Bone Biologics Announces Validated Shelf Life Extension Of Its rhNELL-1 Protein Product To 29 Months

The updated shelf life is supported by continued third-party stability data. The additional five months of validated product life is expected to provide greater flexibility in lot sizing and distribution planning as the Company progresses rhNELL-1 toward the manufacturing scale required for a future pivotal study.

"Reaching 29 months is a direct result of the ongoing stability work our team has been executing," said Jeffrey Frelick, Bone Biologics President and Chief Executive Officer. "Beyond the incremental operational benefit, this result gives us increased confidence in the robustness of our rhNELL-1 formulation as we continue to prepare for the next phase of development. We believe a longer validated shelf life translates to more efficient use of manufactured material and greater scheduling latitude across our clinical and supply chain operations."

The Company previously stated its objective of achieving a shelf life sufficient to support scaled manufacturing ahead of a pivotal study. The 29-month validation is expected to bring the program meaningfully closer to that threshold.

NB1, the Company's lead product candidate, combines rhNELL-1 protein with demineralized bone matrix to provide controlled bone regeneration. Bone Biologics is currently conducting a multicenter, prospective, randomized pilot clinical study evaluating NB1 in up to 30 subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion in Australia.