Imbed Biosciences Begins Clinical Evaluation of DualGuard Study

Imbed Biosciences has announced that its Investigational Device Exemption (IDE) study evaluating the safety of the investigational DualGuard™ Silver-Gallium Matrix has been registered on ClinicalTrials.gov.

The study focuses on wounds at split-thickness skin graft donor sites and will be conducted at three American Burn Association (ABA) verified burn centers. This milestone advances DualGuard's clinical development and addresses biofilm-related challenges in wound care.

DualGuard™ utilizes Imbed's SAMatrix™ technology, combining the antimicrobial properties of silver and gallium. Gallium is designed to work synergistically with silver by disrupting bacterial metabolism, offering a novel approach against drug-resistant bacteria and biofilm formation.

Preclinical studies have demonstrated significant efficacy of the silver-gallium combination against multispecies biofilms. According to the company, this marks the first time a wound care matrix containing gallium is being evaluated in human clinical trials.

The study's primary objective is to assess the safety and tolerability of DualGuard™. Its effectiveness in wound healing will also be evaluated. The results are expected to guide further development and potential commercialization.