Avant Technologies News

Avaí Bio and Austrianova to Present Latest Data on Klotho Anti-Aging Therapy at Annual Klotho Conference

Tue, 07 Apr 2026 08:00

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

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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Avaí Bio and Austrianova Begin Production of Master Cell Bank for Klotho Anti-Aging Therapy Under GMP Standards

Tue, 03 Mar 2026 08:30

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.

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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Avaí Bio and Austrianova Begin Production of Master Cell Bank for Klotho Anti-Aging Therapy Under GMP Standards

Tue, 03 Mar 2026 08:30

About Avaí Bio, Inc.

About Austrianova (SGAustria Pte. Ltd.)

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

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

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Avant Technologies Completes Rebranding with Name Change to Avaí Bio and Launch of New Website

Wed, 11 Feb 2026 08:43

LAS VEGAS, Feb. 11, 2026 /PRNewswire/ -- Avant Technologies, Inc. (OTCQB: AVAI) ("Avaí" or the "Company"), an emerging biotechnology company focused on developing cell-based therapies for diabetes and age-related disorders, today announced the completion of its corporate name change to Avaí Bio, Inc. (OTCQB:AVAI). The rebranding, effective today, February 11, 2026, reflects the Company's sharpened focus on advancing transformative treatments for type 1 and insulin-dependent type 2 diabetes, age-related diseases, and healthy longevity through genetically modified cellular platforms and protective encapsulation technologies.

The Company's common stock will continue trading under the ticker symbol AVAI on OTC Markets, with no change to the CUSIP number. Shareholders, partners, and investors can now access the updated corporate identity and comprehensive pipeline details at the new website: https://www.avaibio.com.

"This name change marks a defining moment in our evolution from a technology-focused entity to a dedicated biotechnology innovator at the forefront of cellular medicine," said Chris Winter, CEO of Avaí Bio. "Avaí Bio better captures our mission to deliver life-changing therapies that address unmet needs in diabetes management, age-related diseases, and anti-aging. By leveraging genetically engineered cell lines, state-of-the-art encapsulation to shield cells from immune rejection, and strategic joint ventures, we are positioned to accelerate progress toward functional cures and extended healthy lifespans."

Key elements of Avaí Bio's pipeline include:

Diabetes Development Program: Genetically modified cell lines engineered to produce, store, and secrete insulin, combined with proprietary encapsulation for immune protection—aiming to provide a sustainable, immunosuppression-free solution for type 1 and insulin-dependent type 2 diabetes.

α-Klotho Development Program: Advancement of a "longevity protein" overexpression cell line to combat age-related decline, targeting broader anti-aging and chronic disease applications.

Strategic collaborations, including the formation of Insulinova (diabetes program) and Klothonova (α-Klotho program) to drive clinical translation through joint research, licensing, and encapsulation expertise.

By rebranding to Avaí Bio, the Company aligns its corporate identity with its core operations in sourcing, developing, and protecting advanced cellular therapies—positioning it to attract top-tier partnerships, accelerate R&D, and bring groundbreaking treatments closer to patients.

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

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

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Avai Bio Evaluating Advanced Cells for Diabetes Therapy at 15th Annual EPITA Symposium

Mon, 26 Jan 2026 08:30

LAS VEGAS, Jan. 26, 2026 /PRNewswire/ -- Avai Bio, Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging biotechnology company focused on developing cell-based therapies for diabetes and age-related disorders, today announced its participation in the 15th European Pancreas and Islet Transplantation Association (EPITA) Symposium, held January 25-27, 2026, in Igls, Austria. As a leader in immunosuppression-free cell therapy solutions, Avai Bio is actively evaluating advanced cells for potential application in a diabetes therapy at this premier European event.

The EPITA Symposium brings together global scientists, clinicians, and industry leaders to advance biological therapies for diabetes, including islet transplantation and beta cell replacement. EPITA stands as one of the world's flagship associations for networking on these critical topics, fostering collaboration to make therapies widely available.

Dr. Eva Maria Lilli Brandtner, Avai Bio' expert representative, is assessing promising cells for inclusion with the company's Cell-in-a-Box^® technology, developed in partnership with SGAustria. This clinically proven microencapsulation platform offers a safe, side-effect-free alternative to traditional immunosuppression, protecting transplanted insulin-producing cells from immune rejection without potential risks, such as tumor formation or infections that may be associated with gene editing and/or immunosuppression.

"While stem cell-derived beta cells undoubtedly represent a breakthrough in unlimited insulin sources, immune protection still remains a key challenge," said Dr. Brandtner. "Avai Bio's Cell-in-a-Box^® technology addresses this effectively, positioning us to contribute meaningfully to beta cell replacement therapies for type 1 and insulin-dependent type 2 diabetes patients worldwide."

Avai Bio aims to strengthen its role in the community through this engagement, highlighting its innovative approach to enabling scalable, patient-friendly cell therapies.

About Avai Bio, Inc.

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

About SGAustria Pte. Ltd.

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

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

You can also follow us on social media at:
https://twitter.com/Avai BioTechAI
https://www.facebook.com/Avai BioTechAI
https://www.youtube.com/@Avai BioTechAI

Forward-Looking Statements

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

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Avai Bio Highlights the Critical Role of Cell Encapsulation Technology in Revolutionizing Diabetes Treatment

Tue, 16 Dec 2025 08:15

LAS VEGAS, Dec. 16, 2025 /PRNewswire/ -- Avai Bio, Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging biotechnology company focused on developing cell-based therapies for diabetes and age-related disorders, today highlights the essential importance of cell encapsulation technology in enabling effective, long-term treatments for type 1 and insulin-dependent type 2 diabetes. By protecting genetically modified cells that produce and secrete insulin, this innovative approach addresses key barriers to cell-based therapies, offering hope for millions of patients worldwide who rely on daily insulin injections.

Last month Avai Bio and SGAustria Pte. Ltd. (SGAustria), a leading biotechnology company specializing in clinically proven cell encapsulation, formed a groundbreaking joint venture and license agreement aimed at revolutionizing a diabetes treatment through innovative stem cells and/or other cells combined with encapsulation technologies. The partnership will lead to the creation of Insulinova, Inc., a U.S. company, to facilitate and conduct clinical trials.

According to the International Diabetes Federation (IDF), 1 in 9 adults (20-79 years) is living with diabetes, while another 4 in 10 are unaware that they have the condition. The IDF estimates that 589 million people globally live with both type 1 and insulin-dependent type 2 requiring constant management to prevent life-threatening complications. And the IDF is projecting that by 2050, approximately 853 million people will be living with diabetes—a 46% increase.

Traditional treatments, such as insulin pumps or injections, provide symptom relief but do not cure the underlying issue: the body's inability to produce sufficient insulin. Avai Bio and SGAustria's diabetes development program focuses on genetically modified cells engineered to produce, store, and secrete insulin in response to blood glucose levels, mimicking the function of healthy pancreatic beta cells.

However, historically, a major challenge in deploying these cells has been the immune system's rejection of implanted foreign material, often necessitating lifelong immunosuppressive drugs that carry significant risks. Cell encapsulation technology—like SGAustria's Cell-in-a-Box^®—overcomes this challenge by creating a protective barrier around the cells, shielding them from immune attacks while allowing nutrients, oxygen, and insulin to pass through freely. This encapsulation enables the safe, sustained delivery of insulin without the need for immunosuppression, potentially providing a functional cure for type 1 diabetes and reducing dependency on external insulin for affected type 2 patients.

Brian Salmons, Chief Executive Officer (CEO) at SGAustria, said, "Our Cell-in-a-Box® technology is a pivotal advancement for a diabetes treatment, and through our joint venture with Avai Bio, we are poised to deliver a transformative therapy. By safeguarding insulin-producing cells from immune rejection while ensuring long-term functionality, we're paving the way for a future where patients can manage diabetes without the burden of daily interventions."

Recent advancements in encapsulation devices, including Cell-in-a-Box^® have demonstrated promising results in preclinical and clinical studies. For instance, encapsulated stem cell-derived beta cells have been shown to exert glucose control in patients, resolving hypoglycemic events and enhancing overall well-being. Avai Bio and SGAustria's ongoing research builds on these breakthroughs, with secured joint venture and licensing agreements to integrate state-of-the-art encapsulation with its planned cell-based diabetes treatment. This positions the company at the forefront of developing therapies that could eliminate the burden of daily insulin management.

"Cell encapsulation is a game-changer in the field of regenerative medicine," added Chris Winter, CEO at Avai Bio. "By partnering with SGAustria, we're ensuring that any genetically modified insulin-producing cells that we develop together can thrive in the body long-term and offer the potential of restoring natural glucose control and dramatically improving patients' quality of life. This technology not only minimizes risks like immune rejection but also prevents potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies."

About Avai Bio Technologies, Inc.

About SGAustria Pte. Ltd.

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI https://www.facebook.com/Avai BioTechAI https://www.youtube.com/@Avai BioTechAI

Forward-Looking Statements

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

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

Tue, 09 Dec 2025 08:30

LAS VEGAS, Dec. 9, 2025 /PRNewswire/ -- Avai Bio, Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging biotechnology company focused on developing cell-based therapies for diabetes and age-related disorders, today announced a newly published study from the Mayo Clinic reinforces the critical role of the "longevity protein" α-Klotho in vascular health and aging. The research, appearing in the Journal of the American Heart Association, demonstrates a strong association between declining α-Klotho levels and arterial stiffness, endothelial dysfunction, vascular calcification, and significantly reduced patient survival.

The 148-patient study explained:

Low α-Klotho levels are associated with vascular calcification not only in patients with chronic kidney disease but also in the general population without CKD, highlighting its role in vascular aging.
Low α-Klotho levels are independently associated with increased mortality, regardless of age, sex, and comorbidities, suggesting that Klotho could serve as a prognostic biomarker for long-term survival.

And the study's authors concluded, "Further research is needed to unravel the mechanisms through which α-Klotho influences vascular calcification and aging, in order to identify targeted treatments that could prevent or reverse these processes."

Klothonova, a joint venture company established between Austrianova and Avai Bio, is developing a cutting-edge cell-based therapy designed to address this need by sustainably restoring circulating α-Klotho levels in patients.

The therapy utilizes genetically modified human cells that continuously produce and secrete α-Klotho. These cells are encapsulated using Austrianova's clinically validated Cell-in-a-Box^® technology, which protects the implanted cells from immune rejection while allowing long-term protein delivery.

Dr. Brian Salmons, CEO of Austrianova, said of the study, "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 our proven Cell-in-a-Box^® platform—already demonstrated as safe and effective in human cancer trials—we believe we can meaningfully elevate systemic α-Klotho levels and positively impact cardiovascular disease and other age-related conditions associated with Klotho deficiency."

Chris Winter, CEO of Avai Bio, added, "An ever-growing body of scientific literature, including this new Mayo Clinic study, confirms α-Klotho as a master regulator of aging and longevity. The age-related decline in α-Klotho is implicated in a wide range of chronic diseases that appear reversible when Klotho levels are restored. Our encapsulated cell therapy approach has the potential to be a true game-changer—not only for cardiovascular health but for healthy longevity in general."

The study's authors also expressed that low Klotho levels are linked to diabetes, peripheral arterial disease, and other age-related conditions. These conditions often precede more severe cardiovascular diseases, highlighting the importance of Klotho in maintaining vascular integrity and function. Furthermore, Klotho is recognized for its antiaging properties.

Reference: https://www.ahajournals.org/doi/10.1161/JAHA.125.043654

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

About Klothonova
Klothonova is a 50/50 joint venture between Avai Bio Technologies and Austrianova, focused on developing novel cell-based therapies utilizing the Klotho protein for age-related conditions. Headquartered in Las Vegas, Nevada, Klothonova combines expertise in genetic engineering, cell encapsulation, and therapeutic delivery to pioneer sustainable, long-acting treatments.

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

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI
https://www.linkedin.com/company/avant-technologies-ai

https://www.facebook.com/Avai BioTechAI

https://www.youtube.com/@Avai BioTechAI

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:
Avai Bio, Inc.
kkerr@avanttechnologies.com

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

Tue, 09 Dec 2025 08:30

LAS VEGAS, Dec. 9, 2025 /PRNewswire/ -- Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging biotechnology company focused on developing cell-based therapies for diabetes and age-related disorders, today announced a newly published study from the Mayo Clinic reinforces the critical role of the "longevity protein" α-Klotho in vascular health and aging. The research, appearing in the Journal of the American Heart Association, demonstrates a strong association between declining α-Klotho levels and arterial stiffness, endothelial dysfunction, vascular calcification, and significantly reduced patient survival.

The 148-patient study explained:

Low α-Klotho levels are associated with vascular calcification not only in patients with chronic kidney disease but also in the general population without CKD, highlighting its role in vascular aging.
Low α-Klotho levels are independently associated with increased mortality, regardless of age, sex, and comorbidities, suggesting that Klotho could serve as a prognostic biomarker for long-term survival.

Klothonova, a joint venture company established between Austrianova and Avant, is developing a cutting-edge cell-based therapy designed to address this need by sustainably restoring circulating α-Klotho levels in patients.

Chris Winter, CEO of Avant Technologies, added, "An ever-growing body of scientific literature, including this new Mayo Clinic study, confirms α-Klotho as a master regulator of aging and longevity. The age-related decline in α-Klotho is implicated in a wide range of chronic diseases that appear reversible when Klotho levels are restored. Our encapsulated cell therapy approach has the potential to be a true game-changer—not only for cardiovascular health but for healthy longevity in general."

Reference: https://www.ahajournals.org/doi/10.1161/JAHA.125.043654

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

About Klothonova
Klothonova is a 50/50 joint venture between Avant Technologies and Austrianova, focused on developing novel cell-based therapies utilizing the Klotho protein for age-related conditions. Headquartered in Las Vegas, Nevada, Klothonova combines expertise in genetic engineering, cell encapsulation, and therapeutic delivery to pioneer sustainable, long-acting treatments.

More information about Avant can be found at https://avanttechnologies.com

You can also follow us on social media at:

https://twitter.com/AvantTechAI
https://www.linkedin.com/company/avant-technologies-ai

https://www.facebook.com/AvantTechAI

https://www.youtube.com/@AvantTechAI

Contact:
Avant Technologies, Inc.
kkerr@avanttechnologies.com

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

Tue, 09 Dec 2025 08:00

LAS VEGAS, December 09, 2025--(BUSINESS WIRE)--Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging biotechnology company focused on developing cellbased therapies for diabetes and age-related disorders, today announced a newly published study from the Mayo Clinic reinforces the critical role of the "longevity protein" α-Klotho in vascular health and aging. The research, appearing in the Journal of the American Heart Association, demonstrates a strong association between declining α-Klotho levels and arterial stiffness, endothelial dysfunction, vascular calcification, and significantly reduced patient survival.

The 148-patient study explained:

Low α‐Klotho levels are associated with vascular calcification not only in patients with chronic kidney disease but also in the general population without CKD, highlighting its role in vascular aging.
Low α‐Klotho levels are independently associated with increased mortality, regardless of age, sex, and comorbidities, suggesting that Klotho could serve as a prognostic biomarker for longterm survival.

And the study’s authors concluded, "Further research is needed to unravel the mechanisms through which α-Klotho influences vascular calcification and aging, in order to identify targeted treatments that could prevent or reverse these processes."

The therapy utilizes genetically modified human cells that continuously produce and secrete αKlotho. These cells are encapsulated using Austrianova’s clinically validated Cell-in-a-Box^® technology, which protects the implanted cells from immune rejection while allowing long-term protein delivery.

Dr. Brian Salmons, CEO of Austrianova, said of the study, "This landmark publication by Prof. Amir Lerman’s team at Mayo Clinic provides compelling clinical evidence linking lower αKlotho levels to cardiovascular disease progression and mortality. By encapsulating α-Klothoproducing cells with our proven Cell-in-a-Box^® platform - already demonstrated as safe and effective in human cancer trials - we believe we can meaningfully elevate systemic α-Klotho levels and positively impact cardiovascular disease and other age-related conditions associated with Klotho deficiency."

Chris Winter, CEO of Avai Bio, added, "An ever-growing body of scientific literature, including this new Mayo Clinic study, confirms α-Klotho as a master regulator of aging and longevity. The age-related decline in α-Klotho is implicated in a wide range of chronic diseases that appear reversible when Klotho levels are restored. Our encapsulated cell therapy approach has the potential to be a true game-changer - not only for cardiovascular health but for healthy longevity in general."

The study’s authors also expressed that low Klotho levels are linked to diabetes, peripheral arterial disease, and other age‐related conditions. These conditions often precede more severe cardiovascular diseases, highlighting the importance of Klotho in maintaining vascular integrity and function. Furthermore, Klotho is recognized for its antiaging properties.

Reference: https://www.ahajournals.org/doi/10.1161/JAHA.125.043654

About Avai Bio

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

About Klothonova

Klothonova is a 50/50 joint venture between Avai Bio and Austrianova, focused on developing novel cell-based therapies utilizing the Klotho protein for age-related conditions. Headquartered in Las Vegas, Nevada, Klothonova combines expertise in genetic engineering, cell encapsulation, and therapeutic delivery to pioneer sustainable, long-acting treatments.

About Austrianova

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

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI
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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.

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Avai Bio Inc.
kkerr@avanttechnologies.com

Avai Bio and Austrianova Secure Exclusive License for Klotho Producing Cell Line to Advance Anti-Aging Therapies

Tue, 18 Nov 2025 08:00

LAS VEGAS, November 18, 2025--(BUSINESS WIRE)--Avai Bio, Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging biotechnology company focused on developing cellbased therapies for diabetes and age-related disorders, today announced that its 50/50 joint venture (Klothonova) with Austrianova has entered into an exclusive, worldwide License Agreement with Klothea Bio, Inc. The license agreement, effective immediately, grants Klothonova exclusive global rights to develop, manufacture, and commercialize Klothea Bio’s proprietary Klotho producing cells, encapsulated using Austrianova’s proprietary Cell-in-a-Box^® technology, for the treatment of diseases and conditions in humans and animals.

Under the terms of the agreement, Klothea Bio—a Delaware-based biotechnology company specializing in Klotho protein research and therapeutic applications—provides Klothonova access to a proprietary Klotho generating cell line.

Klotho, often referred to as the "longevity protein," has demonstrated significant potential in combating key drivers of aging such as cellular senescence and chronic inflammation. The collaboration aims to accelerate the development of regenerative and anti-aging therapies that target the cellular mechanisms underlying longevity and chronic disease, positioning Klothobased treatments at the forefront of next-generation anti-aging innovations.

Under the agreement, Klothonova will leverage this technology in conjunction with Austrianova’s proprietary Cell-in-a-Box^® encapsulation platform to encapsulate Klothea’s genetically modified cell line that overexpresses Klotho proteins. This aims to create encapsulated, implantable therapies capable of sustained, localized delivery, enhancing safety and efficacy for applications in regenerative medicine and disease prevention.

"This license represents a pivotal milestone for Klothonova and underscores Avai Bio’s commitment to transforming biotech innovation into real-world impact," said Avai Bio CEO, Chris Winter. "By combining Klothea’s cutting-edge Klotho expertise with our joint venture’s advanced cell encapsulation technology, we’re poised to pioneer therapies that could redefine healthy aging and extend quality of life for millions."

The Field of Use encompasses the treatment of a wide array of diseases and conditions, enabling Klothonova to pursue comprehensive development programs from preclinical research through commercialization. Key terms in the agreement include milestone payments tied to development and regulatory achievements, as well as royalties on net sales, ensuring aligned incentives for rapid advancement.

This agreement builds on the September 2025 formation of Klothonova as a joint venture between Avai Bio and Austrianova, which was established to focus on Klotho-based cell therapies. Since its launch in October 2025, Klothonova has initiated the preparatory work needed for GMP-manufacturing of the encapsulated Klotho-overexpressing cell line, with plans to advance into IND-enabling studies in the coming year.

About Avai Bio

About Klothonova

About Austrianova

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

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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.

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Contacts

Avai Bio, Inc.
kkerr@avanttechnologies.com

Avai Bio Signs Joint Venture to Advance Cell-Based Diabetes Treatment

Tue, 04 Nov 2025 08:00

LAS VEGAS, November 04, 2025--(BUSINESS WIRE)--Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), a Nevada-based corporation, and SGAustria Pte. Ltd. (SGAustria), a Singapore-based biotechnology company, today announced the formation of a groundbreaking Joint Venture and License Agreement aimed at revolutionizing a diabetes treatment through innovative stem cell and encapsulation technologies.

The Joint Venture will now pursue a Research Collaboration Agreement (RCA) to advance a proprietary differentiation process that efficiently converts stem cells into insulin-producing and regulating cells, forming the core of its therapy for type 1 and some insulin-dependent type 2 diabetes.

This alliance focuses on researching, developing, producing, and marketing sophisticated diabetes treatments that employ encapsulated stem cells-differentiated before, during, or after encapsulation. By integrating potential RCA-derived stem cell expertise with SGAustria’s encapsulation platform, the partners seek to deliver safe, potent, and scalable solutions for type 1 and some insulin-dependent type 2 diabetes patients globally.

The partnership will lead to the creation of Insulinova, Inc., a U.S. company, to facilitate clinical trials. SGAustria’s exclusive license, plus a future license upon successful RCA completion, equips the Joint Venture to tackle one of our most urgent health crises.

Avai Bio’s Chief Executive Officer (CEO), Chris Winter, commenting on the partnership, "We’re thrilled to join forces with SGAustria in this game-changing Joint Venture. Merging our capital and forward-thinking strategy with their advanced biotech innovations, we’re setting the stage for revolutionary diabetes therapies that have the potential to transform countless lives. This milestone represents a defining step for Avai Bio as we commit to the advancement of regenerative healthcare."

Key Contributions to the Joint Venture:

SGAustria brings to the Joint Venture its proprietary, clinically proven cell-encapsulation technology, designed to protect, isolate, store, and transport living cells. Backed by over 50 peer-reviewed publications and contracts with leading global biotechnology companies, SGAustria’s expertise in cell biology and GMP-grade manufacturing will support the development and commercialization of these treatments.

Avai Bio will provide initial funding over the next eight months to achieve established criteria relevant for an efficient, sustainable, and reproducible treatment of diabetes. Additionally, Avai Bio will leverage its resources to secure further funding to advance the Joint Venture toward a potential Phase 1 clinical trial in the United States or equivalent territory.

"SGAustria’s encapsulation platform holds tremendous promise for reshaping cell therapies, and this Joint Venture stands as proof of that potential," stated Brian Salmons, CEO of SGAustria. "Teaming up with Avai Bio and a prospective RCA partner allows us to leverage our combined capabilities to deliver cutting-edge, reliable diabetes treatments, supported by our established proficiency in GMP production and cellular science."

About Avai Bio Inc.

Avai Bio Inc. is an emerging Nevada-based technology company dedicated to advancing innovative technologies and strategic partnerships to drive value in the biotech and technology sectors.

About SGAustria Pte. Ltd.

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

You can also follow us on social media at:

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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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251104188384/en/

Contacts

Avai Bio Inc.
info@avaibio.com

Avai Bio and Austrianova Launch Klothonova, Begin Developing Age Related Cellular Therapies Using 'Longevity Protein' Klotho

Tue, 21 Oct 2025 08:00

LAS VEGAS, Oct. 21, 2025 /PRNewswire/ -- Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company") and global biotechnology firm, Austrianova, today announced the official launch of their joint venture, Klothonova LLC, and its groundbreaking Klotho development program. This initiative aims to engineer a genetically modified cell line that overexpresses the Klotho protein, paving the way for innovative cell-based therapies to combat age-related diseases such as Alzheimer's and cancer, while also advancing anti-aging and longevity treatments. By harnessing Austrianova's proprietary cell-encapsulation technology, Klothonova is positioning itself at the forefront of anti-aging biotechnology.

The program's initial phase has focused on R&D based proof of concept studies. A population of genetically modified human cells has been generated by Austrianova and shown to over-produce the Klotho protein. These cells were then successfully encapsulated in Austrianova's proprietary Cell-in-Box technology and shown to produce similar amounts of the Klotho protein to that produced by non-encapsulated cells. Although non-optimized, the encapsulated cells used in the study demonstrate quite clearly the feasibility of using encapsulated cells to continuously produce the Klotho protein.

The next stage for the program is to move forward with a proprietary GMP grade human cell clone that will be used in preclinical and eventually clinical studies. In preparation for this next stage, Austrianova is conducting routine servicing and requalification on its already ISO9001:2015 compliant, state of the art GMP isolator and facility, and preparing the necessary documentation needed for the next steps of the program. These essential steps will ensure the reproducibility and safety of the Klotho protein-producing cell lines, laying a strong foundation for producing high-quality clinical-grade therapeutics.

"The R&D level proof of concept study provides a clear rationale for the program, giving a green light to move to GMP studies. In addition, the meticulous preparations of the GMP facility at Austrianova represent a foundational milestone in bringing Klotho-based therapies to patients who need them most," said Chris Winter, CEO of Avai Bio. "By prioritizing GMP compliance from the outset, Klothonova is committed to delivering safe, effective treatments that could transform the landscape of age-related disease management."

Dr. Brian Salmons, CEO of Austrianova, added, "Once again our encapsulation technology has proven it is ideal for long term continuous production of yet another protein, in this case, Klotho. Our expertise in cell encapsulation combined with Avai Bio's innovative vision makes this joint venture uniquely positioned for success. The preparations we are undertaking today ensure that every cell we produce meets the highest standards of quality and safety, accelerating our path toward clinical trials."

This development program builds on the joint venture agreement signed in September 2025, which established Klothonova as a Nevada-based entity equally owned by Avai Bio and Austrianova's affiliate, SGAustria Pte. Ltd. The JV's focus on Klotho - a protein renowned for its anti-aging and protective effects on organs - aligns with growing market demand for cellbased therapies, projected to reach $44 billion globally¹.

https://www.biospace.com/press - releases/cell - therapy - market - size - uplifts - usd - 44 - 39 - bn - at - 22 https://www.biospace.com/press-releases/cell-therapy-market-size-uplifts-usd-44-39-bn-at-22-69-healthy-cagr-by-2034 69 - healthy - cagr - by - 2034

About Avai Bio Inc.
Avai Bio Inc. is dedicated to advancing health through strategic biotech partnerships, focusing on innovative cell-based therapies to combat chronic and age-related diseases and promote longevity.

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 Avai Bio can be found at https://avaibio.com

You can also follow us on social media at:

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Contact:
Avai Bio Inc.
info@avaibio.com

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Avai Bio and Austrianova Launch Klothonova, Begin Developing Age Related Cellular Therapies Using 'Longevity Protein' Klotho

Tue, 21 Oct 2025 08:00

https://www.biospace.com/press - releases/cell - therapy - market - size - uplifts - usd - 44 - 39 - bn - at - 22 https://www.biospace.com/press-releases/cell-therapy-market-size-uplifts-usd-44-39-bn-at-22-69-healthy-cagr-by-2034 69 - healthy - cagr - by - 2034

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 Avai Bio can be found at https://avaibio.com

You can also follow us on social media at:

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Contact:
Avai Bio Inc.
info@avaibio.com

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Avai Bio, Inc. Bolsters Strategic Vision with Targeted Biotech Partnerships for Innovative Cell-Based Therapies

Thu, 25 Sep 2025 08:00

LAS VEGAS, Sept. 25, 2025 /PRNewswire/ -- Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), today announced a pivotal evolution in its business direction, emphasizing strategic partnerships through joint ventures and licensing agreements to advance treatments for a range of chronic and age-related conditions. In alignment with this refined mission, the company has applied for a corporate name change to better reflect its focus on pioneering biotechnology collaborations aimed at enhancing better health and longevity.

This new model positions Avai Bio at the forefront of collaborative biotech innovation, identifying promising cell lines from around the globe and forging alliances with leading biotech companies, scientists, and clinicians. By partnering rather than bearing the full burden of development costs and risks, Avai Bio and its partners leverage complementary expertise and resources to accelerate the creation of groundbreaking therapies. Key areas of focus include diabetes, anti-aging, Alzheimer's disease, heart disease, cancer, kidney disease, other age-related conditions, and the promotion of longevity.

Central to Avai Bio's approach are partnerships with biotech companies specializing in genetically modified cell lines designed to perform essential functions within the body that may be deficient in patients. Additionally, the company is collaborating with a leading global cell-encapsulation technology firm to safeguard these cells during therapeutic applications, ensuring their efficacy and safety in development programs.

"Our transition to a partnership-driven model represents a transformative step for Avai Bio, enabling us to harness global innovations in cell therapy while mitigating traditional development challenges," said Chris Winter, Chief Executive Officer of Avai Bio. "By combining forces with top-tier experts, we're not just identifying diseases - we're actively developing solutions that could change lives."

Highlighting this strategy, Avai Bio's first joint venture with Ainnova Tech, Inc. integrates its advanced Vision AI platform to detect a spectrum of diseases, including diabetes-related complications, through non-invasive diagnostics. Building on this, the company's latest joint venture focuses on developing a cell line therapy that produces the Klotho protein, a key regulator in aging and disease processes. Future collaborations will expand these efforts, creating a robust pipeline to both identify and treat serious illnesses.

This unique ecosystem of joint ventures empowers Avai Bio to bridge the gap between disease detection and targeted treatment, fostering rapid advancements in personalized medicine.

About Avai Bio Inc.

Avai Bio Inc. is dedicated to advancing health through strategic biotech partnerships, focusing on innovative cell-based therapies and AI-driven diagnostics to combat chronic and age-related diseases and promote longevity.

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

You can also follow us on social media at:

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https://www.facebook.com/Avai BioTechAI

https://www.youtube.com/@Avai BioTechAI

Forward-Looking Statements

Contact:

Avai Bio Inc.
info@avaibio.com

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Avai Bio, Inc. Issues Retraction of September 24, 2025 Press Release

Wed, 24 Sep 2025 11:38

LAS VEGAS, Sept. 24, 2025 /PRNewswire/ -- Avai Bio, Inc. (OTCQB: AVAI) ('Avai Bio' or the 'Company') today announced the retraction of its press release issued on September 24, 2025, regarding a purported Joint Venture and License Agreement with Art-Islets Pte. Ltd. and Austrianova (SGAustria Pte. Ltd.).

The September 24 release contained statements that were issued in error. No binding Joint Venture or License Agreement among Avai Bio, Art-Islets, and Austrianova has been executed at this time. Accordingly, any descriptions of collaborative activities, technology contributions, or anticipated clinical development milestones contained in that release should not be relied upon.

Avai Bio regrets the confusion caused by the earlier announcement and is committed to providing only accurate and verified information to its shareholders, partners, and the public.

For future updates and accurate Company information, please visit: https://avaibio.com

Forward-Looking Statements

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and are subject to risks and uncertainties. Actual results may differ materially. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made. Avai Bio undertakes no obligation to revise or update such statements.

Contact:
Investor Relations
Avai Bio, Inc.
Email: info@avaibio.com

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Global Cell Therapy Market Size Expected to Reach $44 Billion as Demand for Regenerative Medicine Rises

Thu, 18 Sep 2025 08:45

MarketNewsUpdates News Commentary

NEW YORK, Sept. 18, 2025 /PRNewswire/ -- Cell therapy refers to a treatment that involves the use of living cells to treat diseases. The cell therapy market has been experiencing significant growth due to the rising awareness about the benefits of cell therapies. They help regenerate damaged tissues and organs. They have the potential to treat a range of conditions, such as cancer, autoimmune diseases, infectious diseases, urinary issues, spinal cord injuries, joint cartilage damage, immune system weakness, and neurological disorders. Cell therapies target only damaged tissues, reducing the chances of getting damage to other tissues. Numerous cell types are used as part of a therapy or treatment for various illnesses. The demand for cellular therapy is increasing rapidly, contributing to the growth of the market. Transplanting human cells to replace or repair damaged tissue and/or cells is known as cellular therapy (CT). Cell therapies enhance patient outcomes due to their fewer side effects. According to a report from BioSpace the global cell therapy market size was USD 5.88 billion in 2024 and is expected to reach around USD 44.39 billion by 2034, expanding at a compound annual growth rate (CAGR) of 22.69% between 2025 and 2034. The growth of the cell therapy market is driven by the increase in investments in research and development and advancements in biotechnology. Healthcare companies active in the markets this week include: Avai Bio Inc. (OTCQB: AVAI), Tempus AI, Inc. (NASDAQ: TEM), CRISPR Therapeutics (NASDAQ: CRSP), BioNTech SE (NASDAQ: BNTX), Bristol Myers Squibb Company (NYSE: BMY).

The report said: "Major Trends in the Cell Therapy Market Are: Demand for Regenerative Medicine: Patients with untreated illnesses and disorders are rapidly shifting toward regenerative medicine due to its ability to restore the functions of tissues or organs lost due to disease and injuries. Regenerative therapies can be tailored to individual patient needs. This personalization further improves treatment outcomes; Rising Prevalence of Chronic Diseases: The prevalence of chronic diseases, such as cancer, diabetes, and CVDs, is rising across the globe, which is a key factor boosting the demand for cell-based therapies. These therapies offer innovative treatment options to manage these conditions and provide long-term benefits. In addition, the rising investments in the development of targeted therapies to treat chronic diseases further contribute to market expansion; Advancements in Technology: Technological advancements significantly boost the growth of the market. Innovations in technologies like gene editing, gene modification, and viral vectors are enhancing the effectiveness of cell therapies. These technologies further accelerate the production of cell therapies and reduce production costs; and Increasing Government Support: Increasing government initiatives to support stem cell research through federal funding is considered particularly important in cell therapy."

Avai Bio, Inc. (OTCQB: AVAI) and Austrianova Sign Joint Venture, Licensing Agreement to Advance Klotho-Based Therapies - Avai Bio, Inc. ("Avai Bio" or the "Company"), a Nevada-based corporation, and Austrianova (SGAustria Pte. Ltd.), a Singapore-based biotechnology leader, today announced the formation of a Joint Venture and License Agreement to establish Klothonova, Inc., a new Nevada corporation focused on pioneering cell-based therapies utilizing encapsulated Klotho-producing cells.

Under the terms of the agreement, Klothonova will leverage Austrianova's proprietary cell-encapsulation technology to develop and commercialize treatments targeting Alzheimer's disease, heart disease, cancer, kidney disease, other age-related conditions, and longevity promotion. Austrianova, renowned for its expertise in cell biology, GMP-grade cell products, and encapsulation technologies—backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies—will contribute its intellectual property and "know-how" to the venture. Avai Bio will provide capital, along with additional resources, to support Klothonova's formation and operations.

Klothonova will operate as a 50/50 joint venture, with ownership equally split between Avai Bio and Austrianova. The company will be focusing on developing innovative treatments through the overexpression of the Klotho protein, encapsulated using Austrianova's cutting-edge technology. This exclusive license will enable Klothonova to address critical medical needs and explore longevity-enhancing solutions across global markets.

"We are thrilled to partner with Austrianova, whose world-class expertise in cell encapsulation and GMP manufacturing complements our vision for advancing transformative healthcare solutions," said Chris Winter, Chief Executive Officer (CEO) at Avai Bio. "Klothonova represents a significant step toward addressing some of the most pressing medical challenges of our time."

Austrianova's CEO, Brian Salmons, added, "This joint venture with Avai Bio allows us to combine our proprietary technologies with Avai Bio's resources to accelerate the development of Klotho-based therapies. We are excited about the potential to improve patient outcomes and promote healthier, longer lives."

Klotho is regarded as an "anti-aging" protein, known for its crucial role in modulating aging and supporting diverse physiological functions. Discovered in 1997, it is primarily produced in the kidneys and brain and has been linked to improved cognitive function, cardiovascular health, and kidney function, while also showing potential in combating age-related diseases such as Alzheimer's, cancer, and heart disease. By leveraging Klotho's therapeutic properties through advanced cell encapsulation technology, Klothonova is poised to become a leader in the biotech industry, with a mission to develop and commercialize innovative treatments that enhance quality of life and promote longevity.

Klothonova will prioritize the development of treatments for major indications, with each program independently managed to ensure focused progress. This strategic collaboration positions Klothonova to lead in the rapidly evolving field of cell-based therapeutics. CONTINUED… Read this and more news for Avai Bio at: https://finance.yahoo.com/quote/AVAI/news/

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

Renalytix plc recently announced an agreement with Tempus AI, Inc. (NASDAQ: TEM) to make kidneyintelX.dkd prognostic blood testing more widely available for eligible patients within its US network of healthcare institutions. Eligible patients have type 2 diabetes with chronic kidney disease, impacting nearly 15 million individuals in the US.

Renalytix's kidneyintelX.dkd will be the first test offered in Tempus' portfolio in the chronic kidney disease category, indicated for use as an aid in predicting level of risk (high, moderate, low) for progressive decline in kidney function in type 2 diabetes patients with diagnosed chronic kidney disease stages 1-3b.

CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, recently announced that a late-breaking oral presentation highlighting the Company's Phase 1 clinical data of its investigational CRISPR/Cas9 in vivo gene editing therapy, CTX310™, targeting angiopoietin-related protein 3 (ANGPTL3) for cardiovascular and cardiometabolic disease, will be presented at the American Heart Association (AHA) Scientific Sessions 2025, taking place November 7 – 10, 2025, in New Orleans, Louisiana. Additionally, the Company will present a poster presentation on CTX340™, its in vivo preclinical program targeting angiotensinogen (AGT) for the treatment of refractory hypertension.

The data in the abstracts and presentations are embargoed until the date and time of presentation. A copy of each presentation will be available at www.crisprtx.com once the presentation concludes.

BioNTech SE (NASDAQ: BNTX) and Bristol Myers Squibb Company (NYSE: BMY) recently presented interim data from a global randomized Phase 2 trial (NCT06449209) evaluating pumitamig (also known as BNT327 or BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer ("ES-SCLC"). The data, which are consistent with data presented at the European Lung Cancer Congress ("ELCC") 2025 from a Phase 2 trial conducted in China (NCT05844150), showed encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival. Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The data are being presented today as a late-breaker oral presentation at the IASLC 2025 World Conference on Lung Cancer ("WCLC") hosted by the International Association for the Study of Lung Cancer in Barcelona.

"Small cell lung cancer is the most aggressive type of lung cancer with rapid growth, a poor prognosis and 5-year relative survival rate of just 5% in advanced stages.1,2,3 While approximately 60-70% of patients initially respond to current standard of care treatments, most progress within months after treatment signifying an urgent need for new treatment options which improve outcomes," said John V. Heymach, M.D., Lead Investigator and Chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "The response rate and early progression free survival we are seeing in this interim analysis are encouraging and merit further investigation in a larger trial to validate pumitamig's potential to offer patients more durable anti-tumor responses relative to current standard of care."

"Every innovation we pursue starts with the needs of patients. These interim data for pumitamig presented today show encouraging signals for our science-driven approach to address two fundamental drivers of small cell lung cancer in one single molecule," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our ultimate goal is to translate science into meaningful survival benefits for many patients by overcoming some of the biggest treatment challenges, not only in small cell lung cancer but also across other difficult-to-treat solid tumors. These interim data for pumitamig represent an important step in the right direction."

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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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Avai Bio and Austrianova Sign Joint Venture, Licensing Agreement to Advance Klotho-Based Therapies

Thu, 18 Sep 2025 08:30

LAS VEGAS, Sept. 18, 2025 /PRNewswire/ -- Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), a Nevada-based corporation, and Austrianova (SGAustria Pte. Ltd.), a Singapore-based biotechnology leader, today announced the formation of a Joint Venture and License Agreement to establish Klothonova, Inc., a new Nevada corporation focused on pioneering cell-based therapies utilizing encapsulated Klotho-producing cells.

Under the terms of the agreement, Klothonova will leverage Austrianova's proprietary cellencapsulation technology to develop and commercialize treatments targeting Alzheimer's disease, heart disease, cancer, kidney disease, other age-related conditions, and longevity promotion. Austrianova, renowned for its expertise in cell biology, GMP-grade cell products, and encapsulation technologies - backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies - will contribute its intellectual property and 'know-how' to the venture. Avai Bio will provide capital, along with additional resources, to support Klothonova's formation and operations.

Klothonova will operate as a 50/50 joint venture, with ownership equally split between Avai Bio and Austrianova. The company will be focusing on developing innovative treatments through the over expression of the Klotho protein, encapsulated using Austrianova's cutting-edge technology. This exclusive license will enable Klothonova to address critical medical needs and explore longevity-enhancing solutions across global markets.

"Klothonova represents a significant step toward addressing some of the most pressing medical challenges of our time."

Klotho is regarded as an 'anti-aging' protein, known for its crucial role in modulating aging and supporting diverse physiological functions. Discovered in 1997, it is primarily produced in the kidneys and brain and has been linked to improved cognitive function, cardiovascular health, and kidney function, while also showing potential in combating age-related diseases such as Alzheimer's, cancer, and heart disease. By leveraging Klotho's therapeutic properties through advanced cell encapsulation technology, Klothonova is poised to become a leader in the biotech industry, with a mission to develop and commercialize innovative treatments that enhance quality of life and promote longevity

About Avai Bio Inc.

Avai Bio Inc. is an emerging Nevada-based technology company dedicated to advancing innovative technologies and strategic partnerships to drive value in the biotech and technology sectors.

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 peerreviewed publications and partnerships with global pharmaceutical and biotech companies.

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI

https://www.facebook.com/Avai BioTechAI

https://www.youtube.com/@Avai BioTechAI

Forward-Looking Statements

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:
Avai Bio Inc.
info@avaibio.com

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Avai Bio and Ainnova Tech Announce Enhanced Patient Recruitment Strategy Ahead of FDA Clinical Trial

Tue, 12 Aug 2025 08:00

LAS VEGAS, Aug. 12, 2025 /PRNewswire/ -- Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that Ainnova is refining its patient recruitment strategy for the Company's planned clinical trial for its Vision AI platform in the early detection of diabetic retinopathy. Ainnova will work directly with Fortrea, a globally recognized Contract Research Organization (CRO) renowned for its expertise in ophthalmology studies and medical device trials, following the guidance the Company received from its recent meeting with the U.S. Food and Drug Administration (FDA).

The planned clinical study, which will be performed in 8-10 clinical sites around the U.S., will prioritize the recruitment of approximately 1,000 multiethnic patients, with a focus on individuals living with diabetes. By targeting community clinics and primary care facilities rather than specialized ophthalmology centers, Ainnova aims to capture real-world data that reflects the diverse population affected by diabetic retinopathy. This strategic approach ensures the study aligns with the practical realities of diabetes care, providing robust and relevant data to support the Company's FDA 510(k) submission.

"We are excited to move forward with an enhanced patient recruitment process," said Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avai Bio and Ainnova to advance and commercialize Ainnova's technology portfolio. "By focusing on community clinics and targeting a multiethnic group of around 1,000 diabetic patients, we aim to ensure that our study accurately represents the diverse population affected by diabetic retinopathy.

"Working with Fortrea, an expert CRO in ophthalmology, allows us to confidently navigate this process with a partner that shares our commitment to quality and efficiency. We are getting closer to initiating a clinical study that will significantly contribute to obtaining FDA 510(k) approval and making our Vision AI platform a crucial tool in early disease detection."

Ainnova's collaboration with Fortrea underscores its commitment to conducting a rigorous and inclusive clinical study. By leveraging Fortrea's deep expertise in ophthalmology and medical device trials, Ainnova is well-positioned to deliver high-quality data to support the regulatory approval process to market Vision AI, a platform poised to transform early disease detection for diabetic patients worldwide, in the United States.

AAC has the worldwide licensing rights for Ainnova's technology portfolio. The licensing rights include the U.S., where the FDA regulates drug and medical device development, so the success of Ainnova's clinical trial is paramount to marketing the technology portfolio in the United States. Entering the U.S. market will unlock significant commercial potential, and this early engagement with the FDA ensures AAC can do so with speed, credibility, and a validated product.

About Ainnova Tech, Inc.

Ainnova is a Nevada-based healthtech startup with headquarters in San Jose, Costa Rica, and Houston, Texas. Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce Vision AI – our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions.

About Avai Bio Inc.

Avai Bio Inc. is an emerging technology company developing solutions in healthcare using artificial intelligence and biotechnologies. With a focus on pushing the boundaries of what is possible in AI and biotechnology, Avai Bio serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology.

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI
https://www.facebook.com/Avai BioTechAI
https://www.youtube.com/@Avai BioTechAI

Forward-Looking Statements

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SOURCE Avai Bio Inc.

Avai Bio and Ainnova Tech Advance Clinical Trial Protocol Following FDA Feedback

Tue, 29 Jul 2025 08:00

LAS VEGAS, July 29, 2025 /PRNewswire/ -- Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced an update on the Company's clinical trial protocol following a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA).

Following its mid-July meeting with the FDA, Ainnova has revised its clinical trial protocol with the FDA's comments in mind. The new protocol will be resubmitted for FDA review to ensure compliance, which will mitigate potential costly errors in the development process for Ainnova's planned trial for its Vision AI platform in the early detection of diabetic retinopathy.

Late last week, Ainnova's clinical development team met with Fortrea, the Company's Contract Research Organization, to present the updated protocol document. Upon approval, this protocol will pave the way for the initiation of a new clinical trial aligned with the revised guidelines.

"We are committed to meeting the highest regulatory standards, and we're confident that these protocol refinements will strengthen our path toward FDA 510(k) clearance," said Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avai Bio and Ainnova to advance and commercialize Ainnova's technology portfolio. "We anticipate finalizing the clinical trial budget soon, with estimated costs coming more into focus as we refine our protocol and navigate the process."

The company remains focused on advancing its innovative Vision AI platform to address the early detection of diabetic retinopathy, with the goal of achieving FDA 510(k) approval to obtain clearance from the FDA to market its Vision AI technology in the U.S. and deliver transformative solutions to the market.

About Ainnova Tech, Inc.
Ainnova is a Nevada-based healthtech startup with headquarters in San Jose, Costa Rica, and Houston, Texas. Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce Vision AI - our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions.

About Avai Bio Inc.
Avai Bio Inc. is an emerging technology company developing solutions in healthcare using artificial intelligence and biotechnologies. With a focus on pushing the boundaries of what is possible in AI and biotechnology, Avai Bio serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology.

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI
https://www.facebook.com/Avai BioTechAI
https://www.youtube.com/@Avai BioTechAI

Contact:
Avai Bio Inc.
info@avaibio.com

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SOURCE Avai Bio Inc.

Avai Bio and Ainnova Tech Advance Clinical Trial Protocol Following FDA Feedback

Tue, 29 Jul 2025 08:00

LAS VEGAS, July 29, 2025 /CNW/ -- Avai Bio Inc. (OTCQB: AVAI) ("Avai Bio" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced an update on the Company's clinical trial protocol following a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA).

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

You can also follow us on social media at:

https://twitter.com/Avai BioTechAI
https://www.facebook.com/Avai BioTechAI
https://www.youtube.com/@Avai BioTechAI

Contact:
Avai Bio Inc.
info@avaibio.com

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SOURCE Avai Bio Inc.

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