Biologics Take Giant Leap Forward: Biotech Firm Prepares for NB1 Pilot Clinical Trial with Help from Expert Contract Research Organization

Bone Biologics Corporation, a leader in developing orthobiologic products for spine fusion markets, is thrilled to announce their collaboration with Avania, a renowned global, full-service CRO. This partnership will enable Bone Biologics to conduct a pilot clinical trial to assess the safety and effectiveness of their novel NB1 in patients with degenerative disc disease undergoing a Transforaminal Lumbar Interbody Fusion (TLIF) procedure. Avania’s specialized expertise in medical devices, novel technology and drug-device combination products will ensure the success of this groundbreaking trial.

This exciting, randomized trial will evaluate the safety and preliminary effectiveness of NB1 bone graft in 30 subjects with degenerative disc disease who are undergoing a TLIF. The trial is due to commence in the second half of 2023, subject to approval from the Monash Health system ethics committee in Australia. It will be conducted across multiple sites to ensure the best possible results.

The NB1 bone graft device, enhanced with the addition of rhNELL-1, is expected to result in an increased quantity and maturity of bone, as well as a faster spinal fusion rate. The inclusion of rhNELL-1 works to stimulate bone formation through its receptor-mediated intracellular signaling and gene expression of osteogenic genes. In this way, rhNELL-1 provides an ancillary osteopromotive effect, working to improve bone formation.

Bone Biologics is thrilled to announce the engagement of Avania, a prominent CRO, as the company progresses towards human testing of NB1. With the recent engagement of a contract manufacturer and finalizing the supply agreement with the carrier, the company is now well-positioned to enter the clinic later this year. CEO Jeffrey Frelick is confident that these steps will bring the team one step closer to bringing NB1 to market.

About Bone Biologics

Bone Biologics is pioneering regenerative medicine for bone, leveraging the preclinical research of the Nell-1 protein to develop a bone graft substitute product. Their focus is on bone regeneration in spinal fusion procedures, but they have rights to apply their technology to trauma and osteoporosis treatments as well. With the help of strategic partners, Bone Biologics is on the forefront of revolutionizing bone regeneration and improving the quality of life for those with bone-related disorders.

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