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AVAI PAID ADVERTORIAL *
Avaí Bio, Inc. (OTC: AVAI)

Targeting Multi-Billion-Dollar Diabetes & Longevity Markets Through Advanced Cell-Based Therapies

Developing a bio-artificial pancreas for type 1 and insulin-dependent type 2 diabetes and α-Klotho-based therapies for age-related diseases and anti-aging treatments through proprietary live-cell encapsulation technology.

OTC
AVAI
Avaí Bio, Inc.
The Global Health Crisis

The Scale of Unmet Medical Need

Chronic diseases are expanding globally, placing unprecedented pressure on patients and healthcare systems worldwide.

🩸
589M
Adults Affected by Diabetes
The global diabetes epidemic currently affects 589 million adults aged 20–79, with projections forecasting an increase to 643 million by 2030, and 853 million by 2050. In the U.S., diabetes affects 38.4 million people (11.6% of the population). Projections estimate 55 million cases by 2030 and up to 74 million by 2050. Diabetes caused at least $1 trillion dollars in health expenditure – a 338% increase over the last 17 years.i
❤️
19.8M
CVD Deaths in 2022
Cardiovascular diseases (CVDs) are the leading cause of death globally, responsible for 19.8 million deaths in 2022, representing 32% of all worldwide deaths. Of these, 85% were due to heart attacks and strokes, with over three-quarters occurring in low- and middle-income countries. In 2021, CVDs also accounted for at least 38% of the 18 million premature deaths (under age 70) caused by noncommunicable diseases.ii
🧬
20M
New Cancer Cases in 2022
Cancer remains another major global challenge, accounting for approximately 20 million new cases and 9.7 million deaths in 2022, with the most common types including breast, lung, colorectal, and prostate cancers.iii
🫘
850M+
Chronic Kidney Disease
Similarly, chronic kidney disease (CKD) has reached epidemic proportions, with more than 850 million individuals affected globally and over 1.5 million deaths in 2021.iv

Diabetes alone caused at least $1 TRILLION in health expenditure — a 338% increase over 17 years.i

At Avaí Bio, Inc. (OTC: AVAI), efforts are centered on transforming chronic disease treatment through protected, living-cell therapies that target insulin deficiency and longevity biology, with the goal of advancing more durable and autonomous therapeutic solutions.

Root Causes

Targeting the Root Causes of Diabetes & Age-Related Diseases

Diabetes Type 1 and Type 2 Explanation
Current Approach
⚠ The Problem

Current Treatments Only Manage Symptoms

Diabetes and age-related diseases continue to expand globally, placing significant pressure on patients and healthcare systems. Current treatments primarily manage symptoms—such as insulin replacement or disease-specific drug regimens—without restoring the body's underlying biological function. As key regulatory proteins decline with age and insulin-producing cells are lost, long-term disease progression remains a major unmet medical need.

Insulin Producing Cells - Cell Therapy
Avaí Bio Approach
✦ The Solution

Restoring Biological Function With Living-Cell Therapies

Avaí Bio, Inc. (OTC: AVAI) is developing encapsulated, genetically engineered cell therapies designed to restore essential biological activity. Its bio-artificial pancreas program aims to enable continuous insulin production for diabetes, while its α-Klotho program focuses on sustained delivery of a longevity-associated protein linked to age-related decline. By combining engineered cell lines with advanced Cell-in-a-Box® encapsulation technology, the company is advancing durable, protected therapeutic platforms for large and growing markets.

Market Opportunity

Targeting Large and Rapidly Expanding Global Diabetes, Longevity, and Cell Therapy Markets

Avaí Bio, Inc. (OTC: AVAI) operates at the intersection of large and rapidly expanding global healthcare markets.

$135B+
Current Market Value
Global Diabetes Industry
The global diabetes industry, including medications and devices, is currently valued at over $135 billion, reflecting the scale of demand for more durable and biologically integrated solutions. vi
$44.4B
Projected by 2034
Global Cell Therapy Market
In parallel, the global cell therapy market, valued at $5.88 billion in 2024, is projected to reach $44.39 billion by 2034, growing at a CAGR of 22.69%, highlighting accelerating adoption of advanced regenerative platforms. vii
$43.7B
Expected by 2033
Longevity Therapeutics Market
Additionally, the global longevity therapeutics market was valued at $23.24 billion in 2024, and is expected to grow to $43.72 billion by 2033, reinforcing strong momentum in age-related therapeutic innovation. viii

Avaí Bio, Inc. (OTC: AVAI) Appears Well Positioned to Capture Growth Across Diabetes, Longevity, and Cell Therapy Markets

Key Developments

Recent Strategic Milestones

Critical steps driving Avaí Bio's advancement toward clinical-stage biotechnology leadership.

🔄
Corporate Rebranding to Avaí Bio, Inc.
Completion of corporate rebranding to Avaí Bio, Inc., reflecting sharpened biotechnology focus (February 2026).
🤝
Insulinova, Inc. Joint Venture Formed
Formation of Insulinova, Inc. joint venture with SGAustria to advance encapsulated diabetes therapies toward clinical development.
🧬
Klothonova Joint Venture Launched
Launch of Klothonova, a 50/50 joint venture with Austrianova focused on α-Klotho cell therapies.
📜
Exclusive Global License Secured
Secured exclusive global license for proprietary Klotho-producing cell line.
🎓
15th EPITA Symposium Participation
Participation in the 15th EPITA Symposium (Austria) evaluating advanced beta-cell technologies.
🏭
GMP Manufacturing Advancement
Advancement toward GMP manufacturing preparation for clinical-grade encapsulated cell lines.
A Message for You

From Avaí Bio to Investors

Greeting Investors *

Avaí Bio Is Advancing Innovative Cell-Based Therapies Targeting Large & Expanding Global Markets

Avaí Bio, Inc. (OTC: AVAI) is advancing innovative cell-based therapies targeting large and expanding global markets in diabetes and age-related disease. The company's strategy centers on restoring essential biological functions through engineered, living-cell platforms designed for sustained therapeutic delivery.

For diabetes, Avaí Bio and its joint venture partner SGAustria are developing a bio-artificial pancreas utilizing encapsulated insulin-producing cells. This program leverages Austrianova's Cell-in-a-Box® technology to protect transplanted cells while enabling continuous, glucose-responsive insulin release.

In parallel, Avaí Bio has partnered with Austrianova to advance therapies based on the "Longevity Protein" α-Klotho, a key regulator associated with aging biology and systemic health.

Through structured joint ventures and licensing agreements, Avaí Bio is building a protected, scalable cellular therapy platform positioned within high-growth healthcare sectors.

*See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.

Leadership Vision

Words From Our CEO

CW
Chris Winter
CEO
Avaí Bio, Inc.
CEO Statement

This name change marks a defining moment in the Company's evolution from a technology-focused entity to a dedicated biotechnology innovator at the forefront of cellular medicine. Avaí Bio more accurately reflects the Company's mission to advance therapies addressing unmet needs in diabetes management and age-related diseases. Through genetically engineered cell lines, advanced encapsulation technologies designed to shield cells from immune rejection, and strategic joint ventures, Avaí Bio is positioned to advance progress toward long-term biological restoration and improved healthy lifespan outcomes.”

Why Watch AVAI

Top Reasons to Have AVAI on Your Radar *

01
Dual-Pipeline Strategy — Advancing both a diabetes program and an α-Klotho longevity program within large global markets.
02
Targeting a $135+ Billion Diabetes Industry — Positioned within one of the largest and fastest-growing chronic disease markets worldwide. vi
03
Expanding Longevity Sector — Participating in a global longevity therapeutics market projected to exceed $43 billion by 2033. viii
04
High-Growth Cell Therapy Market — Operating within a sector forecasted to grow to $44.39 billion by 2034. vii
05
Bio-Artificial Pancreas Development — Focused on restoring insulin production through encapsulated, engineered cells. vi
06
Longevity Protein α-Klotho Program — Advancing sustained protein delivery associated with aging biology.
07
Strategic Joint Ventures — Collaborations with SGAustria and Austrianova strengthen development capabilities. ix
08
Cell-in-a-Box® Encapsulation Technology — Utilizing protective, immune-isolating delivery systems for long-term therapeutic function.
09
Mayo Clinic Study Reinforces α-Klotho Relevance — A newly published Mayo Clinic study linked low α-Klotho levels to vascular calcification, cardiovascular progression, and increased mortality risk, supporting the scientific foundation behind Avaí Bio’s encapsulated α-Klotho cell therapy program.
10
Exclusive Global Klotho Cell Line License Secured — Klothonova has secured an exclusive worldwide license for a proprietary Klotho-producing cell line, strengthening Avaí Bio’s intellectual property position and providing long-term development and commercialization rights in the longevity therapeutics space.
11
Progress Toward GMP Manufacturing — Preparatory steps underway to support clinical-grade production and regulatory advancement.
12
Active Scientific Engagement and Industry Presence — Participation in global forums such as the EPITA Symposium evaluating advanced beta-cell technologies.

*See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.

Press Release

α-Klotho & Cardiovascular Research Breakthrough

Key Development

Avaí Bio and Austrianova Advancing α-Klotho Cell Therapy as Mayo Clinic Study Links Low α-Klotho Levels to Poor Cardiovascular Survival

BS
Dr. Brian Salmons
CEO, Austrianova

“This landmark publication by Prof. Amir Lerman's team at Mayo Clinic provides compelling clinical evidence linking lower α-Klotho levels to cardiovascular disease progression and mortality. By encapsulating α-Klotho-producing cells with the proven Cell-in-a-Box® platform—already demonstrated as safe and effective in human cancer trials—Austrianova believes systemic α-Klotho levels can be meaningfully elevated, potentially influencing cardiovascular disease and other age-related conditions associated with Klotho deficiency.”

CW
Chris Winter
CEO, Avaí Bio

“An expanding body of scientific literature, including this Mayo Clinic study, highlights α-Klotho as a significant regulator of aging biology. The age-related decline in α-Klotho has been associated with multiple chronic conditions. Avaí Bio's encapsulated cell therapy approach is designed to support sustained α-Klotho delivery, targeting mechanisms linked to cardiovascular health and longevity.”

Avaí Bio — About Us
Company Overview

Building a Next-Generation Cellular Therapy Platform

Avaí Bio is an emerging biotechnology company partnering with leading-edge biotech firms, universities, scientists, and clinicians to uncover innovative solutions for diverse healthcare challenges, driving the development of advanced therapies that improve patient outcomes and quality of life. Avaí's mission is to transform healthcare through cutting-edge cellular technology and protective live-cell encapsulation, reshaping how patients see their available treatment options

Avaí Bio currently has two development programs in its cellular therapies pipeline, a diabetes development program to advance a treatment for type 1 and type 2 insulin-dependent diabetes, and an α-Klotho protein development program to advance therapies for age-related diseases and anti-aging treatments. Avaí has secured Joint Venture and Licensing Agreements to develop both cell lines.

What Avaí Does

Avaí Bio focuses on identifying genetically modified cell lines globally to tackle challenging diseases or medical conditions and then developing therapies that supply what a patient's body can no longer provide effectively. The success of these cell lines depends on their safe delivery into the body and the subsequent protection from the patient's immune system. To achieve this, Avaí Bio has teamed up with a cell encapsulation company utilizing cutting-edge encapsulation technology to shield these cells.

Cells and DNA — Avaí Bio

Advancing Innovative Cellular Therapies

Identifying and developing targeted, cutting edge, cell-based treatments

Advancing Diabetes
Advancing Diabetes
Developing a treatment for type 1 and insulin-dependent type 2 diabetes.
Explore
Advancing α-Klotho
Advancing α-Klotho
Developing solutions for age-related diseases using the "longevity protein."
Explore
Cell Encapsulation
Cell Encapsulation
Protecting each live-cell therapy with a state-of-the-art encapsulation technology.
Explore
Our Pipeline

Development Pipeline

Avaí Bio currently has two development programs in its cellular therapies pipeline, a diabetes development program and a α-Klotho protein development program. Avaí has secured Joint Venture and Licensing Agreements to develop both cell lines.

Diabetes Development Program

Diabetes Development Program

Developing a cell line that is genetically modified to produce, store and secrete insulin in type 1 and insulin-dependent type 2 diabetics.

Learn More
α-Klotho Development Program

α-Klotho Development Program

Developing a genetically modified cell line that overexpresses the production of the α-Klotho protein for age-related treatments and anti-aging therapies.

Learn More
Leadership

Executive Team

CW

Chris Winter

Chief Executive Officer

Chris Winter has over thirty-five years of experience in the investment banking and commodities industries working on numerous private placements, public offerings, mergers and acquisitions. He has worked closely with several Western European clients, assisting them in entering public U.S. markets and capital funding projects. Chris held a Series 3 license in Commodities, as well as Series 7 and 63 licenses in Securities from 1987 to 1994. In 1995, he opened a private investment banking consulting firm that worked with several companies, domestically and abroad. He has participated in raising over $70,000,000.00 throughout his career. In addition to his consulting business, in 2003, Chris took the helm as an Officer and Director with Innovative Holdings Alliance, Inc. and its predecessor Companies where he worked with attorneys, accountants, and auditors as well as the applicable regulatory agencies. From the mid-1990's to present, Chris has worked directly with a wide variety of industries including communication transmission, electric generation and storage, gold and silver mining, multi-media, infomercials, health care and equipment, and banking to name a few.

Latest News

In Summary

Avaí Bio, Inc. (OTC: AVAI) is advancing a focused cell-based therapy platform targeting diabetes and age-related diseases. The company's strategy centers on restoring essential biological functions through engineered, living-cell technologies designed for sustained therapeutic delivery.

Through its diabetes program, developed with joint venture partner SGAustria, Avaí Bio is progressing a bio-artificial pancreas approach using encapsulated insulin-producing cells, intended to enable continuous, glucose-responsive insulin delivery.

In parallel, the company is advancing its α-Klotho "Longevity Protein" program in collaboration with Austrianova, utilizing Cell-in-a-Box® encapsulation technology to support controlled, long-term protein secretion.

Positioned within expanding diabetes, longevity, and cell therapy markets, Avaí Bio is building a structured, partnership-driven platform focused on scalable innovation and long-term value development.

Avaí Bio, Inc. (OTC: AVAI)

A Company to Watch as It Advances Cell-Based Therapies for Diabetes and Longevity

Visit avaibio.com

*See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.

Sources

i — https://diabetesatlas.org/

ii — https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

iii — https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing

iv — https://www.worldkidneyday.org/wp-content/uploads/2025/02/WKD-2025-policy-brief.pdf

v — https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-21851-z

vi — https://avaibio.com/diabetes

vii — https://www.biospace.com/cell-therapy-market-size

viii — https://www.datamintelligence.com/research-report/longevity-therapeutics-market

ix — https://avaibio.com/

x — https://avaibio.com/klotho

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