Renovos Attains FDA Breakthrough Device Designation for RENOVITE® BMP-2

Renovos FDA approval
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Renovos, a pioneering biotechnology company, proudly announces its recent achievement of Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its groundbreaking product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2). This designation underscores the innovative nature of RENOVITE® BMP-2 and its potential to transform orthopedic applications through advanced bone graft materials.

Understanding RENOVITE® BMP-2

RENOVITE® BMP-2 is a revolutionary orthobiologic that leverages a proprietary synthetic nanoclay gel in its development. This gel is poised to be a safer and more effective alternative to existing bone graft materials. What sets it apart is its injectable nature, offering an easy-to-use solution for precise, localized bone formation at the target site.

The nanoclay gel encapsulates BMP-2, a crucial growth factor that stimulates the in-growth of bone-forming cells. Unlike conventional methods, the gel does not leach BMP-2, ensuring highly targeted bone fusion. Furthermore, the gel biodegrades naturally as new bone forms, enhancing the safety and efficacy of the entire regenerative process.

The first product under the RENOVITE® banner, the BMP-2 gel, is specifically designed for orthopedic applications. This includes spinal fusion, addressing bone defects, and ankle surgery. The gel’s injectable delivery system and its ability to retain Bone Morphogenic Protein 2 only for in-growing cells make it a groundbreaking advancement in orthobiologics.

Renovos Nanoclay Platform

The RENOVITE® nanoclay platform is a key enabler for localized concentration and release of biologics, drugs, and cells. This platform significantly enhances the safety and efficacy of these agents in the realm of regenerative medicine and tissue regeneration.

Global Bone Graft Substitute Market Insights

In the dynamic landscape of the bone graft substitute market, distinct segments and key players shape the industry’s trajectory. As of 2022, the synthetic bone graft segment retained its dominance over the DBM (Demineralized Bone Matrix) segment, propelled by robust unit sales growth on a global scale. This preference for synthetic grafts is particularly evident in spinal surgeries, where they are favored over larger volume applications such as fracture repair.

The choice between synthetic grafts and alternatives, like allograft bone, is dictated by the specific indications. Larger volume requirements, common in fracture repair, often lean towards more economical options like allograft bone. Despite a mixed body of evidence regarding the efficacy of synthetics across different indications, their popularity has surged when paired with biologically active products such as growth factors, cellular allografts, and cell therapy.

Current Competition in the Global Bone Graft Substitute Market 

Leading the charge in 2022, Stryker claimed the largest share in the total bone graft substitute market. This achievement can be attributed to Stryker’s strategic acquisition of Orthovita in May 2011, which brought the synthetic product Vitoss™ into its portfolio. Vitoss™, along with the innovative Vitoss™ Bioactive bone graft substitute featuring a unique bioactive additive, catapulted Stryker to the forefront of the synthetic market.

Not to be overshadowed, Medtronic secured the second-largest share in the total bone graft substitute market in 2022. This success was fueled by Medtronic’s leadership in the demineralized bone graft market and a commendable performance in the rapidly expanding synthetic bone graft market. Medtronic’s flagship DBM product line, Grafton®, comes in several variations, ranging from matrix plugs to strips, to provide the best possible filler for different types of bone damage.

DePuy Synthes clinched the third-largest share in the total bone graft substitute market in 2022. This achievement is bolstered by the distribution of the DBX® DBM product line, processed by the Musculoskeletal Transplant Foundation (MTF). Marketed as an allograft bone void filler, the DBX® DBM line undergoes rigorous testing for osteoinductive qualities, making it a reliable option for bone formation.


Renovos’ attainment of FDA Breakthrough Device Designation for RENOVITE® BMP-2 heralds a new era in orthobiologics. The innovative nanoclay gel and localized delivery system offer a paradigm shift in bone graft materials, promising increased safety and efficacy. As RENOVITE® BMP-2 continues its development journey, it holds the potential to redefine standards in orthopedic applications, setting the stage for transformative advancements in regenerative medicine.

To learn more about the Global Bone Graft Substitute Market, or the Global Orthopedic Biologics/Biomaterials Market as a whole, request a complimentary executive summary of our 2023 report below


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