Avai Bio Inc. (OTCQB:AVAI)

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Avaí Bio and Austrianova Announce Research Collaboration with San Raffaele Hospital to Advance Encapsulated Cell Therapy for Diabetes

LAS VEGAS, NEVADA, Aug. 12, 2026 (GLOBE NEWSWIRE) — Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”) and Austrianova, its joint venture partner in Insulinova, today announced that Insulinova has entered into a Research and Option Agreement with Ospedale San Raffaele S.r.l. (OSR), a leading European biomedical research institution, to collaborate on the development of an encapsulated cell therapy for the treatment of Type 1 and insulin-dependent Type 2 diabetes. 

OSR, located in Milan, Italy, is internationally recognized for its leadership in diabetes research, regenerative medicine, and stem cell biology. The collaborative research program will be led by Professor Lorenzo Piemonti, Head of the Regenerative Medicine and Transplant Unit, Director of the Diabetes Research Institute at OSR, and Associate Professor of Endocrinology at Vita-Salute San Raffaele University, together with Dr. Valeria Sordi, Head of the Beta Cell Differentiation Unit, whose pioneering work in beta cell replacement has helped position OSR among the world’s leading centers for diabetes research. 

The collaboration combines three complementary strengths: OSR’s expertise in developing stem cell-derived insulin-producing beta cells, Austrianova’s Cell-in-a-Box® encapsulation technology, and Insulinova’s mission to advance these technologies toward commercial cell therapies for diabetes. 

Under the agreement, Insulinova will collaborate with OSR to evaluate the combination of stem cell-derived beta cells with Insulinova’s proprietary cell encapsulation platform, based on Austrianova’s Cell-in-a-Box® technology. The objective is to evaluate whether encapsulation can support beta cell survival and function while providing immune protection, with the long-term goal of reducing or potentially avoiding the need for systemic immunosuppression. 

Insulinova will provide full funding for the research program, supply its proprietary encapsulation equipment, specialized encapsulation materials, technical expertise, and scientific support. OSR will contribute its expertise in stem cell differentiation and beta cell replacement, research personnel, and laboratory facilities. 

“Stem cell-derived beta cells represent a promising approach to restoring insulin production in people with diabetes, but protecting transplanted cells from immune-mediated damage remains a major challenge,” said Dr. Valeria Sordi.  “This collaboration will allow us to investigate whether the Cell-in-a-Box® encapsulation platform can provide a suitable environment for stem cell-derived beta cells while preserving their viability and function. We look forward to evaluating the potential of this approach as part of the broader effort to develop safe and effective beta cell replacement therapies.” 

Chris Winter, Chief Executive Officer of Avaí Bio, added, “This agreement represents a significant milestone in the advancement of our diabetes program. By bringing together OSR’s internationally recognized expertise in stem cells and beta cell replacement with the technologies and capabilities of our joint venture, Insulinova, we have established a strong framework to advance this program toward commercialization. Just as importantly, the agreement positions Insulinova to further develop innovation arising from this collaboration and advance the development of potential new cell therapies for diabetes.”

“Cell-in-a-Box® was developed to overcome one of the fundamental challenges in cell therapy—protecting therapeutic cells while allowing them to function normally,” said Dr. Brian Salmons, Chief Executive Officer of Austrianova. “Combining that technology with OSR’s expertise in producing stem cell-derived beta cells creates an exciting opportunity to develop a next-generation therapy for diabetes. We believe this collaboration highlights the strength of Insulinova’s platform and its potential to bring meaningful innovation to patients.” 

About Avaí Bio, Inc. 

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies. 

About Austrianova (SGAustria Pte. Ltd.) 

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies. 

About Ospedale San Raffaele 

San Raffaele Hospital, part of the San Donato Group, is a university hospital and internationally renowned research institute with highly specialized expertise in the diagnosis and treatment of several major diseases. Founded in 1971 and recognized in 1972 as a Scientific Institute for Research, Hospitalization and Healthcare (IRCCS), it serves as a Highly Specialized Emergency Center (E.A.S.) and as the teaching hospital of Vita-Salute San Raffaele University. 

The IRCCS San Raffaele Hospital is accredited by the Italian National Health Service and offers more than 60 clinical specialties. Its multidisciplinary organization, state-of-the-art technology, and the continuous integration of scientific research, education, and clinical practice have enabled the institution to achieve outstanding results over the years, placing it at the top of the Italian rankings for scientific productivity and establishing it as a leading reference center in Europe and worldwide for the study and treatment of numerous diseases, as well as for the development of innovative therapies. 

More information about OSR can be found at www.hsr.it 

More information about Avaí Bio can be found at https://www.avaibio.com  

You can also follow us on social media at: 

https://x.com/AvaiBio 

https://www.facebook.com/AvaiBio 

Forward-Looking Statements 

Certain statements contained in this press release may constitute “forward-looking statements.”  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact.  Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (https://www.sec.gov).  In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products.  The forward-looking statements included in this press release represent the Company’s views as of the date of this press release and these views could change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of the press release. 

Issued on behalf of Avaí Bio, Inc. (OTCQB: AVAI)

LAS VEGASJuly 21, 2026 /PRNewswire/ — (American News Group News Commentary) For the millions of people who manage diabetes with daily insulin injections, the holy grail has always been the same: a therapy that senses blood sugar and releases the right amount of insulin on its own, the way a healthy pancreas does. A growing group of biotech companies is chasing that goal with cell-based therapies, and this week one small player took a concrete step toward making its version real.

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The milestone is a supply deal, which may sound unglamorous, but in cell therapy the source of the cells is often the whole ballgame. Without a reliable, high-quality supply of insulin-producing cells, even the most elegant delivery technology has nothing to deliver.

Key Takeaways

Avaí Bio, Inc. (OTCQB: AVAI) and its joint-venture partner Austrianova reached an agreement in principle with an internationally acclaimed partner to supply the insulin-producing cells for Insulinova, their cell-based diabetes therapy.

The therapy pairs those cells with Austrianova’s Cell-in-a-Box® encapsulation technology, designed to produce insulin in response to the body’s changing needs.

The broader cell-therapy-for-diabetes field is drawing serious attention, with Vertex Pharmaceuticals (Nasdaq: VRTX)Eledon Pharmaceuticals (Nasdaq: ELDN)Sernova Biotherapeutics (OTC: SEOVF), and Viking Therapeutics (Nasdaq: VKTX) all advancing programs across the diabetes and metabolic landscape.

A Critical Piece of the Puzzle Falls Into Place

Avaí Bio, Inc. (OTCQB: AVAI), an emerging biotechnology company developing cell-based therapies for diabetes, age-related disorders, and anti-aging, announced that together with its joint-venture partner Austrianova it has concluded negotiations and reached agreement on the terms of a collaboration with a premier, internationally acclaimed partner to provide insulin-producing cells for Insulinova’s diabetes therapy.

Insulinova is a joint venture between Avaí and Austrianova, established in late 2025 to develop a cell-based therapy for diabetes. The approach combines cells that have gone through an innovative cell-programming process to become insulin-producing cells with Austrianova’s proprietary Cell-in-a-Box® encapsulation technology. Once implanted, the encapsulated cells are designed to produce insulin in response to the body’s changing needs, offering the potential for a more natural alternative to insulin injections for people with type 1 and insulin-dependent type 2 diabetes.

“We are delighted to have successfully completed negotiations and reached this important agreement, which represents a significant milestone for Insulinova and the advancement of our diabetes program,” said Chris Winter, Chief Executive Officer of Avaí Bio. “Securing a world-class partner to supply the insulin-producing cells is a critical step in advancing the Insulinova program.”

Winter added that combining that cell supply with Austrianova’s encapsulation technology brings together the key components needed to move the therapy forward. He framed the ambition plainly: the company believes the combination has the potential to restore natural, glucose-responsive insulin production and ultimately provide an alternative to lifelong insulin injections for people living with type 1 and insulin-dependent type 2 diabetes.

Why the Cell Source and the Capsule Both Matter

The scientific logic behind Insulinova rests on solving two problems at once. The first is producing insulin-making cells that behave the way healthy ones do. The second is keeping those cells alive and protected once they are placed in the body, without triggering the immune system to destroy them. That is where the Cell-in-a-Box® technology comes in.

“Our team has spent many years developing and validating the Cell-in-a-Box® technology,” said Dr. Brian Salmons, Chief Executive Officer of Austrianova. “Clinical studies have demonstrated that encapsulated cells can survive for extended periods following implantation, while the capsules protect the cells and allow them to produce biologically active compounds. We believe this technology is ideally suited to support implanted insulin-producing cells, with the potential to provide regulated, glucose-responsive insulin production for people with diabetes.”

Austrianova, based in Singapore, is a biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell-line development, with a track record backed by more than 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies. That depth is part of what makes the encapsulation side of the Insulinova equation credible, and why securing an equally strong cell supplier matters so much.

The companies were careful to note the deal is not fully closed. The agreement is subject to the execution of definitive agreements and customary closing conditions, which Avaí expects to complete in the coming days, with further details to follow upon completion. In other words, this is an agreement on terms, and investors will want to watch for confirmation that the definitive documents have been signed.

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The Wider Race to Replace Insulin Injections

Avaí and Austrianova are working in a field that has attracted some of biotech’s most closely watched programs. Curing or functionally reversing diabetes with cell-based therapy has moved from science fiction to active clinical reality, and a handful of companies are pursuing it from different angles, each worth understanding as context.

Vertex Pharmaceuticals (Nasdaq: VRTX)

Vertex Pharmaceuticals has set the pace in stem-cell-derived islet therapy with zimislecel, formerly known as VX-880. In data published in the New England Journal of Medicine and presented at the American Diabetes Association’s 2025 scientific sessions, all 12 patients in the early-stage portion of its trial showed restored insulin production, and 10 of the 12 no longer needed injected insulin at one year, though the therapy requires ongoing immunosuppression. Vertex has since moved into the pivotal phase of its study and has guided toward global regulatory submissions in 2026. The read-across for Avaí is direct: Vertex is proving that lab-made cells can restore glucose-responsive insulin production in humans, which is the same destination Insulinova is aiming for by a different route.

Eledon Pharmaceuticals (Nasdaq: ELDN)

Eledon Pharmaceuticals is attacking the other half of the cell-therapy problem: keeping transplanted cells alive. Its lead candidate, tegoprubart, is an anti-CD40L antibody designed to prevent the immune system from rejecting transplanted tissue. In an investigator-led study at the University of Chicago, patients with type 1 diabetes who received islet transplants alongside tegoprubart reportedly achieved striking rates of insulin independence. Eledon’s angle underscores why encapsulation approaches like Insulinova’s are so appealing, since a capsule that physically shields the cells could reduce or sidestep the heavy immunosuppression that transplant-based rivals still depend on.

Sernova Biotherapeutics (OTC: SEOVF)

Sernova Biotherapeutics is perhaps the closest structural analogue to what Avaí and Austrianova are building. Its Cell Pouch is an implantable, vascularized “bio-hybrid organ” designed to house insulin-producing cells in a protected environment, the same core idea as encapsulation. Sernova has reported insulin independence in patients in its Phase 1/2 University of Chicago trial and, in June 2026, received FDA orphan drug designation for autologous islet transplantation to prevent diabetes following total pancreatectomy. The comparison is instructive because it validates the central Insulinova thesis, that housing insulin-producing cells in a protective, implantable structure can work, while also showing how competitive the protected-cell space is becoming.

Viking Therapeutics (Nasdaq: VKTX)

Viking Therapeutics sits in the adjacent metabolic-disease arena, developing GLP-1-based therapies for obesity and related conditions. It is not a cell-therapy company, but it belongs in the frame because it illustrates the scale of investor appetite for next-generation diabetes and metabolic treatments. Viking’s shares have been among the sector’s more active names in 2026, a reflection of how much capital is chasing better answers to metabolic disease. For a company like Avaí, that backdrop matters: the same demand that lifts GLP-1 developers is the demand a functional insulin replacement would ultimately tap into.

A Small Company With a Big Target

None of this makes Insulinova a finished product. Avaí is an emerging, small-cap biotech, the therapy is preclinical, and even the cell-supply agreement announced this week still needs definitive documents to close. Those are real caveats, and the comparisons above are to companies at more advanced stages. But the strategic picture is coherent: with Austrianova’s validated Cell-in-a-Box® encapsulation on one side and a newly secured, world-class cell supplier on the other, Avaí has now lined up the two hardest inputs its diabetes program needs.

Whether Insulinova ultimately reaches patients will depend on data still to come. For now, a small company has quietly assembled the pieces to chase one of medicine’s most valuable prizes, and the coming days should reveal whether the definitive agreements turn this week’s milestone into a firm foundation.

Article Source:

[1] Avaí Bio, Inc., “Avaí Bio and Austrianova Reach Agreement for Insulin-Producing Cells with Internationally Acclaimed Partner to Advance Diabetes Therapy,” press release, July 21, 2026.

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Statements on this page about Avaí Bio, Inc., Austrianova, and the Insulinova joint venture, including references to the Cell-in-a-Box® encapsulation technology and insulin-producing cells, describe investigational research and early-stage development that has not been evaluated or approved by the U.S. Food and Drug Administration or any other regulatory authority. Insulinova is preclinical, and the cell-supply agreement described is subject to the execution of definitive agreements and customary closing conditions and may not close on the expected terms or at all. Forward-looking statements involve known and unknown risks and uncertainties; readers should not place undue reliance on them.

References to Vertex Pharmaceuticals, Eledon Pharmaceuticals, Sernova Biotherapeutics, and Viking Therapeutics, and any of their respective products or clinical programs, are for comparative and illustrative context only. Avaí Bio, Inc. is not a party to, and is not affiliated with, the studies, products, or corporate activities of those companies, and their programs are at different and generally more advanced stages of development. Each company’s programs carry their own independent risks and must be evaluated on their own merits.

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LAS VEGASJuly 21, 2026 /PRNewswire/ — Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced that, together with its joint venture partner Austrianova, it has successfully concluded negotiations and reached agreement on the terms of a collaboration with a premier, internationally acclaimed, partner to provide insulin-producing cells for Insulinova’s groundbreaking diabetes therapy.

Avaí Bio, Inc. Logo

Insulinova is a joint venture (JV) between Avaí and Austrianova, established in late 2025 to develop a revolutionary cell-based therapy for diabetes. The therapy combines cells that have undergone an innovative cell-programming process to become insulin-producing cells with Austrianova’s proprietary Cell-in-a-Box® encapsulation technology. Once implanted, the encapsulated cells are designed to produce insulin in response to the body’s changing needs, with the potential to provide a more natural alternative to insulin injections for people with type 1 and insulin-dependent type 2 diabetes.

“We are delighted to have successfully completed negotiations and reached this important agreement, which represents a significant milestone for Insulinova and the advancement of our diabetes program,” said Chris Winter, Chief Executive Officer of Avaí Bio. “Securing a world-class partner to supply the insulin-producing cells is a critical step in advancing the Insulinova program.

Together with Austrianova’s Cell-in-a-Box® encapsulation technology, this agreement brings together the key components needed to move this promising therapy forward. We believe this combination has the potential to restore natural, glucose-responsive insulin production and ultimately provide an alternative to lifelong insulin injections for people living with type 1 and insulin-dependent type 2 diabetes.”

Dr Brian Salmons, Chief Executive Officer of Austrianova, added, “Our team has spent many years developing and validating the Cell-in-a-Box® technology. Clinical studies have demonstrated that encapsulated cells can survive for extended periods following implantation, while the capsules protect the cells and allow them to produce biologically active compounds. We believe this technology is ideally suited to support implanted insulin-producing cells, with the potential to provide regulated, glucose-responsive insulin production for people with diabetes.”

The agreement is subject to the execution of definitive agreements and customary closing conditions. The Company expects these documents to be completed in the coming days and will provide further details upon completion.

About Avaí Bio, Inc.

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies.

About Austrianova (SGAustria Pte. Ltd.)

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies.

More information about Avaí Bio can be found at https://www.avaibio.com 

You can also follow us on social media at:

https://x.com/AvaiBio

https://www.facebook.com/AvaiBio

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements.” Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (https://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products. The forward-looking statements included in this press release represent the Company’s views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of the press release.

Contact:

Avaí Bio, Inc.
info@avaibio.com

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LAS VEGASMay 20, 2026 /PRNewswire/ — Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced—together with its joint venture partner and global biotechnology firm, Austrianova— a major milestone in the Company’s path to clinical trials, the completion of a Master Cell Bank (MCB) of genetically modified cells that overexpress the α-Klotho protein.

Avaí Bio, Inc. Logo (PRNewsfoto/Avaí Bio, Inc.)

Now, the MCB will undergo comprehensive testing to confirm the absence of pathogenic viruses, as well as standard assays to verify the MCB is free from adventitious agents such as bacteria, mycoplasma, fungi, and yeast to meet regulatory expectations, including those set by the FDA. This testing will be conducted independently by a top-tier, accredited third-party provider, separate from Austrianova, Avaí Bio, and their combined joint venture, Klothonova. Following successful completion, the next step will be the generation of a “Working Cell Bank” (WCB) using α-Klotho protein–overexpressing cells derived from the MCB. These cells will be used to manufacture the final Cell-in-a-Box® encapsulated clinical product.

A Master Cell Bank is a GMP-compliant, fully characterized, and homogeneous collection of vials derived from a single clone. It serves as the critical starting material for the scale-up and production of cell therapies, ensuring product consistency while reducing risk by protecting against contamination, degradation, extraneous agents, and genetic instability. By establishing and maintaining a high-quality MCB as the primary source for all Working Cell Banks under Good Manufacturing Practice (GMP) standards, Avaí Bio and Austrianova strengthen the foundation for a reliable, scalable, and sustainable supply chain.

This milestone marks a significant step forward in Klothonova’s mission to develop a sustainable, cell-based approach to restoring declining levels of the α-Klotho “longevity protein” associated with aging. The approach is intended to address both general aging1 and age-related conditions, including kidney disease, neurodegenerative disorders, and vascular diseases2.

“We are pleased that this first step in the production phase of α-Klotho producing cells has been successfully completed. We look forward to the completion of the subsequent steps needed to fulfill our commitment to deliver safe, effective treatments for the ever-burgeoning array of aging associated diseases,” said Chris Winter, Chief Executive Officer of Avaí Bio.

Dr Brian Salmons, Chief Executive Officer of Austrianova, added, “The Austrianova team is pleased to have completed the production of the α-Klotho protein expressing cells on behalf of Klothonova, our Joint Venture with Avaí Bio. We look forward to completing the next steps that will culminate with the production of Cell-in-a-Box® encapsulated clinical product for application to patients.”

This milestone represents the most recent progress under the joint venture agreement signed in September 2025, which established Klothonova as a Nevada-based company equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd. The joint venture is dedicated to the sustainable production of α-Klotho—often referred to as the “longevity protein”—a key regulatory protein widely recognized for its anti-aging properties and protective effects on multiple organs, delivered through encapsulated cell-based therapies for patients.

  1. https://www.mdpi.com/2073-4409/15/6/507
  2. https://www.dovepress.com/klotho-protein-a-multifaceted-guardian-of-healthy-aging-and-its-therap-peer-reviewed-fulltext-article-IJN

About Avaí Bio, Inc.

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies.

About Austrianova (SGAustria Pte. Ltd.)

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies.

More information about Avaí Bio can be found at https://www.avaibio.com

You can also follow us on social media at:

https://x.com/AvaiBio
https://www.facebook.com/AvaiBio

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements.” Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (https://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products. The forward-looking statements included in this press release represent the Company’s views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of the press release.

Contact:
Avaí Bio, Inc.
info@avaibio.com

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LAS VEGAS, April 7, 2026 /PRNewswire/ — Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced that in collaboration with its joint venture partner, Austrianova, a global biotechnology company, it will present the latest data from its α-Klotho anti-aging therapy. The presentation will take place at the Second Annual Klotho Conference, which focuses on the future of Klotho-based therapies.

 

Representing Avaí Bio, Austrianova, and their joint venture, Klothonova, Rahul Pawa, Chief Production Officer at Austrianova, will deliver the presentation during the September conference. The presentation will focus on the production of the longevity protein α-Klotho from encapsulated cells, an approach designed to sustainably restore circulating α-Klotho levels and support potential therapeutic applications in aging and related conditions. (https://klothoconference.com/speakers)

The conference brings together a distinguished group of thought leaders, researchers, drug developers, clinicians, executives, analysts, and investors at the forefront of Klotho science and innovation. Featured speakers include key researchers and medical experts, including Dr. Makoto Kuro-o, the physician-scientist widely recognized for discovering the Klotho gene.

“We look forward to sharing the latest data from Klothonova’s progress in α-Klotho production from encapsulated cells at this prestigious forum,” said Brian Salmons, Chief Executive Officer of Austrianova. “We are honored to be invited by Harvard-trained neuroscientist Carmen Abrahams to participate in this conference and to present the latest data on production of α-Klotho using Cell-in-a-Box® alongside our peers.”

About Avaí Bio, Inc.
Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies.

About Austrianova (SGAustria Pte. Ltd.)
Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies.

More information about Avaí Bio can be found at https://www.avaibio.com

You can also follow us on social media at:
https://x.com/AvaiBio
https://www.facebook.com/AvaiBio

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements.” Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to

raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products. The forward-looking statements included in this press release represent the Company’s views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of the press release.

Contact:
Avaí Bio, Inc.
info@avaibio.com

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SOURCE Avai Bio, Inc.

Next-generation cellular therapies and regenerative medicine drive exponential expansion

NEW YORK, March 3, 2026 /PRNewswire/ — Market News Updates News Commentary – The global anti-aging therapy market is gaining serious momentum as people live longer and actively look for ways to stay healthier, more energetic, and more youthful. What was once considered a niche cosmetic category has evolved into a major healthcare and biotech opportunity. Industry forecasts project the broader anti-aging market could surpass $420 billion by 2030, growing at an estimated 8–9% compound annual growth rate (CAGR). This growth is being fueled by rising healthcare awareness, advances in biotechnology, and increased demand for treatments that target aging at the cellular level rather than just addressing surface symptoms. Healthcare companies active in the markets this week include: Avaí Bio, Inc. (OTCQB: AVAI), Geron Corporation (NASDAQ: GERN), Intellia Therapeutics, Inc. (NASDAQ: NTLA), Niagen Bioscience, Inc. (NASDAQ: NAGE), Ocugen, Inc. (NASDAQ: OCGN).

 

The therapeutic side of the market is where investors are seeing particularly exciting potential. The anti-aging drugs segment — which includes therapies aimed at improving longevity, cellular repair, and age-related disease prevention — is projected to grow from under $100 million in 2025 to nearly $3 billion by 2040. As research into senolytics, gene therapies, and regenerative medicine accelerates, companies are moving beyond supplements and skincare into science-backed pharmaceutical solutions. This shift is attracting capital from biotech investors who see aging not just as a condition, but as a treatable biological process.

Growth is also being supported by expanding clinic networks, medical tourism, and increased adoption of non-invasive and preventative treatments across North America, Europe, and Asia-Pacific. The global anti-aging services segment alone is expected to approach $90+ billion by 2030, reflecting strong consumer willingness to spend on longevity-focused care. For investors, the anti-aging therapy market represents a powerful convergence of healthcare innovation, demographic trends, and consumer demand — positioning it as one of the more dynamic long-term growth themes in modern medicine.

Avaí Bio and Austrianova Begin Production of Master Cell Bank for Klotho Anti-Aging Therapy Under GMP Standards – Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced—together with its joint venture partner and global biotechnology firm, Austrianova—the initiation of production for a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein. 

These cells will enable Klothonova, the parties’ joint venture (JV), to advance its anti-aging product candidate within the ongoing α-Klotho development program, following the successful completion of all preparatory activities in February.

This milestone supports the JV’s efforts to create a sustainable, cell-based approach to restoring circulating levels of the α-Klotho “longevity protein” for potential therapeutic benefits in aging and related conditions.

A Master Cell Bank (MCB) is a GMP-compliant, fully characterized, and homogeneous collection of vials derived from a single clone. The MCB is a critical starting material that forms the foundation for the scale-up and production of cell therapies. It serves as an essential resource, ensuring product consistency and reducing risk by safeguarding against contamination, degradation, extraneous agents, and genetic instability. Establishing and maintaining a high-quality MCB, which serves as the primary source for all working cell banks—under Good Manufacturing Practices (GMP) standards positions Avaí Bio and Austrianova for long-term success by supporting a reliable and sustainable supply chain. 

The banked cells will ultimately be used to produce the final Cell-in-a-Box® encapsulated cell product, intended for use in innovative cell-based therapies targeting age-related diseases, such as Alzheimer’s and cancer, while also 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, Chief Executive Officer 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.”

This is the latest development as part of the JV agreement signed in September 2025, which established Klothonova as a Nevada-based entity, equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd. The JV focuses on sustainable production of α-Klotho—known as the “longevity protein” and a key regulatory protein that is well documented for its anti-aging and protective effects on organs—in patients using encapsulated cell-based therapies. CONTINUED… Read this and more news for Avaí Bio, Inc. at: https://finance.yahoo.com/quote/AVAI/news/

In other recent developments and happenings in the biotech market include:

Geron Corporation (NASDAQ: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, recently reported financial results for the fourth quarter and full year of 2025 and recent business highlights.

“Strategic actions we have taken in the second half of 2025 position Geron to drive RYTELO demand growth and invest to create value while lowering our total operating expenses year-over-year. In 2026, we are laser-focused on executing our commercial strategy,” said Harout Semerjian, President and Chief Executive Officer of Geron. “The commercial opportunity for RYTELO in second-line lower-risk MDS is significant and supported by its FDA label, NCCN Guidelines and a growing body of scientific evidence. In the second half of 2026, we look forward to the IMpactMF interim analysis in relapsed/refractory myelofibrosis and the first data from real-world experience trials focused on the use of RYTELO in LR-MDS. Our priorities are to drive U.S. commercial growth, pursue pathways to bring RYTELO to patients outside the U.S., remain financially disciplined, and evaluate opportunistic innovation as we transform Geron into a leading, sustainable hematology company.”

Intellia Therapeutics, Inc. (NASDAQ: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, recently announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran (nex-z) for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

“We are very pleased to have aligned with the FDA on the path forward for our MAGNITUDE clinical trial, with measures designed to further enhance patient safety and allow us to continue to investigate nex-z in a broad ATTR-CM population,” said Intellia President and Chief Executive Officer John Leonard, M.D. “With the resolution in January of the clinical hold on our MAGNITUDE-2 Phase 3 trial for patients with hereditary ATTR with polyneuropathy, our attention now turns to completing enrollment in both ongoing trials. We appreciate the FDA’s responsiveness throughout this process and thank the many investigators and patients who are participating in these trials.”

Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, recently announced the broadening of its NAD+ precursor intellectual property (IP) portfolio with the newly granted U.S. Patent No. 12,558,367, which covers the methods of use of nicotinamide riboside (NR) and derivatives in intravenous and injectable formulations.

Rob Fried, CEO of Niagen Bioscience, commented, “This patent expands our intellectual property for our patented NR ingredient, Niagen®, into IV and injectable delivery formats. With expected protection through 2044, it supports Niagen’s exclusivity in delivering a superior IV and injectable product with significantly faster delivery and improved comfort for patients across our expanding U.S. clinic footprint.”

Ocugen, Inc. (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, recently announced that enrollment is now complete for the OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP). As a one-year clinical trial, topline data will be available in the first quarter of 2027. These data are anticipated to support the Biologics License Application (BLA) filing for OCU400 and potential approval in 2027. The European Medicines Agency (EMA) has also provided acceptability of the U.S.-based trial for submission of a Marketing Authorization Application (MAA).

“With enrollment complete for OCU400, we enter into a very significant time as a Company,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This milestone brings us even closer to potentially delivering our first novel modifier gene therapy candidate to market and providing a one-time treatment for life to hundreds of thousands of RP patients across the globe with unmet medical need.”

DISCLAIMER: MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU’S market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU was not compensated for news coverage of the current press releases issued by Avaí Bio, Inc. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

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SOURCE Market News Updates

LAS VEGAS, March 3, 2026 /PRNewswire/ — Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced—together with its joint venture partner and global biotechnology firm, Austrianova—the initiation of production for a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein. 

These cells will enable Klothonova, the parties’ joint venture (JV), to advance its anti-aging product candidate within the ongoing α-Klotho development program, following the successful completion of all preparatory activities in February.

This milestone supports the JV’s efforts to create a sustainable, cell-based approach to restoring circulating levels of the α-Klotho “longevity protein” for potential therapeutic benefits in aging and related conditions.

A Master Cell Bank (MCB) is a GMP-compliant, fully characterized, and homogeneous collection of vials derived from a single clone.  The MCB is a critical starting material that forms the foundation for the scale-up and production of cell therapies.  It serves as an essential resource, ensuring product consistency and reducing risk by safeguarding against contamination, degradation, extraneous agents, and genetic instability.  Establishing and maintaining a high-quality MCB, which serves as the primary source for all working cell banks—under Good Manufacturing Practices (GMP) standards positions Avaí Bio and Austrianova for long-term success by supporting a reliable and sustainable supply chain.  

The banked cells will ultimately be used to produce the final Cell-in-a-Box® encapsulated cell product, intended for use in innovative cell-based therapies targeting age-related diseases, such as Alzheimer’s¹ and cancer², while also 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, Chief Executive Officer 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.”

This is the latest development as part of the JV agreement signed in September 2025, which established Klothonova as a Nevada-based entity, equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd.  The JV focuses on sustainable production of α-Klotho—known as the “longevity protein” and a key regulatory protein that is well documented for its anti-aging and protective effects on organs—in patients using encapsulated cell-based therapies.

  1. https://jamanetwork.com/journals/jamaneurology/article-abstract/2844556
  2. https://pubmed.ncbi.nlm.nih.gov/40004457/

About Avaí Bio, Inc.

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies.

About Austrianova (SGAustria Pte. Ltd.)

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies.

More information about Avaí Bio can be found at https://www.avaibio.com

You can also follow us on social media at:
https://x.com/AvaiBio
https://www.facebook.com/AvaiBio

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements.”  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact.  Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products.  The forward-looking statements included in this press release represent the Company’s views as of the date of this press release and these views could change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of the press release.

Contact:
Avaí Bio, Inc.
info@avaibio.com

 

 

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SOURCE Avaí Bio, Inc.

About Avai Bio Inc.

Avaí Bio, Inc. (OTCQB: AVAI) is a Las Vegas-based biotechnology company developing cell-based therapies for two of the largest and most intractable disease challenges of the modern era: diabetes and biological aging. Formerly known as Avant Technologies, Inc., the company completed its corporate rebrand to Avaí Bio on February 11, 2026, a name change that reflects a sharply narrowed focus on genetically modified cellular platforms and protective encapsulation technologies. The company’s core strategy is partnership-driven: rather than building laboratory infrastructure from scratch, Avaí Bio identifies genetically modified cell lines and cutting-edge encapsulation technology through joint ventures and licensing agreements with established biotechnology partners, most notably Austrianova — a Singapore-based firm with over 50 peer-reviewed publications and a clinically validated proprietary cell encapsulation platform called Cell-in-a-Box®.

The company currently operates two active joint venture programs. Insulinova, Inc. — formed in a 50/50 JV with Austrianova’s affiliate SGAustria Pte. Ltd. in November 2025 — is developing a cell-based therapy for type 1 and insulin-dependent type 2 diabetes using genetically engineered insulin-producing cells protected from immune rejection by the Cell-in-a-Box® encapsulation system. Klothonova, Inc. — a second 50/50 JV with Austrianova established in October 2025 — is developing a cell-based anti-aging therapy that overexpresses α-Klotho, the so-called “longevity protein,” with the goal of sustainably restoring circulating Klotho levels to combat age-related disease across indications including Alzheimer’s, cardiovascular disease, kidney disease, and cancer. Together, these two programs position Avaí Bio at the intersection of the global diabetes market — currently valued at over $135 billion — and the longevity biotech market, valued at $9.86 billion in 2025 and projected to reach nearly $29.7 billion by 2034.

The Insulinova Diabetes Program

The scale of the diabetes problem that Insulinova is targeting is genuinely staggering. According to the International Diabetes Federation, 589 million adults globally live with diabetes today — roughly 1 in 9 people aged 20 to 79 — with projections pointing to 853 million by 2050. Type 1 diabetes and insulin-dependent type 2 diabetes are characterized by the body’s inability to produce sufficient insulin, leaving patients dependent on daily injections or insulin pump therapy for the rest of their lives. While these therapies are life-sustaining, they do not restore normal glucose regulation, require constant monitoring, and carry daily risks of dangerous blood sugar excursions. The Insulinova program is designed to address the root cause: engineering cells that behave like healthy pancreatic beta cells, producing and secreting insulin dynamically in response to blood glucose fluctuations, then encapsulating those cells so the immune system cannot destroy them.

The technical approach centers on a two-step process: first, developing or selecting a genetically modified human cell line engineered for high-efficiency insulin production and glucose-responsive secretion; second, encapsulating those cells inside the Cell-in-a-Box® system before implantation, creating what the company describes as a “bio-artificial pancreas.” Avaí Bio participated in the 15th Annual European Pancreas and Islet Transplantation Association (EPITA) Symposium in Igls, Austria, in January 2026 — one of the world’s premier gatherings for scientists and clinicians working on biological therapies for diabetes — where company representative Dr. Eva Maria Lilli Brandtner evaluated advanced cell candidates for potential inclusion in the Insulinova program. No specific clinical trial timelines or IND filing dates have been announced to date, and investors should understand the program is at an early, pre-clinical stage of development.


The Klothonova Anti-Aging Program

The α-Klotho protein was discovered in 1997 and has since become one of the most intensively studied molecules in aging biology. It functions as a master regulator of multiple physiological processes — modulating phosphate metabolism, protecting the cardiovascular system, supporting kidney function, and exerting what published research describes as broad neuroprotective effects. Critically, circulating α-Klotho levels decline sharply and consistently with age in humans, and low Klotho levels have been associated in peer-reviewed studies with arterial stiffness, vascular calcification, endothelial dysfunction, Alzheimer’s disease risk, cancer susceptibility, and significantly reduced survival — including in a 148-patient Mayo Clinic cohort study published in the Journal of the American Heart Association (cited by Avaí Bio in December 2025 communications). The therapeutic logic of the Klothonova program is straightforward: if declining Klotho is mechanistically linked to the pathologies of aging, then sustainably restoring Klotho levels using an implantable cell-based delivery system could potentially address multiple age-related diseases simultaneously.

In March 2026, Klothonova and Austrianova announced the initiation of GMP-compliant Master Cell Bank (MCB) production for the genetically modified, α-Klotho overexpressing cell line that will form the basis of the therapy. An MCB is a foundational manufacturing milestone in cell therapy development: it is a fully characterized, homogeneous bank of vials derived from a single validated clone, providing the consistent, quality-controlled cellular starting material required for all subsequent manufacturing scale-up and regulatory submissions. Establishing the MCB under GMP standards is a prerequisite for IND-enabling studies and eventual clinical trial submissions. In April 2026, Avaí Bio and Austrianova announced that Klothonova’s Chief Production Officer, Rahul Pawa, will present the program’s latest data at the Second Annual Klotho Conference in September 2026, alongside Dr. Makoto Kuro-o — the physician-scientist who originally discovered the Klotho gene. Presenting alongside the field’s founding scientist at a dedicated Klotho conference is a meaningful signal of Klothonova’s scientific credibility within the research community.

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