Renovos Biologics, an investee company of Biocomposites, has achieved a significant milestone with the grant of Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its flagship product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2). 

The breakthrough designation is a recognition of RENOVITE® BMP-2's potential to provide more effective diagnosis and treatment for conditions related to bone regeneration.

RENOVITE® BMP-2, built on a proprietary synthetic nanoclay gel, is positioned as a safer and more efficient alternative to existing bone graft materials. This injectable gel, containing BMP-2 growth factor, enables precise and localized bone formation at the targeted site. The nanoclay gel ensures safe and highly targeted bone fusion without leaching BMP-2, with the gel biodegrading as new bone forms.

Dr. Agnieszka Janeczek, CEO of Renovos Biologics, emphasized, "We are very pleased with the Breakthrough Device Designation from the FDA, being among just one hundred or so companies granted this designation in orthopaedics since the programme's launch in 2015. This designation is a major milestone in our development journey. The accelerated regulatory feedback and prioritised review will shorten the time to market and allow faster access to expanded treatment options for patients suffering from degenerative disc disease."

Michael Harris, Chief Executive Officer of Biocomposites, said, "The granting of FDA Breakthrough Device Designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market RENOVITE® - a next-generation drug carrier. At Biocomposites, our expertise in this field ideally positions us to support and enhance RENOVITE®'s progress towards pre-market approval."

The FDA's Breakthrough Device Designation program aims to expedite the development and review process for medical devices offering more effective diagnosis or treatment for life-threatening or debilitating conditions. 

Renovos, having met the criteria demonstrating significant advantages over standard care, will now benefit from more frequent interactions with FDA regulatory experts during submissions, followed by prioritized reviews.