WORK Medical Technology Group LTD Subsidiary Obtains Manufacturing Approval for Its AI-Automated Blood Cell Morphology Analyzer

Rhea-AI Summary

WORK Medical Technology Group (Nasdaq: WOK) announced that its subsidiary Hunan Saitumofei received manufacturing approval from the Hunan Provincial Medical Products Administration for a Class II AI‑Automated Human Blood Cell Morphology Analyzer on December 29, 2025. The analyzer combines a main optical imaging unit and embedded analysis software to perform white blood cell differentials and quantify red blood cell and platelet morphology using deep‑learning algorithms.

Manufacturing is scheduled to begin in the first half of 2026. The company says the device aims to increase efficiency, consistency, and accuracy in microscopic exams, reduce manual workload and costs, and support early screening and quality control in hematology and oncology settings.

Positive

• Regulatory approval obtained from Hunan Provincial Medical Products Administration
• Manufacturing scheduled to begin in H1 2026
• Device integrates AI deep‑learning with automated imaging and workflow
• Supports white blood cell differentials and RBC/platelet morphology quantification

Negative

• Approval issued by a provincial regulator (Hunan) rather than a national authority

Argus Dec 29 session

+24.00% close to close Open Argus

Details

News Market Reaction – WOK

In the Dec 29 session, WOK gained 24.00%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +24.0% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +24.0% in the session following this news. A strong positive reaction aligns with the milestone nature of obtaining manufacturing approval for a Class II AI-automated blood cell morphology analyzer. Prior AI-focused contracts and investments have also seen constructive responses. However, recent reverse splits and capital-raising activity highlighted in filings add ongoing dilution and listing-risk considerations. Investors would need to weigh technological progress against governance structure, financing mechanisms, and execution toward the planned first-half 2026 manufacturing start.

Key Figures

Device class: Class II medical device Manufacturing start: First half of 2026

Device class

Class II medical device

Regulatory classification of AI blood cell morphology analyzer

Manufacturing start

First half of 2026

Planned start of analyzer manufacturing

Historical Context

5 past events · Latest: Dec 24

5 events

1. Dec 24

   Reverse stock split

   24h Move

   -32.9%

   Announced 1-for-100 reverse split to support Nasdaq minimum bid compliance.

2. Nov 04

   Service contract win

   24h Move

   +11.3%

   Subsidiary retained US$114,000 antibody R&D testing service contract.

3. Oct 21

   Strategic investment

   24h Move

   +9.2%

   US$1 million equity investment for 10% stake in Neologics Bioscience.

4. Oct 16

   Reverse stock split

   24h Move

   +1.6%

   1-for-100 reverse split to regain compliance under Nasdaq Rule 5550(a)(2).

5. Oct 14

   Delisting notice

   24h Move

   -4.1%

   Nasdaq delisting determination letter after shares closed at or below $0.10.

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

Key Terms

class II medical device, artificial intelligence, deep-learning algorithms, hematology, +3 more

7 terms

class II medical device regulatory

"received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II medical device"

A class II medical device is a product that poses moderate risk to patients and therefore must meet specific regulatory rules for safety and performance beyond basic checks but not the most stringent requirements used for highest-risk devices. For investors, this classification signals predictable but nontrivial development costs and approval steps—usually longer and more expensive than the lowest-risk products but clearer and faster than the highest-risk ones—affecting time to market, potential liabilities, and revenue forecasts.

artificial intelligence technical

"Class II medical device, the Artificial Intelligence (“AI”)-Automated Human Blood Cell Morphology Analyzer"

Artificial intelligence is the ability of computers and machines to perform tasks that typically require human thinking, such as understanding language, recognizing patterns, or making decisions. For investors, it matters because AI can enhance efficiency, uncover new insights, and enable smarter strategies, potentially impacting the value and performance of companies that develop or utilize this technology.

deep-learning algorithms technical

"combines high-speed digital imaging, deep-learning algorithms, and a fully automated workflow"

Deep-learning algorithms are computer programs that learn to recognize complex patterns by studying vast amounts of data, much like a child improves at identifying animals after seeing many pictures. For investors, they matter because these algorithms can power better forecasting, automate decision-making, reduce costs, enable new products or services, and introduce operational or regulatory risks that can affect a company’s competitive edge and financial performance.

hematology medical

"expected to become standard equipment in hematology and oncology departments"

Hematology is the branch of medicine that studies blood, its components (like red and white cells and platelets), and disorders that affect them. For investors, it matters because treatments, diagnostics, and devices that diagnose or fix blood problems can drive sales, regulatory risk, and patent value—think of it as investments in the maintenance and repair of the body's delivery system, where breakthroughs or setbacks can quickly change a company's prospects.

oncology medical

"expected to become standard equipment in hematology and oncology departments"

Oncology is the branch of medicine focused on understanding, diagnosing, and treating cancer, including the development and testing of drugs, therapies, and screening methods. It matters to investors because advances, trial results, regulatory approvals, or setbacks in cancer research can dramatically change the value of companies and the size of potential markets—think of oncology news as weather reports that help investors steer financial decisions in a high-stakes field.

peripheral blood smears medical

"describe the morphology of white blood cells, red blood cells, and platelets in peripheral blood smears"

A peripheral blood smear is a laboratory test where a thin layer of blood is spread on a glass slide, stained, and examined under a microscope to see the size, shape and appearance of red and white blood cells and platelets. For investors, it matters because these slides are a basic diagnostic tool and often used as evidence in clinical trials, regulatory reviews and product performance studies—think of them as close-up photos that reveal whether a treatment or diagnostic is working and can affect demand, approvals and company valuations.

cell morphology screening medical

"supporting clinicians in cell morphology screening"

Cell morphology screening is a laboratory method that uses microscopes and automated imaging to observe and measure changes in the shape, structure and behavior of cells after they are exposed to drugs, chemicals or genetic changes. For investors, it matters because these visual readouts help researchers spot promising or problematic effects early—like watching how leaves wilt or perk up after treatment—which can speed development, lower costs and reduce the risk of late-stage failures in drug and biotech programs.

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

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Hangzhou, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, today announced that its subsidiary, Hunan Saitumofei Co., Ltd., has received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II medical device, the Artificial Intelligence (“AI”)-Automated Human Blood Cell Morphology Analyzer. This regulatory approval represents a milestone in WORK Medical’s research and development strategy and is expected to position the Company’s new AI-driven device as a key growth catalyst.

The analyzer consists of a main unit and embedded analysis software. The main unit integrates an optical imaging system, sample-handling module, barcode scanner, automatic oil-immersion unit, control board, and protective housing. It performs white blood cell differential counts on human blood smears and quantifies morphological parameters of red blood cells and platelets, supporting clinicians in cell morphology screening. Powered by advanced AI automation, the analyzer combines high-speed digital imaging, deep-learning algorithms, and a fully automated workflow to identify, pre-classify, and describe the morphology of white blood cells, red blood cells, and platelets in peripheral blood smears. The analyzer, scheduled to begin manufacturing in the first half of 2026, is designed to enhance efficiency, consistency, and accuracy in microscopic examinations while reducing manual workload and operational costs.

Mr. Shuang Wu, the Chief Executive Officer and Chairman of the Board of Directors of WORK Medical, commented: “This new analyzer integrates cutting-edge AI technology into traditional medical testing, improving consistency, efficiency, and accuracy while minimizing manual intervention and associated costs. The device has progressed from an auxiliary image-reading tool into a fully automated, standardized, and remotely accessible core testing platform. With continuous AI-algorithm iteration and pipeline integration, it is expected to become standard equipment in hematology and oncology departments at tertiary hospitals and primary-care laboratories, and is aimed to provide support for early screening of blood disorders, quality-control enhancement, and labor-cost optimization. We are optimistic about this product line’s growth and its revenue potential for the Company.”

About WORK Medical Technology Group LTD

WORK Medical Technology Group LTD, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, is a supplier of medical devices that develops and manufactures Class I and II medical devices and sells Class I and II disposable medical devices through operating subsidiaries in China. The Company has a diverse product portfolio comprising 21 products, including customized and multifunctional masks and other medical consumables. All the products have been sold in 34 provincial-level administrative regions in China, with 15 of them sold in more than 30 countries worldwide. The Company has received a number of quality-related manufacturing designations and has registered 17 products with the U.S. Food and Drug Administration allowing their products to enter the U.S. market. For more information, please visit the Company’s website: https://www.workmedtech.com/corporate.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results set forth in the Company’s annual report on Form 20-F and other documents filed by the Company with the U.S. Securities and Exchange Commission. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

For more information, please contact:

WORK Medical Technology Group LTD
Investor Relations Department
Email: ir@workmedtech.com

Ascent Investor Relations LLC
Tina Xiao
Phone: +1-646-932-7242
Email: investors@ascent-ir.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What regulatory approval did WORK Medical (WOK) receive on December 29, 2025?

A subsidiary received manufacturing approval from the Hunan Provincial Medical Products Administration for a Class II AI‑Automated Human Blood Cell Morphology Analyzer.

When will WORK Medical (WOK) begin manufacturing the AI blood cell analyzer?

Manufacturing is scheduled to begin in the first half of 2026.

What functions does the WOK AI‑Automated Human Blood Cell Morphology Analyzer perform?

It performs white blood cell differential counts and quantifies morphological parameters of red blood cells and platelets using automated imaging and AI algorithms.

How does WORK Medical (WOK) say the analyzer will affect clinical labs?

The company says it should increase efficiency, consistency, and accuracy while reducing manual workload and operational costs in microscopic examinations.

Which WORK Medical subsidiary obtained the manufacturing approval for the analyzer?

The approval was granted to Hunan Saitumofei Co., Ltd.