The $45 Billion Cell Therapy Boom Just Hit a Manufacturing Milestone Most Investors Haven’t Noticed

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AVAI, FBLG, FATE, MESO, and LGVN as Regenerative Medicine Moves From Lab to GMP Manufacturing Facilities

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Issued on behalf of Avaí Bio, Inc.

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Companies mentioned in this article: Avaí Bio (OTCQB: AVAI), FibroBiologics (NASDAQ: FBLG), Fate Therapeutics (NASDAQ: FATE), Mesoblast (NASDAQ: MESO), Longeveron (NASDAQ: LGVN)

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Key Takeaways:

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• Avaí Bio (OTCQB: AVAI) has initiated manufacturing of a Master Cell Bank of genetically modified cells that overexpress the α-Klotho “longevity protein,” a GMP-compliant production milestone that transitions its anti-aging program from research into the manufacturing phase.

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• The global cell and gene therapy market is forecast to surge from $10.4 billion to more than $45 billion by 2035, with over 40 FDA-approved products and North America commanding more than half the global market[1].

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• Avaí Bio’s dual-program approach targets both the Klothonova anti-aging platform and the Insulinova diabetes program, leveraging Austrianova’s Cell-in-a-Box® encapsulation technology backed by 50+ peer-reviewed publications.

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• Peer-reviewed research links α-Klotho to reduced risk of Alzheimer’s, cardiovascular disease, and certain cancers — with natural levels dropping approximately 50% after age 40, creating a significant therapeutic intervention opportunity.

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VANCOUVER, British Columbia, March 18, 2026 (GLOBE NEWSWIRE) — USANewsGroup.com News Commentary — The global cell therapy market is projected to surpass $8.2 billion in 2026, driven by clinical breakthroughs and manufacturing milestones reshaping regenerative medicine. CAR T-cell therapy alone is valued at nearly $7 billion this year, expanding at an 18% CAGR as off-the-shelf platforms eliminate logistical barriers. The broader cell and gene therapy sector is forecast to surge to more than $45 billion by 2035, with more than 40 FDA-approved products now available and dozens more advancing through late-stage trials[1].

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Within that landscape, a less visible but potentially transformative category is emerging: longevity therapeutics. The science of aging has evolved from philosophical curiosity into a clinical discipline, and the companies that can manufacture and deliver the proteins and cells that reverse age-related decline are positioning themselves at the frontier of a market that didn’t exist five years ago.

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Avaí Bio (OTCQB: AVAI) — Master Cell Bank Milestone for α-Klotho Longevity Protein

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Avaí Bio (OTCQB: AVAI) recently announced a production milestone alongside joint venture partner Austrianova, initiating manufacturing of a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein. These cells will enable Klothonova, the parties’ joint venture, to advance its anti-aging product candidate within the Cell-in-a-Box® encapsulated cell platform.

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A Master Cell Bank is the GMP-compliant, fully characterized starting material for all downstream production — the moment a cell therapy program shifts from research into manufacturing infrastructure. The banked cells will be used to produce the final Cell-in-a-Box® encapsulated cell product, targeting age-related diseases including Alzheimer’s and cancer while advancing anti-aging and longevity treatments.