Curated News
By: NewsRamp Editorial Staff
April 06, 2026

UHP Gains FDA Approval for New CelluSTAT Study Plan, Aims to Resolve Warning Letter

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Original Source

TLDR

  • United Health Products gains FDA approval for a partner-led clinical study, creating a clear path to resolve regulatory issues and potentially access the lucrative surgical market.
  • The FDA approved UHP's plan for a partner to sponsor a new clinical study of CelluSTAT gauze and conduct a GCP audit to assess compliance protocols.
  • This regulatory progress moves UHP closer to bringing its all-natural hemostatic gauze to market, potentially improving surgical bleeding control with a safer product.
  • United Health Products is navigating FDA regulations through a partner-sponsored study and audit, aiming to demonstrate CelluSTAT gauze's effectiveness after past clinical trial violations.

Impact - Why it Matters

This development is crucial for investors, healthcare providers, and patients because it represents a pivotal step for United Health Products in overcoming a significant regulatory hurdle. The FDA's approval of a new clinical study pathway and audit plan suggests the agency is working collaboratively with the company to address past compliance issues, which could restore confidence in UHP's management and its flagship product, CelluSTAT. For the medical device industry, this case illustrates the rigorous but navigable process of resolving FDA Warning Letters through corrective actions and strategic partnerships. Successfully bringing CelluSTAT to market could introduce a new, all-natural hemostatic option for surgical and trauma care, potentially improving patient outcomes in bleeding control. The resolution of the Warning Letter and positive study results would be essential for UHP's financial viability and its ability to compete in the multi-billion dollar hemostat market.

Summary

United Health Products, Inc. (OTCQB: UEEC) has reached critical regulatory milestones with the U.S. Food & Drug Administration (FDA) regarding its CelluSTAT Hemostatic Gauze product. Following a Warning Letter issued in March 2025 concerning violations during a 2019 clinical trial, the FDA has now formally approved a collaborative plan. This strategy involves partnering with an established U.S. manufacturer and distributor of hemostatic products, who will serve as the Sponsor for a new clinical study of CelluSTAT. United Health Products will retain an exclusive right of reference to all data from this study, which it intends to use in a revised Premarket Approval (PMA) application. This arrangement allows a new study to proceed, subject to an Investigational Device Exemption, while the company concurrently works to resolve the outstanding Warning Letter.

In a significant parallel development, the FDA has also approved the external audit firm that will conduct a Good Clinical Practices (GCP) audit of UHP's protocols, procedures, and personnel. This audit, recommended by the FDA and scheduled for the coming months, aims to assess and confirm the company's capability to conduct its own clinical trials in full compliance with FDA regulations. CEO Bran Thom emphasized that these milestones result from 14 months of investigation and discussion with the FDA to address concerns over the company's 2018-2019 actions. Thom expressed optimism about the clear path forward to demonstrate the safety and efficacy of CelluSTAT through a new study and noted ongoing discussions with several medical device companies for the substitute sponsor collaboration. The company anticipates that the GCP audit, alongside other corrective actions, will ultimately lead to the resolution and lifting of the Warning Letter.

United Health Products has developed and patented CelluSTAT Hemostatic Gauze, an all-natural, Neutralized Regenerated Cellulose hemostatic agent designed to control mild to moderate bleeding. The company's primary goal is to gain FDA approval to access the human surgical market. For more information, stakeholders can visit the company's new website at www.uhpcorp.com or contact them via email or phone. This regulatory update was originally released on www.newmediawire.com, highlighting the company's progress in navigating complex FDA compliance pathways to bring its innovative medical product to market.

Source Statement

This curated news summary relied on content disributed by NewMediaWire. Read the original source here, UHP Gains FDA Approval for New CelluSTAT Study Plan, Aims to Resolve Warning Letter

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