Latest news with #VELDONA®
Associated Press
30-04-2025
- Business
- Associated Press
Ainos Forms Partnership with ASE's Key Site to Power AI-Driven SmellTech in Semiconductor Smart Manufacturing
Expanding AI Nose's Commercial Opportunity for Smarter, Safer, and More Sustainable Factories SAN DIEGO, CALIFORNIA / ACCESS Newswire / April 30, 2025 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ('Ainos' or the 'Company'), a leader in AI-driven scent digitization, has announced it has formed a strategic partnership with ASE Chung Li ('ASECL') - a key site of Advanced Semiconductor Engineering, Inc., the world's leading provider of semiconductor assembly and test services. This new milestone expands the joint effort to power AI scent digitization in smart manufacturing. Under a legally binding Memorandum of Understanding (MOU), Ainos and ASECL aims to first optimize AI Nose for ASECL's environment, then strategize to deploy AI Nose in ASECL's operation. ASECL, a member of the ASE Group, delivers comprehensive semiconductor manufacturing services, including engineering test, package design, IC assembly, wafer probing, final test, and design manufacturing services (DMS). Unlocking a New Dimension in Smart Manufacturing Despite the growing sophistication of semiconductor fabs, airborne VOCs (volatile organic compounds) remain a largely untapped source of process insight. These compounds can subtly impact yield, equipment health, and worker safety. Ainos' AI Nose transforms VOC patterns into real-time 'Smell ID' data-enabling intelligent monitoring, predictive analytics, and ESG compliance at scale. How AI Nose Will Enhance Smart Factory Operations: 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 Follow Ainos on X, formerly known as Twitter, ( @AinosInc ) and LinkedIn to stay up-to-date. About ASE Advanced Semiconductor Engineering, Inc. (ASE), a member of ASE Technology Holding Co., Ltd. (NYSE: ASX, TAIEX: 3711) is the leading global provider of semiconductor manufacturing services in assembly and test. Alongside a broad portfolio of established assembly and test technologies, ASE is also delivering innovative VIPack™, advanced packaging, and system-in-package solutions to meet growth momentum across a broad range of end markets, including AI, automotive, 5G, high-performance computing, and more. To learn about our advances in SiP, fanout, MEMS and sensor, flip chip, and 2.5D, 3D and TSV technologies, all ultimately geared towards applications to improve lifestyle and efficiency, please visit: ASE Website, or follow ASE on LinkedIn & X: @aseglobal. Forward-Looking Statements 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 are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, our expectation that we will incur net losses for the foreseeable future; our ability to become profitable; our ability to raise additional capital to continue our product development; our ability to accurately predict our future operating results; our ability to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop; the ability to obtain and maintain regulatory approval of our product candidates; delays in completing the development and commercialization of our current and future product candidates; developing and commercializing additional products, including diagnostic testing devices; our ability to compete in the marketplace; compliance with applicable laws, regulations and tariffs, and factors described in the Risk Factors section of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise. Contact Information Feifei Shen [email protected] SOURCE: Ainos, Inc. press release
Associated Press
14-04-2025
- Business
- Associated Press
Ainos Secures TFDA Approval and IRB Clearance to Advance VELDONA Clinical Trials for HIV Oral Warts and Sjögren's Syndrome in Taiwan
Dual Trials Accelerate VELDONA® Toward Rare Disease Market Entry Bridging Strategy Aims to Fast-Track U.S. Regulatory Approvals SAN DIEGO, CALIFORNIA / ACCESS Newswire / April 14, 2025 / Ainos, Inc. (Nasdaq:AIMD, AIMDW) ('Ainos' or the 'Company'), pioneer of low-dose oral interferon therapeutics, today announced significant progress in advancing its oral interferon drug platform, VELDONA® in the rare disease space. The Taiwan Food and Drug Administration (TFDA) has approved the Company's clinical trial for human immunodeficiency virus (HIV)-related oral warts, while Institutional Review Board (IRB) clearance has been granted for its upcoming Sjögren's Syndrome (pSS) study. The upcoming Taiwan trials will be conducted using the Company's next-generation VELDONA® formulation, aiming to confirm efficacy equal to or better than previous results, as well as accelerating US and Taiwan regulatory approval and commercialization. 'The upcoming Taiwan trials using our new formulation aim to confirm efficacy equal to or better than previous results. We are also pursuing bridging consultations with both Food and Drug Administration (FDA) and TFDA. If regulators confirm alignment, we could accelerate market entry through a harmonized approval process. Our partnership with Taiwan Tanabe Seiyaku for manufacturing and market development of our pSS program further strengthens our commercialization pathway,' said Chun-Hsien (Eddy) Tsai, Chairman, President, and CEO of Ainos. 'Ainos is steadily advancing across three core growth pillars: scent digitization with AI Nose technology, AI-powered point-of-care testing powered by AI Nose, and VELDONA®. These strategic pillars form a foundation to our growth. We're executing rapidly and building momentum across the VELDONA® platform. Our ability to launch two Taiwan trials in parallel reflects our dedication to capital efficiency, operational strength and delivering innovative, patient-friendly therapies to the market,' Mr. Tsai added. 'HIV-related oral warts and primary Sjögren's Syndrome both lack effective standard treatments and impose meaningful burdens on quality of life. As an oral therapy, VELDONA® provides a convenient, non-invasive alternative to injectable interferons-especially important for chronic or immune-compromised patients. We believe our previous Phase II and III trials delivered positive results, and we see significant potential for VELDONA® in these indications,' said Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos. These studies expand Ainos' immunotherapy footprint in underserved rare disease segments, in line with the Company's previously announced development plans. TFDA Approves HIV Oral Warts Trial; Enrollment to Begin in June Ainos' planned trial, titled 'Evaluation of Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-Seropositive Subjects Receiving Combination Anti-Retroviral Therapy' (Protocol ID: 03HUHI19), will be conducted at National Taiwan University Hospital (NTUH). Oral warts are a frequent and painful complication in HIV-positive patients. According to UNAIDS, approximately 39.9 million people globally live with HIV in 2023, with 1.3 million new infections and 630,000 AIDS-related deaths reported that year. Despite prevalence, oral wart treatment remains a poorly addressed niche with limited therapeutic options. The market for managing HIV-related HPV manifestations, including oral warts, is estimated at $500-700 million globally, driven by demand for safer and more tolerable long-term treatments1. Ainos plans to begin the trial in June 2025 and targets completion in 2H 2026. Primary and secondary endpoints will evaluate the efficacy of VELDONA® plus antiretroviral therapy compared to placebo. Bestat Pharmaservices Corporation, a TFDA-accredited contract research organization (CRO), will manage the study under Good Clinical Practice (GCP) standards. IRB Clears Sjögren's Syndrome Trial; TFDA Review in Progress The planned trial, titled 'An Open-Label Study to Evaluate the Efficacy Of VELDONA® in Patients with Primary Sjögren's Syndrome' (Protocol ID: 24PSS01) received IRB approval from Taipei Medical University - Joint IRB on October 25, 2024 (Approval No.: TMU-JIRB N202408042). TFDA submission is underway, with clearance expected in August 2025. Sjögren's Syndrome is a chronic autoimmune disease affecting salivary and tear glands, with limited treatment options. According to National Center for Biotechnology Information (NCBI), the condition affects an estimated 400,000 to 3.1 million people in the U.S. alone, mostly women aged 45-55. The global market for Sjögren's Syndrome therapeutics is projected to reach about $3.3 billion by 2030, driven by rising prevalence and increasing demand for effective therapies2. The trial will take place at Shuang Ho Hospital and evaluate whether VELDONA® improves salivary flow and alleviates dryness symptoms. Secondary endpoints include ESSPRI/ESSDAI scores, symptom-specific VAS ratings, and salivary gland imaging. Ainos aims to initiate site initiation visit (SIV) and first patient first visit (FPFV) in October 2025 and targets to conclude the trial in 1H 2027. ComboTrial Consultancy Ltd, a TFDA-recognized CRO, will manage the trial. Ainos has previously completed three U.S. clinical trials evaluating VELDONA® in pSS. Results showed significant improvement in oral dryness with a favorable safety profile. VELDONA®: Transforming Immunotherapy Through Oral Delivery Harnessing nearly four decades of development, VELDONA® is Ainos' proprietary low-dose oral interferon-alpha platform, designed to activate immune responses via oromucosal delivery. The platform delivers therapeutic benefit at ultra-low doses, minimizing systemic side effects often associated with injectable interferons. By targeting rare and underserved indications, Ainos is positioning VELDONA® as a versatile, scalable solution for chronic autoimmune and infectious diseases across global markets. [1]: Market scope estimate based on various analysis of HPV/HIV co-infection treatment segments. [2]: Market Report Analytics, 'Sjogrens Syndrome Therapeutics Market CAGR Growth Drivers and Trends: Forecasts 2025-2033.' 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 Ainos' commitment to enabling AI with the ability to smell and individuals to live healthier. Ainos' 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. For more information, visit: Follow Ainos on X, formerly known as Twitter, ( @AinosInc ) and LinkedIn to stay up-to-date. Forward-Looking Statements 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 are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, our expectation that we will incur net losses for the foreseeable future; our ability to become profitable; our ability to raise additional capital to continue our product development; our ability to accurately predict our future operating results; our ability to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop; the ability to obtain and maintain regulatory approval of our product candidates; delays in completing the development and commercialization of our current and future product candidates; developing and commercializing additional products, including diagnostic testing devices; our ability to compete in the marketplace; compliance with applicable laws, regulations and tariffs, and factors described in the Risk Factors section of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise. Contact Information Feifei Shen [email protected] SOURCE: Ainos, Inc. press release
Associated Press
27-01-2025
- Business
- Associated Press
Ainos Achieves Major Breakthrough: Japan Patent Approval for VELDONA Redefines Antiviral Innovation
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 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.
