South Korean MedIAN’s lung cancer AI diagnostic tool “Aionis LCS,” developed by MedIAN, has received FDA approval, and it has jointly established a U.S. distribution network with Tempus AI.

French medical artificial intelligence company Median Technologies is accelerating the commercialization process of lung cancer early detection software “Eyonis LCS” in the United States. Following the approval of the U.S. Food and Drug Administration (FDA)510(k), the company appointed a local legal representative and signed a distribution cooperation agreement with Tempus AI ($TEM), specifically completing preparations for entering the U.S. market.

Full-scale commercialization in the U.S. underway… Simultaneous FDA approval and expansion of sales network

In its annual performance report for 2025 and Q1 2026 business update released on the 23rd, the company stated that Eyonis LCS received FDA 510(k) approval in February this year. According to the company, this product is an AI medical software used for detecting and diagnosing cancer in lung cancer screening programs based on low-dose CT scans. Performance tests show a sensitivity of 93.3%, specificity of 92.4%, and a negative predictive value of 99.9%.

Median Technologies’ target is approximately 14.5 million lung cancer screening candidates in the U.S. The company emphasizes that its advantage lies in utilizing the existing reimbursement code “NT-APC 1508,” which allows for about $650 (approximately 960,450 Korean won) reimbursement per procedure, with the system already in place.

Partnering with Tempus AI, first sales target set for the end of the year

The company signed a non-exclusive distribution agreement with Tempus AI on February 12. Under this agreement, Eyonis LCS will be integrated into Tempus’s “Pixel” platform and supplied through a network of U.S. healthcare institutions, oncology specialists, and diagnostic centers. After obtaining CE marking in Europe in the future, Tempus AI also plans to assist in expanding into the European market.

The U.S. subsidiary Median Eyonis’s new representative is Oran Muduroglu, who has over 30 years of experience in the medical technology industry. The company expects Oran Muduroglu to leverage his experience in building enterprise-level imaging and clinical workflow platforms to lead the U.S. commercialization strategy.

Median Technologies expects to open its first operational site in the U.S. in Q3 2026, with initial sales expected by the end of 2026. In Europe, a decision on CE marking for Eyonis LCS is anticipated within Q2 2026.

Profitability improvement confirmed… Operating loss reduced by 28%

In terms of performance, cost control has been effective. Median Technologies reported full-year 2025 revenue of €23.4 million, a 2.2% increase year-over-year. Operating loss decreased from €22.5 million in 2024 to €16.3 million in 2025, a reduction of 27.6%. This aligns with the company’s emphasized “28% reduction” trend.

Personnel costs decreased from €23.8 million to €19.7 million, and external expenses also declined by €2.9 million due to optimized costs in image interpretation, data transmission, and server hosting. The average number of employees decreased from 241 to 208, reflecting improved operational efficiency.

However, net loss widened. Due to a €13.2 million non-cash impact from fair value changes of European Investment Bank (EIB) warrants and increased financial expenses, net financial loss for 2025 was €17.7 million. As a result, net loss increased by €8.83 million compared to the previous year.

Order backlog hits record high… Cash reserves sufficient until year-end

The company’s main revenue source, the iCRO business segment, showed steady performance. iCRO provides AI central imaging services for clinical trials of anti-cancer drugs. As of March 31, 2026, the order backlog reached €79.8 million, a record high, up 4.2% from €76.6 million at the end of 2025. Revenue in Q1 2026 was €5.8 million.

As of the end of March 2026, cash and cash equivalents totaled €14 million. Although slightly down from €18.2 million at the end of 2025, the company states that current funds can support operations until the end of 2026. Additionally, if the warrants issued in 2025 are further exercised, up to €44.4 million could be raised, further increasing cash reserves.

Median Technologies plans to continue developing “Eyonis IPN” for lung nodules and “Eyonis HCC” for hepatocellular carcinoma while advancing the commercialization of Eyonis LCS for lung cancer diagnosis. Given the FDA approval, distribution cooperation, cost reductions, and record-breaking order backlog, whether Median Technologies can successfully transition from a “tech company” to a revenue-generating commercial enterprise this year remains a key focus.

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