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Ispire Technology files application with FDA for age-verification component

Ispire Technology (ISPR) Advances Vapor Safety and Compliance With First-Ever FDA PMTA Filing for Blockchain-Powered Age-Gating System Ispire’s Strategic Investment in IKE Tech Positions Company at Forefront of Vapor Innovation, Youth Prevention and Regulatory Readiness Ispire Technology announced that 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 FDA for its Bluetooth Low Energy System-on-a-Chip.This filing marks 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. IKE formally requested an expedited review of the application. 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. The submission builds on a pre-PMTA meeting with the FDA in Q4 2024, during which regulators confirmed their willingness to evaluate component-based PMTAs.

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