Ispire Technology Advances Vapor Safety and Compliance With First-Ever FDA PMTA Filing for Blockchain-Powered Age-Gating System
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.Ispire Technology (NASDAQ: ISPR) ha annunciato un progresso rivoluzionario nella sicurezza del vaping attraverso la sua joint venture IKE Tech. L'azienda ha presentato la prima PMTA e TPMF mai inviata alla FDA per un sistema di verifica dell'età abilitato alla blockchain progettato per dispositivi ENDS. Il sistema innovativo BLE System-on-a-Chip richiede una verifica continua e in tempo reale dell'età per l'accesso al dispositivo, raggiungendo un 100% di efficacia nella prevenzione dell'uso da parte di minorenni e una verifica demografica durante i test.
La tecnologia ha mostrato risultati impressionanti nello Human Factors Validation Study, con tassi di errore degli utenti inferiori all'1% e una soddisfazione degli utenti del 91%. IKE Tech ha richiesto una revisione accelerata da parte della FDA, citando benefici per la salute pubblica. La presentazione segue un incontro pre-PMTA positivo con la FDA nel quarto trimestre del 2024, durante il quale i regolatori hanno mostrato apertura verso PMTA basate su componenti.
Il sistema mira a creare uno standard autorizzato dalla FDA per la prevenzione giovanile, mantenendo al contempo l'accesso degli adulti ad alternative a rischio ridotto, aprendo potenzialmente nuove opportunità per prodotti di vaping aromatizzati.
Ispire Technology (NASDAQ: ISPR) ha anunciado un avance revolucionario en la seguridad del vapeo a través de su empresa conjunta IKE Tech. La compañía ha presentado la primera PMTA y TPMF ante la FDA para un sistema de verificación de edad habilitado por blockchain diseñado para dispositivos ENDS. El innovador sistema BLE System-on-a-Chip requiere una verificación continua y en tiempo real de la edad para acceder al dispositivo, logrando un 100% de efectividad en la prevención del uso por menores y una verificación demográfica durante las pruebas.
La tecnología mostró resultados impresionantes en el Estudio de Validación de Factores Humanos, con tasas de error del usuario por debajo del 1% y un 91% de satisfacción del usuario. IKE Tech ha solicitado una revisión acelerada por parte de la FDA, citando beneficios para la salud pública. La presentación sigue a una reunión pre-PMTA exitosa con la FDA en el cuarto trimestre de 2024, donde los reguladores mostraron apertura hacia PMTAs basadas en componentes.
El sistema busca establecer un estándar autorizado por la FDA para la prevención juvenil, manteniendo al mismo tiempo el acceso de adultos a alternativas de riesgo reducido, abriendo potencialmente nuevas vías para productos de vapeo con sabor.
Ispire Technology (NASDAQ: ISPR)는 합작 회사인 IKE Tech를 통해 베이핑 안전성에 획기적인 발전을 발표했습니다. 이 회사는 ENDS 기기를 위해 설계된 블록체인 기반 연령 확인 시스템에 대해 FDA에 최초의 PMTA 및 TPMF를 제출했습니다. 혁신적인 BLE System-on-a-Chip은 기기 접근을 위해 지속적이고 실시간 연령 확인을 요구하며, 테스트에서 미성년자 사용 방지 100% 효과와 인구통계학적 확인을 달성했습니다.
이 기술은 인간 요인 검증 연구에서 사용자 오류율 1% 미만과 91% 사용자 만족도를 포함한 인상적인 결과를 보였습니다. IKE Tech는 공중 보건상의 이점을 들어 FDA에 신속 검토를 요청했습니다. 이 제출은 2024년 4분기에 FDA와 성공적인 사전 PMTA 회의를 거친 후 이루어졌으며, 규제 당국은 부품 기반 PMTA에 대해 개방적인 태도를 보였습니다.
이 시스템은 청소년 예방을 위한 FDA 승인 표준을 만들면서도 성인이 저위험 대체 제품에 접근할 수 있도록 하여, 향후 맛이 첨가된 베이핑 제품에 대한 새로운 길을 열 가능성이 있습니다.
Ispire Technology (NASDAQ : ISPR) a annoncé une avancée majeure en matière de sécurité du vapotage via sa coentreprise IKE Tech. La société a déposé la première PMTA et TPMF auprès de la FDA pour un système de vérification d'âge basé sur la blockchain conçu pour les dispositifs ENDS. Le système innovant BLE System-on-a-Chip nécessite une vérification continue et en temps réel de l'âge pour accéder à l'appareil, atteignant une efficacité de 100 % dans la prévention de l'utilisation par les mineurs et une vérification démographique lors des tests.
La technologie a montré des résultats impressionnants lors de l'étude de validation des facteurs humains, avec un taux d'erreur utilisateur inférieur à 1 % et une satisfaction utilisateur de 91 %. IKE Tech a demandé une révision accélérée par la FDA, invoquant des bénéfices pour la santé publique. Cette soumission fait suite à une réunion pré-PMTA réussie avec la FDA au quatrième trimestre 2024, où les régulateurs ont montré une ouverture envers les PMTA basées sur les composants.
Le système vise à établir une norme autorisée par la FDA pour la prévention chez les jeunes tout en maintenant l'accès des adultes à des alternatives à risque réduit, ouvrant potentiellement de nouvelles voies pour les produits de vapotage aromatisés.
Ispire Technology (NASDAQ: ISPR) hat eine bahnbrechende Entwicklung in der Sicherheit beim Vaping durch sein Joint Venture IKE Tech angekündigt. Das Unternehmen hat die erste PMTA und TPMF bei der FDA für ein blockchain-basiertes Altersverifizierungssystem für ENDS-Geräte eingereicht. Das innovative BLE System-on-a-Chip verlangt eine kontinuierliche, Echtzeit-Altersverifizierung für den Gerätezugang und erzielte in Tests eine 100%ige Wirksamkeit bei der Verhinderung von Minderjährigenutzung sowie eine demografische Verifizierung.
Die Technologie zeigte beeindruckende Ergebnisse in der Human Factors Validation Study, darunter Benutzerfehlerquoten unter 1% und eine Nutzerzufriedenheit von 91%. IKE Tech hat eine beschleunigte FDA-Prüfung beantragt und dabei gesundheitliche Vorteile für die Öffentlichkeit angeführt. Die Einreichung folgt auf ein erfolgreiches Pre-PMTA-Meeting mit der FDA im vierten Quartal 2024, bei dem die Regulierungsbehörden offen für komponentenbasierte PMTAs waren.
Das System zielt darauf ab, einen von der FDA genehmigten Standard zur Jugendschutzprävention zu schaffen und gleichzeitig Erwachsenen den Zugang zu risikoärmeren Alternativen zu ermöglichen, was potenziell neue Wege für aromatisierte Vaping-Produkte eröffnet.
- 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
- FDA approval not guaranteed despite innovative technology
- Implementation timeline and regulatory review period uncertain
- Success dependent on industry-wide adoption of the technology
Insights
Ispire's PMTA filing for blockchain age-verification technology addresses youth vaping concerns while potentially creating competitive regulatory advantage and new revenue streams.
Ispire Technology's announcement represents a groundbreaking regulatory initiative in the vaping industry. Through joint venture IKE Tech, they've submitted the first-ever component PMTA for a blockchain-powered age verification system designed for universal integration across ENDS devices. What makes this system unique is its requirement for continuous real-time verification rather than one-time age checks at purchase.
The Human Factors Validation Study results are remarkable:
This filing follows a successful pre-PMTA meeting with regulators in Q4 2024, indicating the FDA is receptive to component-based applications and willing to provide cross-center guidance. The request for expedited review could potentially accelerate the authorization timeline if regulators agree the technology offers substantial public health benefits.
If authorized, this technology could significantly influence the regulatory landscape for vaping products. The press release specifically notes its potential to enable expanded regulatory pathways for flavored products—a category that has faced severe restrictions due to youth appeal concerns. By establishing a new standard for youth prevention, Ispire is strategically positioning itself as a compliance leader while potentially creating new commercial opportunities.
Ispire's blockchain-powered verification system creates a secure, tamper-resistant age-gating solution with strong validation results and significant market potential.
The technical architecture of Ispire's age verification platform represents a significant advancement in applying blockchain technology to real-world compliance challenges. By combining Bluetooth Low Energy (BLE) System-on-a-Chip hardware with blockchain verification, IKE Tech has created a solution that addresses the persistent weakness in current age verification systems: the gap between point-of-purchase verification and ongoing device usage.
The blockchain implementation provides critical security advantages. Blockchain's inherent properties—immutability, distributed verification, and tamper-resistance—create a verification system that's exceptionally difficult to circumvent. This represents a technological leap beyond conventional age-gating mechanisms that can often be bypassed by determined users.
What's particularly noteworthy is the system's interoperability design. Rather than creating a proprietary, closed ecosystem, Ispire is developing an open standard for industry-wide adoption. This approach maximizes both regulatory impact and commercial potential.
The validation metrics demonstrate impressive technical execution:
By positioning this as a component solution rather than a standalone product, Ispire creates multiple potential implementation pathways: licensing the technology to other manufacturers, integrating it into their own devices, and potentially establishing a new compliance standard that positions them at the forefront of regulatory-ready vaping technology.
Ispire's Strategic Investment in IKE Tech Positions Company at Forefront of Vapor Innovation, Youth Prevention and Regulatory Readiness
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
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
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SOURCE Ispire Technology Inc.
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