IKE Tech LLC and Ispire Technology Inc. Announce Positive Pre-PMTA Submission Meeting with the FDA
Ispire Technology (NASDAQ: ISPR) and IKE Tech announced a successful pre-PMTA meeting with FDA's Center for Tobacco Products for their innovative Age Verification technology for electronic nicotine delivery systems (ENDS). The technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products.
IKE Tech will submit a component PMTA, which if authorized, would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete required studies in Q1 2025.
Ispire Technology (NASDAQ: ISPR) e IKE Tech hanno annunciato un incontro preliminare PMTA di successo con il Centro per i Prodotti del Tabacco della FDA riguardo la loro innovativa tecnologia di verifica dell'età per i sistemi di erogazione di nicotina elettronica (ENDS). Questa tecnologia mira a prevenire l'accesso dei giovani, mentre espande l'accesso al mercato degli adulti ai prodotti autorizzati PMTA aromatizzati.
IKE Tech presenterà una PMTA di componente, che, se autorizzata, consentirebbe ai produttori di ENDS di integrare la loro soluzione di verifica dell'età basata su blockchain. La FDA ha indicato la possibilità di una revisione prioritaria e accettazione di una PMTA di componente. L'azienda prevede di completare gli studi richiesti nel primo trimestre del 2025.
Ispire Technology (NASDAQ: ISPR) e IKE Tech anunciaron una reunión preliminar de PMTA exitosa con el Centro de Productos del Tabaco de la FDA para su innovadora tecnología de verificación de edad para sistemas de entrega de nicotina electrónicos (ENDS). La tecnología tiene como objetivo prevenir el acceso de los jóvenes mientras expande el acceso al mercado para adultos a productos autorizados por PMTA con sabor.
IKE Tech presentará un PMTA de componente, que, si se autoriza, permitiría a los fabricantes de ENDS incorporar su solución de verificación de edad basada en blockchain. La FDA indicó la posibilidad de considerar una revisión prioritaria y la aceptación de un PMTA de componente. La empresa planea completar los estudios requeridos en el primer trimestre de 2025.
Ispire Technology (NASDAQ: ISPR)와 IKE Tech는 FDA의 담배 제품 센터와 전자 니코틴 전달 시스템 (ENDS)에 대한 혁신적인 연령 확인 기술에 대한 성공적인 사전 PMTA 회의를 발표했습니다. 이 기술은 청소년의 접근을 방지하면서도 성인 시장의 향료 PMTA 승인 제품에 대한 접근을 확대하는 것을 목표로 합니다.
IKE Tech는 컴포넌트 PMTA를 제출할 예정이며, 승인될 경우 ENDS 제조사들이 블록체인 기반의 연령 게이팅 솔루션을 통합할 수 있게 됩니다. FDA는 컴포넌트 PMTA의 우선 심사 고려와 수락 가능성을 나타냈습니다. 회사는 2025년 1분기까지 필요한 연구를 완료할 계획입니다.
Ispire Technology (NASDAQ: ISPR) et IKE Tech ont annoncé une réunion pré-PMTA réussie avec le Centre des Produits du Tabac de la FDA concernant leur technologie innovante de vérification de l'âge pour les systèmes de livraison de nicotine électroniques (ENDS). Cette technologie vise à empêcher l'accès des jeunes tout en élargissant l'accès du marché des adultes aux produits autorisés PMTA aromatisés.
IKE Tech soumettra un PMTA de composant, qui, s'il est autorisé, permettrait aux fabricants d'ENDS d'incorporer leur solution de vérification de l'âge basée sur la blockchain. La FDA a indiqué une éventuelle prise en compte pour un examen prioritaire et l'acceptation d'un PMTA de composant. L'entreprise prévoit de compléter les études requises au premier trimestre 2025.
Ispire Technology (NASDAQ: ISPR) und IKE Tech haben ein erfolgreiches vorläufiges PMTA-Treffen mit dem Zentrum für Tabakprodukte der FDA für ihre innovative Altersverifizierungstechnologie für elektronische Nikotinzustellsysteme (ENDS) angekündigt. Die Technologie zielt darauf ab, den Zugang von Jugendlichen zu verhindern, während sie den Zugang für Erwachsene zu aromatisierten, PMTA-autorisierten Produkten erweitert.
IKE Tech wird eine Komponenten-PMTA einreichen, die, falls genehmigt, es ENDS-Herstellern ermöglichen würde, ihre blockchain-basierte Altersverifizierungslösung zu integrieren. Die FDA hat eine mögliche vorrangige Überprüfung und Annahme einer Komponenten-PMTA in Aussicht gestellt. Das Unternehmen plant, die erforderlichen Studien im ersten Quartal 2025 abzuschließen.
- FDA's positive indication for priority review consideration
- Potential for component PMTA approval enabling wider industry adoption
- Technology could unlock new market opportunities in flavored ENDS products
- Innovation could provide competitive advantage in regulatory compliance
- Studies and PMTA completion not expected until Q1 2025
- Final FDA authorization still pending and not guaranteed
- Success depends on meeting all statutory requirements
Insights
This pre-PMTA meeting represents a significant regulatory breakthrough for Ispire and the broader ENDS industry. The FDA's willingness to consider a component PMTA and potential priority review signals a positive shift in regulatory approach. The key innovation lies in the point-of-use age verification system that could become an industry standard, potentially unlocking the currently restricted flavored ENDS market.
The blockchain-based verification system addresses one of FDA's primary concerns - youth access to vaping products. If authorized, this technology could create substantial market opportunities by enabling other manufacturers to incorporate the system through the Tobacco Product Master File pathway. The Q1 2025 timeline for completing required studies suggests potential market implementation by late 2025, assuming standard FDA review timelines.
The blockchain-based identity verification system represents a novel technological solution to a complex regulatory challenge. By creating a universal, plug-and-play age-gating solution, IKE Tech is positioning itself as a potential infrastructure provider for the entire ENDS industry. This approach could create significant recurring revenue streams through licensing and implementation fees.
The technology's design as a component rather than a finished product is strategically brilliant, as it allows for wider adoption across different manufacturers and devices. The creation of a Tobacco Product Master File further strengthens the company's potential market position as a critical technology provider in the
Seeks Authorization for Pioneering Point-of-Use Identity and Age Verification Technology to Reduce Youth Access and Expand the Adult Market for Reduced-Risk Vapor Products
This critical regulatory milestone marks an important step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products. The IKE Tech Identity and Age Verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage.
IKE Tech's age-gating technology seeks to provide and support a platform for the introduction of additional PMTA approved characterizing flavors for ENDS products; assisting adult smokers seeking a transition from combustible cigarettes to reduced-risk flavored vapor alternatives. Due to its innovative design, reliance on blockchain technology, and partnership with leading Identify and Age Verification providers, the IKE Tech system is an advanced component that could be used -- in any ENDS device -- to ensure only authorized adult users can access vaping products.
FDA Alignment on Key Points:
- Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
- Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.
IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.
"Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire's mission," said Michael Wang, Co-CEO of Ispire. "We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer vaping products."
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
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
View original content:https://www.prnewswire.com/news-releases/ike-tech-llc-and-ispire-technology-inc-announce-positive-pre-pmta-submission-meeting-with-the-fda-302307753.html
SOURCE Ispire Technology Inc.
FAQ
What is the status of Ispire Technology's (ISPR) PMTA submission for age verification technology?
How does ISPR's age verification technology work for ENDS devices?
When will Ispire Technology (ISPR) complete the required PMTA studies?
What are the potential benefits of ISPR's age verification technology for ENDS manufacturers?
