Imbed Biosciences Receives FDA IDE Approval for Silver-Gallium Antimicrobial Study on Donor Site Wounds
Imbed Biosciences, a leader in innovative wound care synthetic matrix technology, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for its Investigational Device Exemption (IDE) application. This approval paves the way for a feasibility clinical trial aimed at validating the safety of Imbed’s pipeline polymeric matrix, which incorporates silver and gallium ions, in treating human donor site wounds.
Imbed Biosciences, a leader in groundbreaking wound care technology, recently announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) application. This marks a significant milestone in the company’s mission to address the challenges of treating non-healing wounds, a condition that affects millions of people worldwide. The approval allows Imbed to conduct a feasibility clinical trial to assess the safety of its polymeric matrix, which integrates silver and gallium ions, in treating human donor site wounds.
The prevalence of biofilms in non-healing wounds is estimated to be as high as 80%, making it one of the leading causes of delayed wound healing. With non-healing wounds costing the U.S. healthcare system over $50 billion annually, managing biofilm-infected wounds represents a significant financial burden, accounting for at least $40 million of the total annual cost. Terry Bromley, CEO of Imbed Biosciences, commented on the urgent need for solutions to this widespread issue: “Imbed is evolving our core technology platform to address this pressing medical need to treat non-healing wounds. We are excited to take this important regulatory next step and look forward to affirming the safety observed to date in pre-clinical studies.”
In the clinical trial, Imbed aims to validate the efficacy of its proprietary polymeric matrix, which incorporates both bacteriostatic gallium ions and broad-spectrum antimicrobial silver ions. According to Gaurav Pranami, Ph.D., Vice President of Research & Development at Imbed, in vitro studies have shown that this combination can effectively dismantle polymicrobial biofilms on wound surfaces, promoting healing in chronic wounds that have stalled in the inflammation phase. By integrating non-toxic levels of gallium and silver, the matrix aims to provide a safe, effective solution for managing chronic wounds, including those associated with biofilm infections.
The potential benefits of Imbed’s technology extend beyond civilian healthcare applications. Combat-related wounds, such as burns and blast-related injuries sustained by warfighters, often suffer from microbial contamination, which can lead to biofilm formation and impair the healing process. Imbed’s silver/gallium matrix offers a lightweight, shelf-stable solution that can be used in field care settings to prevent microbial colonization. This is especially critical in combat situations where patients may experience prolonged wait times before being evacuated to formal care facilities. The matrix provides temporizing coverage, preventing deterioration and supporting wound healing during this critical window.
Ankit Agarwal, Ph.D., Founder and Chief Scientific Officer of Imbed, highlighted the versatility of the company’s platform technology, noting that this approval is a key milestone in advancing wound care solutions. “This approval represents a major milestone for Imbed,” said Agarwal. “It once again proves the versatility of our platform technology for adoption in advanced wound care clinical protocols. It also follows the recent FDA 510(k) clearance of our matrix incorporating silver and lidocaine, which provides local anesthetic action for painful skin wounds. Imbed’s synthetic matrix, with its porous architecture, allows for the incorporation of a range of bioactive molecules for wound management, offering a complete toolkit for managing pain, infection, and tissue regeneration in a variety of wound types.”
The development of the Silver-Gallium matrix is supported by funding from various sources, including Small Business Innovation Research (SBIR) grants #SB1AR079347 and #R44AR073710 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health (NIH). Additionally, the U.S. Army Medical Research and Development Command’s Military Infectious Diseases Research Program (MIDRP) has awarded Imbed a research contract through the Medical Technology Enterprise Consortium (MTEC) for the development of prototype solutions aimed at preventing combat wound infections following blast injuries and burns.
Imbed Biosciences is a privately held medical device company specializing in synthetic antimicrobial matrix technology (SAM Technology™). The company’s innovative platform combines multiple agents into an ultra-thin, biocompatible matrix to enhance skin regeneration and promote wound healing. Imbed’s current portfolio includes commercially available products such as Microlyte®, Surgaflex™, and PelashieldAM™, which are indicated for the treatment of chronic, acute, and burn wounds, respectively.
The approval of Imbed’s Silver-Gallium matrix marks an important step forward in the development of advanced wound care solutions. As the company continues to innovate, its technologies have the potential to revolutionize the treatment of non-healing wounds, offering hope to millions of patients worldwide who suffer from chronic wounds and infections.
