Bone Biologics is a clinical-stage medical device company developing NB1, a bone graft device targeting spinal fusion surgery. NB1 combines NELL-1, a recombinant human protein growth factor, with demineralized bone matrix (DBM) sourced from MTF Biologics. The device is designed to promote targeted bone regeneration without the inflammatory side effects associated with existing growth factors. The primary clinical need NB1 addresses is enabling effective bone fusion without requiring a second surgery to harvest the patient's own bone (autograft), which carries risks of pain, longer surgery, and infection. Bone Biologics currently has no revenue and is entirely dependent on capital raises to fund operations. The company is running a pilot clinical study in Australia, enrolling up to 30 patients undergoing lumbar spinal fusion, with plans to use that data to support a larger U.S. pivotal trial and ultimately an FDA Pre-Market Approval (PMA) application. If commercialized, NB1 would be sold as single-dose kits to hospitals and surgical centers. The company licenses the underlying IP from UCLA, which carries royalty obligations of 3% on net sales, minimum annual royalties, and milestone payments. Bone Biologics operates with just two full-time employees, outsourcing all clinical, regulatory, and manufacturing work. Beyond spinal fusion, the company holds licenses from UCLA covering non-union trauma and osteoporosis indications, though these remain speculative and would require separate development programs.
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