Ispire-Backed IKE Tech Invited to Participate in FDA Roundtable on PMTA Submissions

Rhea-AI Summary

Ispire (NASDAQ: ISPR) said IKE Tech, a joint venture with Ispire as a founding partner, was invited to an FDA Roundtable on PMTA submissions on February 10, 2026. The invitation, limited to 30 companies, recognizes IKE Tech as a stakeholder and the role of point-of-use age-gating technology. IKE will join the Manufacturing Controls panel and has submitted the first-ever component PMTA for an interoperable, blockchain-enabled Bluetooth age-verification system.

The company framed the engagement as a chance to inform PMTA guidance and advance regulatory-ready, youth-protective technical controls for ENDS products.

Positive

• Invitation to FDA roundtable on Feb 10, 2026 — limited to 30 companies
• IKE will appear on the Manufacturing Controls panel
• First-ever component PMTA submission for interoperable age-verification technology
• Development of a blockchain-enabled, Bluetooth-based point-of-use age-gating component

Negative

• None.

Key Figures

Roundtable date: February 10, 2026 Participants: 30 companies FDA panels: 5 panels

3 metrics

Roundtable date February 10, 2026 FDA small ENDS manufacturers roundtable

Participants 30 companies Number of ENDS manufacturers invited nationwide

FDA panels 5 panels FDA-led panel discussions at the roundtable

Market Reality Check

Price: $3.53 Vol: Volume 37,509 vs 20-day a...

low vol

$3.53 Last Close

Volume Volume 37,509 vs 20-day average 59,939 ahead of this FDA-focused news. low

Technical Trading above 200-day MA at 2.67, while shares closed at 3.53 pre-announcement.

Peers on Argus

ISPR was down 2.49% while tobacco peers were mixed: TPB up 0.97%, UVV up 0.47%, ...

ISPR was down 2.49% while tobacco peers were mixed: TPB up 0.97%, UVV up 0.47%, but KAVL, XXII and GNLN declined between 9.57% and 11.96%, suggesting stock-specific dynamics rather than a uniform sector move.

Historical Context

5 past events · Latest: Feb 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 03	Board appointments	Positive	-2.5%	MAPS strengthened board and CFO arrangement to support sector growth.
Feb 03	Earnings call schedule	Neutral	-2.5%	ISPR set date and access details for Q2 FY2026 earnings call.
Jan 15	Financing extension	Positive	+8.5%	CACC extended $100M asset-backed facility and reduced borrowing spread.
Nov 26	Product ecosystem launch	Positive	-0.4%	ISPR unveiled next-gen cannabis hardware ecosystem at MJBizCon 2025.
Nov 17	Regulatory response	Positive	+5.1%	ISPR and IKE Tech backed FDA ENDS crackdown and promoted traceability tech.

Pattern Detected

For ISPR, technology- and regulation-focused ENDS news previously coincided with a positive move, while product and routine communication updates saw flat to modestly negative reactions.

Recent Company History

Recent ISPR news shows a mix of strategic and regulatory developments. On Nov 17, 2025, Ispire and IKE Tech highlighted FDA enforcement funding and promoted their age-verification technology, with a 5.13% move afterward. A new cannabis hardware ecosystem unveiling at MJBizCon on Nov 26, 2025 saw a modest -0.41% reaction. The scheduled Q2 FY2026 earnings call on Feb 3, 2026 coincided with a -2.49% move. Today’s FDA roundtable invitation fits the ongoing narrative around compliance-focused innovation.

Market Pulse Summary

This announcement highlights ISPR’s role in regulatory discussions through IKE Tech’s participation ...

Analysis

This announcement highlights ISPR’s role in regulatory discussions through IKE Tech’s participation in an FDA roundtable limited to 30 ENDS manufacturers, centered on PMTA submissions and age-gating technology. It builds on prior FDA-focused collaboration announced on Nov 17, 2025. Against this, recent filings reported ongoing net losses and a stockholders’ deficit, so future updates on PMTA-related progress, revenue trends, and regulatory adoption of age-verification tools remain important watch points.

Key Terms

pmtA, premarket tobacco product application, blockchain-enabled

3 terms

pmtA regulatory

"Roundtable Discussion with Small ENDS Manufacturers on Premarket Tobacco Product Application (PMTA) Submissions."

A Premarket Tobacco Product Application (PMTA) is a formal submission to a regulatory agency seeking permission to legally sell a new or changed tobacco or nicotine product. It lays out safety data, product design, and evidence that the product is appropriate for public health; approval is like a green light to enter the market. For investors, PMTA outcomes can make or break a company’s ability to sell products, affecting revenue forecasts and stock value, much like a building permit determines whether a construction project can proceed.

premarket tobacco product application regulatory

"Manufacturers on Premarket Tobacco Product Application (PMTA) Submissions."

A premarket tobacco product application is the formal submission a company must file with regulators to get permission to market a new or significantly changed tobacco product. Think of it as a permit showing evidence that the product is acceptable for public health—companies must provide scientific data on ingredients, emissions and likely impact on users and non-users. Investors care because approval determines whether a product can be sold, affects revenue potential, regulatory risk and a company’s valuation.

blockchain-enabled technical

"IKE is developing a blockchain-enabled, Bluetooth-based age-gating component designed to verify legal-age access"

A product, service, or process described as blockchain-enabled uses a tamper-resistant, shared digital record to store and verify transactions or data, so multiple parties can see the same information and changes are permanently recorded. For investors this matters because it can lower costs, reduce reliance on middlemen, and increase transparency and traceability—like replacing private ledgers with a public, auditable spreadsheet—while also bringing new operational and regulatory risks to weigh.

AI-generated analysis. Not financial advice.

Invitation-Only Forum Underscores FDA Recognition of IKE Tech as a Key Stakeholder and Highlights the Strategic Role of Age-Gating Technology in the Future of ENDS Regulation and Compliance

LOS ANGELES, Feb. 4, 2026 /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" or "IKE"), a joint venture that includes Ispire as a founding partner, has been invited by the U.S. Food and Drug Administration (FDA) to participate in its Roundtable Discussion with Small ENDS Manufacturers on Premarket Tobacco Product Application (PMTA) Submissions.

The invitation-only roundtable, taking place February 10, is the first FDA forum of its kind focused on gathering direct feedback from select electronic nicotine delivery system (ENDS) manufacturers on the PMTA process. Participation is limited to 30 companies nationwide, underscoring FDA recognition of IKE Tech as an important stakeholder in the evolving regulatory framework for ENDS products.

IKE is set to participate on the Manufacturing Controls panel — one of five FDA-led panel discussions designed to examine real-world challenges, best practices and opportunities for improving the PMTA process.

"This invitation reflects growing recognition by regulators that technology, particularly point-of-use age-gating, is a critical component of a responsible ENDS ecosystem," said Michael Wang, Co-CEO of Ispire. "This is a significant opportunity to contribute constructively to a dialogue that can improve regulatory clarity while advancing public health objectives. The FDA's engagement reinforces that age-gating is no longer a peripheral concept — it is central to the future of regulation. We look forward to sharing how technical controls can offer a more effective pathway for adult products while ensuring the highest standards of youth protection."

IKE is developing a blockchain-enabled, Bluetooth-based age-gating component designed to verify legal-age access at the point of use, rather than solely at retail. The technology recently became the subject of the first-ever component PMTA submission for an interoperable age-verification system, positioning it as a potential enabling technology for next-generation regulatory compliance.

Wang added: "Our strategic investment in IKE Tech positions Ispire at the center of regulatory dialogue as the FDA evaluates how innovation can strengthen compliance, protect youth and support lawful market pathways for adult products. By aligning commercial participation with strategic integration, we are advancing our long-term commitment to safety-focused innovation and regulatory readiness"

The FDA roundtable is intended to provide manufacturers with an opportunity to share firsthand experience and perspectives on PMTA submissions, including scientific, manufacturing and operational considerations. Feedback from the session is expected to inform future FDA guidance and potential refinements to the PMTA review process.

About IKE Tech LLC
IKE Tech LLC is a joint venture comprised of Ispire Technology Inc., Touch Point Worldwide Inc. d/b/a Berify, and Chemular Inc. Founded in 2024, IKE Tech is building the identity layer for the physical world. With patented technologies spanning blockchain authentication, secure BLE communication, and AI-enhanced access control, IKE powers secure, user-centric device interactions across regulated and high-risk sectors.

IKE's System-on-a-Chip allows manufacturers to embed customizable, interoperable access controls into vapor devices — ensuring authorized adult use and preventing youth access through real-time mobile and biometric authentication. Visit www.iketech.com.

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 www.ispiretechnology.com 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: whether the Company may be successful in re-entering the U.S. ENDS market; the approval or rejection of any PMTA submitted by the Company; whether the Company will be successful in its plans to further expand into the African market; whether the Company's joint venture with Touch Point Worldwide Inc. d/b/a/ Berify and Chemular Inc. (the "Joint Venture") may be successful in achieving its goals as currently contemplated, with different terms, or at all; the Joint Venture's ability to innovate in the e-cigarette technology space or develop age gating or age verification technologies for nicotine vaping devices; 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 in meeting its goals; the ability of its customers to derive the anticipated benefits of the Ispire ONE™ and the success of its 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, 2025 and any subsequent filings which Ispire makes with the SEC. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this 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 applicable law. You should read this press release with the understanding that our actual future results may be materially different from what we expect.

IR Contact:
Phil Carlson
+1-212-896-1233
ispire@kcsa.com

PR Contact:
Ellen Mellody
+1-570-209-2947
ispire@kcsa.com

 

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SOURCE Ispire Technology Inc.

FAQ

Why was IKE Tech (ISPR) invited to the FDA PMTA roundtable on February 10, 2026?

IKE Tech was invited as a recognized stakeholder to discuss PMTA challenges and solutions. According to the company, the forum seeks direct feedback from select ENDS manufacturers to inform PMTA guidance and improve the review process.

What will IKE Tech (ISPR) discuss on the Manufacturing Controls panel at the FDA roundtable?

IKE Tech will address manufacturing controls and real-world PMTA challenges. According to the company, the discussion will cover best practices, operational considerations, and opportunities to improve PMTA submissions.

What is notable about IKE Tech's component PMTA submission mentioned by Ispire (ISPR)?

IKE Tech filed the first-ever component PMTA for an interoperable age-verification system. According to the company, the submission centers on a blockchain-enabled, Bluetooth age-gating component for point-of-use verification.

How does the FDA roundtable invitation affect Ispire's (ISPR) regulatory positioning?

The invitation signals regulatory recognition of Ispire-linked technology in ENDS compliance. According to the company, participation reinforces its role in shaping PMTA guidance and advancing age-gating solutions.

Will feedback from the February 10, 2026 FDA roundtable change PMTA guidance for ENDS manufacturers?

Feedback is intended to inform future FDA guidance and potential PMTA refinements. According to the company, the session collects firsthand manufacturer perspectives to help refine the PMTA review process.