-- eyonis$(R)$ LCS 510(k) clearance sets stage for commercialization in the United States -- New leadership of U.S. subsidiary and collaboration with Tempus accelerate rollout -- 28% reduction in operating loss in 2025 year--over--year, demonstrating strengthened cost discipline and operational efficiency -- iCRO order backlog reaches a new record at EUR79.8 million as of March 31, 2026 -- Cash and cash equivalents of EUR14.0 million as of March 31, 2026 -- Cash runway through year--end 2026, with potential for further extension subject to the exercise of 2025 warrants, representing up to EUR44.4 million in additional proceeds SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--April 23, 2026--
Regulatory News:
Median Technologies (FR0011049824, ALMDT, "Median" or the "Company"), developer of eyonis(R), a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-powered and central imaging services for oncology drug developers, today reported its 2025 consolidated annual financial results, and provided key business highlights (unaudited) for the first quarter of 2026. The consolidated financial statements for the financial year ended December 31, 2025, were audited and approved by the Company's Board of Directors on April 22, 2026.
Fredrik Brag, CEO and Founder of Median Technologies, commented: "Median Technologies began 2026 with a transformational milestone, securing U.S. FDA 510(k) clearance for eyonis(R) LCS and accelerating commercialization efforts to support and scale lung cancer screening programs--delivering a major advance in cancer care by enabling the diagnosis of lung cancer at a stage when it can be cured. Oran Muduroglu, named President of our U.S. subsidiary Median eyonis Inc., brings extensive experience of translating technical innovation into broad U.S. adoption and we have concluded a collaboration with Tempus to expand access. We also anticipate a decision on CE marking for eyonis(R) LCS in the second quarter of 2026, a key regulatory milestone toward broader market access.
The foundation for this momentum was a year of disciplined execution and tangible progress for Median Technologies in 2025, marked by a 28% year--over--year reduction in operating loss while continuing to invest in our strategic priorities. The record EUR79.8 million iCRO order backlog highlights the strength and visibility of our business.
Our cash position of EUR14.0 million as of March 31, 2026 supports the execution of our strategic priorities--including the ramp-up of U.S. commercialization of eyonis(R) LCS and the anticipated CE marking decision--providing a cash runway through year--end 2026 and beyond, with the potential for further extension subject to the exercise of 2025 warrants, representing up to approximately EUR44 million in additional proceeds."
Q1 2026 Operational and Financial Update (unaudited)
eyonis(R) LCS Software as a Medical Device: AI-driven Innovation for Lung Cancer Screening
Q1 2026 Key Achievements
Median Technologies successfully executed on key strategic milestones in the first quarter of 2026, significantly advancing its readiness for the commercial launch of eyonis(R) LCS in the United States.
On February 9, 2026, Median Technologies announced that it has received FDA 510(k) clearance for eyonis(R) LCS, the first AI--based device for the detection and diagnosis of lung cancer in screening programs. eyonis(R) LCS uniquely combines detection and characterization of lung cancer on low--dose CT scans, with 93.3% sensitivity, 92.4% specificity and a 99.9% negative predictive value (manufacturer performance testing on a lung cancer screening reference population). U.S. authorization is expected to enable large--scale deployment of lung cancer screening programs for the approximately 14.5 million eligible individuals nationwide, supported by a clear and predictable reimbursement pathway through the existing NT--APC 1508 code with current reimbursement set at approximately USD 650 per procedure.
On February 12, 2026, Median Technologies announced collaboration with Tempus AI, Inc. $(TEM)$, a U.S. technology company leading the adoption of AI to advance precision medicine, to expand access to eyonis(R) LCS Software as a Medical Device in the United States. The non-exclusive distribution agreement leverages Tempus' established position in oncology and AI-based precision medicine, and its strong network of healthcare providers, oncologists, and diagnostic centers. Under the distribution agreement, eyonis(R) LCS will be integrated into the clinical workflow through the Tempus Pixel platform. Tempus AI would also support the commercial rollout of eyonis(R) LCS across Europe, after the achievement of eyonis(R) LCS CE marking.
On February 18, 2026, Median Technologies announced the naming of Oran Muduroglu as President of Median eyonis Inc., the Company's U.S. subsidiary responsible for the commercial deployment of eyonis(R) LCS in the United States. A seasoned medical technology entrepreneur, Oran Muduroglu will lead the U.S. commercial rollout of eyonis(R) LCS. He brings more than three decades of experience designing, building, and scaling enterprise imaging and clinical workflow platforms, with a proven track record of translating complex technological innovation into broad adoption across the U.S. healthcare market.
On March 18, 2016, Median Technologies announced that the eyonis(R) Quality Management System has achieved ISO 13485:2016 certification. This key milestone supports the industrialization and global scaling of the eyonis(R) portfolio, strengthens the Company's regulatory pathway, and reinforces Median Technologies' commitment to delivering safe, reliable, and clinically meaningful oncology solutions.
Strategic Outlook and Upcoming Key Milestones
To support the commercial development of eyonis(R) LCS in the United States, Median eyonis Inc. is implementing a comprehensive go--to--market strategy aimed at accelerating adoption and gaining broad market access within lung cancer screening programs. This strategy is built on a multi--channel commercial model that integrates direct enterprise sales, strategic non--exclusive distribution partnerships, and seamless incorporation into established clinical workflows. To execute this strategy, Median eyonis Inc. is actively strengthening its U.S.-based commercial, technological and clinical support infrastructure and engaging with leading U.S. healthcare institutions and networks to establish strategic clinical partnerships that will enable broad and scalable access to eyonis(R) LCS nationwide.
Following the execution of its first non--exclusive eyonis(R) LCS distribution agreement with Tempus, Median Technologies is engaged in advanced discussions with several additional industry leaders to further expand its commercial reach across the United States and Europe. The Company is targeting additional non--exclusive distribution agreements with top--tier imaging, cloud technology, and diagnostics partners to support scalable market penetration.
The Company expects the first U.S. sites to be operational in Q3 2026, with first revenue generation by the end of 2026.
In Europe, the Company expects a decision on eyonis(R) LCS CE marking in the second quarter of 2026, paving the way for broad adoption and expanded access to potentially hundreds of thousands of patients across European lung cancer screening programs.
In 2026, alongside the commercial rollout of eyonis(R) LCS, Median Technologies will continue development of additional SaMD within the eyonis(R) portfolio, with a focus on eyonis(R) IPN (Incidental Pulmonary Nodules) and eyonis(R) HCC (Hepatocellular Carcinoma). The expansion of this portfolio will leverage current commercial efforts and reinforce Median's global position in early cancer diagnosis based on AI.
iCRO: AI-driven and central imaging services for oncology drug development
Q1 2026 Key Achievements
Median's order backlog(1) and revenue come entirely from the iCRO Business Unit, which provides AI-powered and central imaging services for industry--sponsored oncology clinical trials.
As of March 31, 2026, the Company's order backlog reached EUR79.8 million an all--time high, providing strong revenue visibility over the next several years. This represents an increase of 4.2% compared to December 2025 (EUR76.6 million).
Q1 2026 revenue totaled EUR5.8 million.
2026 Strategic Outlook and Key Milestones
Median's iCRO business is actively executing its global key account strategy across the three major industry regions--North America, Europe, and Asia.
Leveraging its well--recognized expertise in oncology imaging and artificial intelligence, iCRO is well positioned to attract new clients across both large pharmaceutical companies and emerging biotech organizations, while deepening existing relationships by expanding the scope of services supporting drug development.
Since late 2025, Median iCRO has expanded its capabilities to provide central imaging services in new therapeutic areas beyond oncology, with a particular focus on central nervous system $(CNS)$ and musculoskeletal (MSK) clinical trials, expanding its addressable market.
The profitability of the iCRO business is expected to continue to increase throughout the rest of 2026, driven by Median's highly differentiated, high--value imaging technologies and sustained growth in demand for advanced AI--enabled solutions. Furthermore, the progressive integration of AI into imaging project operational workflows--currently under development--is expected to create meaningful operating leverage by enhancing service quality, accelerating project execution, and improving business scalability and overall productivity.
Company cash and cash equivalents as of March 31, 2026
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