Bone Biologics Corporation, a medical device enterprise, specializes in fostering bone regeneration for spinal fusion, leveraging its advanced recombinant human protein technology. Its flagship product, NELL-1/DBX, is a unique combination of an osteostimulative recombinant protein designed for precise, targeted control over bone regrowth. The company is currently advancing the NELL-1/DBX Fusion Device, intended for spinal fusion interventions in skeletally mature individuals experiencing single-level degenerative disc disease within the L4-S1 spinal segments. This versatile platform technology also holds the potential to deliver superior outcomes across a wide spectrum of surgical specialties, including spinal, various orthopedic fields, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine. Bone Biologics holds a licensing agreement with the UCLA Technology Development Group, which authorizes the development and commercialization of NELL-1 for its spinal fusion applications. The firm was established in 2004 and is based in Burlington, Massachusetts.
Bone Biologics Expands Trial Sites
Bone Biologics said six hospital sites in Australia are now under agreement for its first-in-human pilot trial of NB1, doubling the number of participating centers and strengthening its expectation of completing enrollment by year-end 2026.
The pilot study tests the rhNELL-1-based bone graft in up to 30 adults with degenerative disc disease undergoing transforaminal lumbar interbody fusion, with fusion success at 12 and 24 months and Oswestry Disability Index change as primary clinical endpoints.
The FDA's Division of Orthopedic Devices previously reviewed the study design, and pilot findings are intended to support progression to a potential pivotal study in the United States; management cited a cash runway through the second quarter of 2027 and a 32-month validated shelf life for rhNELL-1.