Curated News
By: NewsRamp Editorial Staff
December 15, 2025
UHP Advances FDA Talks & CelluSTAT Gauze Shows Superior Safety in New Study
TLDR
- 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.
Impact - Why it Matters
This news matters because it highlights progress for a medical device that could improve patient outcomes in common surgeries. If approved, CelluSTAT Hemostatic Gauze offers a potential alternative to current products, with new data suggesting it is absorbed faster and causes less tissue inflammation. This could reduce risks of post-surgical complications like chronic pain, infection, or issues with medical imaging, leading to better recovery for patients and potentially lowering healthcare costs. The company's engagement with the FDA is a critical step toward making this product available, impacting the future of surgical hemostasis and the medical device market.
Summary
United Health Products, Inc. (UHP) is navigating a critical regulatory hurdle with the FDA while simultaneously advancing its flagship medical product. The company recently received an evaluation from the FDA regarding a Warning Letter issued in March 2025 concerning violations in its 2019 clinical trial for CelluSTAT Hemostatic Gauze. UHP disputes some of the FDA's findings and has scheduled a conference before year's end to resolve these issues, aiming to commence a new clinical study in early 2026. This regulatory progress is crucial as UHP seeks Premarket Approval to enter the human surgical market.
In parallel, UHP has bolstered its application with compelling new pre-clinical data. A recent long-term study compared its CelluSTAT gauze to the current "standard of care" product. The results were significant: the CelluSTAT material was completely absorbed within two weeks with no tissue reaction, whereas the standard gauze remained present for over eight weeks and showed evidence of tissue reactivity at three months. These findings, which confirm prior studies, suggest CelluSTAT carries a lower risk of post-surgical complications like chronic inflammation. The company is now organizing further studies to potentially expand CelluSTAT's use into common laparoscopic procedures, with plans to submit these results in a supplemental FDA application. For more details, investors and interested parties can visit the company's new website at www.uhpcorp.com.
This corporate update, originally released on www.newmediawire.com, highlights UHP's dual-track strategy of addressing regulatory concerns while generating robust scientific evidence for its innovative, all-natural hemostatic agent. The product, a patented Neutralized Regenerated Cellulose gauze designed to control mild to moderate bleeding, represents a potential advancement in surgical care. The company's proactive engagement with the FDA and its ongoing research initiatives underscore its commitment to bringing this technology to market, pending regulatory clearance.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, UHP Advances FDA Talks & CelluSTAT Gauze Shows Superior Safety in New Study
