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

Rhea-AI Summary

Bone Biologics Corporation (NASDAQ: BBLG) has engaged Avania as the Contract Research Organization (CRO) for its upcoming pilot clinical trial of NB1, targeting degenerative disc disease patients undergoing Transforaminal Lumbar Interbody Fusion (TLIF). The multicenter trial will assess the safety and effectiveness of the NB1 bone graft in 30 subjects, anticipated to start in late 2023, pending ethics committee approval from the Monash Health system in Australia. The inclusion of rhNELL-1 in the NB1 device is expected to enhance bone formation. CEO Jeffrey Frelick expressed optimism about moving into human testing with Avania's support.

Positive

• Engagement of Avania as a reputable CRO to facilitate clinical trials.
• Initiation of clinical trial for NB1 expected in late 2023.
• Inclusion of rhNELL-1 in NB1 expected to enhance bone formation and spinal fusion rates.

Negative

• Dependence on ethics committee approval which may cause delays.
• Risks associated with clinical research and product development.

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.

“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.”

About Bone Biologics

Bone Biologics was founded to pursue regenerative medicine for bone. The Company is undertaking work with select strategic partners that builds on the preclinical research of the Nell-1 protein. Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications. For more information, please visit www.bonebiologics.com.

Forward-looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes,'' "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop our lead product NELL-1 and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended December 31, 2021 and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230126005289/en/

LHA Investor Relations

Kim Sutton Golodetz

212-838-3777

kgolodetz@lhai.com

Source: Bone Biologics Corporation

FAQ

What is the purpose of Bone Biologics' clinical trial with NB1?

The trial aims to evaluate the safety and effectiveness of the NB1 bone graft in patients with degenerative disc disease undergoing TLIF procedures.

When is the clinical trial for NB1 expected to start?

The trial is expected to begin in the second half of 2023, pending ethics approval.

What does rhNELL-1 do in the NB1 bone graft?

rhNELL-1 is included to promote bone formation and enhance the rate of spinal fusion.

How many subjects will be involved in the NB1 clinical trial?

The trial will involve 30 subjects.

Who is conducting the clinical trial for Bone Biologics?

The clinical trial will be managed by Avania, a global contract research organization.