Issued on behalf of Avaí Bio, Inc.

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

Key Takeaways:

• 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.

• 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].

• 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.

• 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.

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].

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.

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

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.

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.

“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. Prof. Walter H. Gunzburg, Chairman of Austrianova, added: “MCBs are a prerequisite for the production of Cell-in-a-Box® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards.”

Avaí Bio’s dual-program approach targets both the Klothonova α-Klotho anti-aging program and the Insulinova diabetes program, each leveraging the same encapsulation technology. The addressable markets span Alzheimer’s ($32.8 billion by 2033), cardiovascular disease (leading global cause of death), and kidney disease (850 million affected worldwide).

CONTINUED… Read this and more news for Avaí Bio at: USANewsGroup.com

In other industry developments and happenings in the market include:

FibroBiologics (NASDAQ: FBLG) — 270+ Patents and New Osteoporosis Cell Therapy IP

FibroBiologics (NASDAQ: FBLG), a clinical-stage biotech with more than 270 patents issued and pending, announced the issuance of a new U.S. patent covering fibroblast cell therapy for osteoporosis treatment. The patent covers methods of treating bone diseases through administration of fibroblast cells designed to modulate bone remodeling by inhibiting osteoclast activity and promoting osteoblast activity. CEO Pete O’Heeron called it “a bold step forward in our mission to rethink what’s possible in regenerative medicine.” The company is developing treatments across wound healing, multiple sclerosis, disc degeneration, psoriasis, and additional orthopedic indications.

Fate Therapeutics (NASDAQ: FATE) — Off-the-Shelf CAR T as Same-Day Outpatient Therapy

Fate Therapeutics (NASDAQ: FATE) reported that patients in its FT819 clinical trial have been successfully treated with off-the-shelf CAR T-cell therapy as same-day hospital discharge — a milestone that eliminates the extended inpatient stays required by current autologous CAR T programs. The company ended fiscal 2025 with $205 million in cash and investments, projecting runway through year-end 2027. Fate expects to commence its first Phase 2 clinical trial in lupus nephritis while expanding enrollment across multiple autoimmune indications.

Mesoblast (NASDAQ: MESO) — First FDA-Approved MSC Product Expanding to Adult Indications

Mesoblast (NASDAQ: MESO) presented data showing that Ryoncil® achieved similarly high survival outcomes in steroid-refractory acute graft-versus-host disease regardless of patient age or treatment line. Ryoncil® is the first mesenchymal stromal cell product approved by the FDA for any indication. Mesoblast plans to commence enrollment in a pivotal trial of early second-line Ryoncil® in adults, targeting a population approximately three times the size of the pediatric market. The company holds over 1,000 granted patents worldwide.

Longeveron (NASDAQ: LGVN) — Phase 2b Results Published in Cell Stem Cell

Longeveron (NASDAQ: LGVN) announced that its Phase 2b clinical trial results were published in Cell Stem Cell, demonstrating that intravenous laromestrocel improved the physical condition of patients with age-related frailty after nine months. The randomized trial of 148 individuals showed patients receiving laromestrocel achieved a 63.4-meter improvement in six-minute walk distance. Longeveron is developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, with programs spanning hypoplastic left heart syndrome, Alzheimer’s disease, and pediatric dilated cardiomyopathy.

The regenerative medicine sector is crossing the threshold from experimental science to manufactured therapeutics. Avaí Bio (OTCQB: AVAI) has just taken the manufacturing step that positions its α-Klotho longevity program for production — in a market where the protein it’s restoring is linked to some of the most consequential diseases of aging, and where the technology to deliver it is backed by decades of peer-reviewed science.

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

Article Source: https://usanewsgroup.com/avai-profile/

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SOURCES:

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

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

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

4. FDA Approved Cell and Gene Therapy Products — https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products