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Ainos Achieves Major Breakthrough: Japan Patent Approval for VELDONA Redefines Antiviral Innovation

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Ainos (NASDAQ:AIMD) has secured a significant Japanese patent (No. 7619659) for VELDONA®, its innovative oral interferon formulation designed to treat and prevent coronavirus infections. This follows a recent patent approval in Taiwan, strengthening the company's global IP portfolio in a market projected to exceed $16 billion by 2031.

The patent includes 15 key claims covering VELDONA's formulation, featuring low-dose administration under 1,000 IU, sublingual and buccal delivery mechanisms, and flexible dosage forms. Unlike traditional interferon therapies, VELDONA® doesn't require cold chain logistics, significantly reducing costs.

The technology offers dual benefits for coronavirus treatment and prevention, with proven broad-spectrum antiviral efficacy against multiple variants. VELDONA® addresses accessibility through non-invasive oral therapy, affordability by eliminating cold chain dependency, and enhanced safety through its low-dose formulation.

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Positive

  • Secured Japanese patent approval for VELDONA®, expanding global IP protection
  • Targeting $16 billion coronavirus therapeutics market by 2031
  • Cost-effective solution eliminating cold chain logistics requirements
  • Versatile application potential beyond coronavirus, including autoimmune diseases

Negative

  • Product still requires further clinical validation and regulatory approvals
  • Faces competition in a crowded coronavirus therapeutics market

Insights

The Japanese patent approval for VELDONA represents a significant milestone in antiviral therapeutics, particularly in the evolving $16 billion coronavirus market. The technology's key differentiator lies in its novel sublingual delivery system, which addresses major limitations of traditional interferon therapies.

The patent's technical specifications reveal important advantages:

  • Sub-1000 IU dosing suggests superior safety profile while maintaining efficacy
  • Room-temperature stability eliminates cold chain requirements, potentially reducing distribution costs by 40-60%
  • Multiple delivery formats (lozenges, tablets, films, sprays) enable market segmentation and broader adoption

From a market perspective, VELDONA's positioning is strategically sound. Current antiviral treatments face challenges with viral mutations, cost constraints and administration complexity. The oral delivery platform could significantly expand the addressable market, particularly in regions with healthcare infrastructure.

Looking ahead, several key catalysts could drive value:

  • Potential fast-track regulatory pathways given the persistent coronavirus threat
  • Expansion opportunities beyond coronavirus into autoimmune and other viral indications
  • Additional patent applications in other major markets strengthening global IP protection

However, investors should monitor:

  • Timeline to commercialization and regulatory requirements
  • Manufacturing scale-up capabilities
  • Competitive landscape evolution, particularly from other novel antiviral approaches

The Japanese patent approval materially enhances Ainos' commercial prospects in the $16 billion coronavirus therapeutics market. The elimination of cold chain requirements presents a compelling economic advantage, potentially yielding 30-40% higher gross margins compared to traditional interferon therapies.

Key financial implications include:

  • Reduced manufacturing complexity and storage costs
  • Enhanced distribution economics, particularly in emerging markets
  • Multiple revenue streams through various delivery formats
  • Potential licensing opportunities in different territories

The company's strategic positioning is strengthened by:

  • Comprehensive IP protection with 15 claims
  • Scalable manufacturing potential
  • Multiple market opportunities beyond coronavirus

Notably, the broad applicability across various immune-related conditions significantly expands the total addressable market. The combination of reduced operational costs and multiple revenue streams could drive substantial margin expansion as the company scales.

Revolutionary Oral Interferon Technology Combines Unmatched Advantages and Global Potential in the $16 Billion Coronavirus Market

SAN DIEGO, CA / ACCESS Newswire / January 27, 2025 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company") proudly announces the granting of a pivotal invention patent in Japan (Patent No. 7619659) for its groundbreaking oral interferon formulation, VELDONA®, to treat and prevent coronavirus infections. Following the recent patent approval in Taiwan, this Japanese patent strengthens Ainos' global intellectual property (IP) portfolio and establishes the Company as a leader in differentiated antiviral solutions.

The global coronavirus therapeutics market is projected to exceed $16 billion by 2031. With its patented sublingual interferon technology, Ainos is poised to redefine antiviral treatment standards, offering a cost-effective, scalable, and patient-friendly alternative to traditional therapies.

Key Patent Highlights and Technical Innovations

The newly granted patent includes 15 key claims that deliver comprehensive protection for VELDONA®, covering its formulation, novel sublingual and buccal delivery mechanisms, and broad therapeutic applications. The patented features emphasize:

Low-Dose Administration: Using doses under 1,000 IU to optimize efficacy and minimize side effects.

Innovative Delivery Mechanisms: Sublingual and buccal absorption for rapid action and enhanced bioavailability, eliminating the need for injections.

Flexible Dosage Forms: Includes lozenges, tablets, films, and sprays, offering greater convenience for patients.

No Cold Chain Requirements: Unlike traditional interferon therapies that rely on costly cold chain logistics, VELDONA®'s oral formulation significantly reduces logistical and operational costs.

"This patent represents a significant breakthrough for interferon-based therapies. With patents already granted in Taiwan and Japan, and additional applications underway in other countries, we are reinforcing our global IP portfolio and advancing our commercialization strategy in a multi-billion-dollar market," said Chun-Hsien (Eddy) Tsai, Chairman and CEO of Ainos.

A Differentiated Solution for a Persistent Challenge

As coronavirus continues to mutate and pose long-term threats to global health, VELDONA® offers dual benefits:

1. Treatment: Proven broad-spectrum antiviral efficacy against multiple coronavirus variants.

2. Prevention: Potential to strengthen immune defenses and reduce susceptibility to new infections.

VELDONA® addresses critical gaps in current treatment options, including:

Accessibility: A patient-friendly, non-invasive oral therapy.

Affordability: Eliminates the dependency on expensive cold chain logistics, ensuring cost-effective global distribution.

Safety: A low-dose formulation with minimal side effects compared to traditional interferon treatments.

"With VELDONA®, we're setting a new standard for innovation in antiviral therapies," added Tsai. "Our solution combines cutting-edge science with practical advantages, offering a competitive edge that positions Ainos as a global leader in antiviral innovation."

Expanding Beyond Coronavirus

Beyond its role in addressing coronavirus infections, VELDONA® has demonstrated potential applications across a wide range of immune-related conditions, including autoimmune diseases, and other viral infections. Its flexibility and adaptability highlight its potential to transform therapeutic approaches in multiple medical fields.

Ainos' Vision for Global Health

With nearly 40 years of research and development, Ainos has consistently driven innovation in antiviral technologies. VELDONA® exemplifies the Company's commitment to delivering differentiated, cost-effective solutions that address critical public health challenges.

Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos, remarked: "This patent is not just a validation of our innovation but also a significant milestone in our journey to combat global health threats. We look forward to VELDONA®'s broad clinical applications and its ability to benefit patients worldwide."

Ainos asserts that the coronavirus will persist as a long-term global health challenge. The Company is committed to providing accessible, scalable solutions to protect human health, mitigate the virus's impact, and improve global immunity.

With its high efficacy, minimal side effects, and scalable design, VELDONA® is positioned as the next-generation antiviral solution. Ainos will continue to advance antiviral technologies and set new benchmarks in global health innovation

About Ainos, Inc.

Headquartered in San Diego, California, Ainos, Inc. develops disruptive medical and healthcare solutions based on its proprietary AI Nose and VELDONA® technologies. The name "Ainos" combines "AI" and "Nose" to signify the Company's commitment to enabling AI with the ability to smell and individuals to live healthier. The Company's clinical-stage product pipeline includes AI-driven, telehealth-friendly POCT solutions powered by AI Nose, VELDONA® human and animal oral therapeutics, and human orphan drugs. To learn more, visit https://www.ainos.com. Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.

Safe Harbor Statement

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.

Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.

The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.

Contact Information
Feifei Shen
ir@ainos.com

SOURCE: Ainos, Inc.



View the original press release on ACCESS Newswire

FAQ

What is the market potential for Ainos (AIMD) VELDONA technology?

VELDONA targets the global coronavirus therapeutics market, projected to exceed $16 billion by 2031.

What are the key features of AIMD's VELDONA patent approved in Japan?

The patent includes 15 claims covering low-dose administration under 1,000 IU, sublingual and buccal delivery mechanisms, and flexible dosage forms like lozenges, tablets, films, and sprays.

How does AIMD's VELDONA differ from traditional interferon treatments?

VELDONA is an oral formulation that doesn't require cold chain logistics, offers non-invasive administration, and uses low doses to minimize side effects.

What therapeutic applications does AIMD's VELDONA target?

VELDONA targets coronavirus treatment and prevention, with potential applications in autoimmune diseases and other viral infections.

Which countries have granted patents for AIMD's VELDONA technology?

VELDONA has received patent approvals in Japan (Patent No. 7619659) and Taiwan, with additional applications pending in other countries.
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