[Edaily Reporter YU JIN-HEE ] Huino, an AI-based digital healthcare company, has submitted its application for a preliminary review for listing on KOSDAQ and has officially entered the initial public offering (IPO) race. Amid increasingly stringent screening of biotech IPOs, the company aims to succeed by leveraging its technological capabilities and profitability. Huino is expected to successfully complete the listing process, backed by a large-scale order from its strategic investor (SI), the Yuhan(000100), and its dominant position in the market for top-tier general hospitals.

On Track to Achieve Record-High Revenue and Break Even in a Quarter

According to the pharmaceutical, biotech, and investment banking (IB) industries, Huino recently applied to the Korea Exchange (KRX) for a preliminary review for a KOSDAQ listing. Previously, the company secured an “A” rating from one and a “BBB” rating from another of the two specialized technology evaluation agencies designated by the KRX, thereby qualifying for a technology-based special listing.

The company plans to finalize the public offering process, building on its strong first-half performance and confirmed order volume. It has its sights set on breaking its annual revenue record and reaching the quarterly break-even point (BEP). Consequently, the company is expressing strong confidence in its listing efforts.

Huino’s greatest strength is that its growth is backed by tangible “numbers.” The company is estimated to have achieved cumulative revenue of approximately $4.52 million (about 6 billion won) in the first half of this year alone. This figure far exceeds last year’s total annual revenue.

Behind this steep growth in performance lies a solid distribution partnership with Yuhan. Yuhan recently placed an order with Huino for the core equipment of “MEMO CUE,” an AI-based smart in-hospital monitoring solution. Covering a total of 1,000 hospital beds, the contract is valued at approximately 4 billion won—the largest single supply contract to date.

This order was based not on mere sales forecasts but on pre-order demand from actual hospitals. Additional supply contracts for the second half of the year are also in the pipeline. As a result, the market expects MEMO CUE’s supply volume to easily exceed 2,500 beds by the end of the year. Once revenue recognition for these orders begins in earnest, total annual revenue is projected to exceed 15 billion won. Combined with efforts to streamline R&D costs, the company is highly likely to reach the break-even point by the end of this year.

The core technology highlighted by Huino is “MEMO AI,” a proprietary artificial intelligence model for arrhythmia detection. It was trained on over 750,000 ECG clinical data points verified by cardiologists. Its technical prowess was recognized when it ranked first globally in the “PhysioNet Challenge” organized by Harvard Medical School and the Massachusetts Institute of Technology (MIT) in 2021.

In particular, it has dramatically reduced “alarm fatigue”—a chronic challenge for clinical staff caused by false positives. Through beat-by-beat precision analysis, it completely filters out unnecessary false alarms. This is what has significantly boosted the clinical efficiency and productivity of medical staff.

The hardware’s sophistication is another key differentiator. The Huino wearable patch was the first in Korea to obtain “CF (Cardiac Floating) defibrillation protection” certification—the highest level of electrical safety rating for patient-contact devices. This allows even critically ill patients with implantable cardioverter-defibrillators (ICDs) or pacemakers (PPMs) to undergo continuous monitoring without turning off their devices.

The company has also secured approval from the U.S. Food and Drug Administration (FDA). By applying an ultra-low-power design, it supports up to 14 days of continuous measurement, surpassing the limitations of competing devices. Recently, Huino completed its precision diagnostics lineup by obtaining manufacturing certification from the Ministry of Food and Drug Safety for the “Memo Patch T,” a multi-lead ECG device capable of multi-directional waveform measurement.

These are the reasons why Huino was able to secure large-scale investments from leading companies even amid a downturn in the biotech investment market. Since its founding, the company has raised a cumulative total of 80 billion won in investments from institutional investors, including Yuhan Corporation.

Market Share Exceeds 40% in Tertiary General Hospitals… Expanding Global Sales Channels in the U.S. and Japan

Although a latecomer, the company is making its mark in the market. According to a statistical analysis of Holter monitoring data by the Health Insurance Review and Assessment Service (HIRA), Huino holds a market share of over 40% in the domestic top-tier general hospital market. Despite entering the market about two years later than its competitors, it has rapidly secured a foothold in the top-tier medical institutions.

Memo Q, which secured reimbursement under the National Health Insurance ECG monitoring fee schedule, has been adopted one after another by major hospitals, starting with H+ Yangji Hospital. The company has established an infrastructure covering approximately 1,000 beds, centered on key hospitals such as Korea University Anam Hospital, Busan Veterans Hospital, and Gangneung Korea Hospital. Its flexibility—utilizing existing wireless communication networks without requiring separate capital expenditure (CAPEX) for infrastructure construction—has significantly lowered the barrier to adoption for hospitals.

The commercialization of “Vital-PICASO,” an AI solution for the early prediction of clinical deterioration and a key component of the company’s next-generation pipeline, is also imminent. The hypotension prediction model, developed in collaboration with researchers at Seoul National University Hospital, recorded an accuracy metric (AUROC) of 0.91. The closer the value is to 1, the higher the accuracy. Based on the Ministry of Food and Drug Safety’s certification as an innovative medical device, the company plans to seek approval for non-insured coverage within the year.

Overseas expansion is also proceeding smoothly. After obtaining certification from Japan’s Ministry of Health, Labor and Welfare, the company has signed an exclusive sales agreement with a major local medical device distributor and is preparing to begin supply. In the massive U.S. market, the company is partnering with Yuhan USA and Professor Matsushita’s research team at Johns Hopkins University to integrate the product with local electronic medical records (EMR) systems. It is also accumulating clinical evidence through key medical institutions, such as hospitals affiliated with Harvard Medical School. Recently, the company signed an exclusive distribution agreement with a specialized Vietnamese firm, establishing a foothold in Southeast Asia.

However, there are practical hurdles to overcome during the public offering process. Above all, the key question is whether the company’s valuation of approximately 300 billion won—set during its previous Series C funding round—will meet market expectations. The stock price trends and valuation volatility of #SEERS, a peer company that recently listed on KOSDAQ, could serve as a benchmark for comparison. The immediate priority is to bridge the gap between the high expectations of early-stage venture capital (VC) investors and the current subdued sentiment in the initial public offering (IPO) market.

It is also important to note that competition in the wearable ECG market is intensifying by the day. SEERS Technology has expanded its market reach through a low-margin strategy, and MEZOO Co., Ltd., which has partnered with Donga ST(170900), is also hot on its heels, having recorded sales of around 9.5 billion won in the first half of the year. Amid aggressive marketing campaigns by latecomers, the medium- to long-term challenge is whether the company can maintain its dominance and profitability beyond tertiary general hospitals to include general hospitals and clinics.

In response, Gil Young-jun, CEO of Huino, emphasized, “Based on synergies with Yuhan Corporation, we are expanding the supply of Memo Q beyond cardiac wards to all types of wards,” adding, “We will clearly demonstrate the company’s true corporate value in the capital markets through verified market share at tertiary general hospitals and global export achievements, rather than inflated expectations.”