Investigational Device Exemption (IDE) enables Imbed’s Silver-Gallium, Ultra-Thin Matrix Technology to be tested in human clinical studies, a key step towards marketing approval
Fully synthetic, bioresorbable, ultra-thin matrix with integration of silver and gallium ions designed to prevent biofilm formation in wounds and allow progression of normal wound healing
Imbed Biosciences (“Imbed”), a pioneer in breakthrough wound care synthetic matrix technology, today announced the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to conduct a feasibility clinical trial to validate the safety of their pipeline polymeric matrix with silver and gallium ions in human donor site wounds.
“The prevalence of biofilms in non-healing wounds is estimated to be 80%. With non-healing wounds costing the US healthcare system over $50 billion annually, this suggests that managing biofilm-infected wounds accounts for at least $40 million per year of this tremendous burden," says Terry Bromley, Chief Executive Officer. “Imbed is evolving our core technology platform to address this pressing medical need to treat non-healing wounds. We are excited to be taking this important regulatory next step and look forward to affirming the safety observed to date in pre-clinical studies.”
Gaurav Pranami, Ph.D., Vice President, Research & Development at Imbed, commented, “we have documented in our in vitro studies that combining non-toxic levels of bacteriostatic gallium ions with broad spectrum antimicrobial silver ions in our patented polymeric matrix, could synergistically work to dismantle polymicrobial biofilms on a surface. The matrix could thus help in restoring healing progression in chronic wounds stalled in the inflammation phase.”
In addition to bio-infected wounds sustained by civilians, combat-related wounds, such as burns and blast-related injuries sustained by warfighters, are inevitably contaminated with bacteria that may colonize and form biofilm that impair wound healing. The silver/gallium matrix addresses the unmet need for a lightweight, shelf-stable and easy-to-use temporizing coverage for field care of thermal burns, helping to limit deterioration by preventing microbial colonization during the prolonged time it may take for evacuation to a formal care setting.
“This approval represents a major milestone for Imbed,” asserts Founder and Chief Scientific Officer, Ankit Agarwal, Ph.D. “It once again proves the versatility of our platform technology for adoption in advanced wound care clinical protocols and comes on the heels of the recent FDA 510(k) clearance of our matrix incorporating both silver and lidocaine for effecting local anesthetic action in painful skin wounds. Imbed’s synthetic matrix, with its porous architecture, allows for the incorporation of a range of bioactive molecules for wound management and presents a complete toolkit for managing pain and infection in a variety of acute, chronic and burn wounds.”
Development Funding Support
Funding for the development of Imbed’s Silver-Gallium film 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 by the U.S. Army Medical Research and Development Command’s (USAMRDC) Military Infectious Diseases Research Program (MIDRP). The research contract was awarded through the Medical Technology Enterprise Consortium (MTEC) for prototype solutions that prevent combat wound infections following blast injuries and burns.*
About Imbed Biosciences
Imbed Biosciences Inc. is a privately held medical device company and innovator of Synthetic Antimicrobial Matrix Technology (SAM Technology™), with both commercially available and emerging, pipeline solutions. Imbed’s revolutionary platform technology enhances skin regeneration by integrating multiple agents into an ultra-thin biocompatible matrix to facilitate wound healing. Imbed’s current portfolio includes Microlyte®, Surgaflex™, and PelashieldAM™, indicated across a range of chronic, acute and burn wounds, respectively.
For more information, visit ImbedBio.com and connect with us on LinkedIn, X and Facebook.
*Effort sponsored by the Government under Other Transaction Number W81XWH-15-9-0001; The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250311875009/en/
“Imbed is evolving our core technology platform to address the pressing need to treat non-healing wounds. We are excited to take this important regulatory step to affirm the safety observed to date in pre-clinical studies," said CEO Terry Bromley.
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