Bioventus, LLC., has gotten the go-ahead from the FDA to market its bone graft, SIGNAFUSE® in a strip format. The Durham, North Carolina-based orthobiologics company has been selling SIGNAFUSE putty since its 2015 acquisition of BioStructures, LLC. and received FDA 510(k) clearance June 18, 2020 for the strips. SIGNAFUSE putty was first brought to market in 2014.
FDA Clears Bioventus’ Signafuse® Bone Graft Strips
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The material is composed mostly of bioactive glass (55% by weight). The remaining material is a biphasic mineral consisting of β-tricalcium phosphate (60%) and hydroxyapatite (HA) mineral (40%), ratios used commonly in synthetic bone grafts based on research from the late 1990s.
Strips will be available in lengths from 25-200 millimeters and will facilitate large, multilevel procedures better than putty alone, such as in posterior lumbar fusion procedures. The inclusion of bioactive glass was shown to induce osteoblast differentiation according to the company’s internal research.
Vice President of Marketing Megan Osorio said in a press release from the company, “Apart from the ideal combination of biomaterials that contribute to healing, and best-in-class handling, this product is unique in that it offers a great solution for patients that require more significant interventions such as spinal deformity correction.”
Chief Commercial Officer John Nosenzo commented on efficiencies for surgical facilities, “We also believe SIGNAFUSE in the strip format will provide efficiencies for the hospital, either by opening fewer packages or cost savings opportunities vs. alternative grafts.”
The company announced that the product will be available in Q3 of 2020.
In addition to SIGNAFUSE putty, and now strips, the company also offers biologic products such as an allogenic morphogenetic protein product, OsteoAMP, and autologous cell and bone marrow extraction tool, cellxtract. Other divisions of the company offer ultrasound bone healing and injectable biologic products for joint therapies.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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