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Company Overview

Company Overview

Sensing Ahead, Caring More

Since its founding in 2000, the Company has grown as a specialized In Vitro Diagnostics (IVD) medical device company based on biosensor technology. Its main business areas are Blood Glucose Monitoring (BGM), in which patients with diabetes measure their blood glucose themselves; Continuous Glucose Monitoring (CGM), which attaches a sensor to the body to monitor blood glucose changes in real time; and Point-of-Care Testing (POCT), which provides rapid test results at clinical settings. This chapter introduces the Company's key status and business areas, along with its global manufacturing infrastructure and partnerships, and presents the strategies and future plans for its growth drivers — the CGM and POCT businesses.


1. Company Introduction

Established in 2000, i-SENS is an IVD medical device leader listed on the KOSDAQ market since 2013 (ticker: 099190). Based on the 2025 consolidated financial statements (K-IFRS), the Company recorded annual revenue of KRW 315,445 million. Headquartered at the i-SENS Building (43 Banpo-daero 28-gil, Seocho-gu, Seoul), the Company maintains a strong global footprint across eight countries, including South Korea, the United States, Mexico, China, India, Chile, Germany, and Malaysia. Notably, i-SENS Jiangsu in China serves as a key international manufacturing hub, while other overseas subsidiaries focus primarily on regional sales, marketing, and distribution.


Item

Description

Corporate Name

i-SENS, Inc.

Industry

Medical device manufacturing (In Vitro Diagnostics, IVD)

Representatives

Co-CEO Geun-Sik Cha · Co-CEO Hak-Hyun Nam

Corporate Form

Stock corporation, KOSDAQ-listed

Ticker Symbol

099190

Headquarters Location

i-SENS Building, 43 Banpo-daero 28-gil, Seocho-gu, Seoul

Global Presence

Korea, U.S.A., Mexico, China, India, Chile, Germany, Malaysia

Employees

957 employees (as of end of 2025, National Pension Service basis)¹

Credit Rating

Korea Enterprise Data credit rating certificate (credit rating A0)

ESG Rating

Korea Institute of Corporate Governance and Sustainability (KCGS) 2025 ESG rating B+; EcoVadis Bronze rating

Global OEM/ODM and Distribution Partners

The Company partners with global medical device and IVD companies including AgaMatrix, ARKRAY, CVS Pharmacy, embecta, HANDOK, LifeScan, and Sanofi. Specific transaction arrangements follow individual contracts and business division standards.

Key Products

BGM: CareSens® N, POP, Dual, Pro and other blood glucose meters and blood glucose test strips

CGM: CareSens® Air, POCT: i-Smart®, A1Care, ivisen IA-1100 and other point-of-care devices

1) The Company's year-end headcount is 960 employees, but the number of National Pension Service subscribers stands at 957 employees (calculated based on workplace-subscribing employees aged 18 to under 60, excluding employees aged 60 or older and those exempted by law). 


[Figure 1-1] i-SENS at a Glance

2. Business Areas and Market Structure

i-SENS operates in the In Vitro Diagnostics (IVD) field around three main products: the Blood Glucose Monitoring (BGM) device, with which patients measure their own blood glucose; the Continuous Glucose Monitoring (CGM) device, which attaches a sensor to the body to monitor blood glucose changes in real time; and the Point-of-Care Testing (POCT) device, which provides results on the spot rather than in a hospital or laboratory. The 2025, the revenue mix by product breakdown stood at 82% for BGM, 12% for POCT, and 6% for CGM. Most of the Company's revenue comes from the long-established BGM segment, while CGM and POCT are growth businesses to be expanded going forward.

Business Segment

2025 Revenue Share

Key Products

Blood Glucose Monitoring — BGM

82%

CareSens series — 12 own-brand products including CareSens N, POP, Dual, and Pro

Continuous Glucose Monitoring — CGM

6%

CareSens Air (launched domestically in September 2023, available in 27 countries as of 2025) · CareSens Air 2 (planned for global launch in 2027)

Point-of-Care Testing — POCT

12%

Blood gas, electrolyte, immunoassay, and coagulation analyzers — A1Care, i-SmartCare 10, PT2, ivisen IA-1100


[Figure 2-1] Three Core Business Portfolio

[Figure 2-2] Global IVD Market and i-SENS Business Segment Revenue Share


3. Supply Chain and Production Capacity

The Company is continuously scaling its domestic and international manufacturing infrastructure to meet surging global demand. As of 2025, i-SENS operates four primary production sites—the Wonju, Songdo, Songdo No. 2, and China plants—boasting an aggregate annual capacity of 2.4 billion BGM strips and 2 million CGM sensors. To support market expansion, the Company plans to scale its annual CGM sensor capacity to approximately 5.4 million units by expanding production lines at the Songdo No. 2 Plant in the first quarter of 2027.

[Figure 3-1] i-SENS Global Production Infrastructure


4. Key Customers and Partnerships

We serve global markets through a dual-track strategy encompassing both our proprietary own-brand channels and OEM/ODM partnerships. While the BGM segment leverages both tracks simultaneously, the CGM business currently focuses primarily on driving market penetration via the proprietary CareSens® Air brand. In the own-brand segment, we supply products through major international public healthcare systems and private commercial channels. For OEM/ODM operations, we collaborate closely with leading global distributors, medical device firms, and IVD companies. Looking ahead, the CGM division is accelerating integration with insulin pumps, digital health platforms, and hospital ecosystems to enhance connectivity within the broader digital healthcare landscape.

 

Plant

Location

Role

Annual Production Capacity

Wonju Plant

Munmak-eup, Wonju City

Large-scale base

BGM strips 1.4 billion units

Songdo Plant

Songdo, Incheon

Core base

BGM strips 700 million units

Songdo No. 2 Plant

Songdo, Incheon

Expansion base (completed 2023)

CGM sensors 2 million units (+3.4 million units, Q1 2027)

China Plant

Zhangjiagang City, Jiangsu Province, China

Global production base

BGM strips 300 million units

 


 

[Figure 4-1] Global Partners under the own-brand products and OEM/ODM Model


5. CGM Growth Strategy

Building on the stable foundation of the BGM business, the Company is driving CGM and POCT as key growth areas. CGM is expected to grow in the global market due to the rise in the diabetic population, expanding insurance coverage, and increasing demand for digital healthcare. POCT is seeing expanding use in medical environments where rapid test results are critical, such as hospitals, clinics, and emergency settings. In the CGM segment, the Company is expanding overseas regulatory approvals and partnerships centered on CareSens® Air, and is reinforcing usability and product competitiveness through the development of the next-generation product, CareSens® Air 2. The Company plans to expand into the market in phases, taking into account the global regulatory approval schedule, production capacity expansion, and the expansion of insurance coverage. In the POCT segment, the Company provides a portfolio of products required for hospital-based point-of-care diagnostics, including blood gas analyzers, electrolyte analyzers, immunoassay analyzers, and blood coagulation analyzers. Based on the trust the Company has built with leading medical institutions, the Company aims to expand its POCT business and contribute to improved hospital diagnostic efficiency through rapid and accurate analytical solutions.

Market size, growth rate, launch timing, and regulatory information presented in this report are based on external market data and the Company's business plans. Actual results may vary depending on market conditions, regulatory review, insurance coverage, production capacity, and partnership progress.

[Figure 5-1] Global CGM Market Outlook and Insurance Coverage Expansion


6. POCT Segment Strategy

The POCT segment is securing an expanding footprint within the IVD market, particularly in critical care settings such as hospitals, clinics, and emergency rooms where rapid diagnostic turnaround is vital. i-SENS delivers a comprehensive product portfolio tailored for decentralized clinical testing, including blood gas, electrolyte, immunoassay, and coagulation analyzers. Building upon the deep trust established with leading medical institutions, we aim to scale our POCT business and enhance hospital operational efficiency by delivering rapid, highly accurate analytical solutions.

 


 


 

7. Future Plans

The Company plans to advance its product portfolio across BGM, CGM, and POCT and to strengthen its mid- to long-term growth foundation based on the expansion of global regulatory approvals and production capacity.

Category

Key Initiatives

Direction

Pipeline

CareSens Air: Expansion of approved age range and indications · CareSens Air 2: Development and global regulatory approvals

Expand the indications of existing CGM products to enhance usability and accessibility. Lay the foundation to enter major markets including Korea, Europe, and the United States through next-generation CGM product development.

Production Capacity

Expansion of CGM sensor production capacity

Strengthen production base to respond to growing global demand through CGM line expansion at the Songdo No. 2 Plant.

Revenue Growth

Reinforcing the mid- to long-term growth foundation of the CGM business

Drive CGM business growth based on global regulatory approvals, production capacity expansion, partnership expansion, and the potential expansion of insurance coverage.

Shareholder Return

Pursuit of expanded mid- to long-term shareholder returns

Continuously review return policies that enhance shareholder value while balancing growth investment and financial stability.