Bone Biologics Advances Preparations for NB1 Pilot Clinical Trial with Engagement of Contract Research Organization

Excerpt from the Press Release:

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, announces it has engaged Avania as the contract research organization (CRO) for the Company’s pilot 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 preliminary 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, pending approval from the Monash Health system ethics committee in Australia.

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.

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