Curated News
By: NewsRamp Editorial Staff
July 07, 2026

United Health Products Partners with NAMSA for CelluSTAT Study

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Original Source

TLDR

  • United Health Products gains a competitive edge by partnering with NAMSA to advance CelluSTAT toward FDA approval for the surgical market.
  • NAMSA will seek an IDE, conduct a clinical study of CelluSTAT, and provide data for UHP's PMA application while resolving the FDA Warning Letter.
  • This study aims to validate CelluSTAT's safety and effectiveness, potentially offering a natural hemostatic gauze to control bleeding in surgeries.
  • NAMSA, a MedTech CRO with FDA experience, will sponsor the study, leveraging decades of expertise in Class III hemostatic agent trials.

Impact - Why it Matters

This partnership is crucial because it advances the clinical validation of CelluSTAT, a hemostatic gauze that could offer a safe, all-natural alternative for controlling bleeding in surgeries. For patients and healthcare providers, successful FDA approval would mean access to a new tool that may reduce complications from bleeding, improving surgical outcomes and potentially saving lives. Investors should note that this collaboration de-risks the regulatory process, as NAMSA's expertise increases the likelihood of a successful study and eventual market entry.

Summary

United Health Products, Inc. (OTCQB: UEEC) has announced a strategic collaboration with NAMSA, a global leader in MedTech contract research, to conduct a new clinical study of its CelluSTAT Hemostatic Gauze. NAMSA will serve as the Sponsor for the study, initially seeking an Investigational Device Exemption (IDE) to organize and conduct a trial of UHP's neutralized cellulose hemostat technology. This move aligns with UHP's recent proposal to the FDA, which was approved in March 2026, to have a non-affiliated party oversee the study. Upon completion, UHP will hold an exclusive right of reference to all study data for use in a revised Premarket Approval (PMA) application, allowing the study to proceed while UHP works with the FDA to resolve an outstanding Warning Letter.

NAMSA is a contract research organization (CRO) with a 100% focus on medical device and in vitro diagnostic technologies. Its experts have decades of experience in clinical trial management for Class III hemostatic agents and have worked for the FDA Center for Devices and Radiological Health. Brian Thom, UHP's CEO, expressed confidence in NAMSA's ability to gain approval for and efficiently sponsor a human study that will validate the safety and effectiveness of CelluSTAT Hemostatic Gauze. UHP's patented Neutralized Regenerated Cellulose hemostatic agent is an all-natural product designed to control mild to moderate bleeding, and the company is seeking approval to access the human surgical market.

This collaboration marks a significant step forward for UHP as it navigates the regulatory pathway. The company's new website, www.uhpcorp.com, provides additional information, and the original release can be viewed on NEWMEDIAWIRE. The partnership with NAMSA leverages their deep experience in clinical studies and FDA processes, potentially accelerating the path to market for CelluSTAT and providing a much-needed hemostatic solution for surgical settings.

Source Statement

This curated news summary relied on content disributed by NewMediaWire. Read the original source here, United Health Products Partners with NAMSA for CelluSTAT Study

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