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IKE Tech LLC and Ispire Technology Inc. Announce Positive Pre-PMTA Submission Meeting With the FDA

IKE Tech LLC and Ispire Technology Inc. Announce Positive Pre-PMTA Submission Meeting With the FDA

IKE Tech LLC 和 Ispire Technology Inc. 宣布与 FDA 进行了积极的 Pre-PMTA 提交会议
雾麻科技 ·  2024/11/18 13:00

IKE Tech LLC and Ispire Technology Inc. Announce Positive Pre-PMTA Submission Meeting with the FDA

IKE Tech LLC 和 Ispire Technology Inc. 宣布与 FDA 举行积极的 PMTA 提交前会议


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


寻求对开创性的使用点身份和年龄验证技术的授权,以减少青少年的准入并扩大低风险蒸气产品的成人市场

Los Angeles, November 18, 2024Ispire Technology Inc. ("Ispire" or the "Company") (NASDAQ: ISPR), a trailblazer in vaping technology and precision dosing, and IKE Tech LLC ("IKE Tech"), a joint venture among three leading technology and research companies Ispire, Touch Point Worldwide d/b/a Berify and Chemular Inc., announced a successful in person pre-PMTA (Pre-Market Tobacco Product Application) submission meeting with FDA's Center for Tobacco Products (CTP) for their Age Verification technology, designed to allow adult access to electronic nicotine delivery systems (ENDS) while preventing youth access to such products at point-of-use.

洛杉矶,2024年11月18日——电子烟技术和精确剂量的开拓者Ispire Technology Inc.(“Ispire” 或 “公司”)(纳斯达克股票代码:ISPR)和由三家领先科技和研究公司Ispire、Touch Point Worldwide d/b/a Berify和Chemular Inc. 组成的合资企业IKE Tech LLC(“IKE Tech”)(“IKE Tech”),由三家领先的技术和研究公司Ispire、Touch Point Worldwide d/b/a Berify和Chemular Inc.亲自宣布,市场烟草制品(申请)提交会议 美国食品和药物管理局烟草制品中心 (CTP)的年龄验证技术旨在允许成人使用电子尼古丁输送系统(ENDS),同时防止青少年在使用点获得此类产品。

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.

这一重要的监管里程碑标志着在提供创新、安全的通用解决方案的道路上迈出了重要的一步,该解决方案旨在防止年轻人获得ENDS,并扩大选择使用经调味的PMTA授权产品的成年人的市场。IKE Tech身份和年龄验证技术为选择使用调味蒸汽产品的成年人提供了机会,同时引入了一种开创性的方法来减少年轻人的使用和使用。

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.

IKE Tech的年龄限制技术旨在为ENDS产品引入其他经PMTA批准的口味特征提供和支持平台;帮助寻求从可燃香烟过渡到低风险调味蒸气替代品的成年吸烟者。由于其创新的设计、对区块链技术的依赖以及与领先的身份和年龄验证提供商的合作,IKE Tech系统是一个高级组件,可用于任何ENDS设备中,以确保只有授权的成年用户才能访问电子烟产品。

FDA Alignment on Key Points:

FDA 在关键点上保持一致:

  • 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.
  • 成分PMTA:IKE Tech将提交成分的PMTA,而不是向消费者出售的成品烟草制品,美国食品和药物管理局表示,如果满足所有法定要求,它将接受这种成分的PMTA。此外,由于该组件采用了新的使用点技术,美国食品药品管理局表示将考虑批准IKE Tech系统优先审查的申请。如果获得授权,该组件PMTA将允许ENDS制造商在其烟草成品PMTA中使用IKE Tech系统,作为即插即用的年龄控制解决方案,这可能允许批准各种调味的ENDS产品。
  • 创建烟草制品主文件 (TPMF):IKE 将为 IKE 组件创建和归档 TPMF。一旦获得授权,该组件和TPMF可以提供给ENDS设备制造商,以整合到产品中,但须经协议。

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.

IKE Tech预计将在2025年第一季度完成对IKE Tech系统组件PMTA的必要研究,包括身份和年龄验证部分。

"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."

Ispire联席首席执行官迈克尔·王表示:“我们致力于通过创新减少危害,以及与监管机构的合作是Ispire使命的核心。”“我们很自豪能够推出旨在负责任地支持成人消费者选择的技术,同时显著减少年轻人获得的机会。这项技术代表了我们致力于与监管指南保持一致,为更安全的电子烟产品设定新标准。”

About IKE Tech LLC

关于 IKE 科技有限责任公司

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.

IKE Tech LLC是一家合资企业,由三家领先的技术和研究公司——Ispire Technology Inc.、Touch Point Worldwide Inc. d/b/a Berify和Chemular Inc. 组成,致力于彻底改变身份和年龄验证(IAV)技术解决方案。这些公司意识到缺乏通用的销售点IAV解决方案,也意识到需要这种解决方案,因此联手创建了独特的IAV技术组件。IKE 的使命是通过 (i) 允许授权的成年用户访问电子尼古丁输送系统,同时 (ii) 通过兼容不同设备和平台的 “即插即用” 组件防止未成年人访问 IAV 的黄金标准。

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.

关于Ispire Technology Inc
Ispire从事品牌电子烟和大麻电子烟产品的研发、设计、商业化、销售、营销和分销。该公司的运营子公司在全球拥有或许可了400多项专利。Ispire的品牌电子烟产品以Aspire的名义销售,主要通过其全球分销网络在全球销售(美国、中华人民共和国和俄罗斯除外)。该公司还与全球电子烟品牌和零售商建立原创设计制造(ODM)关系。该公司的大麻产品以Ispire品牌名称销售,主要以ODM的形式向其他大麻蒸气公司销售。Ispire在美国、欧洲和南非销售其大麻电子烟硬件,最近在加拿大和拉丁美洲开始了营销活动和客户互动。欲了解更多信息,请访问 或者关注 Ispire Instagram, 领英, 推特优酷.

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.

前瞻性陈述
本新闻稿包含经修订的1933年《证券法》(“证券法”)第27A条、经修订的1934年《证券交易法》第21E条和经修订的1995年《私人证券诉讼改革法》所指的前瞻性陈述,旨在涵盖这些条款设立的安全港。前瞻性陈述基于某些假设,描述了公司的未来计划、战略和预期,通常可以通过使用前瞻性术语来识别,例如 “相信”、“预期”、“可能”、“应该”、“将”、“可能”、“寻求”、“打算”、“计划”、“目标”、“项目”、“估计”、“预测”、“战略”、“未来”,” “可能” 或其他类似术语,尽管并非所有前瞻性陈述都包含这些识别词。除本新闻稿中包含的有关公司战略、前景、财务状况、运营、成本、计划和目标的历史事实陈述外,所有陈述均为前瞻性陈述。可能导致公司实际业绩和财务状况与前瞻性陈述中显示的重大差异的重要因素。此类前瞻性陈述包括但不限于风险和不确定性,包括以下方面的风险和不确定性:公司及时收取应收账款的能力、公司的业务战略、公司向Ispire ONE进行营销的能力、Ispire ONE在实现目标后取得的成功、客户从Ispire ONE中获得预期收益的能力以及其产品在市场上的成功;Ispire ONE 事实证明是安全的,“风险因素”、“管理层的” 中描述的风险和不确定性关于财务状况和经营业绩的讨论和分析”、“前瞻性陈述警示说明” 以及Ispire截至2023年6月30日止年度的10-k表年度报告以及Ispire随后向美国证券交易委员会提交的任何文件中描述的额外风险。您不应依赖前瞻性陈述作为对未来事件的预测。新闻稿中的前瞻性陈述仅与截至新闻稿中发表声明之日的事件或信息有关。除非法律要求,否则在陈述发表之日之后,我们没有义务更新或修改任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因,也没有义务反映意外事件的发生。您应该在阅读本新闻稿时了解我们的实际未来业绩可能与我们的预期存在重大差异。

IR Contacts:
For more information, kindly contact:
Investor Relations
Sherry Zheng
718.213.7386
ir@ispiretechnology.com

投资者关系联系人:
欲了解更多信息,请联系:
投资者关系
郑雪莉
718.213.7386
ir@ispiretechnology.com

KCSA Strategic Communications
Phil Carlson
212.896.1233
ispire@kcsa.com

KCSA 战略传播
菲尔·卡尔森
212.896.1233
ispire@kcsa.com

PR Contact:
Ellen Mellody
570.209.2947
EMellody@kcsa.com

公关联系人:
艾伦·梅洛迪
570.209.2947
EMellody@kcsa.com

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