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.
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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).