United Health Products Advances FDA Approval Process for Surgical Hemostatic Agent

United Health Products is making significant strides in its regulatory journey to bring CelluSTAT, an all-natural hemostatic agent designed to control mild to moderate bleeding, to the surgical market. The company has been actively engaging with the FDA to resolve preclinical testing protocol concerns and prepare for its investigational device exemption (IDE) application.

Following discussions with the FDA in late January, the company has successfully addressed initial concerns regarding its preclinical testing protocols. UHP plans to submit comprehensive responses to the FDA's comments in early February, demonstrating its commitment to meeting rigorous regulatory standards.

The company has simultaneously been preparing for its clinical study, identifying suitable surgical sites through a large, multi-state healthcare services provider. By coordinating with a contract research organization and developing investigator training materials, UHP is positioning itself to potentially complete its clinical study report by mid-summer.

To support these critical initiatives, UHP has raised over $400,000 through private placement transactions with existing shareholders. The company is also exploring additional funding strategies to ensure continued progress. In an effort to enhance its market visibility, UHP has applied for an uplisting to the OTCQB exchange from its current OTCPK platform, signaling confidence in its future prospects.

While the path to FDA approval remains complex, with no guarantees of success, United Health Products is methodically advancing its regulatory strategy. The potential approval of CelluSTAT could represent a significant breakthrough in surgical bleeding control, offering healthcare providers an innovative, all-natural solution for managing surgical hemorrhage.

The medical device market continues to evolve, and UHP's focused approach to developing and commercializing its hemostatic agent demonstrates the ongoing innovation in surgical technologies. Successful navigation of the FDA's stringent approval process could open substantial market opportunities for the company's regenerated cellulose product.