Controlled and extended drug release platform.
Elute, Inc. (“Elute” or the “Company”), a Delaware Corporation, is a clinical stage company and emerging leader in the development of patented drug eluting devices designed for controlled and sustained release of drugs. Elute’s lead product is EP Granules with Tobramycin, a bone void filler that has been shown to provide clinically relevant 8-week delivery of antibiotics and grow new bone in voids that result from bone infections, especially surrounding total hip and knee replacement joints or, periprosthetic joint infections (PJIs). On May 28, 2021, the Company was granted a IDE approval by the FDA for its lead product to conduct a 132 patient clinical study. We believe this is the first of deNovo regulatory pathway to be authorized for a combination device + drug product in the US. Upon final approval, we believe that EP Granules with Tobramycin will be a new standard of care in the surgical treatment of bone infections.