BioBurst Fluid

BioBurst Fluid is a cryopreserved, human umbilical cord blood–derived cellular allograft marketed for regenerative orthopedic applications, particularly to aid bone consolidation in spinal fusion and treatment of bone non-unions and foot/ankle disorders.[1][3][8][10][7] Developed by Burst Biologics (Smart Surgical), it consists of a cellular suspension rich in growth factors and cytokines (including EGF, PDGF, HGF, VEGF and others) and viable cells, intended to promote proliferation, migration, angiogenesis, and osteogenic activity of mesenchymal and stromal cells in the local environment.[1][3][7] The product is manufactured for allogeneic use, is intended for injection or application to surgical and injury sites (including intra-articular and orthopedic uses), and has been investigated in prospective multicenter clinical studies and a spinal fusion registry, but it has been deemed by FDA to be an unapproved drug and biological product with significant cGMP and donor-screening deficiencies, including potential contamination and inadequate Zika virus risk screening.[5][10][7][12][2][9]

Brand names

BioBurst Fluid

Other names

UCBpBioBurst