Bone Biologics Corp., a developer of orthobiologic products for spine fusion markets, has engaged Avania as the contract research organization (CRO) for the Company’s clinical trial with NB1. Avania is an integrated global, full-service CRO with specialized expertise in medical devices, novel technology and drug-device combination products. The trial will evaluate the safety and effectiveness of Bone Biologic’s novel NB1 in patients with degenerative disc disease undergoing a Transforaminal Lumbar Interbody Fusion (TLIF) procedure.
 
This multicenter, parallel group, randomized trial is designed to evaluate the safety and effectiveness of NB1 bone graft in 30 subjects with degenerative disc disease undergoing a TLIF. The trial is expected to be initiated in the second half of 2023.
 
For the NB1 bone graft device, the inclusion of rhNELL-1 provides an ancillary osteopromotive effect that is expected to increase both the quantity and maturity of bone and to increase the rate of spinal fusion. The proposed mechanism of action for rhNELL-1 to improve bone formation is based on published research and involves classic receptor binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation.
 
“We are encouraged by our progress in advancing NB1 into human testing and engaging Avania supports our plans to enter the clinic later this year,” said Jeffrey Frelick, chief executive officer of Bone Biologics. “We have been steadfastly preparing for this trial and engaging a prominent CRO builds upon the recent engagement of a contract manufacturer and finalizing the supply agreement with the carrier.”