Elute Earns U.S. FDA Clearance for Its Novel Synthetic Resorbable Bone Void Filler

SALT LAKE CITY, March 12, 2025 /PRNewswire/ -- For the thousands of patients in the United States requiring treatment for bone loss or defects caused by trauma or infections, Elute, Inc., a clinical stage company and emerging leader with a groundbreaking controlled and extended drug delivery platform, proudly announces U.S. Food and Drug Administration (FDA) approval of BonVie+™, a novel bone void filler implant.

Treatment for bone voids and restoring bone loss includes surgical debridement, followed by filling the voids with a synthetic bone graft substitute material like bone cement or calcium sulfate-based granules. The disadvantages of bone cement include its non-biodegradability, inability to support bone regrowth, and in most cases, the need for an additional surgical procedure to remove the beads and subsequent bone grafting.1 Calcium sulfate-based bone graft substitutes are biodegradable, but are known to cause seromas and lead to significant wound drainage.2 

Elute has now enhanced its resorbable bone graft technology with the introduction of BonVie+, designed for controlled resorption and replacement by new bone. “This new era in resorbable bone graft fillers represents over a decade of innovation, equipping clinicians with unparalleled consistency in bone restoration and predictable clinical results,” said Ashok Khandkar, CEO of Elute.

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