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 and Ispire Technology Inc. Announce Positive Pre-PMTA Submission Meeting with the FDA
IKE Tech LLC 和 Ispire Technology Inc. 宣佈與 FDA 舉行積極的 PMTA 提交前會議
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
尋求對開創性的使用點身份和年齡驗證技術的授權,以減少青少年的准入並擴大低風險蒸氣產品的成人市場
Los Angeles, November 18, 2024 – Ispire 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.
洛杉磯,2024年11月18日——電子煙技術和精確劑量的開拓者Ispire Technology Inc.(「Ispire」 或 「公司」)(納斯達克股票代碼:ISPR)和由三家領先科技和研究公司Ispire、Touch Point Worldwide d/b/a Berify和Chemular Inc. 組成的合資企業IKE Tech LLC(「IKE Tech」)(「IKE Tech」),由三家領先的技術和研究公司Ispire、Touch Point Worldwide d/b/a Berify和Chemular Inc.親自宣佈,市場菸草製品(申請)提交會議 美國食品和藥物管理局菸草製品中心 (CTP)的年齡驗證技術旨在允許成人使用電子尼古丁輸送系統(ENDS),同時防止青少年在使用點獲得此類產品。
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.
這一重要的監管里程碑標誌着在提供創新、安全的通用解決方案的道路上邁出了重要的一步,該解決方案旨在防止年輕人獲得ENDS,並擴大選擇使用經調味的PMTA授權產品的成年人的市場。IKE Tech身份和年齡驗證技術爲選擇使用調味蒸汽產品的成年人提供了機會,同時引入了一種開創性的方法來減少年輕人的使用和使用。
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的年齡限制技術旨在爲ENDS產品引入其他經PMTA批准的口味特徵提供和支持平台;幫助尋求從可燃香菸過渡到低風險調味蒸氣替代品的成年吸菸者。由於其創新的設計、對區塊鏈技術的依賴以及與領先的身份和年齡驗證提供商的合作,IKE Tech系統是一個高級組件,可用於任何ENDS設備中,以確保只有授權的成年用戶才能訪問電子煙產品。
FDA Alignment on Key Points:
FDA 在關鍵點上保持一致:
- 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將提交成分的PMTA,而不是向消費者出售的成品菸草製品,美國食品和藥物管理局表示,如果滿足所有法定要求,它將接受這種成分的PMTA。此外,由於該組件採用了新的使用點技術,美國食品藥品管理局表示將考慮批准IKE Tech系統優先審查的申請。如果獲得授權,該組件PMTA將允許ENDS製造商在其菸草成品PMTA中使用IKE Tech系統,作爲即插即用的年齡控制解決方案,這可能允許批准各種調味的ENDS產品。
- 創建菸草製品主文件 (TPMF):IKE 將爲 IKE 組件創建和歸檔 TPMF。一旦獲得授權,該組件和TPMF可以提供給ENDS設備製造商,以整合到產品中,但須經協議。
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預計將在2025年第一季度完成對IKE Tech系統組件PMTA的必要研究,包括身份和年齡驗證部分。
"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聯席首席執行官邁克爾·王表示:「我們致力於通過創新減少危害,以及與監管機構的合作是Ispire使命的核心。」「我們很自豪能夠推出旨在負責任地支持成人消費者選擇的技術,同時顯著減少年輕人獲得的機會。這項技術代表了我們致力於與監管指南保持一致,爲更安全的電子煙產品設定新標準。」
About IKE Tech LLC
關於 IKE 科技有限責任公司
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是一家合資企業,由三家領先的技術和研究公司——Ispire Technology Inc.、Touch Point Worldwide Inc. d/b/a Berify和Chemular Inc. 組成,致力於徹底改變身份和年齡驗證(IAV)技術解決方案。這些公司意識到缺乏通用的銷售點IAV解決方案,也意識到需要這種解決方案,因此聯手創建了獨特的IAV技術組件。IKE 的使命是通過 (i) 允許授權的成年用戶訪問電子尼古丁輸送系統,同時 (ii) 通過兼容不同設備和平台的 「即插即用」 組件防止未成年人訪問 IAV 的黃金標準。
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.
關於Ispire Technology Inc
Ispire從事品牌電子煙和大麻電子煙產品的研發、設計、商業化、銷售、營銷和分銷。該公司的運營子公司在全球擁有或許可了400多項專利。Ispire的品牌電子煙產品以Aspire的名義銷售,主要通過其全球分銷網絡在全球銷售(美國、中華人民共和國和俄羅斯除外)。該公司還與全球電子煙品牌和零售商建立原創設計製造(ODM)關係。該公司的大麻產品以Ispire品牌名稱銷售,主要以ODM的形式向其他大麻蒸氣公司銷售。Ispire在美國、歐洲和南非銷售其大麻電子煙硬件,最近在加拿大和拉丁美洲開始了營銷活動和客戶互動。欲了解更多信息,請訪問 或者關注 Ispire Instagram, 領英, 推特 和 優酷.
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.
前瞻性陳述
本新聞稿包含經修訂的1933年《證券法》(「證券法」)第27A條、經修訂的1934年《證券交易法》第21E條和經修訂的1995年《私人證券訴訟改革法》所指的前瞻性陳述,旨在涵蓋這些條款設立的安全港。前瞻性陳述基於某些假設,描述了公司的未來計劃、戰略和預期,通常可以通過使用前瞻性術語來識別,例如 「相信」、「預期」、「可能」、「應該」、「將」、「可能」、「尋求」、「打算」、「計劃」、「目標」、「項目」、「估計」、「預測」、「戰略」、「未來」,” 「可能」 或其他類似術語,儘管並非所有前瞻性陳述都包含這些識別詞。除本新聞稿中包含的有關公司戰略、前景、財務狀況、運營、成本、計劃和目標的歷史事實陳述外,所有陳述均爲前瞻性陳述。可能導致公司實際業績和財務狀況與前瞻性陳述中顯示的重大差異的重要因素。此類前瞻性陳述包括但不限於風險和不確定性,包括以下方面的風險和不確定性:公司及時收取應收賬款的能力、公司的業務戰略、公司向Ispire ONE進行營銷的能力、Ispire ONE在實現目標後取得的成功、客戶從Ispire ONE中獲得預期收益的能力以及其產品在市場上的成功;Ispire ONE 事實證明是安全的,「風險因素」、「管理層的」 中描述的風險和不確定性關於財務狀況和經營業績的討論和分析”、「前瞻性陳述警示說明」 以及Ispire截至2023年6月30日止年度的10-k表年度報告以及Ispire隨後向美國證券交易委員會提交的任何文件中描述的額外風險。您不應依賴前瞻性陳述作爲對未來事件的預測。新聞稿中的前瞻性陳述僅與截至新聞稿中發表聲明之日的事件或信息有關。除非法律要求,否則在陳述發表之日之後,我們沒有義務更新或修改任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因,也沒有義務反映意外事件的發生。您應該在閱讀本新聞稿時了解我們的實際未來業績可能與我們的預期存在重大差異。
IR Contacts:
For more information, kindly contact:
Investor Relations
Sherry Zheng
718.213.7386
ir@ispiretechnology.com
投資者關係聯繫人:
欲了解更多信息,請聯繫:
投資者關係
鄭雪莉
718.213.7386
ir@ispiretechnology.com
KCSA Strategic Communications
Phil Carlson
212.896.1233
ispire@kcsa.com
KCSA 戰略傳播
菲爾·卡爾森
212.896.1233
ispire@kcsa.com
PR Contact:
Ellen Mellody
570.209.2947
EMellody@kcsa.com
公關聯繫人:
艾倫·梅洛迪
570.209.2947
EMellody@kcsa.com
譯文內容由第三人軟體翻譯。