FDA Approves Clinical Study for Imbed Biosciences’ Antimicrobial Matrix Tech

Imbed Biosciences has earned U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct a feasibility clinical trial on its 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,” Imbed Biosciences CEO Terry Bromley said. “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 regulatory next step and look forward to affirming the safety observed to date in pre-clinical studies.”

“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,” Imbed Biosciences Vice President of Research & Development Gaurav Pranami, Ph.D., commented. “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,” Imbed Biosciences Founder/Chief Scientific Officer Ankit Agarwal, Ph.D., asserted. “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.”

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.

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 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.