Coreline Succeeds in Germany, VUNO Stalled in U.S.... Diverging Overseas Performance for Korean Medical AI

Coreline Expands Subscription Revenue, Benefiting from German Lung Cancer Screening Reimbursement
Lunit Achieves Topline Growth via Major North American Radiology Service Channels
VUNO Faces Uncertainty in U.S. Insurance Entry Due to DeepCARS FDA Approval Delay

The first-quarter performance of major domestic medical artificial intelligence (AI) companies targeting overseas markets has drawn attention for its varied outcomes depending on the country. Coreline Soft, which has entered Germany's national lung cancer screening program, saw its revenue increase by nearly 50%. Lunit, which secured partnerships with major radiology service providers in North America, posted its highest-ever first-quarter results. In contrast, VUNO, which missed the timing to enter the U.S. insurance market due to delayed U.S. Food and Drug Administration (FDA) approval, experienced a decline in revenue.

German Lung Cancer Screening Reimbursed... Coreline Expands Subscription-Based Revenue

According to the industry on May 19, Coreline Soft's consolidated revenue for the first quarter was 1.3 billion won, up 48.7% year-on-year. Overseas revenue accounted for 62.4%, exceeding half of the total. The market is paying close attention to changes in Coreline Soft's revenue structure. The share of permanent licenses—sales that end after a single purchase—has declined, while a structure in which revenue is generated repeatedly based on the number of screenings and contract terms has become established. In the first quarter, recurring revenue based on usage and contract period accounted for 49.0%, up 10.1 percentage points from 38.9% a year earlier. Revenue from pay-per-use (PPU) billing increased by 319.7% over the past year.

The most prominent growth in Coreline Soft's recurring revenue was seen in Germany. Since April 1, Germany has begun covering low-dose computed tomography (LDCT) lung cancer screening for smokers aged 50 to 75 under its national health insurance system. This means that out-of-pocket costs for patients have virtually disappeared. The newly eligible population for screening is estimated at around 5.5 million people. In the first quarter, Coreline Soft secured 11 new hospital contracts in Germany, surpassing its annual target of 10 new contracts for 2025 within just one quarter. Major German medical institutions, including Charite Berlin, Heidelberg University Hospital, and Hannover Medical School Hospital, have become clients.

Lunit Expands Partnerships with Major North American Radiology Companies... Growth in Scale, Profitability Remains a Challenge

Unlike Coreline Soft, which is aiming to be incorporated into national screening systems, Lunit is focusing on securing screening volumes through direct contracts with major local radiology service providers. Lunit reported consolidated first-quarter revenue of 24 billion won, up 25% year-on-year, marking its highest-ever first-quarter result. Overseas revenue made up as much as 97% of the total.

The key driver of this growth was expansion in North America. The results of the first quarter reflected the impact of Lunit International, a Lunit subsidiary, renewing its contract with RadNet, one of the largest outpatient radiology service providers in North America. RadNet operates outpatient imaging centers across the United States, and as the number of screening images analyzed by Lunit Insight increases, so does the company’s revenue. Currently, North America accounts for about 70% of Lunit's cancer diagnosis business revenue.

In Japan, revenue from the partnership with Fujifilm grew by 70% compared to the previous quarter. As of the end of the first quarter, Lunit’s solutions had been adopted by around 3,600 medical institutions worldwide, with approximately 9,500 medical professionals using them. The annual number of medical images analyzed is about 19.7 million. However, profitability remains an issue. Lunit posted an operating loss of 13.6 billion won in the first quarter, continuing its losses. Although revenue is rapidly increasing, there is a consensus that the company has not yet entered a full-fledged profit recovery phase.

Delay in Approval for DeepCARS... VUNO's U.S. Market Strategy Stalls

VUNO, a biosignal-based AI medical device company, faced increased uncertainty regarding its U.S. market entry timetable and posted disappointing first-quarter results. Consolidated revenue was 6 billion won, down 19.3% year-on-year, with overseas revenue accounting for only 0.4%.

The U.S. launch of VUNO's flagship product, the AI cardiac arrest prediction solution "VUNO Med DeepCARS," has also hit a snag. VUNO recently received a notice from the FDA that the 510(k) clearance for DeepCARS was denied due to insufficient evidence of substantial equivalence (NSE). The 510(k) is a regulatory process that requires proof that a new product performs substantially similarly to an already approved device. DeepCARS is VUNO's core product, expected to account for 25.7 billion won of the company's total revenue of 34.8 billion won in 2025.

The delay in FDA approval has a major impact as it is directly tied to reimbursement schedules in the U.S. The Centers for Medicare & Medicaid Services (CMS) had considered including DeepCARS in the new technology add-on payment (NTAP) program for hospitals, but the prerequisite was FDA approval. With this certification delay, the timeline for obtaining reimbursement in the U.S. is also likely to be postponed.

Industry insiders say that the monetization strategies of domestic medical AI companies are becoming increasingly divergent. One industry source commented, "For medical AI, it has now become critically important to establish a repeat usage and payment structure within actual healthcare systems," adding, "Ultimately, the gap between companies will widen depending on who is first to build a stable recurring revenue model and successfully link it to profitability."

This content was produced with the assistance of AI translation services.