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FAQ: United Health Products FDA Warning Letter Resolution and Clinical Study Updates
TL;DR
United Health Products' CelluSTAT gauze offers a competitive edge by absorbing faster and causing less tissue reactivity than standard products, potentially reducing post-surgical complications.
UHP submitted FDA responses, completed preclinical studies showing gauze absorption within two weeks versus eight for standard care, and plans a new clinical study in 2026.
CelluSTAT's reduced tissue reactivity and faster absorption could lower surgical complication risks, improving patient recovery and healthcare outcomes for common procedures.
UHP's gauze disappears in two weeks in animal studies while standard gauze lingers for eight, showing promising safety for future surgical use.
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The update covers UHP's efforts to resolve an FDA Warning Letter issued on March 25, 2025 regarding violations during its 2019 clinical trial, along with recent pre-clinical study results for its CelluSTAT Hemostatic Gauze.
UHP is addressing a Warning Letter issued by the FDA on March 25, 2025 that identified certain violations of required clinical procedures during the company's 2019 clinical trial.
On April 14, 2025, UHP submitted a response addressing the violations, followed by a post-audit and validation of certain clinical trial data. The FDA issued an evaluation on December 10, 2025, and UHP has scheduled a conference with the FDA before year-end to discuss disputed findings.
Studies showed CelluSTAT Hemostatic Gauze had no evidence of material two weeks post-implantation and no tissue reaction at any time, while standard gauze remained present for over eight weeks and showed tissue reactivity at three months, suggesting CelluSTAT carries less risk of post-surgical complications.
CelluSTAT showed superior performance with complete absorption within two weeks and no tissue reaction, compared to standard gauze that remained present for over eight weeks and caused tissue reactivity measured by macrophages and giant cells at three months.
UHP is organizing a study to potentially expand indications for CelluSTAT and has scheduled an animal model study to examine its usability in common laparoscopic procedures, with results to be submitted as part of a supplemental FDA PMA application.
UHP believes resolving disputed FDA findings will ultimately result in the ability to commence a new study early in 2026.
CelluSTAT Hemostatic Gauze is an all-natural, patented Neutralized Regenerated Cellulose hemostatic agent designed to control mild to moderate bleeding, with UHP seeking FDA approval to access the human surgical market.
Visit the company's website at www.uhpcorp.com, email info@uhpcorp.com, or call/text 475.755.1005.
Curated from NewMediaWire
