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Ainos Unveils Critical Progress in Ainos Flora Clinical Trials and Next-Gen Plans Powered by NVIDIA CUDA

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Ainos announces significant progress in the clinical trials of its AI Nose-powered Ainos Flora device, designed for rapid, non-invasive detection of bacterial, fungal, and common sexually transmitted infections in women. The trials, conducted at four major medical centers in Taiwan, successfully tested 75 cases, validating the AI algorithm's accuracy through real-world data incorporation and comprehensive data standardization.

Building on current trial success, Ainos aims to develop a next-gen Ainos Flora with NVIDIA CUDA, targeting Q3 for design completion and Q4 for clinical trials. The new device will feature improvements for at-home testing, addressing growing demand for decentralized healthcare solutions. The STI testing market is projected to reach $256 billion by 2028, with POCT accounting for 31%.

Ainos' ongoing innovation in AI and medical technology is supported by over 50 patents. The Ainos Flora device won the 2021 iF's Medicine/Health Design Award, highlighting its effectiveness and user-friendly design for home healthcare.

Positive
  • Successful trial of 75 cases validating AI algorithm's accuracy.
  • Development of next-gen Ainos Flora with NVIDIA CUDA accelerating deep learning.
  • Projected STI testing market to reach $256 billion by 2028.
  • Growing demand for at-home decentralized healthcare solutions.
  • Over 50 approved and pending patents supporting innovation.
  • 2021 iF's Medicine/Health Design Award for Ainos Flora device.
Negative
  • Upcoming clinical trials in Q4 could face delays.
  • Emerging competition in AI-driven POCT market.

Insights

The recent announcement from Ainos regarding the clinical progress and upcoming plans for Ainos Flora, their AI-powered point-of-care testing (POCT) device, has a notable impact on the company's financial outlook. The successful clinical trials of Ainos Flora at four major medical centers in Taiwan, with 75 meaningful case results, solidify the device's clinical validity. This progress is important as it lays a strong foundation for the device's next development phase, potentially expanding its market reach.

The decision to integrate NVIDIA's CUDA platform for deep learning acceleration is likely to speed up the development of the second-generation Ainos Flora device. This technical advancement can significantly reduce the time-to-market, which is essential for capturing market share in the rapidly growing home healthcare sector.

The growing STI testing market, projected to reach US $256 billion by 2028, with POCT accounting for about 31%, presents a substantial revenue opportunity for Ainos. The company's focus on a telehealth-friendly, rapid and user-friendly testing solution aligns well with current market trends, suggesting a strong potential for revenue growth. However, investors should remain cautious of any delays in the completion of software and hardware design scheduled for Q3 and the commencement of new clinical trials planned for Q4, as these milestones are critical for maintaining investor confidence and ensuring timely market entry.

From a medical research perspective, the progress reported in the clinical trials of the Ainos Flora device is substantial. The ability of the AI Nose technology to provide rapid and non-invasive detection of bacterial, fungal and sexually transmitted infections (STIs) offers a significant advancement in women’s health diagnostics. The trials have demonstrated improved recognition accuracy by incorporating more real-world data into the AI model, enhancing reliability with advanced pre-processing data and environmental correction algorithms. This ensures the device's performance is consistent across various conditions, which is critical for clinical adoption.

The planned integration of CUDA for deep learning acceleration is expected to further refine the AI algorithms, enabling faster and more accurate diagnostics. This technological enhancement is particularly important for at-home testing, where ease of use and quick results are paramount.

The emphasis on decentralized healthcare solutions aligns with the increasing demand for home healthcare, allowing patients to manage their health more proactively and reducing the burden on traditional healthcare facilities. This not only supports efficient healthcare delivery but also meets the growing consumer preference for telehealth services.

Incorporating NVIDIA CUDA technology into the next-generation Ainos Flora device marks a significant technological advancement. CUDA is a parallel computing platform and programming model that leverages graphical processing units (GPUs) for general computing. This integration will accelerate the training of deep learning models, enhancing the device's AI capabilities. Faster model training means quicker iteration and improvement of the AI algorithms, leading to more accurate and reliable diagnostics.

This technological leap is particularly relevant in the context of home healthcare, where rapid and precise diagnostics are crucial. The ability to deliver high-performance computing power in a compact, user-friendly device for home use represents a significant innovation. This not only benefits end-users but also positions Ainos Flora as a cutting-edge product in a competitive market.

Additionally, the potential to expand the test portfolio to include viral infections opens new avenues for the device's application, broadening its market appeal and utility. This versatility is likely to attract a wider user base, further driving adoption and market penetration.

Clinical trials for AI Nose-powered Ainos Flora device moves forward with 75 meaningful case results, paving the way for next-gen product targeting at-home testing

Next-Gen Ainos Flora will advance with NVIDIA CUDA, targeting Q3 for design completion and Q4 for clinical trial kickoff

SAN DIEGO, CA / ACCESSWIRE / June 14, 2024 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on novel AI-powered point-of-care testing ("POCT") and VELDONA low-dose interferon therapeutics, today announced critical progress in the clinical trials of its revolutionary "Ainos Flora" volatile organic compound ("VOC") POCT device that is based upon its transformative AI-powered digital nose ("AI Nose") technology. Designed to provide rapid, non-invasive detection of bacterial, fungal, and certain common sexually transmitted infections ("STI") in women, Ainos Flora has been in clinical trials at four major medical centers in Taiwan. The trials have successfully tested 75 clinical cases with meaningful insights, laying a solid foundation for the development of next-generation Ainos Flora.

The trials validate the effectiveness of the AI algorithm model, demonstrating improved recognition accuracy by incorporating more real-world data into the Ainos AI model. Reliability is ensured via comprehensive data standardization facilitated by advanced pre-processing data and environmental correction algorithms for overcoming individual and environmental variations. Additionally, refined software and hardware designs have optimized Ainos Flora's sensing performance and have also mitigated impact from operational environment interference.

Building upon the success of current trials and leveraging the implementation of NVIDIA CUDA, a parallel computing platform and programming model developed by NVIDIA for general computing on graphical processing units ("GPUs") to accelerate deep learning, Ainos is now developing the next generation of the Ainos Flora device, expanding the test portfolio to include viral infection. In recognition of growing demand for decentralized healthcare solutions in home healthcare, the second-generation Ainos Flora will feature improvements that allow users to obtain accurate results quickly and easily without professional medical training, further optimized for at-home testing. Software and hardware design and laboratory testing are expected to be completed by the third quarter of this year, with clinical trials planned to commence in the fourth quarter.

"I believe vaginal health and STI testing are currently massively underserved. Studies show vaginal infection increases risk of STI. Early STIs often have little or no symptoms, but they are still infectious. In the US, 15-24-year-olds account for roughly half of new STI cases and about 15.9 million STI tests were conducted per year in clinical setting. The public needs a telehealth-friendly, rapid, convenient, multi-use test solution to enable routine screening for vaginal health and STI. Ainos Flora is uniquely positioned to fill this unmet need. The STI testing market is projected to be US$256 billion by 2028. POCT accounts for just about 31% of the total STI testing market. We are therefore implementing CUDA to accelerate development," Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and CEO of Ainos, commented.

The Company's ongoing efforts to synergistically unite advanced deep learning algorithms with medical devices demonstrate Ainos' relentless commitment to innovation in AI and medical technology. With over 50 approved and pending patents, Ainos is pioneering the AI Nose technology by seamlessly integrating AI deep learning with digital nose sensors for a new generation of rapid diagnostic tools designed for early, convenient and telehealth-friendly disease diagnosis and health monitoring. This technology has become a core growth driver for the Company, whose name is a fusion of the words "AI" and "Nose". The AI Nose technology platform uses an array of digital nose sensors to identify VOC signals in gases. By utilizing NVIDIA CUDA, Ainos is positioned to accelerate deep learning model training further, delivering faster and more convenient medical services.

The Company's flagship VOC POCT device, Ainos Flora, won the 2021 iF's Medicine/Health Design Award. This compact, non-invasive device collects VOC samples near the patient's genital area, offering a rapid, private, and user-friendly testing experience. This technology not only aids in swift diagnosis and treatment by healthcare professionals but also empowers individuals to manage their health proactively through remote self-monitoring.

Tsai added, "We are witnessing a rapid increase in demand for home healthcare as we believe the industry shifts from traditional hospital and clinical diagnosis to innovative solutions incorporating AI-enabled medical devices, telehealth services, and cloud applications. In response to this evolving landscape, we are driving forward our cutting-edge AI Nose-powered POCT solutions like Ainos Flora to stay at the forefront of this transformation. We are dedicated to making medical diagnostics more accessible and user-friendly with our extensive expertise and trusted experiences, and we are confident that Ainos will play a pivotal role in the telehealth and AI-driven future of healthcare."

About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and VELDONA low-dose interferon therapeutics. The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.

The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. 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.

Investor Relations Contact

Feifei Shen
Email: IR@ainos.com

SOURCE: Ainos, Inc.



View the original press release on accesswire.com

FAQ

What progress has Ainos made in its clinical trials for the Ainos Flora device?

Ainos has successfully tested 75 clinical cases, validating the AI algorithm's accuracy and laying a solid foundation for the next-gen Ainos Flora.

When does Ainos plan to complete the design of the next-gen Ainos Flora?

Ainos targets Q3 for the design completion of the next-gen Ainos Flora device.

When are the clinical trials for the next-gen Ainos Flora expected to begin?

The clinical trials for the next-gen Ainos Flora are planned to commence in Q4.

What technology is Ainos leveraging for the next-gen Ainos Flora development?

Ainos is using NVIDIA CUDA to accelerate deep learning in the development of the next-gen Ainos Flora.

How is the Ainos Flora device designed to benefit users?

The Ainos Flora device provides rapid, non-invasive detection of bacterial, fungal, and common sexually transmitted infections, optimized for at-home testing.

Ainos, Inc.

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