United Health Products Seeks FDA Approval for CelluSTAT Hemostatic Gauze via Clinical Trial
Key Insights
United Health Products (search) has filed an Investigational Device Exemption (IDE) application with the FDA for its CelluSTAT (search) Hemostatic Gauze.
The clinical trial will involve approximately 30 subjects across 3-5 surgical facilities to assess CelluSTAT (search)'s non-inferiority and superiority.
UHP is collaborating with a CRO and evaluating surgical sites, with study commencement planned post-FDA approval.
United Health Products (search) (OTCPK: UEEC) is advancing its CelluSTAT (search) Hemostatic Gauze product towards potential FDA approval through a planned clinical trial. The company submitted an Investigational Device Exemption (IDE) application to the FDA on November 29th, marking a crucial step in securing regulatory clearance for its all-natural hemostatic agent designed to control mild to moderate bleeding (search) during surgical procedures. The study aims to demonstrate CelluSTAT's non-inferiority and superiority compared to the standard of care in open abdominal surgeries.
Clinical Trial Design and Objectives
The proposed clinical trial will enroll approximately 30 subjects across 3-5 surgical facilities. The primary objectives include confirming non-inferiority and demonstrating superiority of CelluSTAT (search) against the current standard of care in open surgical procedures within the abdominal cavity. Safety will also be a key endpoint. The FDA typically responds to IDE applications within 30 days, contingent on resource availability.
Collaboration and Site Selection
UHP has partnered with a contract research organization (CRO) to manage the clinical study, ensuring adherence to Good Clinical Practice guidelines. The CRO will oversee project management, site monitoring, safety oversight, and data management. Simultaneously, UHP is actively evaluating surgical centers to identify suitable sites for conducting the clinical trial. During the FDA review period, the company will finalize site evaluations, develop training materials for site investigators, and engage a Central IRB to oversee the study process, with the goal of initiating subject enrollment promptly after IDE approval.
Funding and Corporate Initiatives
Completing the clinical study and addressing all FDA requirements necessitates external funding. UHP is in discussions with potential capital providers, including existing investors, to secure the required funds. The company aims to negotiate investment terms that minimize dilution for current shareholders. Furthermore, UHP is undertaking several corporate initiatives to enhance shareholder value, including expanding its Board of Directors, establishing a qualified Audit Committee, retaining an investor relations firm, and pursuing an uplisting from the OTCPK exchange to a more established platform like OTCQB, targeted for completion in the first quarter of 2025, subject to securing necessary capital.
About CelluSTAT
CelluSTAT (search) is a hemostatic agent developed and patented by UHP, composed of Neutralized Regenerated Cellulose. It is designed as an all-natural solution for controlling mild to moderate bleeding (search). The company is focused on obtaining approval to market CelluSTAT for use in human surgical procedures.