Curated News
By: NewsRamp Editorial Staff
June 06, 2025
United Health Products Awaits FDA Decision on Hemostatic Gauze Study
TLDR
- United Health Products, Inc. advances towards FDA approval for CelluSTAT Hemostatic Gauze, positioning itself for a competitive edge in the human surgical market.
- United Health Products, Inc. addresses FDA's BIMO audit findings, completing pre-IDE approval tasks to expedite patient enrollment for its clinical study.
- CelluSTAT Hemostatic Gauze by United Health Products, Inc. promises to improve surgical outcomes, offering a natural solution for controlling bleeding.
- Discover how United Health Products, Inc. is innovating with CelluSTAT Hemostatic Gauze, a breakthrough in natural bleeding control technology.
Impact - Why it Matters
This news is significant for healthcare professionals and investors alike, as it highlights the potential for a new, all-natural hemostatic agent to enter the surgical market. The FDA's decision could pave the way for improved patient outcomes in surgeries requiring mild to moderate bleeding control. For investors, the approval could signify a major milestone for United Health Products, potentially impacting its stock value and market position.
Summary
United Health Products, Inc. (OTCQB: UEEC) has recently provided an update on its ongoing discussions with the Food & Drug Administration (FDA) regarding its Investigational Device Exemption (IDE) application. The FDA's Office of Product Evaluation and Quality has reviewed the application for a follow-on clinical study involving 27 patients undergoing organ space procedures, finding no deficiencies but requiring the company to address findings from a Bioresearch Monitoring (BIMO) audit of its initial 2019 clinical study. United Health Products submitted its detailed response to these findings on April 14, 2025, and the FDA's review is currently ongoing. The company has completed all preparatory study tasks ahead of IDE approval to expedite patient enrollment once approved.
United Health Products is known for its patented Neutralized Regenerated Cellulose hemostatic agent, CelluSTAT Hemostatic Gauze, an all-natural product aimed at controlling mild to moderate bleeding. The company is striving for approval to enter the human surgical market. For more details, visit their website at www.uhpcorp.com or contact them directly. This update was originally released on www.newmediawire.com.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, United Health Products Awaits FDA Decision on Hemostatic Gauze Study
