Announcement • Jun 04
Median Technologies SA has completed a Follow-on Equity Offering in the amount of €50 million. Median Technologies SA has completed a Follow-on Equity Offering in the amount of €50 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,000,000
Price\Range: €5
Transaction Features: Regulation S Announcement • May 27
Median Technologies SA has filed a Follow-on Equity Offering in the amount of €50 million. Median Technologies SA has filed a Follow-on Equity Offering in the amount of €50 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,000,000
Price\Range: €5
Transaction Features: Regulation S Board Change • May 20
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. No independent directors (7 non-independent directors). Member of Clinical Advisory Board for Lung Cancer Screening Javier Zulueta was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Announcement • May 01
Median Technologies SA, Annual General Meeting, Jun 10, 2026 Median Technologies SA, Annual General Meeting, Jun 10, 2026. Location: 174 avenue victor hugo, paris France Announcement • Mar 03
Median Technologies to Showcase Eyonis®? LCS , Its AI/ML-Based Software as A Medical Device for Lung Cancer Screening, At the European Congress of Radiology Median Technologies announced that it will feature eyonis®? LCS at the European Congress of Radiology (ECR) 2026 in Vienna, March 4-6, 2026. The Median eyonis®? team will welcome attendees at Booth #AI-16, AI Exhibition, Expo X1, from March 4 to March 7 (technical exhibition dates), to present the latest developments related to eyonis®? Lung Cancer Screening (LCS), its AI-powered Software as a Medical Device (SaMD). On February 9, 2026, Median announced that eyonis®? LCS, its AI-based CADe/CADx SaMD for lung cancer screening, received FDA 510(k) clearance for detection and characterization of parenchymal pulmonary nodules in low-dose CT (LDCT) scans. eyonis®? LCS is the only medical device software capable of detecting and characterization of lung cancer in LDCT scans, achieving 93.3% sensitivity, 92.4% specificity, and 99.9% negative predictive value (NPV) (manufact manufacturer values calculated on a lung cancer screening reference population). eyonis®? LCS helps clinicians identify suspicious findings at early stages, enhancing the efficiency and consistency of lung cancer screening programs. Median continues to advance along the European regulatory pathway for eyonis®? LCS and anticipates obtaining CE marking in second quarter 2026. Announcement • Feb 19
Median Technologies Launches Eyonis® Lcs Software for Lung Cancer Screening Following Fda Clearance Median Technologies has announced the launch of eyonis® LCS, an AI-powered Software as a Medical Device (SaMD) for lung cancer screening, following its FDA 510(k) clearance. Oran Muduroglu has been appointed as President of Median eyonis Inc. to lead the U.S. commercialization of this software. The company has established a commercial and clinical infrastructure, including a Medicare reimbursement pathway, to support the expansion of eyonis® LCS across the U.S. The launch strategy includes forming key clinical partnerships and engaging with healthcare providers to enhance access to lung cancer screening programs. The first U.S. sites are expected to be operational in Third Quarter 2026. Announcement • Feb 18
Median Technologies Appoints Oran Muduroglu as President and Executive Chairman of Median Eyonis Inc Median Technologies announced the appointment of Oran Muduroglu as President of Median eyonis Inc., Median’s U.S. subsidiary. Oran will continue to serve as Executive Chairman of the Board of Directors of Median Technologies while assuming operational leadership of U.S. commercialization. Oran brings more than three decades of experience building, engineering, and scaling enterprise imaging and workflow platforms, consistently translating technical innovation into broad U.S. adoption. He led the sale of Cemax to 3M/Imation in 1995, helping accelerate the transition to modern Picture Archiving and Communication Systems (PACS). He later co-founded Stentor, acquired by Philips in 2005, which became one of the first enterprise platforms enabling fully digital imaging workflows and an early SaaS model in medical imaging, reaching the number two U.S. market position within three years. Further, as CEO of Medicalis, acquired by Siemens Healthineers in 2017, he led commercialization of a clinical decision support and workflow platform adopted by approximately nine of the top 15 U.S. health systems. In 2018, Alphabet’s Verily recruited him to lead development of a value-based care platform supporting physician groups in managing Medicare Advantage risk. Across these ventures, Oran has led complex national deployments requiring deep Electronic Medical Records (EMR) and PACS interoperability, rigorous product development, disciplined enterprise sales, and alignment with evolving reimbursement models — experience directly relevant to the U.S. launch of eyonis® LCS. Announcement • Feb 10
Median Technologies Receives FDA 510(K) Clearance for eyonis®? LCS, the First AI Tech-Based Detection and Diagnosis Device for Lung Cancer Screening Median Technologies announced it has received FDA 510(k) clearance for eyonis®? LCS, its AI/ML-powered computer-aided detection and diagnosis (CADe/CADx) Software as a Medical Device intended for lung cancer screening. Lung cancer is the leading cause of cancer death in the United States, and patient outcomes are substantially improved when cancer is identified at early stages. Curable stage 1 lung cancer can be diagnosed through Low-Dose CT (LDCT) screening, yielding ~80% long-term survival versus 15% 5-year survival in symptom-detected disease. By supporting detection and characterization of parenchymal pulmonary nodules on LDCT scans, eyonis®? LCS is designed to help clinicians identify suspicious findings earlier, reduce inter- reader variability and improve the efficiency and consistency of lung cancer screening programs. Based on current eligibility criteria, 14.5 million individuals qualify for screening, and this population is expected to increase over time as screening guidelines expand. Median Technologies believes that eyonis®? LCS can play a major role in helping healthcare systems expand access to screening, reduce operational burden, and support more standardized parenchymal nodule evaluation, particularly as screening volumes grow amid a worsening shortage of radiologists. This opportunity is supported by an existing reimbursement framework: AI-driven CT tissue characterization is reimbursed under Category III CPT codes 0721T and 0722T, both assigned to New Technology APC 1508, with Medicare payments ranging from $601-$700. These codes provide a predictable payment pathway that accelerates adoption of advanced AI medical devices among U.S. imaging providers. eyonis®? LCS is positioned to leverage this established reimbursement pathway, generating immediate economic value for imaging providers and accelerating nationwide adoption. Median plans to commercialize eyonis®? LCS in the United States through a combination of direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments. Median will utilize the current CMS reimbursement framework, including applicable New Technology APC pathways, while working toward broader, long-term insurance coverage. The Company will provide further details regarding the commercial launch in the coming weeks. These statements are not historical facts. They include projections and estimates as well as the assumptions on which are based, statements concerning projects, objectives, intentions, and support support the efficiency and consistency of lung Cancer screening programs. Announcement • Jan 14
Median Technologies SA to Report Fiscal Year 2025 Results on Apr 23, 2026 Median Technologies SA announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Apr 23, 2026 Board Change • Dec 30
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. No independent directors (7 non-independent directors). Member of Clinical Advisory Board for Lung Cancer Screening Javier Zulueta was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Announcement • Nov 26
Median Technologies to Showcase AI-Powered Software as a Medical Device Eyonis LCS for Lung Cancer Screening at the RSNA 2025 Annual Meeting Median Technologies announced that it will attend the Radiological Society of North America (RSNA) 2025 Annual Meeting in Chicago, Il, USA, McCormick Place, from November 30-December 4, 2025. It has been evaluated in two pivotal studies required for marketing approvals in the U.S. and Europe, both of which have been successfully completed: REALITY (ClinicalTrials.gov ID: NCT06576232) and RELIVE (ClinicalTrials.com ID: NCT06751576). Based on these data, Median Technologies submitted its U.S. 510(k) clearance application for eyonis LCS on May 13, 2025, and its European CE mark application on June 30, 2025. eyonis LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet commercially available in the U.S. or Europe. eyoni Lung Cancer Screening (LCS) is an artificial intelligence AI-based computer aided detection and diagnosis (CADe/CADx) system, or Software as a Medical Device (SaMD) that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT). eyoni LCS empowers radiologists to diagnose lung cancer at its earliest, most treatable stages—when curative options remain possible for many patients. eyoni LCS has been the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (Clinicaltrials.gov ID: NCT06576232) and RELIVE (Clinicaltrials.gov ID: NCT06751576), both of which have been successfully completed. Based on these pivotal data, Median Technologies submitted U.S. application for 510(k) clearance of eyoni LCS on May 13th, 2025, and European application for CE mark on June 30th, 2025. eyoni LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet for sale in the US and in Europe. Announcement • Nov 04
Median Technologies Appoints Didric Cederholm to Its Board of Directors, Effective October 30, 2025 Median Technologies SA announced that Didric Cederholm has joined its Board of Directors, chaired by Oran Muduroglu. The appointment was approved during the ordinary shareholders’ meeting, held on October 30, 2025. Didric Cederholm is a Founding Partner and the Chief Investment Officer of Lion Point Capital, a global special situations investment fund. Prior to founding Lion Point Capital, Didric spent nearly eight years at Elliott Management and was previously a Principal at Eos Partners. Didric graduated in 2003 with honors from Columbia Business School, where he was a Fulbright Scholar, and has a LLM from Stockholm University, where he graduated in 2001. From 1997-1999, Didric served in the Swedish Armed Forces as an Interrogation Officer and later as a 2nd Lieutenant in Swedish Military Intelligence. Didric lives in New York City with his wife, Kristin, and their 4 children. Announcement • Sep 29
Median Technologies SA, Annual General Meeting, Oct 31, 2025 Median Technologies SA, Annual General Meeting, Oct 31, 2025. Location: 174 avenue victor hugo, paris France Announcement • Sep 08
Median Technologies SA to Report First Half, 2025 Results on Oct 23, 2025 Median Technologies SA announced that they will report first half, 2025 results on Oct 23, 2025 Announcement • Aug 01
Median Technologies SA has completed a Follow-on Equity Offering in the amount of €23.944738 million. Median Technologies SA has completed a Follow-on Equity Offering in the amount of €23.944738 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 14,424,541
Price\Range: €1.66
Transaction Features: Rights Offering Announcement • Jul 23
Median Technologies SA has filed a Follow-on Equity Offering in the amount of €22 million. Median Technologies SA has filed a Follow-on Equity Offering in the amount of €22 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 13,253,012
Price\Range: €1.66
Transaction Features: Rights Offering Announcement • May 14
Median Technologies Submits U.S. Application for 510(K) Clearance of Eyonis LCS Median Technologies announced that it has filed an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis LCS, its AI/ML tech-based SaMD for computer aided detection and diagnosis (CADe/CADx) in lung cancer screening. The submission is based on positive data from the two pivotal studies of eyonis LC, REALITY and RELIVE, both of which met their primary endpoints. This data demonstrated that eyonis LCS provides robust diagnostic performance for early detection and characterization of lung nodules in high-risk lung cancer populations, with significant potential to impact patients' clinical outcomes. Additionally, Median's eyonis LCS SaMD confirmed safety and efficacy in RELIVE, the second and last pivotal study. RELIVE and REALITY pivotal studies met their primary endpoints and confirmed the device's safety and efficacy. This shows that eyonis LCS has the potential to be a game-changer in lung cancer screening. By providing early detection and characterization at scale, eyonis LCS can significantly improve high-risk patient outcomes. This represents a total addressable annual market of over $10 billion. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia. In the US alone, the direct medical costs of cancer patients care were estimated to be nearly $230 billion in 20231. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that save patients' lives. Announcement • Apr 01
Median Technologies Announces Pivotal Study RELIVE's Final Results Median Technologies disclosed pivotal study RELIVE's final results, which confirm and complement the top-line results released on February 3, 2025. This successfully concludes the pivotal studies of Median's AI/ML-based computer aided detection and diagnosis (CADe/CADx) SaMD, eyonis Lung Cancer Screening (LCS), a key requirement for regulatory submissions in the US and Europe. The US FDA filing is on track for formal submission in May 2025, shortly followed by filing for CE marking in Europe in June. Consequently, given normal review times, Median expects eyonis™ LCS' FDA 510(k) clearance in Third Quarter 2025 and CE marking in First Quarter 2026, as previously communicated. The eyonis™ LCS SaMD was developed for the following intended use: firstly, to allow early detection and characterization of probably benign, suspicious or very suspicious lung nodules in order to aid cancer diagnosis and to drive the clinical management of patients; secondly, to aid radiologists in the detection, localization, characterization and assessment of pulmonary nodules from medical images by generating a proprietary result report that highlights lung nodules as " probably benign" or "suspicious" or "very suspicious" and scores nodules individually; and, thirdly, to aid the identification of tumor at its earliest stage, to allow better patient care while reducing the number of unnecessary tests, procedures and healthcare costs. Based on a highly enriched cohort, RELIVE study final results show that Median's eyonis™ LCSSaMD met all key endpoints, demonstrating statistically significant performance, superior to device safety and efficacy. The results support the intended use for which eyonis™ LCS was developed, which was shared with the EU Notified Body and discussed with the FDA during the Q-submission phase. Device efficacy and safety in line with intended use are mandatory requirements for obtaining marketing authorizations from regulatory bodies in the US and Europe. Median Technologies intends to present pivotal study results including RELIVE study data, at upcoming ad-hoc medical and scientific conferences and submit scientific papers in peer-reviewed publications in the coming quarters. If caught early, lung cancer can most often be cured. AI-based Software as Medical Device will facilitate the scalability of lung cancer screening programs worldwide. Median Technologies has developed eyonis™ LCS as a unique artificial intelligence based SaMD to scale up Low Dose CT lung cancer screening programs in the United States, Europe and the rest of the world in order to save people’s lives, support medical professionals in completing more screening procedures and reduce healthcare costs. Announcement • Feb 25
Median Technologies to Showcase Its Artificial Intelligence Software as a Medical Device for Lung Cancer Screening, eyonis™ LCS, at the European Congress of Radiology Median Technologies 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). 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. Announcement • Feb 03
Median Technologies: Eyonis Lung Cancer Screening (LCS) Meets Primary Endpoint in Relive Clinical Trial, the Final Pivotal Study Required for Regulatory Submissions Median Technologies announced that eyonis™ LCS, its wholly owned proprietary AI/ML-based CADe/CADx Software as a Medical Device (SaMD) for lung cancer screening, met the primary endpoint in RELIVE. Top-line data from RELIVE shows that eyonis™ LCS together with radiologist achieved statistically significant improvement over radiologist alone (p=0.027). RELIVE is the second of two pivotal studies required for marketing authorization in U.S. and Europe. By meeting primary endpoint in RELIVE, eyonis™ LCS has successfully completed its clinical validation and confirmed the analytical validation previously achieved in REALITY, a standalone pivotal study which results were announced in August 2024. Successful pivotal studies are a key prerequisite of regulatory submissions both in the US and in EU. Consequently, eyonis™ LCS regulatory filings are now being prepared for U.S. FDA 510(k) filing and EU CE marking and will be submitted in Second Quarter 2025. Median’s eyonis™ LCS AI/ML-based CADe/CADx SaMD is designed to improve diagnostic accuracy of radiologists in analyzing low dose computed tomography (LDCT) scans for lung cancer screening. Lung cancer is the number one killer of all cancers. A recent study showed that only 16% of lung cancers are diagnosed at an early stage and, because most were detected too late, the average five-year survival rate for all lung cancer patients is 18.6%1. Conversely, Stage 1 lung cancer can be cured, with an 80% survival rate after 20 years. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to reach 92%. The primary objective of RELIVE, a multi-reader multi-case (MRMC) trial conducted on a cohort of 480 patients at high-risk of developing lung cancer, was to demonstrate, through a superiority test run by a set of 16 radiologists, that eyonis™ LCS can improve clinicians’ diagnostic accuracy in analyzing LDCT lung cancer screening scans, by helping in the detection localization and characterization of lung nodules, by reducing false positives and by driving clinical management to avoid unnecessary follow-up procedures. Top-line data from RELIVE shows that eyonis™ LCS achieved statistically significant improvement over radiologist alone (p=0.027). This finding demonstrates that eyonis™ LCS may save lives of patients, time for healthcare professionals as well as reduce cancer costs for payers. Additional RELIVE data, including multiple secondary endpoints, are being analyzed and will be reported in the coming weeks. RELIVE data will be shared in future Median Technologies communications and at upcoming medical and scientific conferences. More information regarding RELIVE study can already be found on ClinicalTrials.gov, study ID NCT06751576. The first pivotal study, REALITY, initially communicated in August 2024, collected retrospective imaging and clinical data from 1,147 patients. REALITY evaluated eyonis™ LCS’ ability to diagnose and characterize cancerous vs non-cancerous patients (i.e. “performance at patient level”), and detect and characterize suspicious versus malignant nodules using LDCT lung screening scans. Both RELIVE and REALITY studies were performed using retrospectively collected imaging and clinical data from patients from five major cancer centers and hospitals in the US and in EU, along with two US data providers. About lung cancer screening in the U.S.:Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history and covered by Medicare; the eligible population is currently of 14.5 million people. There already is an existing reimbursement of $650 per SaMD procedure creating a substantial commercial opportunity to improve patient care in this addressable market. Furthermore, the eligible patient number is expected to rise in the coming years, driven by planned broadening of the eligible U.S. population by USPTF. Similarly, new lung screening program deployments are planned in Europe and Asia. About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an artificial intelligence AI/ML-enabled Software as a Medical Device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to aid 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 - Clinicaltrials.gov ID: NCT0657623) and RELIVE (primary endpoint successfully achieved, secondary endpoints analysis on-going - Clinicaltrials.gov ID: NCT06751576). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) clearance and CE marking in Second Quarter 2025. Announcement • Jan 15
Median Technologies SA to Report Fiscal Year 2024 Results on Apr 29, 2025 Median Technologies SA announced that they will report fiscal year 2024 results at 5:40 PM, Central European Standard Time on Apr 29, 2025 New Risk • Jan 10
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€20m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Negative equity (-€22m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€23m net loss in 2 years). Market cap is less than US$100m (€85.3m market cap, or US$87.4m). Board Change • Dec 30
No independent directors There are 7 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 7 new directors. 2 experienced directors. 3 highly experienced directors. No independent directors (6 non-independent directors). Chairman of the Board of Directors Oran Muduroglu is the most experienced director on the board, commencing their role in 2009. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. Lack of experienced directors. Reported Earnings • Oct 27
First half 2024 earnings released: €0.68 loss per share (vs €0.64 loss in 1H 2023) First half 2024 results: €0.68 loss per share (further deteriorated from €0.64 loss in 1H 2023). Revenue: €10.9m (down 4.0% from 1H 2023). Net loss: €12.5m (loss widened 24% from 1H 2023). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in Europe. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 38% per year, which means it is performing significantly worse than earnings. New Risk • Oct 25
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€10m). Earnings are forecast to decline by an average of 2.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€25m net loss in 3 years). Market cap is less than US$100m (€72.6m market cap, or US$78.6m). New Risk • Sep 09
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €83.8m (US$92.5m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€22m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Negative equity (-€10m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€23m net loss in 3 years). Market cap is less than US$100m (€83.8m market cap, or US$92.5m). Announcement • Sep 05
Median Technologies to Share Positive Pivotal Data for Eyonis LCS Diagnostic Software as Medical Device at the IASLC 2024 World Conference on Lung Cancer Median Technologies announced that the Company will be sharing information on its proprietary AI/ML-powered SaMD, eyonis™ LCS, including recently announced data from the pivotal REALITY study, at Booth #2601 during the 2024 World Conference on Lung Cancer (WCLC), being held in San Diego, CA, USA, from September 7-10, 2024. The WCLC, the premier world conference on lung cancer, is organized by the International Association for the Study of Lung Cancer (IASLC), a global multidisciplinary association dedicated to eradication of all forms of lung cancers. eyonis™ LCS is designed to improving the detection and diagnostic accuracy of LDCT in lung cancer screening procedures. LDCT imaging is the standard of diagnostic care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. The average five-year survival rate for all lung cancer patients is 18.6% because only 16% of lung cancers are diagnosed at an early stage. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%. REALITY evaluating the standalone performance of the medical device in characterizing cancerous vs non-cancerous patients (performance at patient level”), and in detecting and characterizing suspicious versus malignant nodules. Despite the inclusion of many challenging LDCT images, the eyonis™ LCS SaMD achieved exceptional results and met all study primary and secondary endpoints with statistical significance and achieved an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as the primary endpoint for REALITY. REALITY analyses were conducted on data from a cohort of 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.
The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis™ LCS to complement the analytical validation already achieved with REALITY. RELIVE is ongoing and scheduled for completion in the coming months, with an anticipated data read-out in first quarter of 2025. Median Technologies expects eyonis™ LCS regulatory filings in the US for FDA 510(k) clearance and in Europe for CE marking in first half of 2025. eyonis™ Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis™ LCS has been classified by regulators as “Software as Medical Device”, or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Announcement • Aug 29
Median Technologies Announces Pivotal Reality Study of Its Eyonis™? Lcs Lung Cancer Diagnostic Met All Primary and Secondary Endpoints Median Technologies announced that eyonis™? LCS, its proprietary Artificial Intelligence (AI)/machine learning (ML) powered Software as Medical Device (SaMD) for lung cancer screening (LCS), met the primary and all secondary endpoints in REALITY, the first of two pivotal studies required for marketing authorizations in U.S. and Europe. Median’s eyonis™ LCS SaMD is designed for improving the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the standard of care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. The average five-year survival rate for all lung cancer patients is 18.6% because only 16% of lung cancers are diagnosed at an early stage2. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%. Consequently, there is tremendous momentum behind efforts in the U.S., Europe and Asia to increase lung cancer screening and improve its accuracy. Enabling the accurate early detection of lung cancer with eyonis™ LCS could dramatically improve lung cancer survival. Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the US alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $9 billion. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia.Around $230 billion were spent on cancer medical care in 2023 in the US. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that can save patients’ life. Definitive results from REALITY show that eyonis™ LCS can accurately detect and characterize cancerous nodules. The novel SaMD achieved exceptional results, with an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as a primary endpoint for REALITY. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose. The pivotal REALITY study, initiated in July 2023, collected retrospective imaging and clinical data from 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. REALITY evaluated eyonis™ LCS ability to diagnose lung cancer. The objectives were to assess eyonis™ LCS standalone performance in characterizing cancerous vs non-cancerous patients (i.e. “performance at patient level”), and in detecting and characterizing suspicious versus malignant nodules. The primary endpoint of REALITY was determined after consultation with the U.S. regulatory authorities and the primary endpoint was selected to show that eyonis™ LCS would achieve an AUC superior to 0.8. The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis™ LCS to complement the analytical validation already achieved and communicated with REALITY. All the patient recruitment and relevant patient clinical data for the RELIVE study have already successfully been collected from the participating sites. RELIVE is scheduled for completion in the coming months, with an anticipated data read-out in First Quarter 2025 and regulatory filings in H1 2025. Announcement • Jul 12
Median Technologies SA to Report First Half, 2024 Results on Oct 24, 2024 Median Technologies SA announced that they will report first half, 2024 results on Oct 24, 2024 New Risk • May 27
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€22m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-€10m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€17m net loss in 3 years). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (€68.1m market cap, or US$73.9m). Announcement • May 15
Median Technologies SA, Annual General Meeting, Jun 19, 2024 Median Technologies SA, Annual General Meeting, Jun 19, 2024. Location: 174 avenue victor hugo, paris France Reported Earnings • Apr 30
Full year 2023 earnings released: €1.25 loss per share (vs €1.28 loss in FY 2022) Full year 2023 results: €1.25 loss per share. Revenue: €22.8m (down 4.9% from FY 2022). Net loss: €23.0m (loss widened 14% from FY 2022). Revenue is forecast to grow 36% p.a. on average during the next 2 years, compared to a 11% growth forecast for the Healthcare Services industry in Europe. New Risk • Apr 12
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 9.9% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.9% average weekly change). Negative equity (-€16m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€22m net loss in 2 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (€60.6m market cap, or US$65.1m). New Risk • Feb 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Negative equity (-€16m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€22m net loss in 2 years). Share price has been volatile over the past 3 months (6.9% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (€77.9m market cap, or US$83.9m). Announcement • Jan 23
Median Technologies SA to Report Fiscal Year 2023 Results on Apr 25, 2024 Median Technologies SA announced that they will report fiscal year 2023 results at 5:40 PM, Central European Standard Time on Apr 25, 2024 Announcement • Oct 18
Median Technologies's iBiopsy HCC Detection AI Model Developed on the PHELICAR Clinical Data Registry, to Be Presented at the ESMO Congress Median Technologies announced that the first results of its iBiopsy HCC detection AI model developed on the PHELICAR clinical data registry will be presented during the annual congress of the European Society for Medical Oncology (ESMO), taking place from Oct 20 to 24, in Madrid, Spain. The study, conducted using data from the PHELICAR clinical Data registry (CDR), was led by Pr. Olivier Lucidarme, Head of Specialty, and Emergency Imaging Department at the Pitie-Salpetriere AP-HP Hospital, Paris, France, and his team as well as teams from the Beaujon and Paul-Brousse AP-HP Hospitals. This initial work is centered on the detection features of Median's future iBiopsy HCC CADe/CADx SaMD and is based on a cohort of 753 patients from AP-HP, suffering from chronic liver disease and HCC. For the study, data from 561 patients were used for the algorithm's training & tuning, whereas data from 192 patients were used for its testing. Median's iBiopsy AI model, designed to detect HCC lesions as small as 10 mm in diameter, showcased promising results, achieving an impressive sensitivity rate of 92% on the test set. This notable achievement significantly surpasses the average sensitivity of 69%4 observed among radiologists without AI/ML tech-based computer aided detection. The next phase of research will focus on the small-size lesions to improve the diagnosis of very early stage (0) and early-stage (A) HCC. Study results will be presented during the session Basic Science & Translational Research (ID 81), to be held on Sunday 22 October, session time: 8:30 - 10:05 am CEST, oral presentation time: 9:10 am CEST, Santander Auditorium - Hall 9. As a reminder, PHELICAR is part of a large research collaboration agreement signed in March 2020 between AP-HP and Median Technologies, aiming at carrying out studies to be used for the development and validation of Median's iBiopsy®? AI/ML tech-based algorithms. More specifically, PHELICAR is a large-scale clinical data registry (CDR) to accurately identify the specific tumor phenotypes to better diagnose and predict patient outcome in HCC and supports the ongoing rise of predictive and personalized medicine. The Median iBiopsy team will attend the ESMO 2023 Congress and be at booth #522, Hall 5, from October 20 to 23 (exhibition dates) to discuss the study results as well as iBiopsy®? advancements. Announcement • Oct 11
Median Technologies Appoints Ben Mcdonald to Its Board of Directors Median Technologies announced that Ben McDonald has joined its Board of Directors, chaired by Oran Muduroglu. This appointment was approved during the ordinary shareholders’ meeting, held on October 10th. Ben serves on the board of directors for Aegis Group Partners Holdco, Noble Biomaterials, SuperTurbo Technologies, and Next Generation Turbo. He also served on the board of directors of Introhive before its sale to Providence Strategic Growth. Prior to joining Aegis Group Partners, Ben was an investor at Citadel Global Equities and Ailanthus Capital Management, where he focused on the technology sector. He holds an MBA from the University of Cambridge and an HBA from Western University. Announcement • Sep 05
Median Technologies SA, Annual General Meeting, Oct 10, 2023 Median Technologies SA, Annual General Meeting, Oct 10, 2023. Announcement • Jul 28
Median Technologies SA to Report First Half, 2023 Results on Oct 19, 2023 Median Technologies SA announced that they will report first half, 2023 results on Oct 19, 2023 Announcement • Jul 14
Median Technologies SA announced that it expects to receive €10 million in funding from Lake Bridge Capital Inc Median Technologies SA announced that it has entered into security purchase agreement for €10 million in a round of funding on July 12, 2023. The transaction included participation from new investors, Celestial Successor Fund L.P., a fund managed by Lake Bridge Capital Inc. The company issued convertible bonds in the transaction. The bonds will have interest rate at 8.5% and will mature after 7 years of issuance. The conversion price of the convertible bonds was set at €6.458. The transaction is expected to close on July 21, 2023 New Risk • Jul 03
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€17m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€17m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€7.3m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€16m net loss in 3 years). Shareholders have been diluted in the past year (2.0% increase in shares outstanding). Announcement • May 19
Median Technologies SA, Annual General Meeting, Jun 20, 2023 Median Technologies SA, Annual General Meeting, Jun 20, 2023. Reported Earnings • Apr 25
Full year 2022 earnings released: €1.28 loss per share (vs €1.25 loss in FY 2021) Full year 2022 results: €1.28 loss per share (further deteriorated from €1.25 loss in FY 2021). Revenue: €23.9m (up 15% from FY 2021). Net loss: €20.2m (loss widened 4.8% from FY 2021). Revenue is forecast to grow 32% p.a. on average during the next 3 years, compared to a 9.1% growth forecast for the Healthcare Services industry in Europe. Breakeven Date Change • Mar 01
Forecast to breakeven in 2025 The 3 analysts covering Median Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €9.35m in 2025. Average annual earnings growth of 50% is required to achieve expected profit on schedule. Announcement • Dec 22
Median Technologies SA to Report Fiscal Year 2022 Results on Apr 20, 2023 Median Technologies SA announced that they will report fiscal year 2022 results at 5:40 PM, Central European Standard Time on Apr 20, 2023 Board Change • Nov 16
No independent directors There are 8 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 8 new directors. 2 experienced directors. 2 highly experienced directors. No independent directors (5 non-independent directors). Chairman of the Board of Directors Oran Muduroglu is the most experienced director on the board, commencing their role in 2009. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. Lack of experienced directors. Reported Earnings • Oct 22
First half 2022 earnings released: €0.57 loss per share (vs €0.65 loss in 1H 2021) First half 2022 results: €0.57 loss per share (improved from €0.65 loss in 1H 2021). Revenue: €12.8m (up 26% from 1H 2021). Net loss: €8.88m (loss narrowed 6.6% from 1H 2021). Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Healthcare Services industry in Europe. Announcement • Jul 26
Median Technologies SA to Report Q3, 2022 Results on Oct 20, 2022 Median Technologies SA announced that they will report Q3, 2022 results After-Market on Oct 20, 2022 Announcement • Jun 01
Median Technologies SA Launches Imaging Lab, Spearheading the Integration of iBiopsy® Artificial Intelligence Technologies Into iCRO Imaging Services for Oncology Trials Median Technologies SA announced that the company is expanding its portfolio of services with Imaging Lab, a new entity whose mission is to leverage AI, data mining, and radiomics technologies to exploit imaging data from clinical trials in oncology. The creation of Imaging Lab materializes the convergence of iCRO's activities for image management in the development of new oncologic drugs and iBiopsy®'s activities for the development of software as medical device targeting early diagnosis of cancers, especially lung cancer. Announcement • May 24
Median Technologies SA, Annual General Meeting, Jun 14, 2022 Median Technologies SA, Annual General Meeting, Jun 14, 2022, at 17:00 Central European Standard Time. Location: PDGB, 174 avenue Victor Hugo – 75116 Paris Paris France Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Director Oern Stuge was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Apr 24
Full year 2021 earnings released: €1.25 loss per share (vs €1.06 loss in FY 2020) Full year 2021 results: €1.25 loss per share (down from €1.06 loss in FY 2020). Revenue: €20.7m (up 53% from FY 2020). Net loss: €19.3m (loss widened 51% from FY 2020). Over the next year, revenue is forecast to grow 40%, compared to a 26% growth forecast for the industry in Germany. Announcement • Mar 05
Median Technologies SA Files FDA 513(g) Regulatory Submission for iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device Median Technologies SA announced that the company has filed a 513(g) submission on Feb. 17, 2022 to the United States Food and Drug Administration (FDA) for its iBiopsy® Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD). The 513(g) submission will allow Median Technologies to determine the best product classification and choose between the De Novo or the 510(k) regulatory pathways for iBiopsy® LCS CADe/CADx SaMD. The FDA is expected to review the 513(g) submission and provide feedback within 60 calendar days. As next regulatory steps, Median Technologies is preparing several Q-submissions for the second quarter of 2022. Announcement • Nov 24
Median Technologies Announces New Outstanding Performance for Its iBiopsy® Lung Cancer Screening CADx With a Focus on Stage 1 Lung Cancer Characterization Median Technologies announced new outstanding performance of its lung cancer screening (LCS) CADx to characterize malignant vs. benign lung nodules. New results specifically focus on the characterization of stage 1 lung cancer nodules, using Median’s proprietary iBiopsy® deep learning algorithm on low-dose chest computed tomography (LDCT). Lung cancer is the number one cancer killer globally, causing an estimate of 1.8m deaths, accounting for 18% of all cancer deaths in 20202. This is largely due to late-stage diagnosis of the disease associated with poor 5-year survival. Based on information from the International Association for the Study of Lung Cancer (IASLC) staging project3, the 5-year overall survival rate for patients with stage 1 non-small cell lung (NSCLC) cancer is 68-92% whereas it is only 1-10% for patients with stage 4, and unfortunately over 40% of patients already have stage 4 disease at the diagnosis without screening. A noteworthy International Early Lung Cancer Action Program (I-ELCAP) cohort study of stage 1 cancer patients4 revealed an excellent 15-year LCS survival of 92% which again serves to show how critical early stage diagnosis via lung cancer screening remains. Thus, discriminating between benign nodules and stage 1 cancers is crucial to catch the cancer when it is still manageable and curable, which is key in saving patients’ lives. New results released are based on a cohort of 1,737 patients from the National Lung Screening Trial cases (NLST) consisting of a total of 16,249 lung nodules. The training set included 1,239 patients with 11,676 nodules and the test set included 498 patients having a total of 4,573 nodules. Test sensitivity is the ability of a test to correctly identify patients who actually have the disease: the higher the sensitivity of the test, the lower the percentage of false negatives. Test specificity is the ability of a test to correctly identify patients without the disease: the higher the specificity of the test, the lower the percentage of false positives. In a sub-analysis on the stage 1 lung cancers, results show an AUC of 0.984 with a sensitivity of 93.1 % and a specificity of 96.2 %, including stage 1A and 1B lung cancer nodules. For the earliest stage 1A cancer stage nodules, the AUC is 0.982 with a sensitivity of 92.1 % and a specificity of 96.2 %. Knowing the literature reported over 70% false positive rate with LDCT5, Median’s offering is poised to help radiologists optimize the management of screening patients helping eliminate the barriers to widespread screening adoption by decreasing false positive rates, and unnecessary biopsies and follow up scans which add to patient stress. Results will be presented during the AI Showcase Theater at the RSNA Annual Meeting, on Sunday, 28 November, at 12:00 pm CT. Median’s team will be available at booth #4849 Level 3 South Hall (AI Showcase) for the duration of the industrial exhibition (Nov. 28 -Dec. 1). The RSNA Annual Meeting and Scientific Assembly, taking place in Chicago, IL, USA from Nov. 28 to Dec. 2, 2021 is the world's largest medical imaging conference and attracts nearly 25,000 professional attendees from 116 countries. Reported Earnings • Oct 23
First half 2021 earnings released: €0.65 loss per share (vs €0.39 loss in 1H 2020) The company reported a mediocre first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: €10.2m (up 71% from 1H 2020). Net loss: €9.51m (loss widened 105% from 1H 2020). Announcement • Apr 13
Median Technologies SA announced that it has received €28.1 million in funding Median Technologies SA (ENXTPA:ALMDT) announced that it has received €28,100,000 in a round of funding with qualified investors on April 12, 2021. Reported Earnings • Apr 11
Full year 2020 earnings released: €1.05 loss per share (vs €0.66 loss in FY 2019) The company reported a mediocre full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: €13.6m (up 51% from FY 2019). Net loss: €12.8m (loss widened 60% from FY 2019). Announcement • Feb 26
Median Technologies Appoints Thomas Bonnefont as Chief Operating and Commercial Officer Median Technologies announced the appointment of Thomas Bonnefont to the newly created position of Chief Operating and Commercial Officer of the iBiopsy® Business Unit as well as the appointment of Mike Doherty as Sr. Strategy Advisor, iBiopsy® Product Development. They both join Median’s executive team. Mike Doherty is based in the US. As Chief Operating and Commercial Officer, Thomas Bonnefont will supervise the whole iBiopsy ® Business Unit and drive the commercial strategy and market development plans for iBiopsy® products, as well as their implementation. Thomas will take up his position on March 1st as a member of the executive team under the direct responsibility of Fredrik Brag, CEO and Founder of Median. Announcement • Feb 18
Median Technologies Sa Unveils New iBiopsy® Clinical Development Plan on Lung Cancer Screening Median Technologies unveiled a new iBiopsy® Clinical Development Plan (CDP) for the diagnosis of early-stage lung cancer in high-risk populations based on Low Dose Computed Tomography (LDCT) scans, strengthening its positioning in early-stage diagnosis, such as early-stage liver cancer diagnosis and non-alcoholic steatohepatitis (NASH) identification. The company will use its iBiopsy® platform to develop AI-based algorithms enabling the identification and characterization of lesions in thoracic LDCT images, decreasing the number of false positives and overdiagnosis. The company has already collected over 17,000 cases of LCS from multiple databases and is currently curating and annotating a preliminary set of 1,800 data to train and validate its algorithms. The company expects to deliver a proof of concept in second half of based on this subset. Announcement • Feb 10
Median Technologies Inks Major Research Collaboration Agreement With the University of California San Diego Median Technologies announces the company has signed a research collaboration agreement with the University of California San Diego (UC San Diego) aimed at carrying out a study that will be used for its proprietary imaging platform iBiopsy® validation. The study is related to the iBiopsy® NASH Clinical Development Plan (CDP). It is estimated that NASH is affecting 1.5-6.45 % of the global population. There is currently no cure for advanced stage of the disease and diagnosing the disease early can save patients’ lives as NASH, in its early stage, is reversible through changes in eating habits and lifestyle. The clinical interest is therefore to distinguish accurately and non-invasively patients with early fibrosis from patients with advanced fibrosis at risk of progressing to cirrhosis and liver cancer. In this clinical context, the objective of Median’s retrospective study with UC San Diego is to quantify the ability of iBiopsy®’s learning algorithms to discriminate between early and advanced fibrosis grade in NASH patients. The study is led by Dr. Kathryn Fowler, MD, Diagnostic Radiologist, Professor of Radiology at UC San Diego, as Principal Investigator. It will be conducted retrospectively on a cohort of 300+ patients. Median expects confirming the promising results on the NASH Clinical Development Plan, which were released in November 2020. First results of the Median-UC San Diego study are currently expected in first quarter of 2022. UC San Diego is known as a leading university and health care center in the US with worldwide recognition for their work in the field of liver disease, with a strong focus on NALFD and NASH. UC San Diego has been recently ranked #1 in the world for gastroenterology and hepatology (liver) research, based on physicians' research reputation and publications, by the US News and World Report. Beyond the validation of Median’s iBiopsy® technology and its performance to discriminate between early and advanced fibrosis grade in NASH patients, this strategic collaboration with UC San Diego will help advance clinical research intended to improve NASH patient diagnosis and monitoring. 
