Latest news with #ENDS
Associated Press
6 days ago
- Business
- Associated Press
IKE Tech's PMTA for First-Ever Standalone Age-Gating System at Point of Use Accepted for FDA Review Just One Month After Submission
The organization's blockchain technology is set to redefine public health safeguards and help end youth vaping for good. LOS ANGELES, June 4, 2025 /PRNewswire/ -- IKE Tech LLC ('IKE Tech'), a leading innovator at the intersection of Internet of Things (IoT), identity verification, and tokenization technology, has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its Premarket Tobacco Product Application (PMTA), just one month after submission on April 26. This marks the first time the FDA has proceeded with a PMTA for a standalone, interoperable age-gating component providing real-time age verification at the point of use for electronic nicotine delivery systems (ENDS). Potentially compatible with all ENDS devices, the IKE system integrates a Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled IKE Mobile Application, enabling secure, continuous age and identity verification. In a multi-center Human Factors Validation Study, submitted with the PMTA, 0% of underage users were able to activate a device, showcasing the reliability of IKE Tech's blockchain-based technology in safeguarding public health. Receipt of the FDA's Acceptance letter confirms that the IKE Tech PMTA meets regulatory requirements to be accepted and moves the application into the FDA's filing review phase. John Patterson, President of IKE Tech, said: 'Receiving the Acceptance Review letter from the FDA faster than most applications is a major milestone for IKE Tech and a promising step forward for public health in the ENDS category. By leveraging Bluetooth, biometrics, and blockchain, we're unlocking a new era of vaping – one that gives regulators and manufacturers the power to lock out youth and ensure adult-only access. We're proud to be leading the way with a secure, scalable solution that could become the new baseline for responsible product access in the US and beyond.' – ENDS – Notes to Editors: Human Factors Study Design and Key Results Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric activation. Key performance highlights: Devices could only be activated after successfully passing the age-gating process. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error and prevent underage access. About IKE Tech IKE Tech LLC ('IKE Tech') is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products. A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products. IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good. Media contact [email protected] View original content: SOURCE IKE Tech LLC
Yahoo
6 days ago
- Business
- Yahoo
IKE Tech's PMTA for First-Ever Standalone Age-Gating System at Point of Use Accepted for FDA Review Just One Month After Submission
The organization's blockchain technology is set to redefine public health safeguards and help end youth vaping for good. LOS ANGELES, June 4, 2025 /PRNewswire/ -- IKE Tech LLC ("IKE Tech"), a leading innovator at the intersection of Internet of Things (IoT), identity verification, and tokenization technology, has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its Premarket Tobacco Product Application (PMTA), just one month after submission on April 26. This marks the first time the FDA has proceeded with a PMTA for a standalone, interoperable age-gating component providing real-time age verification at the point of use for electronic nicotine delivery systems (ENDS). Potentially compatible with all ENDS devices, the IKE system integrates a Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled IKE Mobile Application, enabling secure, continuous age and identity verification. In a multi-center Human Factors Validation Study, submitted with the PMTA, 0% of underage users were able to activate a device, showcasing the reliability of IKE Tech's blockchain-based technology in safeguarding public health. Receipt of the FDA's Acceptance letter confirms that the IKE Tech PMTA meets regulatory requirements to be accepted and moves the application into the FDA's filing review phase. John Patterson, President of IKE Tech, said: "Receiving the Acceptance Review letter from the FDA faster than most applications is a major milestone for IKE Tech and a promising step forward for public health in the ENDS category. By leveraging Bluetooth, biometrics, and blockchain, we're unlocking a new era of vaping – one that gives regulators and manufacturers the power to lock out youth and ensure adult-only access. We're proud to be leading the way with a secure, scalable solution that could become the new baseline for responsible product access in the US and beyond." – ENDS – Notes to Editors: Human Factors Study Design and Key Results Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric activation. Key performance highlights: 100% of users (n=101) successfully completed age verification 0% of underage users were able to activate a device 100% of devices deactivated after set period of inactivity or loss of Bluetooth signal 91% rated the app "Extremely Easy" or "Very Easy" to use Errors occurred in only 1% of task attempts Devices could only be activated after successfully passing the age-gating process. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error and prevent underage access. About IKE Tech IKE Tech LLC ("IKE Tech") is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products. A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products. IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good. Media contactiketech@ View original content: SOURCE IKE Tech LLC Sign in to access your portfolio
Associated Press
7 days ago
- Business
- Associated Press
Ispire-Backed IKE Tech to Present 7th Annual Next Generation Nicotine Delivery USA Conference
Conference Attendance Follows Groundbreaking FDA PMTA Filing for Blockchain-Powered Age-Gating System LOS ANGELES, June 3, 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, will showcase their technology at the 7th Annual Next Generation Nicotine Delivery USA at the Hyatt Regency in Miami from June 4-5th. This event convenes key business leaders from the FDA, the ENDS (Electronic Nicotine Delivery Systems) sector, and the tobacco industry across the U.S. market to explore strategies for legal compliance and commercial success. The announcement comes on the heels of IKE Tech's historic milestone, in which the joint venture 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. IKE Tech has now received an Acceptance Review letter from the FDA, confirming that their PMTA meets regulatory requirements to be accepted, and moves the application into the FDA's filing review phase. This marked the first-ever complete PMTA submission for a standalone, interoperable, blockchain-enabled age-verification component designed for universal integration across all ENDS devices. Unlike traditional systems that verify age only at the point of purchase, IKE Tech's platform requires continuous, real-time identity verification, offering an unprecedented level of security against underage vaping. IKE has formally requested expedited review of the application, citing its potential to significantly enhance public health. At the conference, John Patterson, senior vice president of International Nicotine at Ispire and president of IKE Tech, will speak on a panel titled " Technology to End Youth Vaping for Electronic Nicotine Delivery Systems,' scheduled for Wednesday, June 4, at 2:00 p.m. In his capacity as President of IKE Tech, Patterson will discuss: To schedule a meeting with John Patterson or other Ispire representatives, please email [email protected]. 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 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 of 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 [email protected] KCSA Strategic Communications Phil Carlson 212.896.1233 [email protected] PR Contact: Ellen Mellody 570.209.2947 [email protected] View original content: SOURCE Ispire Technology Inc.
New Indian Express
03-06-2025
- New Indian Express
Kohli co-owned pub one-8 booked for COTPA violations
'A team of policemen attached to the Cubbon Park police stations visited all the pubs and restaurants in their jurisdiction and found 12 of them did not have designated smoking zones. The checks were made on Thursday and Friday late evening at Grant Circle, Vittal Mallya Road, UB City, Kasturba Road, Church Street, St Marks Road and Lavelle Road,' said an officer. FIRs have been registered against the manager and staff. As per the rules, if restaurants, hotels or pubs have a seating capacity of more than 30, then it is mandated to have a designated smoking zone. Even airports must compulsorily have designated smoking zones. In July, last year, the police had registered an FIR against the manager of One8 Commune for reportedly keeping the pub open beyond the permissible time limit. One8 Commune restaurant was started in December 2023, in Bengaluru. It is located on the sixth floor of the Rathnam's Complex on Kasturba Road in the vicinity of Chinnaswamy Cricket Stadium. It may be recalled that from May 27 to June 2, the city police intensified the enforcement of COTPA, 2003. The police gave special focus to enforcing the ban on Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes and vaping devices. Surprise inspections were conducted at malls, coffee bars, and shops to check for violations related to having a designated smoking zone.
Associated Press
01-05-2025
- Business
- Associated Press
IKE Tech Files First-Ever PMTA for Standalone Interoperable Blockchain-based Age-Gating System at Point of Use - Marking a New Chapter in Youth Vaping Prevention
LOS ANGELES, May 1, 2025 /PRNewswire/ -- IKE Tech LLC('IKE Tech'), a leading innovator in the intersection of Internet of Things (IoT), identity verification (IDV) and tokenization technology, announced today that it has filed a component Premarket Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the US Food and Drug Administration (FDA) for its blockchain-based Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled identity and age-verification IKE Mobile Application. This marks the first ever complete PMTA submission for a standalone, scalable age-gating component that provides real-time continuous age verification at the point-of-use for electronic nicotine delivery systems (ENDS). The IKE System is designed for universal integration across all ENDS devices, utilizing unique blockchain-based tokenization technology to further ensure user privacy and security. According to a multi-center Human Factors Validation Study submitted as part of the PMTA, the IKE system proved to be 100% effective in preventing device activation for anyone under the age of 21. The company has formally requested expedited review of its application, emphasizing the system's potential to enhance public health. 'This is a major milestone for IKE Tech and the ENDS category', commented John Patterson, President of IKE Tech. 'We're not just building technology. We're paving a new regulatory framework that gives the FDA and manufacturers powerful tools to safeguard public health and ensure adult-only access to vaping products. With proven, scalable age-gating technology built into ENDS devices, the sector now has a real opportunity to eliminate underage vaping for good'. One chip, every device: unlocking new era of vaping IKE Tech adopted a rigorous software development lifecycle, following consultation with the FDA. The IKE platform offers a seamless identity and age verification experience via a single, user-friendly mobile app available on iOS and Android. By leveraging blockchain technology, it securely validates user's identity and age through integrated identity verification (IDV) partners, anchoring credentials to a tokenization system without storing sensitive data on user's device, nor on IKE's system, to ensure complete user privacy and security. Unlike existing solutions that allow permanent access after a single verification, IKE's system requires continuous verification to maintain device access. Human Factors Validation study showed 91% of users (aged 18 – 67) rated the app as 'Extremely Easy' or 'Very Easy' to use - with a user error rate of less than 0.8% - proving its appeal to the wider market. 'This is a pivotal moment from a regulatory perspective,' said Kevin Burd, CEO of Chemular. By embedding robust age verification at the point of use, the IKE technology enables manufacturers and regulators to confidently allow access to a broader range of products for verified adults. This approach opens the doors for responsible flavor pathways, empowering adult consumers with more choice, while maintaining the highest levels of youth protection.' Building Smarter and Better ENDS IKE Tech is dedicated to building a better, more secure future for all. To meet the evolving needs of manufacturers, the company is planning to continue integrating advanced features like counterfeit protection, geofencing, targeted messaging, and real-time data access to its systems. These innovations are designed to address underage vaping and combat the illicit market, ensuring that only products that FDA has determined are Appropriate for the Protection of Public Health (APPH) are available to adult users. To learn more about IKE Tech, visit Notes to Editors: Human Factors Study Design and Key Results Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric reactivation. Key performance highlights: Devices could only be reactivated with biometric authentication. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error, prevent underage access, and provide a user-friendly experience for adults. About IKE Tech IKE Tech LLC ('IKE Tech') is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products. A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products. IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good. View original content: SOURCE IKE Tech LLC
