Renovos Biologics secures FDA Breakthrough Device Designation for its innovative synthetic nanoclay bone fusion gel RENOVITE® BMP-2
Biocomposites, a global medical devices company specializing in bone regeneration and infection management, is pleased to announce that its investee, Renovos Biologics (Renovos), has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its leading product, RENOVITE® BMP-2.
This innovative product, utilizing a proprietary synthetic nanoclay gel, is being developed as a safer and more efficient alternative to current bone graft materials. The injectable gel allows for precise, localized bone formation, containing BMP-2, a growth factor that stimulates bone-forming cell growth.
The nanoclay gel ensures secure, highly-targeted bone fusion without BMP-2 leakage, and it naturally degrades as new bone develops. The FDA's recognition is a significant achievement for Renovos, aligning with its mission to swiftly advance and introduce RENOVITE® as a cutting-edge drug carrier to the market.