United Health Products Secures FDA Approval for New Clinical Study Partnership to Advance CelluSTAT Hemostatic Gauze
核心洞察
United Health Products (搜索) received FDA approval for a collaborative clinical study arrangement with a U.S. hemostatic products manufacturer to sponsor a new trial of CelluSTAT Hemostatic Gauze (搜索).
The FDA approved an external audit firm to conduct a Good Clinical Practices audit of UHP's protocols and procedures as part of resolving a Warning Letter issued in March 2025.
This regulatory pathway allows UHP to proceed with an Investigational Device Exemption study while addressing FDA concerns from violations during the company's 2019 clinical trial.
United Health Products (搜索), Inc. (OTCQB: UEEC) has achieved significant regulatory milestones in its efforts to bring CelluSTAT Hemostatic Gauze (搜索) to market, securing FDA approval for a collaborative clinical study arrangement that provides a clear pathway forward following regulatory setbacks.
FDA Approves Collaborative Study Framework
The FDA formally approved UHP's proposal to collaborate with another U.S. manufacturer and distributor of hemostatic products, where the partner will serve as sponsor of a new clinical study of CelluSTAT Hemostatic Gauze (搜索). Under this arrangement, UHP will hold an exclusive right of reference to all data from the study for use in a revised Premarket Approval (PMA) application.
This collaborative framework allows a study to proceed, subject to granting of an Investigational Device Exemption (IDE), while UHP simultaneously works with the FDA to resolve a Warning Letter issued on March 25, 2025, which identified violations that occurred during the company's 2019 clinical trial.
Good Clinical Practices Audit Approved
In addition to the clinical study arrangement, the FDA has approved the external audit firm that will conduct a Good Clinical Practices (GCP) audit of UHP's protocols, procedures and personnel. The audit, recommended by the FDA and scheduled for the coming months, aims to assess and confirm the company's ability to conduct its own clinical trials in accordance with all applicable FDA regulations.
Executive Commentary on Regulatory Progress
Bran Thom, UHP's CEO, characterized these developments as "important milestones" resulting from "the past 14 months of investigation and discussion with the FDA to address their concerns over the company's actions in 2018-19."
"We are pleased to now have a clear path to demonstrating, through a new IDE study, the safety and effectiveness of our CelluSTAT gauze," Thom stated. "We are currently in discussions with several established medical device companies regarding our substitute sponsor plan and hope to enter into a formal collaboration agreement soon."
Thom added that the company looks forward to the GCP audit, which "along with other corrective actions we have proposed, will resolve and lift the Warning Letter."
CelluSTAT Technology Profile
CelluSTAT Hemostatic Gauze (搜索) represents UHP's patented Neutralized Regenerated Cellulose (搜索) hemostatic agent technology. The all-natural product is designed to control mild to moderate bleeding (搜索) and targets the human surgical market. UHP is seeking regulatory approval to access this market segment through the revised PMA pathway.