VANCOUVER — Baystreet.ca — Most people have never heard of α-Klotho. But the scientific community has been quietly obsessed with it since 1997, when Japanese researcher Makoto Kuro-O discovered that mice without the Klotho gene aged rapidly and died young — while mice with extra copies lived up to 30% longer.

In the decades since, the evidence has only gotten stronger. Studies from the Mayo Clinic link declining Klotho to arterial stiffness, endothelial dysfunction, and vascular calcification. Peer-reviewed research connects higher Klotho levels to reduced risk of Alzheimer’s, cardiovascular disease, and certain cancers. The protein modulates aging across the brain, heart, kidneys, and immune system simultaneously. It is, by any objective measure, one of the most consequential protective molecules the human body produces.

And your body cuts production by approximately 50% after age 40.

This biological reality is colliding with a market that’s accelerating toward it. The cell and gene therapy sector is forecast to reach $45 billion by 2035. Cell therapy alone surpassed $8.2 billion this year. CAR T-cell therapy is valued at nearly $7 billion, expanding at an 18% CAGR. The question the entire sector is now answering is no longer whether living cells can treat disease. It’s whether they can be manufactured reliably enough to reach the patients who need them.

That manufacturing question is driving a new class of companies. Caribou Biosciences (NASDAQ: CRBU) is developing next-generation allogeneic CAR-T therapies using its proprietary chRDNA genome-editing platform, designed to create off-the-shelf cell therapies that eliminate the manufacturing bottleneck of patient-specific treatments. Editas Medicine (NASDAQ: EDIT) is advancing in vivo gene editing therapies using CRISPR technology, with clinical programs targeting genetic eye diseases where a single treatment could replace a lifetime of management. Organogenesis (NASDAQ: ORGO) generates over $400 million in annual revenue from its advanced wound care and surgical biologics products, proving that regenerative medicine can reach commercial scale. Inhibrx Biosciences (NASDAQ: INBX) is developing bispecific antibody-based therapies designed to redirect the immune system with greater precision than conventional approaches.

Each of these companies represents a piece of the regenerative medicine puzzle. But none of them is addressing what may be the most fundamental biological target of all: the age-related decline of a protein that protects virtually every major organ system.

Avaí Bio (OTCQB: AVAI) recently announced the initiation of manufacturing a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein, working alongside joint venture partner Austrianova through their shared entity, Klothonova. This is a GMP-compliant production milestone — the foundational step that transitions a cell therapy program from research into the manufacturing phase.

The delivery mechanism is what sets the approach apart. Austrianova’s Cell-in-a-Box® encapsulation technology protects therapeutic cells inside a biocompatible shell, allowing continuous protein secretion without immune rejection. It’s backed by over 50 peer-reviewed publications. The company’s dual-program approach also targets diabetes through the Insulinova platform, which is evaluating advanced cells for potential application in insulin-producing cell therapies following participation at the 15th European Pancreas and Islet Transplantation Association Symposium in January 2026.

“We are excited to enter the first step in the production phase of α-Klotho producing cells as part of our commitment to deliver safe, effective treatments for aging associated diseases,” said Chris Winter, CEO of Avaí Bio.

Your body is losing the protein that protects you from Alzheimer’s, heart disease, cancer, and kidney failure. The science to restore it is no longer theoretical. The manufacturing has begun. And Avaí Bio (OTCQB: AVAI) is building the production platform in a market where the cell and gene therapy sector is heading toward $45 billion and every company with scalable manufacturing infrastructure is being repriced.

For more information on Avaí Bio (OTCQB: AVAI) and its Klothonova and Insulinova programs, visit Baystreet.ca

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SOURCES:

1. Straits Research, Global Cell Therapy Market 2026 — https://straitsresearch.com/report/cell-therapy-market

2. Precedence Research, Cell and Gene Therapy Market Forecast — https://www.precedenceresearch.com/cell-and-gene-therapy-market

3. Grand View Research, CAR T-Cell Therapy Market — https://www.grandviewresearch.com/industry-analysis/car-t-cell-therapy-market-report

4. Astute Analytica, Regenerative Medicine Market 2025–2033 — https://www.globenewswire.com/news-release/2026/01/27/3226653/0/en/Regenerative-Medicine-Market-Review-2020-2024-and-Forecast-2025-2033-A-578-29-Bn-Opportunity-Says-Astute-Analytica.html

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