United Health Products Advances FDA Resolution Process While Reporting Positive Pre-Clinical Study Results
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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United Health Products, Inc. has provided updates on its regulatory progress with the Food & Drug Administration and new pre-clinical study results for its medical device. The company is working to resolve a Warning Letter issued by FDA on March 25, 2025, which identified violations of required clinical procedures during the company's 2019 clinical trial.
Following its April 14, 2025 response to FDA addressing the violations, the company received FDA's evaluation on December 10 containing conclusions on UHP's oversight of the 2019 study, requests for additional information, and comments on the company's plan to complete an additional clinical study. UHP disputes certain FDA findings and has scheduled a conference with FDA before yearend to discuss and resolve these disputed findings. The company believes this will ultimately result in the ability to commence a new study early in 2026.
Concurrently, UHP has completed two long-term pre-clinical studies required for its planned Premarket Approval resubmission. One study compared the rates of absorption and tissue reactivity of UHP's CelluSTAT Hemostatic Gauze with the current standard of care product. Investigators subcutaneously implanted gauze samples into animal models and monitored implantation sites over several months.
The study showed no evidence of any CelluSTAT material two weeks post-implantation and no tissue reaction at any time. In contrast, standard of care gauze material remained present at the implantation site for over eight weeks and showed evidence of tissue reactivity at three months, measured by the presence of macrophages and giant cells. These results confirm prior findings and suggest that use of UHP's CelluSTAT Hemostatic Gauze carries less risk of post-surgical complications such as mass formation, imaging mimicry and chronic inflammation.
Looking ahead, the company is organizing a study to potentially expand the indications for use of CelluSTAT, assuming approval for use in human surgical procedures. UHP has scheduled an animal model study to examine and confirm the usability of CelluSTAT in a variety of the most common laparoscopic procedures, which represent a growing majority of surgeries in the U.S. market today. The results of this planned study will be submitted as part of a supplemental FDA PMA application.
For more information on UHP, visit the company's website at https://www.uhpcorp.com. Additional details about this announcement can be found on https://www.newmediawire.com.
Curated from NewMediaWire
