Latest news with #eyonis™LCS
Business Wire
29-04-2025
- Business
- Business Wire
Median Technologies Reports Full-year 2024 Financial Results
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, 'Median' or the 'Company'), manufacturer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today reported its 2024 consolidated annual financial results, as of December 31, 2024. The consolidated financial statements for the financial year ended December 31, 2024, were audited and approved by the Company's Board of Directors on April 28, 2025. Fredrik Brag, CEO of Median Technologies, commented: 'Median Technologies made significant financial progress in 2024, with growth in revenue and a narrower net loss. Operational efficiencies, announced in 2024, will deliver full results throughout 2025. Our order backlog is at its all-time high. In parallel, we are advancing on the clinical front with the achievement of several significant milestones which pave the way for further important progress through 2025. We successfully completed REALITY, the first pivotal study of our Software as a Medical Device (SaMD) eyonis™ LCS for computer aided detection and diagnosis of lung cancer, in August 2024 and RELIVE, the second and last pivotal study, in March 2025. The U.S. alone has 14.5 million people eligible for an imaging lung cancer screening test and there is already a $650 reimbursement code for the post processing of medical imaging using AI. Our AI-driven SaMD will identify cancer patients at the stage when they could be cured, while also avoiding the significant costs to healthcare systems by reducing the false positives and treatments at a late stage. 'As we move through 2025, we expect to reach further value inflection points including U.S. 510(k) filing of eyonis™ LCS in May, paving the way for commercial launch by the end of the year, and the European CE marking filing in June. Our recent major iCRO agreement with a Top 3 pharma group is already providing strong traction for future growth. After three years of technology investments, iCRO can capitalize on its service differentiation and operational profitability in 2025 to become financially sustainable, enabling Median to focus investments on the eyonis™ LCS commercial launch.' 2024 Financial Highlights On January 31, 2025, the Company reported key business indicators for 2024, and confirms today the audited figures as follows: Full year revenue of €22.9 million as of December 31, 2024, Order backlog 1 at €71.0 million as of December 31, 2024, compared to €66.9 million as of December 31, 2023, a 6.1% YoY increase, Cash and cash equivalents of €8.1 million as of December 31, 2024. Consolidated statement of cash flows under IFRS accounting rules Net cash flow consumption from operating activities decreased from €20.2 million in 2023 to €17.9 million in 2024, driven primarily by working capital efficiencies. Cash and cash equivalents at end of period totaled €8.1 million, compared to €19.5 million at end-2023. The Company's cash position was bolstered in early January 2024 with the drawdown of €8.5m of the second tranche of the 2020 financing facility granted by the European Investment Bank (EIB). Net income statement under IFRS accounting rules Median's 2024 revenue stemmed entirely from the iCRO Business Unit, which provides imaging services to measure drug efficacy in industry-sponsored oncology trials. 2024 full-year revenue was €22.9 million, a 3.3% increase compared to €22.2 million in 2023. Revenue growth accelerated in the second half of 2024 and were 10.2% higher compared to revenues over the same period the prior year. 2024 staff costs were down €1.7 million compared to 2023, from €25.5 million in 2023 to €23.8 million in 2024, primarily due to a decrease in employees' share-based payments. Full year payroll costs remained stable in 2024, which do not yet reflect the significant improvements to enhance the profitability of iCRO operations in H2, 2024. Total headcount decreased from 259 on Dec. 31, 2023, to 227 on Dec. 31, 2024. 2024 external expenses were up €0.6 million compared to 2023. In total, operating loss narrowed slightly, from €23.1 million in 2023 to €22.5 million in 2024. Net financial income was negative in 2024, mainly due to an increase in interest and financial charges of €1.9 million relating to the EIB tranche B financing and the Celestial Successor Fund (CSF) bonds. Most of these interest charges are capitalized, €0.4 million are paid in cash. In total, net loss increased by €2.3 million in 2024, compared to 2023. 2024 operational highlights 2024 operational highlights were published on January 31, 2025. Events subsequent to the financial year-end period Q1 2025 significant events were published . Notable highlights include: The Company's cash position was strengthened in January 2025 with the receipt of €4 million from the initial tranche of the €10 million equity line completed with IRIS, as announced in January 2025. It was further reinforced later in the first quarter with the advanced payment of the 2024 French research and innovation tax credit, of €1.4 million. In Q1 2025, Median and the European Investment Bank (EIB) extended the maturity of the financing facility granted in 2020 by six months, i.e., until October 2025. Furthermore, as previously announced and communicated on the EIB website, the Company is working with the EIB on finalizing an agreement for a new financing facility of up to €37.5 million in the coming weeks, to enable the regulatory and commercialization activities of eyonis™ LCS. Upon completion of the agreement, which would trigger the drawdown of a first tranche, the Company estimates that it will be able to cover its financing needs until Q4 2025. Subsequent tranches of the EIB financing facility will be made available upon completion of certain undisclosed milestones. Fulfilment of these milestones, enabling further drawdowns, should contribute to extending the Company's cash runway until at least the end of 2026. Company upcoming milestones by year-end eyonis™ Lung Cancer Screening (LCS) U.S. FDA 510(k) filing on track for May 2025. eyonis™ LCS filing for CE marking expected in June 2025. eyonis™ LCS commercial launch as soon as year-end 2025 in U.S. pending FDA 510(k) clearance. eyonis™ LCS commercial launch expected in H1 2026 in Europe, pending CE marking. iCRO will continue to increase its profitability, the increase of the order backlog will drive future growth. Median Technologies informs its shareholders and the financial community that its annual financial report on the accounts for the year ended December 31, 2024, has been made available and filed with the French financial market authority (Autorité des Marchés Financiers). The annual financial report is available on the Company's website: About Median Technologies: Pioneering innovative imaging solutions and Software as a Medical Device, 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 a medical device (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). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. 1 The order backlog is the sum of orders received but not yet fulfilled. An increase or decrease in the order backlog corresponds to the order intake of the reporting period, net of invoiced services, completed or cancelled contracts, and currency impact for projects in foreign currency (re-evaluated at the exchange rate on closing date). Orders are booked once the customer confirms, in writing, its retention of the Company's services for a given project. The contract is usually signed a few months after written confirmation.
Business Wire
24-04-2025
- Business
- Business Wire
Median Technologies Reports 2025 Q1 Key Financial Indicators and Provides an Update on Q1 Key Operational Achievements
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, 'Median' or 'The Company'), manufacturer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, releases today its Q1 2025 key financial indicators (unaudited) and provides an update on Q1 operational achievements. Fredrik Brag, CEO and Founder of Median Technologies, commented: 'The past quarter has seen the successful culmination of a transformational period for the Company: we are beginning to see the benefits of ongoing operational optimization in our iCRO business unit, and have recorded a €74.8 million all-time high order backlog. At the same time, after having met all the key endpoints in pivotal studies, RELIVE and REALITY, our lead Software as a Medical Device for lung cancer screening, eyonis™ LCS, has completed clinical development and is entering regulatory registration phase, the final step before commercialization. We expect our game-changing AI-driven SaMD will afford medical professionals' greater efficiency in lung cancer screening – while improving accuracy – to save many lives. Our timing is perfect as the U.S. and the rest of the world are moving now to increase the number of lifesaving lung cancer screenings performed each year. The math is simple, healthcare systems that increase screening capacity, will catch lung cancer early, when it can still be cured; and this will benefit not only the patients we serve but also avoid the tremendous costs of late-stage lung cancer treatment.' eyonis™ LCS SaMD: AI-driven innovation for Lung Cancer Screening Q1 2025 key achievements On March 31, 2025, the Company announced the successful completion of RELIVE, the second pivotal study of eyonis™ LCS, Median's AI-driven Software as a Medical Device (SaMD) for computer aided detection and diagnosis (CADe/CADx) of lung cancer. RELIVE final results confirmed the safety and efficacy of eyonis™ LCS SaMD, successfully completing the studies required to achieve marketing authorizations in the US and Europe. In addition, this March, Median Technologies successfully achieved ISO/IEC 27001:2022 and HDS V2.0 certifications for eyonis™ activities, highlighting the Company's commitment to best practices in information security, including Personal Health Information. The notoriously difficult to obtain ISO 27001:2022 certification (international) and HDS V2.0 certification (France) are key to successful marketing of Median's eyonis™ suite of SaMDs in the US, in Europe and worldwide. The certifications were granted following a rigorous independent audit. ISO/IEC 27001 is the international standard for information security management and sets out a framework for all organizations to establish, implement, operate, monitor, review, maintain and continually improve an Information Security Management System (ISMS). HDS (Hébergeurs de Données de Santé / Health Data Hosting) certification is strongly based on ISO/IEC 27001 requirements and is required for entities that host the personal health data governed by French laws and collected for delivering health services. Upcoming key milestones eyonis™ LCS' regulatory filings for U.S. FDA 510(k) clearance and CE marking, will be submitted in May and June, respectively. Consequently, given normal review times, Median continues to expect eyonis™ LCS' FDA 510(k) clearance in Q3 2025 and CE marking in Q1 2026, as previously communicated. Median eyonis™ teams are preparing for eyonis™ LCS commercial launch in the US, shortly after FDA clearance, around the end of 2025. iCRO: Q1 2025 revenue at €6.0 million confirming return to revenue growth, order backlog at an all-time high of €74.8 million Median revenue during the period stemmed entirely from the iCRO Business Unit, which provides imaging services to measure drug efficacy in industry-sponsored oncology trials. Q1 2025 revenue totaled €6.0 million, up 11%, compared to €5.4 million revenue during the same period in 2024, building on the revenue growth acceleration seen during the second half of 2024. On March 31, 2025, the order backlog 1 hit its highest level ever reached at €74.8 million, vs €71.0 million as of December 31, 2024, i.e., a 5.4% increase primarily driven by new awards and contracts from the undisclosed Top 3 pharma company, to which Median became preferred vendor in May 2024. Cash and cash equivalents as of March 31, 2025 On March 31, 2025, cash and cash equivalents stood at €8.8 million, versus €8.1 million on December 31, 2024. In Q1 2025, the Company's cash position was strengthened with the receipt of €4 million from the first tranche of the equity line completed with IRIS and announced in January 2025 and with the advanced payment of the 2024 French research and innovation tax credit for an amount of €1.4 million. Median and the European Investment Bank (EIB) have extended the maturity of the loan granted in 2020 by six months, i.e., until October 2025. Furthermore, as previously announced, and communicated on the EIB website, the Company is working with the European Investment Bank on finalizing in the coming weeks, an agreement for a new financing facility of up to €37.5 million to enable the regulatory and commercialization activities of eyonis™ LCS. Upon completion of the agreement, which would trigger the drawdown of a first tranche, the Company estimates that it will be able to cover its financing needs until Q4 2025. Subsequent tranches of the above-mentioned EIB financing facility will be made available upon completion of certain undisclosed milestones. Fulfillment of these milestones, enabling further drawdowns, should contribute to extending the Company's cash runway until at least the end of 2026. Next financial release on April 29, 2025, after the market closing: 2024 Financial Report About Median Technologies: Pioneering innovative software as a medical device and imaging 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 a medical device (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). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.
Yahoo
24-04-2025
- Business
- Yahoo
Median Technologies Reports 2025 Q1 Key Financial Indicators and Provides an Update on Q1 Key Operational Achievements
€6.0 million in Q1 2025 revenues, up 11% over Q1 2024 €74.8 million all-time high order backlog as of March 31, 2025 eyonis™ LCS pivotal RELIVE study met all key endpoints U.S. FDA 510(k) filing on track for May 2025, filing for CE marking expected in June 2025. eyonis™ LCS commercial launches as soon as year-end 2025 in U.S. and H1 2026 in Europe, pending regulatory approvals Cash and cash equivalents at €8.8 million as of March 31, 2025 SOPHIA ANTIPOLIS, France, April 24, 2025--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, "Median" or "The Company"), manufacturer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, releases today its Q1 2025 key financial indicators (unaudited) and provides an update on Q1 operational achievements. Fredrik Brag, CEO and Founder of Median Technologies, commented: "The past quarter has seen the successful culmination of a transformational period for the Company: we are beginning to see the benefits of ongoing operational optimization in our iCRO business unit, and have recorded a €74.8 million all-time high order backlog. At the same time, after having met all the key endpoints in pivotal studies, RELIVE and REALITY, our lead Software as a Medical Device for lung cancer screening, eyonis™ LCS, has completed clinical development and is entering regulatory registration phase, the final step before commercialization. We expect our game-changing AI-driven SaMD will afford medical professionals' greater efficiency in lung cancer screening – while improving accuracy – to save many lives. Our timing is perfect as the U.S. and the rest of the world are moving now to increase the number of lifesaving lung cancer screenings performed each year. The math is simple, healthcare systems that increase screening capacity, will catch lung cancer early, when it can still be cured; and this will benefit not only the patients we serve but also avoid the tremendous costs of late-stage lung cancer treatment." eyonis™ LCS SaMD: AI-driven innovation for Lung Cancer Screening Q1 2025 key achievements On March 31, 2025, the Company announced the successful completion of RELIVE, the second pivotal study of eyonis™ LCS, Median's AI-driven Software as a Medical Device (SaMD) for computer aided detection and diagnosis (CADe/CADx) of lung cancer. RELIVE final results confirmed the safety and efficacy of eyonis™ LCS SaMD, successfully completing the studies required to achieve marketing authorizations in the US and Europe. In addition, this March, Median Technologies successfully achieved ISO/IEC 27001:2022 and HDS V2.0 certifications for eyonis™ activities, highlighting the Company's commitment to best practices in information security, including Personal Health Information. The notoriously difficult to obtain ISO 27001:2022 certification (international) and HDS V2.0 certification (France) are key to successful marketing of Median's eyonis™ suite of SaMDs in the US, in Europe and worldwide. The certifications were granted following a rigorous independent audit. ISO/IEC 27001 is the international standard for information security management and sets out a framework for all organizations to establish, implement, operate, monitor, review, maintain and continually improve an Information Security Management System (ISMS). HDS (Hébergeurs de Données de Santé / Health Data Hosting) certification is strongly based on ISO/IEC 27001 requirements and is required for entities that host the personal health data governed by French laws and collected for delivering health services. Upcoming key milestones eyonis™ LCS' regulatory filings for U.S. FDA 510(k) clearance and CE marking, will be submitted in May and June, respectively. Consequently, given normal review times, Median continues to expect eyonis™ LCS' FDA 510(k) clearance in Q3 2025 and CE marking in Q1 2026, as previously communicated. Median eyonis™ teams are preparing for eyonis™ LCS commercial launch in the US, shortly after FDA clearance, around the end of 2025. iCRO: Q1 2025 revenue at €6.0 million confirming return to revenue growth, order backlog at an all-time high of €74.8 million Median revenue during the period stemmed entirely from the iCRO Business Unit, which provides imaging services to measure drug efficacy in industry-sponsored oncology trials. Q1 2025 revenue totaled €6.0 million, up 11%, compared to €5.4 million revenue during the same period in 2024, building on the revenue growth acceleration seen during the second half of 2024. On March 31, 2025, the order backlog1 hit its highest level ever reached at €74.8 million, vs €71.0 million as of December 31, 2024, i.e., a 5.4% increase primarily driven by new awards and contracts from the undisclosed Top 3 pharma company, to which Median became preferred vendor in May 2024. Cash and cash equivalents as of March 31, 2025 On March 31, 2025, cash and cash equivalents stood at €8.8 million, versus €8.1 million on December 31, 2024. In Q1 2025, the Company's cash position was strengthened with the receipt of €4 million from the first tranche of the equity line completed with IRIS and announced in January 2025 and with the advanced payment of the 2024 French research and innovation tax credit for an amount of €1.4 million. Median and the European Investment Bank (EIB) have extended the maturity of the loan granted in 2020 by six months, i.e., until October 2025. Furthermore, as previously announced, and communicated on the EIB website, the Company is working with the European Investment Bank on finalizing in the coming weeks, an agreement for a new financing facility of up to €37.5 million to enable the regulatory and commercialization activities of eyonis™ LCS. Upon completion of the agreement, which would trigger the drawdown of a first tranche, the Company estimates that it will be able to cover its financing needs until Q4 2025. Subsequent tranches of the above-mentioned EIB financing facility will be made available upon completion of certain undisclosed milestones. Fulfillment of these milestones, enabling further drawdowns, should contribute to extending the Company's cash runway until at least the end of 2026. Next financial release on April 29, 2025, after the market closing:2024 Financial Report About Median Technologies: Pioneering innovative software as a medical device and imaging 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 a medical device (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). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. ____________________ 1 The order backlog is the sum of orders received but not yet fulfilled. An increase or decrease in the order backlog corresponds to the order intake of the reporting period, net of invoiced services, completed or cancelled contracts, and currency impact for projects in foreign currency (re-evaluated at the exchange rate on closing date). Orders are booked once the customer confirms, in writing, its retention of the Company's services for a given project. The contract is usually signed a few months after written confirmation. View source version on Contacts MEDIAN TECHNOLOGIESEmmanuelle LeyguesVP, Corporate Marketing & Financial Communications+33 6 10 93 58 Investors - SEITOSEI ACTIFINGhislaine Gasparetto+33 6 21 10 49 U.S. media & investors - COHESION BUREAUChris Maggos+41 79 367 Press – ULYSSE COMMUNICATIONBruno Arabian+33 6 87 88 47 26barabian@ Nicolas Entz+33 6 33 67 31 54nentz@
Yahoo
24-02-2025
- Business
- Yahoo
Median Technologies to Showcase Its Artificial Intelligence Software as a Medical Device for Lung Cancer Screening, eyonis™ LCS, at the European Congress of Radiology
Industry presentation at the AI Theatre: "eyonis™ LCS: Pioneering AI/ML Software as a Medical Device Redefining the Future of Lung Cancer Screening" Median eyonis™ teams will be at booth #AI-18, AI Exhibition, Expo X1 SOPHIA ANTIPOLIS, France, February 24, 2025--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company"), a leading developer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnostics, and a globally leading provider of AI-powered imaging analyses and central imaging services for oncology drug developers, today announced that it will attend the European Congress of Radiology (ECR) 2025 in Vienna, from Feb. 26 to March 2. The Median eyonis™ team will welcome interested parties at Booth #AI-18, AI Exhibition, Expo X1, from February 26 to March 1 (technical exhibits dates). The Company will share the latest developments for eyonis™ Lung Cancer Screening (LCS) Software as a Medical Device (SaMD). The Company recently reported that eyonis™ LCS, its AI-powered SaMD for Lung Cancer Screening met the primary endpoint with statistical significance in RELIVE, the second of two successful pivotal studies required for marketing authorizations in US and Europe ( identifier ID NCT06751576). RELIVE secondary endpoints results will be communicated as soon as all the statistical analyses are finalized. The protocol and primary endpoints for the two pivotal studies, RELIVE and REALITY, were defined in accordance with discussions held with the FDA. By achieving the primary endpoints in both pivotal studies, eyonis™ LCS has successfully completed the regulatory requirements for clinical validation. Consequently, the regulatory dossiers for obtaining the U.S. 510(k) and European CE marking of eyonis™ LCS will be submitted to the agencies in the second quarter of this year. "The recently reported pivotal study results suggest eyonis™ LCS may enable broad implementation of LDCT lung cancer screening procedures by improving lung cancer diagnosis accuracy and addressing the bottlenecks of complexity and time required for analyzing LDCT images," said Thomas Bonnefont, COO and CCO of the eyonis™ Business Unit at Median Technologies. "Based on our strong pivotal results, we are now looking towards our filings for marketing authorizations, in both the US and Europe, in Q2 2025, as soon as we finish the analysis. We will report RELIVE secondary endpoints results in the coming weeks. In the interim, we are very pleased to share the eyonis™ LCS pivotal study results already available, and discuss the game changing potential of our Software as a Medical Device with the radiology community at the European Congress of Radiology", Thomas Bonnefont added. Median's eyonis™ team will present at ECR: Industry Presentation: "eyonis™ LCS: Pioneering AI/ML Software as a Medical Device Redefining the Future of Lung Cancer Screening" Presenter: Valérie Bourdès, MD, VP Clinical and Medical Affairs, eyonis™ - Median TechnologiesSession AI-IND 3 - AI Lightning Talks 3Wednesday, February 26 - 13:30 – 14:30 CETAI Theatre, ACV Building Level -2 Concurrently, Median's iCRO team will present: Research Presentation : "Discord Dilemmas in Lung Cancer Clinical Trials: Navigating Reader Variability in Response Assessment" Author: Hubert Beaumont, Lead Scientist, Median TechnologiesResearch Presentation Session: Oncologic ImagingSession: RPS 116 - Staging, metastases and response assessmentWednesday, February 26 – 8:00 – 9:30 CETACV Building, Research Stage 3 About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an AI/ML-enabled Software as a Medical Device that uses machine learning to analyze imaging data generated with low dose computed tomography (LDCT). eyonis™ LCS aids to diagnose lung cancer at the earliest stages, when it can still be cured in many patients. eyonis™ LCS is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed - ID: NCT06576232) and RELIVE (primary endpoint successfully achieved, secondary endpoints analysis on-going - ID: NCT06751576). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) clearance and CE marking in Q2 2025. About Median Technologies: Pioneering innovative imaging solutions and Software as a Medical Device, 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). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. View source version on Contacts MEDIAN TECHNOLOGIES Emmanuelle LeyguesVP, Corporate Marketing & Financial Communications+33 6 10 93 58 U.S. media & investors Chris MaggosCOHESION BUREAU +41 79 367 Investors Ghislaine GasparettoSEITOSEI ACTIFIN +33 6 21 10 49 Press Caroline CarmagnolALIZE RP +33 6 64 18 99 59median@
Associated Press
24-02-2025
- Business
- Associated Press
Median Technologies to Showcase Its Artificial Intelligence Software as a Medical Device for Lung Cancer Screening, eyonis™ LCS, at the European Congress of Radiology
Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, 'Median' or 'The Company'), a leading developer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnostics, and a globally leading provider of AI-powered imaging analyses and central imaging services for oncology drug developers, today announced that it will attend the European Congress of Radiology (ECR) 2025 in Vienna, from Feb. 26 to March 2. The Median eyonis™ team will welcome interested parties at Booth #AI-18, AI Exhibition, Expo X1, from February 26 to March 1 (technical exhibits dates). The Company will share the latest developments for eyonis™ Lung Cancer Screening (LCS) Software as a Medical Device (SaMD). The Company recently reported that eyonis™ LCS, its AI-powered SaMD for Lung Cancer Screening met the primary endpoint with statistical significance in RELIVE, the second of two successful pivotal studies required for marketing authorizations in US and Europe ( identifier ID NCT06751576). RELIVE secondary endpoints results will be communicated as soon as all the statistical analyses are finalized. The protocol and primary endpoints for the two pivotal studies, RELIVE and REALITY, were defined in accordance with discussions held with the FDA. By achieving the primary endpoints in both pivotal studies, eyonis™ LCS has successfully completed the regulatory requirements for clinical validation. Consequently, the regulatory dossiers for obtaining the U.S. 510(k) and European CE marking of eyonis™ LCS will be submitted to the agencies in the second quarter of this year. 'The recently reported pivotal study results suggest eyonis™ LCS may enable broad implementation of LDCT lung cancer screening procedures by improving lung cancer diagnosis accuracy and addressing the bottlenecks of complexity and time required for analyzing LDCT images,' said Thomas Bonnefont, COO and CCO of the eyonis™ Business Unit at Median Technologies. ' Based on our strong pivotal results, we are now looking towards our filings for marketing authorizations, in both the US and Europe, in Q2 2025, as soon as we finish the analysis. We will report RELIVE secondary endpoints results in the coming weeks. In the interim, we are very pleased to share the eyonis™ LCS pivotal study results already available, and discuss the game changing potential of our Software as a Medical Device with the radiology community at the European Congress of Radiology', Thomas Bonnefont added. Median's eyonis™ team will present at ECR: Industry Presentation: 'eyonis™ LCS: Pioneering AI/ML Software as a Medical Device Redefining the Future of Lung Cancer Screening' Presenter: Valérie Bourdès, MD, VP Clinical and Medical Affairs, eyonis™ - Median Technologies Session AI-IND 3 - AI Lightning Talks 3 Wednesday, February 26 - 13:30 – 14:30 CET AI Theatre, ACV Building Level -2 Concurrently, Median's iCRO team will present: Author: Hubert Beaumont, Lead Scientist, Median Technologies Research Presentation Session: Oncologic Imaging Session: RPS 116 - Staging, metastases and response assessment Wednesday, February 26 – 8:00 – 9:30 CET ACV Building, Research Stage 3 About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an AI/ML-enabled Software as a Medical Device that uses machine learning to analyze imaging data generated with low dose computed tomography (LDCT). eyonis™ LCS aids to diagnose lung cancer at the earliest stages, when it can still be cured in many patients. eyonis™ LCS is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed - ID: NCT06576232) and RELIVE (primary endpoint successfully achieved, secondary endpoints analysis on-going - ID: NCT06751576). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) clearance and CE marking in Q2 2025. About Median Technologies: Pioneering innovative imaging solutions and Software as a Medical Device, 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). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates' or 'plans' and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. Emmanuelle Leygues +33 6 10 93 58 88 [email protected]. media & investors Chris Maggos COHESION BUREAU +41 79 367 6254 [email protected] Ghislaine Gasparetto SEITOSEI ACTIFIN +33 6 21 10 49 24 [email protected] Caroline Carmagnol ALIZE RP +33 6 64 18 99 59 [email protected] KEYWORD: FRANCE EUROPE SOURCE: Median Technologies Copyright Business Wire 2025. PUB: 02/24/2025 11:45 AM/DISC: 02/24/2025 11:45 AM
