Vancouver, British Columbia--(Newsfile Corp. - October 24, 2024) - Ynvisible Interactive Inc. (TSXV: YNV) (FSE: 1XNA) (OTCQB: YNVYF) (the "Company" or "Ynvisible"), a leading provider of printed low-power e-paper display products, is pleased to announce that it has recently delivered more than 10,000 customized e-paper displays to a leading company in the diagnostics sector. This delivery comes as a critical step in the product commercialization process, as the displays were integrated into novel at-home medical diagnostic tests by Ynvisible's customer, and are currently under review by the Food and Drug Administration (FDA) in the United States.
Ynvisible had previously announced this collaboration with an emergent industry leader in medical devices, to develop the next generation of medical at-home testing and diagnostic solutions. The customized displays that Ynvisible developed for this application follow strict medical industry requirements. In addition, switching to Ynvisible's innovative display technology is expected to significantly increase market share over the coming years for this customer, due to the cost-effectiveness and energy efficiency of Ynvisible's e-paper displays, coupled with the advantages of roll-to-roll manufacturing.
Understanding the FDA Process
For devices like those using Ynvisible's displays, the FDA's 510(k) pathway is commonly followed. This process involves demonstrating that the device is equivalent to a legally marketed product. Preclinical tests, clinical studies, and a comprehensive review ensure the device meets FDA standards for safety and efficacy. Once submitted, the FDA generally takes around 90 days to complete the review. This step is crucial for bringing at-home medical devices like this to market.
Obtaining FDA approval for this specific diagnostics solution means that Ynvisible e-paper displays can become a standard solution for a wide range of medical and diagnostics products.
Market Growth in At-Home Diagnostics
The global market for at-home diagnostic testing is expanding rapidly. In 2023, the market was valued at USD 12.73 billion, with projections estimating it will grow to USD 22.1 billion by 2030, driven by a compound annual growth rate (CAGR) of 8.2% (https://www.maximizemarketresearch.com/market-report/at-home-testing-market/189935/).
Several factors are driving this growth, including the increasing prevalence of chronic diseases, the demand for greater convenience, and technological advancements in diagnostic tools.
The ability to conduct medical tests at home has become a priority for many consumers, especially with advancements in diagnostics like glucose monitors and infectious disease tests. The COVID-19 pandemic further accelerated this trend, with demand for home testing rising significantly. Ynvisible's e-paper displays fit perfectly into this expanding market, offering low-power, easy-to-read solutions that support the growing need for accessible, at-home medical diagnostics.
With more than 10,000 units already delivered and the FDA review process underway, Ynvisible is well-positioned to reach a significant position in this market. Ynvisible will provide updates as this project progresses and looks forward to further opportunities within the healthcare sector.
Due to confidentiality agreements, Ynvisible cannot reveal the customer's name or disclose the specific design and functionalities of the product at this time. These agreements are crucial to protecting the customer's competitive advantage, reflecting the strategic value and significance of this collaboration.
About Ynvisible
Ynvisible is disrupting the low-cost and ultra-low-power display industry thanks to the latest advantages in sustainable electronics and roll-to-roll printing production. Ynvisible's printed e-paper displays are ideal for low-power and cost-sensitive applications, such as digital signage, smart monitoring labels for supply chain and logistics, visual indicators for medical and diagnostics, or retail labels and signage. Ynvisible has experience, know-how, and intellectual property in electrochromic materials, inks, and systems, and offers a mix of services, technology and products to brand owners developing smart objects and IoT products. Additional information on Ynvisible is available at www.ynvisible.com.
ON BEHALF OF THE BOARD OF DIRECTORS
Ramin Heydarpour CEO and Executive Chairman Ynvisible Interactive Inc.
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Forward-Looking Statements
This news release contains certain statements that may be deemed "forward-looking" statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Ynvisible Interactive Inc. believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Ynvisible Interactive Inc. management on the date the statements are made. Except as required by law, Ynvisible Interactive Inc. undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
