United Health Products Advances FDA Approval Process for Novel Hemostatic Device

United Health Products (OTCPK: UEEC) has made significant progress in its pursuit of FDA approval for CelluSTAT, a neutralized regenerated cellulose hemostatic agent designed to control surgical bleeding. The company has successfully addressed key FDA concerns regarding preclinical testing protocols and plans to submit additional responses to all preclinical and clinical comments in early February.

The development represents a crucial step forward in bringing a new medical device to the surgical market, where effective bleeding control remains a critical need. UHP has already identified surgical sites through a large, multi-state healthcare services provider for conducting the required clinical studies, with contract negotiations currently underway.

To support these regulatory efforts, UHP has secured over $400,000 through private placement transactions with existing shareholders and is pursuing additional funding. The company has also applied for an uplisting to the OTCQB exchange from its current OTCPK platform, a move that could increase visibility and accessibility for investors.

The company anticipates completing its clinical study report by mid-summer, pending successful execution of its planned timeline. If approved, CelluSTAT could provide surgeons with an all-natural alternative for managing mild to moderate bleeding during surgical procedures. This development could potentially impact surgical outcomes and patient care across multiple medical specialties, though the company notes there is no guarantee of FDA approval.