United Health Products Advances FDA Approval Process for CelluSTAT Hemostatic Gauze

United Health Products, Inc. (OTCPK: UEEC) has made significant strides in its quest for FDA approval of CelluSTAT, a novel hemostatic gauze designed to control mild to moderate bleeding. The company recently held a crucial videoconference with the FDA to discuss its Premarket Approval (PMA) application, marking a pivotal moment in the regulatory process for this potentially game-changing medical device.

The meeting, which took place on October 29, 2024, provided United Health Products with clear direction on addressing deficiencies in its PMA application. The company presented its proposed resolutions to FDA-identified issues, covering areas such as clinical testing, biocompatibility, product sterilization, and shelf life. Many of these concerns have already been resolved, signaling progress in the approval process.

A key focus of the discussion was the results of United Health Products' clinical trial involving 232 patients, with 118 treated using CelluSTAT. The trial demonstrated both non-inferiority and superiority in time to hemostasis compared to the standard of care, with no evidence of result heterogeneity across different procedure categories, surgeons, or clinical sites. Importantly, no adverse events during the study were attributed to CelluSTAT, underscoring its safety profile.

Despite these positive outcomes, the FDA has requested additional data to confirm CelluSTAT's safety and effectiveness in surgical procedures involving the intestinal and thoracic organ space. To address this concern, United Health Products has proposed a supplemental study enrolling a limited number of human subjects across multiple sites, focusing on surgical procedures within the organ space.

This supplemental study process is expected to take approximately 6-7 months and will involve submitting an Investigational Device Exemption (IDE), recruiting a contract research organization, selecting suitable surgical sites, enrolling patients, and analyzing data. Concurrently, the company will complete additional biocompatibility and sterility testing as agreed with the FDA.

The implications of this development are significant for both United Health Products and the medical community. If approved, CelluSTAT could offer surgeons a new tool in managing surgical bleeding, potentially improving patient outcomes and reducing complications. The product's all-natural composition may also appeal to healthcare providers and patients seeking alternatives to synthetic hemostatic agents.

For United Health Products, FDA approval would open access to the lucrative human surgical market, representing a major milestone in the company's growth strategy. The rigorous approval process, while time-consuming, serves to validate the product's safety and efficacy, potentially enhancing its acceptance among medical professionals.

While the additional study requirements have extended the timeline for potential approval, United Health Products remains optimistic about the outcome. CEO Brian Thom expressed confidence in the process, stating, "While we would have preferred to conduct any additional surgical testing under a post-approval study protocol, we respect the FDA's concerns over patient safety and acknowledge the risks associated with hemostatic products such as ours."

As the medical device industry continues to evolve, innovations like CelluSTAT highlight the ongoing efforts to improve surgical outcomes and patient care. The FDA's thorough evaluation process ensures that only products meeting the highest standards of safety and efficacy reach the market, ultimately benefiting patients and healthcare providers alike.

Investors and industry observers will be watching closely as United Health Products progresses through this final phase of the approval process. The outcome could not only impact the company's future but also potentially influence the broader landscape of surgical hemostasis management.