eyonis™ LCS Achieves Key Milestones in REALITY Study; Upcoming Webcast Scheduled
Key Highlights:
- The eyonis™ Lung Cancer Screening (LCS) pivotal REALITY study successfully met all primary and secondary endpoints.
- A webcast featuring Key Opinion Leaders will take place on November 7, 2024, to discuss the results of the REALITY study.
- Median Technologies plans to submit U.S. and European marketing authorization applications for eyonis™ LCS in H1 2025.
- The company reported €6.2 million in Q3 2024 revenue, marking a 10.7% increase compared to Q3 2023.
- Total revenue for the year-to-date (as of September 30, 2024) reached €17.1 million.
- Median iCRO secured its first two projects in Q3 as the preferred provider for a leading oncology pharmaceutical company.
- Cash and cash equivalents totaled €11.5 million as of September 30, 2024.
Operational and Financial Overview:
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) announced that its Board of Directors approved the consolidated IFRS financial statements for H1 2024 on October 23, 2024, along with operational and financial updates for Q3 2024.
Fredrik Brag, CEO and Founder, expressed excitement over the successful results of the eyonis™ LCS in the REALITY study, stating, “This pivotal study marks a significant advancement in early lung cancer diagnostics. We look forward to sharing data from our ongoing second pivotal trial, RELIVE, soon. Our goal is to submit regulatory filings in both the U.S. and Europe by H1 2025.”
He emphasized the importance of early lung cancer diagnosis, which could save healthcare systems significant costs associated with advanced cancer care. Although Lung Cancer Screening has been reimbursed in the U.S. since 2015, the lack of approved software devices has limited its adoption.
Q3 2024 Results:
The eyonis™ LCS achieved remarkable performance during the REALITY study, achieving an area under the curve (AUC) value of 0.904, significantly exceeding the primary endpoint of 0.80. The study analyzed data from 1,147 patients, highlighting the AI capabilities of eyonis™ LCS in diagnosing challenging cases.
A webcast with Key Opinion Leaders involved in the study will occur on November 7, 2024, to discuss its implications for pulmonologists treating lung cancer patients.
iCRO Business Update:
Median Technologies’ iCRO business unit continues to grow, gaining preferred provider status from two top-three global pharmaceutical companies in oncology. In Q3, the company signed two initial studies with a major oncology pharmaceutical firm and secured deals in South Korea and Japan.
In Q3 2024, Median’s revenue reached €6.2 million, a 10.7% increase from both the previous quarter and Q3 2023. The year-to-date revenue stood at €17.1 million, reflecting strong recovery despite earlier delays, particularly in China.
Financial Position:
As of September 30, 2024, cash and cash equivalents amounted to €11.5 million, down from €16 million on June 30, 2024. This does not include an expected €1.6 million tax credit. The company’s operations are fully financed until Q2 2025, with plans to extend the maturity of its 2020 loan and explore additional funding options.
Financial Highlights for H1 2024 (IFRS):
- Revenue: €10.9 million (down from €11.4 million in H1 2023)
- Operating Loss: €13.3 million
- Net Loss: €12.5 million
For further details, the half-year financial report is available on the company’s website: Median Technologies Investor Page.
About eyonis™ LCS:
eyonis™ LCS is an AI-powered diagnostic device designed to analyze imaging data from low-dose computed tomography (LDCT) scans to facilitate early lung cancer diagnosis. It has completed one pivotal study (REALITY) and is currently undergoing a second (RELIVE), with regulatory filings expected in 2025.
About Median Technologies: Pioneering innovative imaging solutions and services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, an AI/ML tech-based suite of software as medical devices (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME).