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Ispire Technology Advances Vapor Safety and Compliance With First-Ever FDA PMTA Filing for Blockchain-Powered Age-Gating System

1. Ispire partnered with IKE Tech to submit a PMTA to the FDA. 2. The PMTA includes a blockchain-enabled age verification system for vaping devices. 3. Success in PMTA could enhance Ispire's market position and regulatory pathway. 4. User validation studies showed 100% effectiveness against underage access. 5. Ispire aims to redefine vaping safety and unlock new revenue opportunities.

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Why Bullish?

The PMTA submission positions ISPR at the forefront of compliance and innovation in vaping. Historical context shows that successful regulatory submissions often lead to market expansion, as seen with other biotech firms after FDA approvals.

How important is it?

The article highlights a major advancement in Ispire's regulatory strategy, which is foundational to their business model. Such innovations are likely to resonate well with investors focused on growth potential in the vaping sector.

Why Long Term?

While initial market reactions may vary, the long-term trajectory will be influenced by regulatory approvals and subsequent sales of products utilizing the new technology. Similar developments in the vaping industry post-FDA approvals have led to sustained growth.

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Ispire's Strategic Investment in IKE Tech Positions Company at Forefront of Vapor Innovation, Youth Prevention and Regulatory Readiness , /PRNewswire/ --  Ispire Technology Inc. ("Ispire" or the "Company") (NASDAQ: ISPR), a trailblazer in vaping technology and precision dosing, announced that IKE Tech LLC ("IKE Tech"), a joint venture that includes Ispire as a founding partner, has filed a component Pre-Market Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the U.S. Food and Drug Administration (FDA) for its Bluetooth Low Energy (BLE) System-on-a-Chip. This filing marks a historic first: a complete PMTA submission for a standalone, interoperable, blockchain-enabled age-verification component, designed for universal integration across all Electronic Nicotine Delivery Systems (ENDS) devices. Unlike traditional systems that verify age once at purchase, IKE's platform requires continuous, real-time verification for device access, providing an unprecedented level of security against underage vaping. IKE formally requested an expedited review of the application, citing the system's potential to enhance public health. "Ispire will benefit not only from commercial sales of the component but also from the rights to integrate the technology into our own devices—positioning us to lead in regulatory-compliant innovation and unlock new revenue opportunities," said Michael Wang, co-CEO of Ispire. "This submission marks a defining moment for both the vaping industry and our mission to lead through innovation. By paving the way for FDA-authorized, interoperable age-gating technology, we're helping to redefine vapor safety, open new global regulatory pathways and create economic value for Ispire and the broader ENDS market." The IKE BLE chip, powered by blockchain technology, is a secure, interoperable, point-of-use identity and age-verification system designed to prevent unauthorized use of ENDS devices. In a multi-center Human Factors Validation Study submitted with the PMTA, the technology achieved: 100% effectiveness in preventing device activation by underage users, 100% accuracy in demographic verification, User error rates below 1%, underscoring ease of use for adults, 91% user satisfaction with app simplicity and functionality.    "We're not just building tech—we're building trust," said John Patterson, president of IKE Tech. "Our goal is to create an interoperable, FDA-authorized standard that puts youth safety first while ensuring adults retain access to reduced-risk alternatives." The PMTA filing includes plans to publish clinical protocols for peer review, reinforcing Ispire's commitment to transparency and scientific rigor. By setting a new standard for youth prevention and device security, this technology has the potential to serve as a key enabler for expanded regulatory pathways for flavored vaping products—critical to offering adult smokers more choices while maintaining youth protections. "With this submission, Ispire and IKE Tech are building a smarter, better vaping future," added Wang. "We are proud to be part of a solution that meets the highest public health standards while opening global regulatory and commercial opportunities for our partners, customers and shareholders." The submission builds on a successful pre-PMTA meeting with the FDA in Q4 2024, during which regulators confirmed their willingness to evaluate component-based PMTAs and encouraged cross-center guidance, particularly in software and data privacy areas. About IKE Tech LLC IKE Tech LLC is a joint venture comprised of three leading technology and research companies -- Ispire Technology Inc, Touch Point Worldwide Inc. d/b/a Berify, and Chemular Inc. -- dedicated to revolutionizing Identity and Age Verification (IAV) technology solutions. Recognizing the absence of a universal point-of-sale IAV solution and recognition of the need for one, these companies joined forces to create a unique IAV technology component. IKE's mission is to set the gold standard for IAV by (i) permitting access to electronic nicotine delivery systems by authorized adult users while (ii) preventing underage access through a "plug and play" component compatible across different devices and platforms.  About Ispire Technology Inc. Ispire is engaged in the research and development, design, commercialization, sales, marketing and distribution of branded e-cigarettes and cannabis vaping products. The Company's operating subsidiaries own or license more than 400 patents worldwide. Ispire's branded e-cigarette products are marketed under the Aspire name and are sold worldwide (except in the U.S., People's Republic of China and Russia) primarily through its global distribution network. The Company also engages in original design manufacture (ODM) relationships with e-cigarette brands and retailers worldwide. The Company's cannabis products are marketed under the Ispire brand name primarily on an ODM basis to other cannabis vapor companies. Ispire sells its cannabis vaping hardware in the US, Europe and South Africa and it recently commenced marketing activities and customer engagement in Canada and Latin America. For more information, visit www.ispiretechnology.com or follow Ispire on Instagram, LinkedIn, Twitter and YouTube. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act") as well as Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended, that are intended to be covered by the safe harbor created by those sections. Forward-looking statements, which are based on certain assumptions and describe the Company's future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate," "strategy," "future," "likely" or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the Company's strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the Company's actual results and financial condition to differ materially from those indicated in the forward-looking statements. Such forward-looking statements include, but are not limited to, risks and uncertainties including those regarding: the Company's ability to collect its accounts receivable in a timely manner, the Company's business strategies, the ability of the Company to market to the Ispire ONE™, Ispire ONE's success if meeting its goals, the ability of its customers to derive the anticipated benefits of the Ispire ONE™ and the success of their products on the markets; the Ispire ONE™ proving to be safe, and the risk and uncertainties described in "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Cautionary Note on Forward-Looking Statements" and the additional risk described in Ispire's Annual Report on Form 10-K for the year ended June 30, 2023 and any subsequent filings which Ispire makes with the U.S. Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in the press release relate only to events or information as of the date on which the statements are made in the press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events except as required by law. You should read this press release with the understanding that our actual future results may be materially different from what we expect. IR Contacts: For more information, kindly contact:Investor RelationsSherry Zheng718.213.7386[email protected] KCSA Strategic Communications Phil Carlson212.896.1233[email protected] PR Contact: Ellen Mellody570.209.2947[email protected] SOURCE Ispire Technology Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

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