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

Rhea-AI Summary

Ispire Technology (NASDAQ: ISPR) has announced a groundbreaking development in vaping safety through its joint venture IKE Tech. The company has filed the first-ever PMTA and TPMF with the FDA for a blockchain-enabled age-verification system designed for ENDS devices. The innovative BLE System-on-a-Chip requires continuous, real-time age verification for device access, achieving 100% effectiveness in preventing underage usage and demographic verification in testing.

The technology demonstrated impressive results in Human Factors Validation Study, including user error rates below 1% and 91% user satisfaction. IKE Tech has requested expedited FDA review, citing public health benefits. The submission follows a successful pre-PMTA meeting with the FDA in Q4 2024, where regulators showed openness to component-based PMTAs.

The system aims to create an FDA-authorized standard for youth prevention while maintaining adult access to reduced-risk alternatives, potentially opening new pathways for flavored vaping products.

Positive

• 100% effectiveness in preventing underage device activation and demographic verification
• First-mover advantage in blockchain-enabled age verification for vaping devices
• Potential new revenue streams from component sales and technology integration
• High user satisfaction (91%) and low error rates (<1%) in validation studies
• Possible expansion of regulatory pathways for flavored vaping products

Negative

• FDA approval not guaranteed despite innovative technology
• Implementation timeline and regulatory review period uncertain
• Success dependent on industry-wide adoption of the technology

Ispire's Strategic Investment in IKE Tech Positions Company at Forefront of Vapor Innovation, Youth Prevention and Regulatory Readiness

LOS ANGELES, May 1, 2025 /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 Relations
Sherry Zheng
718.213.7386
ir@ispiretechnology.com

KCSA Strategic Communications

Phil Carlson
212.896.1233
ispire@kcsa.com

PR Contact:

Ellen Mellody
570.209.2947
EMellody@kcsa.com

 

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SOURCE Ispire Technology Inc.

FAQ

What is Ispire Technology's (ISPR) new blockchain-powered age verification system?

It's a Bluetooth Low Energy System-on-a-Chip that provides continuous, real-time age verification for ENDS devices, achieving 100% effectiveness in preventing underage usage through blockchain technology.

How effective is ISPR's age verification system in preventing underage vaping?

The system demonstrated 100% effectiveness in preventing device activation by underage users and 100% accuracy in demographic verification during Human Factors Validation Study.

What are the key features of Ispire's PMTA filing for its age-gating system?

The filing includes a blockchain-enabled age verification component, clinical protocols for peer review, and demonstrated results of <1% user error rates and 91% user satisfaction in testing.

How could this technology impact Ispire's (ISPR) business opportunities?

The technology could create new revenue streams through component sales and integration rights, while potentially opening regulatory pathways for flavored vaping products and global market expansion.

When did Ispire Technology meet with the FDA regarding their age verification system?

Ispire held a pre-PMTA meeting with the FDA in Q4 2024, where regulators confirmed willingness to evaluate component-based PMTAs and encouraged cross-center guidance.