ELUTE
Elute, Inc. is a clinical-stage company and an emerging leader in the development of patented drug-eluting devices with controlled and sustained therapeutic release. They focus on innovative solutions for unmet clinical needs, particularly in orthopedic infections, with products like EP Granules with Tobramycin designed for local antibiotic delivery to treat bone infections. The company is committed to translating science into novel products that enable patients to lead active, fulfilling lives, and is actively involved in clinical trials and patent development to advance their medical solutions.
Industries
Nr. of Employees
small (1-50)
ELUTE
Products
Antibiotic-loaded resorbable bone void filler (investigational)
A synthetic, resorbable bone void filler engineered to deliver a broad‑spectrum antibiotic locally for approximately eight weeks, minimize systemic exposure, resorb over time, and allow new bone growth; intended for surgical treatment of periprosthetic joint infections.
Antibiotic-loaded resorbable bone void filler (investigational)
A synthetic, resorbable bone void filler engineered to deliver a broad‑spectrum antibiotic locally for approximately eight weeks, minimize systemic exposure, resorb over time, and allow new bone growth; intended for surgical treatment of periprosthetic joint infections.
Services
Sponsorship and operational coordination of prospective, multicenter, randomized, blinded pivotal clinical trials for investigational implantable bone graft devices, including site partnerships and participant protections.
Design and execution of preclinical infection prevention/treatment studies in animal models and development of analytical assays to quantify polymer-controlled antibiotic release.
Sponsorship and operational coordination of prospective, multicenter, randomized, blinded pivotal clinical trials for investigational implantable bone graft devices, including site partnerships and participant protections.
Design and execution of preclinical infection prevention/treatment studies in animal models and development of analytical assays to quantify polymer-controlled antibiotic release.
Expertise Areas
- Clinical trial management for investigational implantable devices
- Drug-eluting implant development
- Orthopedic infection therapeutics
- Polymer and biomaterials engineering
Key Technologies
- Polymer-controlled drug delivery
- Polymer-ceramic composite biomaterials
- Resorbable calcium-salt (carbonate/apatite) materials
- Antibiotic-eluting bone void fillers
News & Updates
Following Elute, Inc.’s Investigational Device Exemption (IDE) authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycin in a pivotal clinical trial, the Hospital for Special Surgery (HSS), and the Rothman Orthopaedic Institute (Rothman) have agreed to become clinical sites to evaluate the safety and efficacy of the EP Granules.
Elute, Inc. announced that it has earned FDA clearance for its synthetic resorbable bone void filler, a significant milestone in its development of innovative orthopedic solutions.
David Grainger, co-founder of Elute, Inc., was elected to the National Academy of Inventors, recognizing his contributions to medical products and materials engineering technologies used for drug delivery and diagnostics.
Elute received a notice of allowance for its invention of 'Implantable Devices for Bone or Joint Defects', providing broad protection for delivering antibiotics for up to eight weeks to eradicate infection and grow new bone.
Following Elute, Inc.’s Investigational Device Exemption (IDE) authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycin in a pivotal clinical trial, the Hospital for Special Surgery (HSS), and the Rothman Orthopaedic Institute (Rothman) have agreed to become clinical sites to evaluate the safety and efficacy of the EP Granules.
Elute, Inc. announced that it has earned FDA clearance for its synthetic resorbable bone void filler, a significant milestone in its development of innovative orthopedic solutions.
David Grainger, co-founder of Elute, Inc., was elected to the National Academy of Inventors, recognizing his contributions to medical products and materials engineering technologies used for drug delivery and diagnostics.
Elute received a notice of allowance for its invention of 'Implantable Devices for Bone or Joint Defects', providing broad protection for delivering antibiotics for up to eight weeks to eradicate infection and grow new bone.