Study Registration (NCT07695688) Supports Imbed's Ongoing Effort to Address Biofilm — a Persistent Challenge Across Wound Care and Beyond

MIDDLETON, Wis., Oct. 1, 2026 /PRNewswire/ -- Imbed Biosciences, developer of the SAMatrix™ (Synthetic Antimicrobial Matrix) technology platform, today announced that its FDA-approved IDE study evaluating the safety of investigational DualGuard™ Silver-Gallium Matrix in split-thickness skin graft donor site wounds is now registered on ClinicalTrials.gov (NCT07695688). The study will be conducted at three American Burn Association (ABA)-verified burn centers. This milestone advances DualGuard's clinical development and reflects Imbed's broader pursuit of solutions to address the evolving challenges biofilm presents across healthcare.

About SAMatrix™ Technology

SAMatrix™ (Synthetic Antimicrobial Matrix) technology — or SAM, for short — was developed to address the complex, multifactorial needs of serious wounds. As a synthetic, resorbable matrix impregnated with antimicrobial silver, SAM integrates multiple wound care agents into a single product. Two versions are currently on the market: the core silver formulation, and PainGuard^®, which adds lidocaine HCl to help manage pain. SAM products can be used at the onset of wound treatment, following debridement, or in surgery, including alongside other wound management technologies.

The Innovation: Adding Gallium — A "Double Punch" Against Drug-Resistant Bacteria

Building on the established silver SAMatrix™ platform, Imbed developed DualGuard™, a Silver-Gallium formulation that adds gallium as a second, synergistic antimicrobial agent within the same matrix architecture.

Gallium's antimicrobial activity works by mimicking ferric iron, disrupting the iron-dependent metabolism many bacteria rely on in iron-limited environments. Because Ga³⁺ closely resembles Fe³⁺, bacteria take it up through their iron-acquisition pathways — but Ga³⁺ cannot support the Fe³⁺/Fe²⁺ redox cycling those pathways depend on, disrupting bacterial metabolism, growth, and biofilm-related activity.

This mechanism is distinct from both conventional antibiotics and silver. Research shows silver and gallium can act synergistically against bacteria, including within biofilm — the basis for what Imbed calls a "Double Punch": two independent, non-overlapping antimicrobial mechanisms delivered from a single, resorbable matrix.

"By combining silver and gallium's distinct, synergistic mechanisms, we believe DualGuard™ has the potential to address an important unmet need in complex wound care, and this study is designed to generate the clinical safety data needed to guide its continued development. Our SAM platform was built to deliver multiple wound care benefits from a single, synthetic matrix — and DualGuard™ represents the next frontier of that mission. This study's registration on ClinicalTrials.gov is a landmark moment for Imbed Biosciences and for the field of antimicrobial wound care. We are proud to be first to bring gallium in a wound care matrix to human clinical evaluation, and grateful to our clinical partners for their continued collaboration on this program."  — Terry Bromley, CEO

Preclinical Evidence: Activity Against Multispecies Biofilms

In preclinical studies using multispecies biofilms of Pseudomonas aeruginosa and Staphylococcus aureus grown on gauze, a single 24-hour application of the Silver-Gallium SAM technology achieved:

• 7.1 log₁₀ reduction in Pseudomonas aeruginosa
• 4.2 log₁₀ reduction in Staphylococcus aureus

These data provide the scientific rationale for evaluating DualGuard™'s safety and performance in human clinical studies.

From FDA Approval to First Patient

In March 2025, FDA granted Investigational Device Exemption (IDE) approval for a clinical study evaluating DualGuard™ in human donor site wounds. With subsequent regulatory and institutional requirements — including IRB and human research oversight approvals — now satisfied, the study is 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 is 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.

Primary Objective: To evaluate the safety of DualGuard™, including adverse event occurrence and infection rates.

Secondary Objective: To evaluate effectiveness, including incidence of complete wound closure (re-epithelialization without drainage or dressing requirements), confirmed at two consecutive visits (Day 14 and Day 28).

Study Registered at ABA-Verified Burn Centers

With all regulatory and institutional requirements satisfied, the study is now registered on ClinicalTrials.gov and will be conducted at three ABA-verified burn centers — the field's gold standard for burn center quality — ensuring enrolled patients will receive care from multidisciplinary teams experienced in burn and reconstructive wound management. To the Company's knowledge, this will mark the first clinical evaluation of gallium incorporated within a wound care matrix. The primary objective of this initial phase is to characterize the safety and tolerability of DualGuard™. Data generated from the study are expected to inform Imbed's future regulatory strategy for DualGuard™.

Looking Ahead

Imbed 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.

Development Funding Support

Funding for Imbed's 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.*

About Imbed Biosciences

Imbed Biosciences is a privately held medical device company advancing the next generation of wound care through its SAMatrix™ technology. The platform incorporates multiple therapeutic agents into an ultra-thin, biocompatible matrix that helps support skin regeneration in chronic and acute wounds. Imbed's expanding portfolio is engineered to reduce infection risk, alleviate pain, and promote healing across the wound care continuum.

*Effort sponsored by the Government under Other Transaction Number W81XWH-15-9-0001.  The views expressed in this press release are those of the author and do not necessarily reflect the official policy or position of the U.S. Army, Department of War, nor the U.S. Government.

Media & Investor Contact
Hillary Rush
Vice President, Marketing
Imbed Biosciences
hrush@imbedbio.com
www.imbedbio.com

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SOURCE Imbed Biosciences