Latest news with #MedianTechnologies
Yahoo
11-07-2025
- Business
- Yahoo
Median Technologies Signs Financial Agreement for up to €37.5 Million New Financing Facility With the European Investment Bank (EIB)
SOPHIA ANTIPOLIS, France, July 11, 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, announced today that the Company signed a financial agreement with the European Investment Bank (EIB) for a new financing facility of up to €37.5 million, on July 11, 2025. The signature of the financial agreement is in line with previous announcements on January 24, 2025, and April 24, 2025 stating that Median and the EIB were working to conclude an agreement for a new financing facility. "We welcome the conclusion of our discussions with the European Investment Bank and the signature of the financial agreement", said Fredrik Brag, CEO and Founder of Median Technologies. "We are very honored to belong to the European innovative ecosystem supported by the EIB, and to contribute to the European technological sovereignty. Proceeds from this new EIB financing facility will strengthen our financial independence to negotiate the best possible options for the commercialization of eyonis® LCS in U.S. and in Europe." Financing Facility Structure The EIB 2025 financing facility could be drawn in three (3) tranches, i.e., €19 million (Tranche A), €8.5 million (Tranche B) and €10 million (Tranche C). Median Technologies will request the drawdown of the €19 million Tranche A, as soon as all contractual conditions with respect to such tranche, are satisfied, specifically: Full issuance of the EIB new Tranche A warrants to the EIB and registration, in accordance with the warrant issuance agreement, Completion of a share capital increase for an amount at least equal to €16 million (issuance premium included), Repayment of the first tranche of the previous EIB 2019 loan, for which the maturity has been extended from April to October 2025. Furthermore, the Company has undertaken to have secured by June 30, 2026, incremental equity financing in a total amount of at least €10 million. The characteristics of tranche A are: Maturity of 72 months, and monthly amortization over a period of 36 months after a 36-month grace period, Annual interest rate of 5%. The release of the tranche A of €19 million will result in the issuance of warrants which quantity and exercise price will depend on the stock price on the date of issuance. At current trading stock price, and after fulfilment of all drawdown conditions, the total amount of shares resulting from the exercise of the warrants would represent 10% of the share capital. As stated in the financial agreement, Tranche B and Tranche C disbursements remain at Median's discretion, subject to certain conditions which are specified in the financial agreement. Intended use of proceeds The EIB funds will be to support eyonis® Lung Cancer Screening (LCS) progress towards major milestones consisting of commercial launch and sales development in the U.S and in Europe, and to accelerate the expansion of Median's proprietary suite of Software as a Medical Device, eyonis®, for image-based early cancer diagnosis, notably the scientific and clinical development of eyonis® IPN for incidental findings of pulmonary nodules, and eyonis® HCC, for primary liver cancer early diagnosis. eyonis® LCS progress status and next steps Regulatory filings for marketing in U.S. and Europe and marketing authorizations: On May 14, 2025, Median Technologies announced the filing of an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis® LCS. On July 1, 2025, the Company announced the filing of an application for Class IIb CE marking of eyonis® LCS. Given the usual timelines for regulatory review, the U.S. FDA 510(k) clearance for eyonis® LCS is expected around the end of Q3 2025, expected to be followed by commercial launch in the US. Median Technologies expects European marketing authorization for eyonis® LCS as soon as Q1 2026. Commercial launch Median Technologies is actively engaged in discussions with several leading players in AI- diagnostic and imaging equipment manufacturing, for the commercialization of eyonis® LCS. Some of these strategic partnerships are expected to be finalized upon FDA marketing authorization of eyonis® LCS. The Company has finalized its US market access strategy, based on a comprehensive mapping of medical institutions involved in screening procedures, particularly in the United States, eyonis® LCS' first and leading market. This mapping has enabled the identification of health institutions generating the highest volume of lung cancer screening procedures, positioning them as key drivers for the commercial launch of eyonis® LCS. Discussions with U.S. payers will be initiated upon FDA marketing authorization. At this stage, preliminary studies have been conducted to estimate the projected economic benefits of using eyonis® LCS in lung cancer screening programs. To date, the Company has developed a detailed mapping of payers in the United States. Furthermore, an initial analysis based on a health economics Markov model simulating lung cancer progression over five years and incorporating the performance of eyonis® LCS, demonstrates that eyonis® LCS enhances early detection and characterization, reduces unnecessary health procedures, and generates significant cost savings for U.S. payers. The results of this preliminary analysis were presented at ISPOR 2025, the leading global conference for health economics and market access, held this past May. Results from the study are available on Median's website. Over the past year, the Median eyonis® team has built a very substantial network of early adopters composed of key opinion leaders. The team has conducted numerous visits to leading healthcare institutions and actively participated in major medical conferences organized by medical societies in pulmonology, oncology, and radiology, both in the U.S. and Europe, including the Radiological Society of North America (RSNA), the European Radiology Society (ESR), the American Thoracic Society (ATS), the European Society of Thoracic Imaging (ESTI), the European Society of Medical Oncology (ESMO), and the American Society of Clinical Oncology (ASCO). The Company now enjoys strong recognition of its eyonis® LCS technology within the medical community, along with a strong brand image associated with the product. Most of the leading healthcare institutions in contact with Median have expressed interest in participating in future health economics studies, which will be launched following regulatory market approvals. 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. View source version on Contacts MEDIAN TECHNOLOGIES Emmanuelle LeyguesVP, Corporate Marketing & Financial Communications+33 6 10 93 58 Investors - SEITOSEI ACTIFIN Ghislaine Gasparetto+33 6 21 10 49 U.S. media & investors - COHESION BUREAU Chris Maggos+41 79 367 Press – ULYSSE COMMUNICATION Bruno Arabian+33 6 87 88 47 26barabian@ Nicolas Entz+33 6 33 67 31 54nentz@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
11-07-2025
- Business
- Business Wire
Median Technologies Signs Financial Agreement for up to €37.5 Million New Financing Facility With the European Investment Bank (EIB)
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, announced today that the Company signed a financial agreement with the European Investment Bank (EIB) for a new financing facility of up to €37.5 million, on July 11, 2025. The signature of the financial agreement is in line with previous announcements on January 24, 2025, and April 24, 2025 stating that Median and the EIB were working to conclude an agreement for a new financing facility. 'We welcome the conclusion of our discussions with the European Investment Bank and the signature of the financial agreement', said Fredrik Brag, CEO and Founder of Median Technologies. 'We are very honored to belong to the European innovative ecosystem supported by the EIB, and to contribute to the European technological sovereignty. Proceeds from this new EIB financing facility will strengthen our financial independence to negotiate the best possible options for the commercialization of eyonis ® LCS in U.S. and in Europe.' Financing Facility Structure The EIB 2025 financing facility could be drawn in three (3) tranches, i.e., €19 million (Tranche A), €8.5 million (Tranche B) and €10 million (Tranche C). Median Technologies will request the drawdown of the €19 million Tranche A, as soon as all contractual conditions with respect to such tranche, are satisfied, specifically: Full issuance of the EIB new Tranche A warrants to the EIB and registration, in accordance with the warrant issuance agreement, Completion of a share capital increase for an amount at least equal to €16 million (issuance premium included), Repayment of the first tranche of the previous EIB 2019 loan, for which the maturity has been extended from April to October 2025. Furthermore, the Company has undertaken to have secured by June 30, 2026, incremental equity financing in a total amount of at least €10 million. The characteristics of tranche A are: Maturity of 72 months, and monthly amortization over a period of 36 months after a 36-month grace period, Annual interest rate of 5%. The release of the tranche A of €19 million will result in the issuance of warrants which quantity and exercise price will depend on the stock price on the date of issuance. At current trading stock price, and after fulfilment of all drawdown conditions, the total amount of shares resulting from the exercise of the warrants would represent 10% of the share capital. As stated in the financial agreement, Tranche B and Tranche C disbursements remain at Median's discretion, subject to certain conditions which are specified in the financial agreement. Intended use of proceeds The EIB funds will be to support eyonis ® Lung Cancer Screening (LCS) progress towards major milestones consisting of commercial launch and sales development in the U.S and in Europe, and to accelerate the expansion of Median's proprietary suite of Software as a Medical Device, eyonis ®, for image-based early cancer diagnosis, notably the scientific and clinical development of eyonis ® IPN for incidental findings of pulmonary nodules, and eyonis ® HCC, for primary liver cancer early diagnosis. eyonis ® LCS progress status and next steps Regulatory filings for marketing in U.S. and Europe and marketing authorizations: On May 14, 2025, Median Technologies announced the filing of an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis ® LCS. On July 1, 2025, the Company announced the filing of an application for Class IIb CE marking of eyonis ® LCS. Given the usual timelines for regulatory review, the U.S. FDA 510(k) clearance for eyonis ® LCS is expected around the end of Q3 2025, expected to be followed by commercial launch in the US. Median Technologies expects European marketing authorization for eyonis ® LCS as soon as Q1 2026. Commercial launch Median Technologies is actively engaged in discussions with several leading players in AI- diagnostic and imaging equipment manufacturing, for the commercialization of eyonis ® LCS. Some of these strategic partnerships are expected to be finalized upon FDA marketing authorization of eyonis ® LCS. The Company has finalized its US market access strategy, based on a comprehensive mapping of medical institutions involved in screening procedures, particularly in the United States, eyonis ® LCS' first and leading market. This mapping has enabled the identification of health institutions generating the highest volume of lung cancer screening procedures, positioning them as key drivers for the commercial launch of eyonis ® LCS. Discussions with U.S. payers will be initiated upon FDA marketing authorization. At this stage, preliminary studies have been conducted to estimate the projected economic benefits of using eyonis ® LCS in lung cancer screening programs. To date, the Company has developed a detailed mapping of payers in the United States. Furthermore, an initial analysis based on a health economics Markov model simulating lung cancer progression over five years and incorporating the performance of eyonis ® LCS, demonstrates that eyonis ® LCS enhances early detection and characterization, reduces unnecessary health procedures, and generates significant cost savings for U.S. payers. The results of this preliminary analysis were presented at ISPOR 2025, the leading global conference for health economics and market access, held this past May. Results from the study are available on Median's website. Over the past year, the Median eyonis ® team has built a very substantial network of early adopters composed of key opinion leaders. The team has conducted numerous visits to leading healthcare institutions and actively participated in major medical conferences organized by medical societies in pulmonology, oncology, and radiology, both in the U.S. and Europe, including the Radiological Society of North America (RSNA), the European Radiology Society (ESR), the American Thoracic Society (ATS), the European Society of Thoracic Imaging (ESTI), the European Society of Medical Oncology (ESMO), and the American Society of Clinical Oncology (ASCO). The Company now enjoys strong recognition of its eyonis ® LCS technology within the medical community, along with a strong brand image associated with the product. Most of the leading healthcare institutions in contact with Median have expressed interest in participating in future health economics studies, which will be launched following regulatory market approvals. 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.
Business Wire
09-07-2025
- Business
- Business Wire
Median Technologies: Half Year Liquidity Contract Statement
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)-- Regulatory News: Under the liquidity contract entrusted by Median Technologies (PARIS: ALMDT, FR0011049824, ALMDT, PEA/SME eligible, 'Median' or 'the Company') to TP ICAP (Europe), the following resources were listed in the liquidity account as of June 30, 2025: 60,808 shares €58,893.66 in cash Transactions during the first half 2025: For information, as of December 31, 2024, the following resources were listed in the liquidity contract: 30,559 shares €134,615.99 in cash For information, as of May 4th, 2020, when the new liquidity contract was set up, the following resources were listed in the liquidity account: 4,404 shares €173,829.64 in cash TP ICAP (Europe) is authorized and regulated by the Autorité de Contrôle Prudentiel (ACPR) and the Autorité des Marchés Financiers (AMF). The daily transaction table is provided in the appendix to this press release. 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 APPENDIX
Business Wire
07-07-2025
- Business
- Business Wire
Median Technologies: Disclosure of Total Number of Voting Rights and Number of Shares in the Capital as of June 30, 2025
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (Paris:ALMDT): (*) Class E preference shares are non-voting (**) pursuant to article 223-11 of the AMF's General Regulations 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
Yahoo
01-07-2025
- Business
- Yahoo
Median Technologies Files European Application for Class IIb CE Marking of Its AI-Based Software as a Medical Device for Lung Cancer Screening, eyonis® LCS
Class IIb CE marking is a prerequisite for Median's eyonis® LCS Software as a Medical Device marketing in Europe Lung cancer screening programs are already implemented in several European countries, and will be gathering pace across the continent, Eligible population in Europe is estimated at 20 million people Median previously submitted U.S. application for FDA 510(k) clearance of eyonis® LCS in May 2025 for marketing in U.S. On track for U.S. commercial launch before year-end and European launch in H1 2026, pending regulatory authorizations SOPHIA ANTIPOLIS, France, July 01, 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, announced today it has filed an application for Class IIb CE marking of eyonis® LCS (Lung Cancer Screening), its AI/ML tech-based Software as a Medical Device (SaMD) for computer aided detection and diagnosis (CADe/CADx) of lung cancer in screening programs. Concurrently to CE marking, Median has also applied for ISO 13485 certification for the Quality Management System supporting the manufacturing of eyonis ® LCS. Median Technologies applied for 510(k) clearance of eyonis® LCS with the U.S. Food and Drug Administration (FDA) on May 2025. Both regulatory filings confirm that timetables for eyonis® LCS are on track, towards commercial launch as soon as year-end 2025 in the U.S., pending FDA 510(k) clearance expected end Q3 2025, and in H1 2026 in Europe, pending Class IIb CE marking expected in Q1 2026. "Filing for CE marking of eyonis® LCS is yet another important step forward for Median, leveraging the Median eyonis® strong technology, clinical development and regulatory capabilities," said Fredrik Brag, CEO and Founder of Median Technologies. "Our regulatory submissions are built on a significant volume of positive clinical data demonstrating eyonis® LCS' safety and efficacy in REALITY and RELIVE successful pivotal studies. We are looking forward to continuing and finalizing our constructive discussions with market stakeholders, in both the U.S. and Europe, as we aim to bring eyonis® LCS to patients eligible for lung cancer screening in existing and future screening programs. Thanks to multiple institutions visits and major medical congresses attendance, our eyonis® team confirms the strong support of lung cancer key opinion leaders belonging to the pulmonology, oncology and radiology scientific bodies and societies in the U.S. and Europe. We are truly blessed with an exceptional appreciation of our highly differentiated technology, which contributes to establishing a powerful brand equity for eyonis® LCS. Additionally, our device market access strategy is already developed, ready for execution in the U.S. and tailored for specific payers to ensure maximum market penetration". Based on SOLACE project data, the overall eligible population in the EU is about 20 million people. Currently, Croatia and Poland have national Low Dose Computed Tomography (LDCT)-based lung cancer screening programs and many other European countries are conducting promising pilot programs. On June 23, 2025, LDCT-based lung cancer screening received green light in Germany for eligible people covered by statutory health insurance providers, with the policy due to go into effect in April 2026. Other European countries are moving toward lung cancer screening programs implementation, including France. In the U.S., the market opportunity includes a population of 14.5 million people, currently eligible for a LDCT lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. The eligible U.S. patient number is expected to rise in the coming years, driven by the planned broadening of the eligibility criteria. About eyonis® LCS: eyonis® 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) to aid radiologists in diagnosis of lung cancer at the earliest stages, when it can still be cured in many patients. eyonis® LCS has been the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY ( ID: NCT06576232) and RELIVE ( 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 eyonis® LCS on May 13th, 2025, and European application for CE mark on June 30th, 2025. 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. View source version on Contacts MEDIAN TECHNOLOGIES Emmanuelle LeyguesVP, Corporate Marketing & Financial Communications+33 6 10 93 58 Investors - SEITOSEI ACTIFIN Ghislaine Gasparetto+33 6 21 10 49 U.S. media & investors - COHESION BUREAU Chris Maggos+41 79 367 Press – ULYSSE COMMUNICATION Bruno Arabian+33 6 87 88 47 26barabian@ Nicolas Entz+33 6 33 67 31 54nentz@ Sign in to access your portfolio
