for its hemostatic agent CelluSTAT, targeting entry into the human surgical market. The company has submitted an application to OTC Markets for OTCQB market quotation and is simultaneously advancing its Premarket Approval (PMA) process with the FDA.
The company has raised over $500,000 through private placement transactions to fund clinical activities, avoiding reliance on its existing equity line of credit. These funds will support ongoing clinical studies and PMA application requirements.
In its FDA interactions, the company has submitted an Investigational Device Exemption (IDE) application and is completing additional sterilization and biotoxicity tests requested by the regulatory agency. Simultaneously, UHP has negotiated a Clinical Trial Agreement with a national hospital and surgical center operator, identifying three facilities to conduct the 27 surgical procedures specified by the FDA.
Despite potential workforce reductions in federal agencies under the Trump Administration, UHP reports that FDA response times remain consistent with historical patterns. The company remains cautiously optimistic about its regulatory and market listing applications, acknowledging that approval is not guaranteed.
The potential market entry of CelluSTAT represents a significant opportunity for United Health Products, offering an all-natural hemostatic solution designed to control mild to moderate bleeding in surgical settings. By methodically addressing regulatory requirements and exploring market listing options, the company is positioning itself for potential commercial advancement.
