Imbed Biosciences Registers Safety Study for DualGuard™ Silver-Gallium Matrix
News related to:Imbed Biosciences · 2 min read
MIDDLETON, Wis., Oct. 1, 2026 /CourierPR/ -- Imbed Biosciences, a developer of advanced wound care technologies, has registered its ongoing safety study of the investigational DualGuard™ Silver-Gallium Matrix on ClinicalTrials.gov. The study, registered as NCT07695688, aims to evaluate the safety of DualGuard™ in split-thickness skin graft donor site wounds, a persistent challenge in wound care.
The study will be conducted at three American Burn Association (ABA)-verified burn centers, marking a significant step in the clinical development of DualGuard™. This initiative reflects Imbed's broader mission to address the evolving challenges posed by biofilm in healthcare.
DualGuard™ builds on the established SAMatrix™ (Synthetic Antimicrobial Matrix) technology platform. By incorporating gallium as a second, synergistic antimicrobial agent, DualGuard™ offers a "Double Punch" against drug-resistant bacteria. Gallium's mechanism of action involves mimicking ferric iron, disrupting the iron-dependent metabolism of bacteria in iron-limited environments. This distinct mechanism, combined with the established silver technology, is expected to provide a robust solution for complex wound care.
In preclinical studies, a single 24-hour application of the Silver-Gallium SAM technology demonstrated significant reductions in bacterial populations. Specifically, the technology achieved a 7.1 log₁₀ reduction in Pseudomonas aeruginosa and a 4.2 log₁₀ reduction in Staphylococcus aureus on gauze.
The FDA granted Investigational Device Exemption (IDE) approval for the clinical study in March 2025. With all regulatory and institutional requirements satisfied, the study is now ready to enroll patients in a multi-center, open-label, randomized, split-wound controlled trial of 53 subjects. Each enrolled subject's donor site wound will be divided into proximal and distal halves, with each half randomized to either DualGuard™ or a control dressing, providing an internally controlled comparison within a single patient.
The primary objective of the study is to evaluate the safety of DualGuard™, including adverse event occurrence and infection rates. Secondary objectives include evaluating the effectiveness of the treatment, specifically the incidence of complete wound closure (re-epithelialization without drainage or dressing requirements), confirmed at two consecutive visits (Day 14 and Day 28).
Funding for the Silver-Gallium matrix comes in part from Small Business Innovation Research (SBIR) grants #SB1AR079347 and #R44AR073710 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS, part of NIH), and a research contract awarded through the Medical Technology Enterprise Consortium (MTEC) by the U.S. Army Medical Research and Development Command's (USAMRDC) Military Infectious Diseases Research Program (MIDRP), for prototype solutions preventing combat wound infections following blast injuries and burns.
This initial phase of the study is expected to generate critical safety data, informing Imbed's future regulatory strategy for DualGuard™. The registration of the study on ClinicalTrials.gov and its conduct at ABA-verified burn centers ensures that enrolled patients will receive care from multidisciplinary teams experienced in burn and reconstructive wound management.
The study's registration marks a landmark moment for Imbed Biosciences and the field of antimicrobial wound care. By combining silver and gallium's distinct, synergistic mechanisms, Imbed believes DualGuard™ has the potential to address an important unmet need in complex wound care. The company will provide updates as the study progresses, continuing its mission to develop next-generation antimicrobial technologies that address the growing threat of drug-resistant infection in wound care.