Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft tissue, is pleased to announce that its investee company, Renovos Biologics (Renovos), has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its lead product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2).
RENOVITE® BMP-2, based on a proprietary synthetic nanoclay gel, is in development as a safer and more effective alternative to currently available bone graft materials. The easy-to-use, injectable gel allows precise, localised bone formation at the target site. It contains BMP-2, a growth factor which promotes in-growth of bone forming cells. The nanoclay gel enables safe, highly-targeted bone fusion, as it does not leach BMP-2, with the gel biodegrading as new bone forms.
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Dr Agnieszka Janeczek, Chief Executive Officer of Renovos Biologics, said: “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 is intended to help provide patients more timely access to medical devices which have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions, by speeding up the development, assessment and review process. Breakthrough designation is only granted after preliminary evidence has been provided demonstrating a reasonable expectation that the device will provide significant advantages over standard of care. The designation will allow Renovos to have more frequent interaction with the FDA’s regulatory experts when preparing its submissions, followed by prioritised reviews.
