Press Releases August 12, 2026 08:00 AM

Bone Biologics Achieves 32-Month Validated Shelf Life for rhNELL-1

Bone Biologics extends validated shelf life of rhNELL-1 protein to 32 months, enhancing manufacturing and distribution efficiency.

By Leila Farooq
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Bone Biologics Corporation announces the extension of the validated shelf life of its rhNELL-1 protein to 32 months, improving flexibility in manufacturing, storage, and distribution as it advances its pilot clinical study for spinal fusion applications. This milestone supports operational efficiency and supply chain flexibility for the company's lead product candidate NB1, currently in clinical trials for degenerative disc disease.

Bone Biologics Achieves 32-Month Validated Shelf Life for rhNELL-1
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Key Points

  • Validated shelf life of rhNELL-1 extended to 32 months, improving manufacturing and supply chain efficiency.
  • NB1, combining rhNELL-1 with demineralized bone matrix, is in a randomized pilot clinical study for spinal fusion in Australia.
  • The milestone supports better inventory management and readiness for pivotal scale-up in development.

BURLINGTON, Mass, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Bone Biologics Corporation ("Bone Biologics" or the "Company") (NASDAQ: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today announces that the validated shelf life of its rhNELL-1 protein has been extended to 32 months.

“Reaching a 32-month validated shelf life gives us greater flexibility in how we manufacture, store and distribute rhNELL-1 as we prepare for pivotal-study scale,” said Jeff Frelick, Chief Executive Officer. “We have achieved each stability milestone on the timeline communicated to shareholders. By extending the period the product can be held before use, we believe this milestone supports more efficient lot sizing, inventory management and distribution planning as our first-in-human NB1 study advances toward completion of enrollment.”

The extension is supported by third-party stability data and builds on the 29-month milestone announced in May 2026 and the 24-month milestone achieved in December 2025, continuing a progression from the Company's earlier validated 12- and 18-month shelf-life milestones. A 32-month validated shelf life is expected to further enhance manufacturing efficiency, lot sizing, inventory management, distribution planning, and supply-chain flexibility as the Company advances rhNELL-1 through development.

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.

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 focusing 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 regarding the timing, implementation, and success of the Company's pilot clinical study, the Company’s development of rhNELL-1 and achievement of operational milestones, the ability of the Company’s lead product candidate NB1 to provide rapid, specific and guided control over bone regeneration and show fusion success in humans, the ability of NB1 to compete in global markets, as well as statements containing the words "may," "believe," "expect," 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, but not limited to, market and other 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 Annual Report on Form 10-K for the year ended December 31, 2025 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.

Contacts

CORE IR
(212) 655-0924
[email protected]


Risks

  • Clinical study results including enrollment speed and success may impact development progress.
  • As a developing company, Bone Biologics faces risks typical for undercapitalized biotechs, including market and operational uncertainties.
  • Regulatory approval and competition in the bone regeneration and orthobiologic markets present ongoing challenges.

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