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Avalon GloboCare Announces FDA Registration Renewal for KetoAir™ and Planned B2B and B2C Launch Through Catch-Up™, Its Automated Generative AI-Powered Short-Form Video SaaS Platform

(Positive)
Tags
AI

Avalon GloboCare (NASDAQ: ALBT) announced renewal of the U.S. FDA establishment registration for the KetoAir™ handheld breathalyzer (registration no. 3026284320). KetoAir measures breath acetone concentration (BrAce) using nanosensor technology to provide non-invasive metabolic and ketosis insights for users on ketogenic programs. Avalon plans a combined B2B and B2C launch for KetoAir via Catch-Up™, its generative AI short-form video SaaS, operated by Avalon Quantum AI, LLC. Marketing through Catch-Up™ is planned to begin in the second quarter of 2026 to support distribution, engagement, and adoption across enterprise and consumer channels.

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Positive

  • FDA establishment registration renewed (Reg. No. 3026284320)
  • Planned B2B and B2C launch via Catch-Up™ platform
  • Marketing start targeted for Q2 2026
  • Device measures BrAce using nanosensor technology
  • Compatible with iOS and Android with companion apps

Negative

  • Commercial launch timing remains planned, not yet initiated

News Market Reaction – ALBT

-5.98% 75.4x vol
32 alerts
-5.98% Session close to close
+50.8% Peak Tracked
-36.5% Trough Tracked
$4.97M Market Cap
75.4x Rel. Volume

In the Jan 20 session, ALBT declined 5.98%, reflecting a notable negative market reaction. Argus tracked a peak move of +50.8% during that session. Argus tracked a trough of -36.5% from its starting point during tracking. Our momentum scanner triggered 32 alerts that day, indicating elevated trading interest and price volatility. Trading volume was exceptionally heavy at 75.4x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.0% in the session following this news. A negative reaction despite operational pr...
Analysis

The stock moved -6.0% in the session following this news. A negative reaction despite operational progress would fit prior patterns, where AI- and platform-focused news led to moves of -10.24% and -5.97%. The market previously treated acquisitions and Nasdaq compliance updates cautiously, even when they supported KetoAir™ and Catch-Up™ integration. A sharp decline around this news could reflect ongoing skepticism about execution or capital structure rather than the FDA registration renewal itself, and might echo earlier post-announcement selling pressure.

Key Figures

FDA registration number: 3026284320
1 metrics
FDA registration number 3026284320 KetoAir™ establishment registration with U.S. Food and Drug Administration

Historical Context

5 past events · Latest: Jan 12 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jan 12 Nasdaq compliance, AI Positive -10.2% Regained Nasdaq equity compliance and highlighted generative AI video platform.
Dec 30 AI platform interview Positive -6.0% Board director highlighted RPM’s Catch-Up generative AI video SaaS platform.
Dec 15 AI acquisition deal Positive -24.6% All-stock acquisition of RPM Interactive to add generative AI video capabilities.
Dec 01 KetoAir progress Positive -8.1% Reported Q3 KetoAir™ expansion, UK launch and Nevada first-responder program.
Aug 28 UK product launch Positive +2.9% Announced start of online KetoAir™ sales in the UK on Sept 1, 2025.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news, especially AI- and platform-related milestones, has often been followed by negative price reactions, even when developments appeared operationally positive.

Recent Company History

Over the last six months, Avalon has focused on KetoAir™ commercialization and building a generative AI video platform to support marketing. Key steps included a UK KetoAir™ launch on Sept 1, 2025, Nevada first-responder deployment, and acquiring RPM Interactive via an all-stock deal valued at $19.5 million. Subsequent AI-tagged news on Nasdaq compliance and the Catch-Up platform drew 24-hour moves of -10.24% and -5.97%. Today’s announcement extends this strategy by tying FDA registration renewal for KetoAir™ to a planned B2B/B2C launch through Catch-Up™.

Key Terms

u.s. food and drug administration (fda), establishment registration, biomarker, nanosensor-based diagnostic technologies, +4 more
8 terms
u.s. food and drug administration (fda) regulatory
"announced the renewal of the U.S. Food and Drug Administration (FDA) establishment"
The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.
establishment registration regulatory
"announced the renewal of the U.S. Food and Drug Administration (FDA) establishment registration"
A government filing that records a physical facility—such as a factory, warehouse, lab, or importer—with the regulator that oversees products like drugs, medical devices, food, or chemicals. It tells regulators where regulated activities occur and is often required before products can be legally marketed or imported. For investors it matters because registration is a basic compliance step that affects whether a business can sell products, meet production timelines, avoid fines, and sustain supply—like a required business license for a production site.
biomarker medical
"breath acetone concentration (BrAce), a key biomarker associated with fat metabolism"
A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.
nanosensor-based diagnostic technologies medical
"Qi Diagnostics Limited, a nanosensor-based diagnostic technologies company."
Nanosensor-based diagnostic technologies use extremely small sensors—often at the scale of molecules—to detect traces of infection, disease markers or chemical signals in blood, breath or other samples. For investors, they matter because these tools can make tests faster, more accurate and cheaper, enabling point-of-care use and larger market reach; commercial success depends on clinical validation, regulatory approval and adoption by healthcare systems.
software-as-a-service (saas) technical
"an automated generative AI-powered software-as-a-service (SaaS) platform for creating"
Software-as-a-service (SaaS) is a way of delivering software over the internet where customers pay a subscription to use applications hosted and maintained by a provider, like renting a tool or streaming a service rather than buying and installing it. For investors it matters because subscriptions create predictable, recurring revenue and can scale quickly with low distribution costs, while metrics like customer retention and churn directly affect future cash flow and valuation.
generative ai technical
"an automated generative AI-powered software-as-a-service (SaaS) platform"
Generative AI is a type of computer technology that can create new content, like text, images, or music, on its own. It’s important because it can produce realistic and useful material quickly, which could change how we create art, write stories, or even develop new products. Think of it as a smart robot that can invent and produce things almost like a human.
short-form video technical
"Catch-Up™, an automated generative AI-powered ... platform for creating short-form video content"
Short-form video is a brief, usually under a few minutes, clip designed for quick consumption on social platforms — like a digital elevator pitch or a moving billboard. For investors it matters because these videos can rapidly grow an audience, drive product discovery and sales, and change marketing costs and user engagement metrics; strong short-form performance can boost revenue potential, customer acquisition efficiency, and a company’s visible growth trajectory.
metabolic state medical
"provides users with real-time, non-invasive insights into metabolic state through breath analysis."
The metabolic state is the current pattern of chemical activity inside a living body or cell—how it uses and stores energy, breaks down nutrients, and builds or repairs tissues. Investors care because changes in metabolic state underlie many diseases and determine how well drugs, diagnostics, or lifestyle products work; think of it like an engine’s running mode that affects performance, fuel needs, and what fixes or upgrades will be effective.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FREEHOLD, N.J., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (“Avalon” or the “Company”) (NASDAQ: ALBT), a diversified company focused on the development of precision diagnostic consumer products and generative AI publishing and software, today announced the renewal of the U.S. Food and Drug Administration (FDA) establishment registration for the KetoAir™ device by Qi Diagnostics Limited, a nanosensor-based diagnostic technologies company. Avalon markets and distributes the KetoAir™ device, a handheld breathalyzer designed for ketogenic health management which is registered with the U.S. Food and Drug Administration under registration number 3026284320.

KetoAir™ is a handheld breathalyzer designed for ketogenic health management and is registered with the U.S. Food and Drug Administration under registration number 3026284320. The device measures breath acetone concentration (BrAce), a key biomarker associated with fat metabolism and nutritional ketosis. Leveraging advanced nano-sensor technology, KetoAir™ provides users with real-time, non-invasive insights into metabolic state through breath analysis. The device is intended for individuals pursuing ketogenic diets for weight management, athletic performance, and therapeutic or lifestyle-based ketogenic programs. KetoAir™ is compatible with both iOS and Android smartphones, with companion applications available through the Apple App Store and Google Play Store.

Avalon plans to launch KetoAir™ in both business-to-business (B2B) and business-to-consumer (B2C) markets via Catch-Up™, an automated generative AI-powered software-as-a-service (SaaS) platform for creating short-form video content, operated through its subsidiary Avalon Quantum AI, LLC. This initiative is designed to support and amplify marketing, distribution, and digital engagement initiatives for KetoAir™.

“We believe that the successful FDA registration renewal for KetoAir™ and our planned B2B and B2C marketing launch through Catch-Up™ mark important milestones for Avalon,” said Meng Li, Avalon’s Interim Chief Executive Officer and Chief Operating Officer. “We plan to initiate marketing efforts through Catch-Up™ in the second quarter of 2026, and aim to create scalable and cost-efficient marketing pathways with the goal of accelerating audience reach, digital engagement, and adoption across both enterprise and consumer markets.”

About Avalon GloboCare Corp.

Avalon GloboCare Corp. (NASDAQ: ALBT) is a diversified company focused on the development of precision diagnostic consumer products, the advancement of intellectual property in cellular therapy, and generative artificial intelligence publishing and software. Avalon is currently marketing the KetoAir™ breathalyzer device and plans to develop additional diagnostic uses of the breathalyzer technology. The KetoAir™ is registered with the U.S. Food and Drug Administration as a Class I medical device. The Company also continues to focus on advancing its intellectual property portfolio through existing patent applications. In addition, Avalon owns and operates commercial real estate.

For more information about Avalon, please visit www.avalon-globocare.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.

No Offer or Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, or a solicitation of any proxy, consent, authorization, vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”).

Additional Information About the Proposed Merger for Investors and Shareholders

This communication relates to the proposed merger (the “proposed Merger”) of Avalon and YOOV Group Holding Limited (“YOOV”). In connection with the proposed Merger, Avalon has filed relevant materials with the U.S. Securities and Exchange Commission (the “SEC”), including a Registration Statement on Form S-4, as amended, that contains a preliminary prospectus and preliminary proxy statement of Avalon (the “proxy statement/prospectus”). This Registration Statement has not yet been declared effective and Avalon has filed or may file other documents regarding the proposed Merger with the SEC. This press release is not a substitute for the proxy statement/prospectus or for any other document that Avalon has filed or may file with the SEC in connection with the proposed Merger. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING THE PROPOSED MERGER. A definitive proxy statement/prospectus will be sent to Avalon’s stockholders. Investors and security holders will be able to obtain these documents (when available) free of charge from the SEC’s website at www.sec.gov. In addition, investors and stockholders should note that Avalon communicates with investors and the public using its website (https://www.avalon-globocare.com), the investor relations website (https://www.avalon-globocare.com/investors) where anyone will be able to obtain free copies of the proxy statement/prospectus and other documents filed by Avalon with the SEC, and stockholders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed Merger.

Participants in the Solicitation

Avalon, YOOV and their respective directors and executive officers and other members of management and employees and certain of their respective significant stockholders may be deemed to be participants in the solicitation of proxies from Avalon and YOOV stockholders in respect of the proposed Merger. Information about Avalon’s directors and executive officers is available in Avalon’s Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 31, 2025. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holding or otherwise, has been and will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed Merger when they become available. Investors should read the definitive proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from the SEC and Avalon as indicated above.

Forward-Looking Statements

Certain statements contained in this press release are “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements are made based on our expectations and beliefs concerning future events impacting the Company and therefore involve several risks and uncertainties. You can identify these statements by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “should”, “may”, and other words and terms of similar meaning or use of future dates; however, the absence of these words or similar expressions does not mean that a statement is not forward-looking. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact, including statements regarding the ability to enter into a definitive agreement, as well as the Company’s commercialization, distribution and sales of its products and the product’s ability to compete with other similar products. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the SEC, accessible through the SEC’s website (http://www.sec.gov), including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed or furnished with the SEC. In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors, including (without limitation) general industry and market conditions and growth rates, economic conditions, and governmental and public policy changes. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. The Company disclaims any obligation to update forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of the press release. The contents of any website referenced in this press release are not incorporated by reference herein.

Contact Information:
Avalon GloboCare Corp.
4400 Route 9 South, Suite 3100
Freehold, NJ 07728
PR@Avalon-GloboCare.com

Investor Relations:
Crescendo Communications, LLC
Tel: (212) 671-1020 Ext. 304
albt@crescendo-ir.com


FAQ

What did Avalon GloboCare (ALBT) announce about KetoAir on January 20, 2026?

Avalon announced renewal of KetoAir™ FDA establishment registration (Reg. No. 3026284320) and plans to launch B2B and B2C marketing via Catch-Up™.

When does Avalon plan to begin marketing KetoAir (ALBT) through Catch-Up™?

Avalon plans to initiate marketing efforts through Catch-Up™ in the second quarter of 2026.

What does the KetoAir device measure and who is it intended for?

KetoAir measures breath acetone concentration (BrAce) as a biomarker of fat metabolism and is intended for individuals pursuing ketogenic diets and related programs.

How will Avalon distribute KetoAir (ALBT) to consumers and enterprises?

Avalon intends to distribute KetoAir via both B2B and B2C channels supported by Catch-Up™, its automated generative AI short-form video SaaS.

Is KetoAir compatible with mobile devices for consumers (ALBT)?

Yes; KetoAir is compatible with iOS and Android smartphones with companion apps available in the Apple App Store and Google Play Store.