Medical Device Network

FDA grants breakthrough device designation for Renovos’ bone graft gel

Renovite BMP-2 is made from a synthetic nanoclay gel, designed to be safer and more effective than current bone graft materials.

UK-based Renovos Biologics has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for Renovite BMP-2 (bone morphogenic protein 2), a synthetic nanoclay bone fusion gel.

Renovite BMP-2 is used as an alternative to a bone graft. The gel, which contains a growth factor BMP-2, allows precise bone formation at the specific area. The nanoclay gel ensures safe and targeted bone fusion without BMP-2 leakage, and naturally degrades as new bone forms.

In July 2023, medical device manufacturer Biocomposites acquired a minority stake in Renovos for an undisclosed sum, to advance Renovite towards pre-market approval as a carrier for orthopaedic, spine and trauma applications.

Biocomposites made a series of acquisitions last year, including bone graft substitute manufacturer Artoss. Germany-based Artoss developed a synthetic degradable bone graft substitute called NanoBone, which consists of unsintered nanocrystalline hydroxyapatite and silica gel.

In the announcement accompanying the breakthrough device designation for Renovite BMP-2, Biocomposites’s CEO Michael Harris said: "The granting of FDA breakthrough device Ddsignation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market Renovite - a next-generation drug carrier.”

According to a market model on GlobalData’s Medical Intelligence Center, the US bone grafts and substitutes market is anticipated to grow from $1.91bn in 2025 to $2.18bn in 2030.

GlobalData is the parent company of Medical Device Network.

There have been several developments over the last year in the bone graft sector. At the end of November 2023, Dimension Inx treated the first patient with its FDA-approved 3D-printed regenerative bone graft product.

In May 2023, the FDA granted a breakthrough device design for Locate Bio’s bone graft technology for patients with degenerative disc disease (DDD). The bone graft releases a protein that drives cell differentiation and bone formation called osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2).