Biocomposites, an international company specializing in medical devices for bone regeneration and infection management, is excited to announce that its affiliated firm, Renovos Biologics (Renovos), has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its flagship product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2). RENOVITE® BMP-2, utilizing a proprietary synthetic nanoclay gel, is currently in development as a safer and more effective alternative to existing bone graft materials. The injectable gel, which is easy to use, facilitates precise and localized bone formation at the targeted site. It incorporates BMP-2, a growth factor that encourages the in-growth of bone-forming cells. The nanoclay gel's distinctive feature is its ability to enable secure and highly-targeted bone fusion without leaching BMP-2, and it naturally degrades as new bone forms.
The FDA's Breakthrough Device Designation program aims to expedite patient access to medical devices with the potential for more effective diagnosis or treatment of life-threatening or debilitating conditions. This designation expedites the development, assessment, and review process, ensuring timely access to innovative medical solutions. Renovos is now granted the opportunity for increased interaction with FDA regulatory experts during submissions, along with prioritized reviews.
The significance of this FDA Breakthrough Device Designation is underscored by its transformative impact on Renovos, aligning with the company's goal to rapidly advance RENOVITE® as a next-generation drug carrier. Biocomposites, leveraging its expertise in the field, stands ready to support and enhance Renovos in navigating the pathway towards pre-market approval. This development marks a crucial step forward in bringing innovative bone regeneration technology to the market.