United Health Products (UHP) has achieved significant milestones in advancing its FDA Pre-Market Approval (PMA) application for CelluSTAT, a novel neutralized regenerated cellulose hemostatic agent designed for surgical applications.
Regulatory Progress and Clinical Trial Preparations
The company has successfully addressed key regulatory hurdles in its Investigational Device Exemption (IDE) application process. Following productive discussions with the FDA on January 28th, 2025, UHP resolved several concerns regarding preclinical testing protocols. The company plans to submit comprehensive responses addressing all preclinical and clinical comments to the FDA in early February.
In parallel with the regulatory process, UHP has made substantial progress in preparing for clinical trials. The company has partnered with a major multi-state healthcare services provider to identify appropriate surgical sites for conducting organ space surgical procedures. These preparations include ongoing contract negotiations with site operators and a Central IRB.
"We are actively developing investigator training materials through our digital media partner to ensure standardized protocol implementation across all study sites," a company representative stated. These preparatory activities are scheduled for completion by March 15th, keeping the company on track for its targeted mid-summer clinical study report completion.
Financial Strategy and Market Position
To support these developments, UHP has successfully secured over $400,000 through private placement transactions with existing long-term shareholders. The funding will primarily support the clinical study and related operational activities. The company is actively pursuing additional funding through similar channels, demonstrating investor confidence in its development program.
In a strategic move to enhance market visibility and accessibility, UHP has submitted an application to uplist from the OTCPK platform to the OTCQB exchange. This transition, if approved, could potentially broaden the company's investor base and improve trading liquidity.
Product Development and Market Potential
CelluSTAT represents an innovative approach to surgical hemostasis, utilizing all-natural materials to control mild to moderate bleeding. The technology builds on the established foundation of regenerated cellulose while incorporating proprietary neutralization processes that differentiate it from existing solutions.
While the company maintains optimism about its regulatory pathway, management acknowledges that FDA approval is not guaranteed. The upcoming clinical trials will be crucial in demonstrating CelluSTAT's safety and efficacy in surgical applications.
