“This antibiofilm dressing research program is built upon the clinical success of our next-generation FDA cleared Microlyte® Matrix silver dressing that has been used in the treatment of thousands of chronic wounds patients in the U.S.,” said Ankit Agarwal, PhD, co-founder and CEO of the company and the Principal Investigator on the grant. Microlyte® Matrix is an ultrathin polymeric film dressing made of bioresorbable synthetic polymers. It contains ionic and metallic silver that kill bacteria in contact with the dressing on a wound surface for up to three days. “Research in this NIH Phase II grant will document a synergy in the unique ability of gallium ions to penetrate biofilms and sensitize bacteria to the antimicrobial action of silver ions,” said Agarwal.
Biofilms are surface-associated bacterial communities that are impenetrable to antibiotics and antimicrobials. Chronic wounds such as diabetic foot ulcers and venous leg ulcers have persistent biofilms that delay healing for several months.
According to the NIH, healthcare costs associated with treatment of chronic wounds exceeds $25 billion annually in the U.S. affecting 6.5 million patients. The standard of care is to surgically debride wounds with a scalpel. However, it leaves behind fragments in the complex topography of wounds which reestablish biofilms within a week. This results into a vicious cycle of repeated surgical debridement and aggressive wound management with high doses of antibiotics.
In Phase I research, the company reported that a combination of silver and gallium in its Microlyte dressing eradicated mature biofilms in a murine wound model that did not respond to a commercial silver dressing. “Innovation is in our Microlyte® multilayer film technology where we can incorporate stabilized forms of silver and gallium metal ions at concentrations that are effective in killing bacteria in biofilms but do not harm skin cells involved in wound healing,” said Gaurav Pranami, PhD, Vice President of R&D at the company and a co-Investigator on the grant.
“There are no effective therapeutic options available in clinics today to completely remove biofilms from wounds. Microlyte® microscale dressing is unique because it adheres intimately with the deep wound tissue surface where bacterial biofilms colonize. The localized therapy with combination of antibiofilm gallium and antimicrobial silver can be both effective and non-toxic,” said co-founder Dr. Michael Schurr, MD, critical care surgeon at Mission Hospital in Asheville, NC, and Director of General Surgery Residency Program at the Mountain Area Health Education Center.
Imbed will collaborate under a subcontract on this grant with scientists in the School of Veterinary Medicine at University of Wisconsin-Madison to conduct preclinical studies in animal wound models necessary for FDA clearance. Prof. Jonathan McAnulty, DVM, PhD, Chair of Surgical Sciences, and Prof. Charles Czuprynski, PhD, Chair of Pathobiological Sciences will be lead investigators on the subcontract. A related press release from the University is available at this link – https://news.wisc.edu/uw-madison-local-startup-testing-a-one-two-punch-against-hard-to-heal-wounds/