United Health Products Reports Decreased Net Loss and Focuses on Regulatory Approvals for CelluSTAT

United Health Products, Inc. (UHP) reported a net loss of $2,001,733 for the fiscal year ending December 31, 2024, a decrease from the previous year's loss of $2,623,267. The company did not generate any revenue in either year, as it has focused its resources on obtaining regulatory approvals for its patented hemostatic gauze product, CelluSTAT. Operating expenses decreased to $2,007,572 from $2,426,539, primarily due to reduced litigation settlement costs and lower legal and professional expenses. The company’s cash position improved slightly, with cash and cash equivalents rising to $168,883 from $95,420 in the prior year.

UHP is actively pursuing FDA Premarket Approval (PMA) for its CelluSTAT product, which is designed to control bleeding from superficial wounds. In March 2024, the company submitted a full PMA application, but received a "Deficiencies Letter" from the FDA in June, outlining approximately 40 specific requests for additional information. UHP has since proposed a multi-site study to address the FDA's concerns regarding the product's safety and effectiveness in surgical procedures involving the intestinal and thoracic organ space. The PMA review process is currently on hold while the company works to fulfill these requirements.

The company has also been exploring strategic partnerships and potential mergers to enhance its market position. UHP has received interest from several medical technology companies regarding its products and business strategy. However, there are no guarantees that any specific transaction will materialize. As of March 26, 2025, UHP had three personnel working under consulting agreements, reflecting a lean operational structure as it navigates regulatory challenges and seeks to expand its market presence.

Financially, UHP reported a negative working capital of $1,449,469 as of December 31, 2024, raising concerns about its ability to sustain operations without additional financing. The company has entered into a common stock purchase agreement with White Lion Capital, allowing it to raise up to $10 million, of which approximately $3.2 million has been utilized to support operations and the PMA application. The company’s auditors have expressed substantial doubt about its ability to continue as a going concern, emphasizing the need for further capital to meet its operational obligations.

Looking ahead, UHP remains focused on securing the necessary regulatory approvals for its CelluSTAT product, which it believes has significant market potential in the Class III surgical market. The company is also evaluating various paths to enhance revenue and profitability, including potential commercial partnerships and licensing agreements. However, the success of these initiatives is contingent upon the timely approval of its PMA application and the overall market acceptance of its hemostatic gauze products.