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

New kit system enables selection of granule sizes suited for patient anatomy in real time

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.

"BonVie+ is a promising new product that overcomes the limitations of current bone graft substitutes," said Amar Ranawat, MD, Professor of Clinical Orthopedic Surgery, Weill Cornell Medical College and attending surgeon at the Hospital for Special Surgery. "This new alternative in the treatment and management of bone defects and should greatly benefit patients in need for bone restoration."

About BonVie+
BonVie+ is a calcium-salt resorbable bone void filler implant used to fill bone defects, and with time, is replaced by new bone into the space previously occupied by the implant.

About Elute, Inc.
Elute, Inc. is an emerging leader in the development of its novel drug eluting device platform for controlled and extended release of drugs. Elute's lead product, EP Granules with Tobramycin, is similar to BonVie+ but is pre-loaded with tobramycin, which is released over 8-weeks in a locally targeted region while allowing growth of new bone. This is an investigational device limited to investigational use in the United States. www.elutinc.com.

About HSS
Hospital for Special Surgery is a leading academic medical center focused on musculoskeletal health. HSS has ranked No. 1 in orthopedics for the 15th consecutive year by U.S. News & World Report. www.hss.edu.

Contact Information
Ashok Khandkar, Ph.D., President and CEO Elute, Inc.
(801) 410-4330

References

1. A Prospective, Randomized Clinical Trial Comparing an Antibiotic-Impregnated Bioabsorbable Bone Substitute With Standard Antibiotic-Impregnated Cement Beads in the Treatment of Chronic Osteomyelitis and Infected Nonunion, McKee et al, J Orthop Trauma, 2010;24:483–490.
2. A Comparative Study of Three Bioabsorbable Antibiotic Carriers in Chronic Osteomyelitis: 313 Patients with Minimum One-Year Follow -Up, McNally et al, Orthopaedic Proceedings, 2015, 97-B No. SUPP_16.
3. Elute data on file. 

SOURCE Elute, Inc.