Renovos Biologics' RENOVITE® BMP-2 Earns FDA Breakthrough Status for Nanoclay Bone Fusion Gel

Thursday, January 04, 2024

Biocomposites, an international medical devices company specializing in the development, manufacturing, and marketing of cutting-edge products for bone regeneration and infection management in bone and soft tissue, is thrilled to announce that its investee firm, Renovos Biologics (Renovos), has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its flagship product, RENOVITE® BMP-2. RENOVITE® BMP-2, crafted from a unique synthetic nanoclay gel, is currently under development as a safer and more efficient alternative to existing bone graft materials.

The user-friendly, injectable gel facilitates precise, localized bone formation at the intended site, containing BMP-2, a growth factor that stimulates the in-growth of bone-forming cells. The nanoclay gel ensures secure, highly-targeted bone fusion by avoiding the leaching of BMP-2, and it biodegrades as new bone develops. The FDA's Breakthrough Device Designation program aims to expedite patient access to medical devices with the potential for improved diagnosis or treatment of life-threatening or irreversibly debilitating conditions.

This designation is granted only after presenting initial evidence indicating a reasonable expectation that the device will offer significant advantages over standard care. Renovos will now benefit from enhanced collaboration with the FDA's regulatory experts during submission preparation, followed by prioritized reviews.


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