FDA Clears Strip Format of Bioventus’ Signafuse Bioactive Bone Graft

Bioventus is launching its Signafuse Bioactive Bone Graft in a new strip format. The strips consist of 55% bioglass by weight and have been shown to induce higher levels of osteoblast differentiation compared to other synthetic bone graft strips.¹
 
The new strips are designed to hydrate and provide handling properties for intraoperative flexibility.  They come in multiple sizes ranging from 25 to 200 millimeters in length, with the longer strips providing an option for large, multilevel procedures.
 
The biphasic mineral in Signafuse is composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate; a ratio supported by multiple prospective² and randomized controlled trials.^3-5
 
“We are excited to expand our portfolio of bone graft solutions with the Signafuse Bioactive Bone Graft strip,” said Megan Osorio, vice president, marketing, Bioventus. “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.”
 
“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,” added John Nosenzo, chief commercial officer, Bioventus.
 
The new strip format of Signafuse will be available in Q3 from Bioventus’ distributor partners across the country.
 
References:
¹ Data on file. RPT-000962. Osteoblast Differentiation Study.
² Cavagna R, Daculsi G, Bouler JM. Macroporous calcium phosphate ceramic: a prospective study of 106 cases in lumbar spinal fusion. J Long-Term Effects Med Implants, 1999;9:403-12.
³ Ransford AO, Morley T, Edgar MA, et al. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br. 1998;80-B:13-8. doi: 10.1302/0301-620x.80b1.7276
⁴ Delécrin J, Takahashi S, Gouin F, Passuti N. A synthetic porous ceramic as a bone graft substitute in the surgical management of scoliosis: a prospective, randomized study. Spine (Phila Pa 1976). 2000;25(5):563-9. doi: 10.1097/00007632-200003010-00006
⁵ Pascal-Moussellard H, Catonné Y, Robert R, Daculsi G. Anterior cervical fusion with PEEK cages: clinical results of a prospective, comparative, multicenter and randomized study comparing iliac graft and a macroporous biphasic calcium phosphate. Spine J. 2006;6(suppl 5):136S. Abstract P109. doi: 10.1016/j.spinee.2006.06.318