Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care




Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care

New publication shows that Prospera-guided care helped >75% of low-risk patients safely avoid routine transbronchial biopsies performed at 9 months

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a new prospective clinical trial in Transplantation Direct. The study, which was conducted by The Ohio State University Wexner Medical Center (OSU-WMC), was initiated to explore whether donor-derived cell-free DNA (dd-cfDNA) surveillance, and specifically Prospera-guided monitoring, could reduce the number of invasive biopsies for patients following lung transplantation.

Lung transplant patients are typically monitored with transbronchial biopsies – at one, three, six, nine, and 12 months after transplantation. These procedures are invasive, costly and associated with significant morbidity¹.

As transplant volumes increased at OSU-WMC, the center launched a quality assurance and performance improvement (QAPI) initiative to evaluate whether the Prospera test could allow them to safely eliminate the 9-month surveillance biopsy.

In the study, 78 lung-transplant recipients were monitored with the Prospera test for one year post-transplant. Prospera testing was incorporated at approximately 8 months to categorize patients as low risk (<1.0 % dd-cfDNA) or high risk (≥1.0 %) for rejection. Physicians could then choose to forgo the 9-month surveillance biopsy for low-risk, clinically stable patients. All participants were recommended for a protocol biopsy at 12 months post-transplant.

Key findings included:

• Physicians chose to omit the 9-month biopsy in ~75% of patients with low-risk Prospera results. For these patients over the ensuing 3 months, there was no significant difference in acute rejection rates, spirometry indices, or donor-specific antibodies compared to patients who underwent the procedure.
• At one year post-transplant, approximately 95% of patients who omitted the 9-month biopsy did not have acute rejection that needed any treatment.
• Patients who omitted the 9-month biopsy maintained lung function and immunologic stability similar to those who underwent the procedure.

“This study highlights how monitoring with Prospera can improve both the patient experience and the sustainability of transplant programs,” said Justin Rosenheck, D.O., clinical assistant professor of internal medicine at The Ohio State University Wexner Medical Center and principal investigator of the study. “These compelling results support our goal of providing more personalized and efficient medical care without compromising patient safety or outcomes.”

“The Prospera test provided actionable patient risk assessments within a structured QAPI framework,” said David Ross, M.D., senior medical director of lung transplantation and molecular diagnostics at Natera. “These data support fewer routine biopsies during dd-cfDNA surveillance while maintaining lung function and immune response. We believe that future clinical studies could further support the safe omission of protocol biopsies implementing the Prospera Lung test, ultimately reducing invasive procedural risks and burdens with optimized health.”

References

1. Huo J, Xu Y, Sheu T, Volk RJ, Shih Y-CT. Complication Rates and Downstream Medical Costs Associated With Invasive Diagnostic Procedures for Lung Abnormalities in the Community Setting. JAMA Internal Medicine. 2019;179(3):324-332.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Genethon Advances Groundbreaking Gene Therapies for Patients with Rare Genetic Diseases




Genethon Advances Groundbreaking Gene Therapies for Patients with Rare Genetic Diseases

Genethon’s Newsletter highlights the latest developments in gene therapies for diseases once considered incurable, including Duchenne muscular dystrophy

PARIS–(BUSINESS WIRE)–Genethon, a unique non-profit gene therapy R&D organization founded by the French Muscular Dystrophy Association (AFM-Telethon), began the new year with an R&D licensing deal for its gene therapy approach to Pompe disease and continues pivotal clinical trials of its best-in-class low dose micro-dystrophin gene therapy (GNT0004) for Duchenne muscular dystrophy (DMD). Read about these and other advances in Genethon’s latest Newsletter.

In his CEO Commentary, Frederic Revah, Ph.D., underscores the dedication, expertise and successes of Genethon’s 240 scientists and professional staff as they pursue new gene therapy treatments for rare genetic diseases, which disproportionately affect children worldwide.

Other Newsletter highlights:

• Genethon’s license agreement with AskBio, a gene therapy subsidiary of Bayer AG, for a proprietary technology developed by Genethon and integrated into AskBio’s gene therapy clinical trial candidate for Pompe disease.
• An update on Genethon’s pivotal clinical trial of its gene therapy for DMD.
• A research discovery that could lead to a combination treatment with gene therapy for DMD.
• Interviews with Dr. Revah in two global publications.

Read the full Newsletter and learn more about Genethon on its website (www.genethon.com).

About Genethon

A pioneer in the discovery and development of gene therapies for rare diseases, Genethon is a non-profit laboratory created by the AFM-Telethon. The first gene therapy drug, to which Genethon contributed, has been approved for marketing for spinal muscular atrophy. With more than 240 scientists and professionals, Genethon’s goal is to develop innovative therapies that change the lives of patients suffering from rare genetic diseases. Thirteen gene therapy products resulting from Genethon’s research, or to which Genethon has contributed, are currently undergoing clinical trials for diseases of the liver, blood, immune system, muscles, and eyes. Others are in preparation for clinical trials over the next five years. More information at www.genethon.com.

Contacts

Media Contact
Stephanie Bardon

SBARDON@afm-telethon.fr

Aesyra Demonstrates Significant Sleep Bruxism Reduction in Clinical Study




Aesyra Demonstrates Significant Sleep Bruxism Reduction in Clinical Study

LAUSANNE, Switzerland–(BUSINESS WIRE)–#aesybite—Aesyra SA, a Swiss medtech company developing innovative digital therapeutics for dental and sleep-related disorders, today announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback.

The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the predefined performance target.

Strong and robust clinical outcomes

In the study (Identifier: NCT06153810), involving 26 adult patients with confirmed sleep bruxism, activation of the AesyBite Active biofeedback system resulted in a 60.6% reduction in total sleep bruxism duration per hour compared to baseline (95% CI: 55.8%–64.9%, p < 0.001). This reduction exceeded the study’s predefined efficacy threshold, confirming the device’s ability to meaningfully reduce bruxism activity during sleep.

In addition to the primary endpoint, statistically significant improvements were observed across multiple secondary measures, including:

• Reduced number of bruxism episodes per hour
• Shorter bruxism episode duration
• Lower intensity of bruxism episodes
• No negative impact on sleep duration

The therapeutic effect was consistent regardless of baseline bruxism severity and independent of the timing of biofeedback activation.

Positive safety and usability profile

No adverse events were reported during the investigation. Patient-reported outcomes showed progressive improvements in orofacial pain, as well as improved comfort and acceptance of the device over time, supporting its suitability for long-term nightly use.

A differentiated approach to treating sleep bruxism

Unlike conventional passive splints, AesyBite™ Active combines a customized oral appliance with embedded sensors and active biofeedback, enabling real-time detection and reduction of bruxism activity without disturbing sleep.

“These results represent a major milestone for Aesyra,” said Marco Letizia, co-founder and CEO of Aesyra SA. “Demonstrating a consistent and robust reduction in sleep bruxism activity, together with an excellent safety profile, strongly supports the clinical value of AesyBite Active and its potential to change how sleep bruxism is treated.”

“The magnitude and consistency of the effect observed in this investigation are particularly encouraging,” added Prof. Marcello Maddalone, Principal Investigator, University of Milano-Bicocca.

“The data support AesyBite Active as an effective and well-tolerated therapeutic option for patients suffering from sleep bruxism.”

Next steps

The study results will support global regulatory submissions and future commercialization efforts. FDA submission has been initiated and regulatory approval in the USA is targeted for 2026. European regulatory approval is planned thereafter. In 2026 Aesyra plans to initiate go-to-market activities with existing partners and will seek additional partners for other commercial activities and to expand clinical indications of its platform technology.

About Aesyra SA

Aesyra SA is a Swiss spin-off from EPFL (École Polytechnique Fédérale de Lausanne) focused on developing smart, data-driven oral medical devices for the diagnosis and treatment of sleep-related dental conditions using its proprietary platform technology.

Its flagship product, AesyBite™ Active, integrates digital sensing and biofeedback to address sleep bruxism in a novel and clinically validated way.

Building on the same technological platform, Aesyra is also developing AesyBite™ Custom, a next-generation digital dentistry solution that leverages patient-specific intraoral 3D scans and additive manufacturing to enhance personalization and wearing comfort in bruxism therapy.

For more information, visit: www.aesyra.com

Contacts

Media: info@aesyra.com

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results




Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

• In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history
• Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion

INCHEON, Korea–(BUSINESS WIRE)–#ADCs–Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025.

“We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio,” said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.”

Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results

In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively.

Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively.

The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships.

• EPYSQLI™ (SB12), a biosimilar to Soliris² (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases.
• OBODENCE™ / OSPOMYV™³ (SB16), a biosimilar to Prolia⁴ (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva³ (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab).⁵
• PYZCHIVA™ (SB17), a biosimilar to Stelara⁶ (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025.
• Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis⁷ (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea⁸ (aflibercept), in the US.

Fiscal Year 2026 Outlook

Samsung Epis Holdings is actively supporting its subsidiaries’ core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab.

Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer.⁹ The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year.

Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform.

About Samsung Epis Holdings Co., Ltd.

As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: www.samsungepisholdings.com.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

About Epis NexLab Co., Ltd.

Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: www.samsungepisholdings.com.

Contacts

Media Contact
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity




Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity

FRANKFURT AM MAIN, Germany–(BUSINESS WIRE)–Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN^® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA). If approved, the indication would expand access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe.

Spasticity is a common and often debilitating condition in children and adolescents with certain neurological conditions, leading to increased muscle tone that can significantly limit movement, function and independence. One of the most common underlying causes of spasticity in children is cerebral palsy (CP), the most frequent motor disability in childhood, with spastic forms accounting for approximately 80% of all cases. In more severe cases, spasticity associated with CP can also affect speech, swallowing and fine motor skills.^1,2

“We have made the conscious and ethical decision to advance our pediatric spasticity program. The submission of this important application for an indication extension in Europe represents another milestone in our long‑term commitment to improving standards of care for children and adolescents living with spasticity,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer, Merz Therapeutics.

Submission based on comprehensive clinical dossier update

The regulatory package submitted to the European Medicines Agency includes a comprehensive update of the clinical dossier, with data from the Phase 3 ELLIE study and prior pediatric spasticity investigations evaluating multipattern treatment of the lower limb, and, where appropriate, concomitant upper‑limb treatment.

The positive results of the prospective, randomized, placebo-controlled, two-stage, double-blind, multicenter, 28-week Phase 3 clinical trial ELLIE were recently presented at the TOXINS 2026 8^th International Congress on Neurotoxins from January 14 to 17, 2026. The Phase 3 trial investigated incobotulinumtoxinA in the treatment of lower limb spasticity in children and adolescents with CP and showed how incobotulinumtoxinA significantly improved lower limb spasticity in children and adolescents with CP, while demonstrating a favorable safety and tolerability profile.³

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and the patient experience as its focus, the company relentlessly pursues innovative treatments and partnerships to address unmet needs in movement disorders, neurodegenerative conditions, liver disease, and other health conditions that severely impact patients’ quality of life.

Merz Therapeutics is headquartered in Frankfurt am Main, Germany, and is active in more than 80 countries. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company with a 118-year legacy. With passion and purpose, Merz Therapeutics continues to advance care in specialty neurology in ways that benefit both patients and society.

Please visit www.merztherapeutics.com.

References:

¹ Cerebral Palsy Guide. Spastic cerebral palsy. https://www.cerebralpalsyguide.com/cerebral-palsy/types/spastic/. Last accessed: 19.01.2026.

² Centers For Disease Control and Prevention. Data and Statics for Cerebral Palsy. https://archive.cdc.gov/www_cdc_gov/ncbddd/cp/data.html. Last accessed: 19.01.2026.

³ Banach M et al. IncobotulinumtoxinA for treatment of lower limb spasticity in children/adolescents with CP (ELLIE). Toxicon. 2026;271(S1):7. Abstract 0076.

Contacts

Press Contact:

Merz Therapeutics GmbH

Luke Anthony Mircea-Willats

Head of Global Communications & Strategic Affairs

merztherapeutics@merz.com

Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com




Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.

This report on Flunitrazepam provides comprehensive insights, including general information, synonyms, chemical composition, safety, hazards, handling, storage, and toxicological and ecological details, along with transport information. This in-depth study serves as a vital resource for understanding the Flunitrazepam market landscape and its growth potential worldwide.

It explores various applications and examines manufacturing methods, supported by an analysis of relevant patents. The global market analysis covers constraints, drivers, and opportunities from 2019 to 2024, supply and demand dynamics, suppliers and regional overviews across Europe, Asia, North America, and other regions.

The report forecasts future trends and supply-demand scenarios up to 2029, with detailed market predictions by region. Additionally, it analyzes market prices across different regions and evaluates the end-use sectors for Flunitrazepam.

The Flunitrazepam global market report covers the following key points:

• Flunitrazepam description, applications and related patterns
• Flunitrazepam market drivers and challenges
• Flunitrazepam manufacturers and distributors
• Flunitrazepam prices
• Flunitrazepam end-users
• Flunitrazepam downstream industries trends

Key questions answered in the report:

• What were the main trends of the global Flunitrazepam market in 2019-2024?
• What was the size of the global Flunitrazepam market in 2019-2024?
• Who are the main players in the global Flunitrazepam market?
• Which drivers and challenges will determine the development of the global Flunitrazepam market during 2025-2029?
• What will the CAGRs be for the global product industry?

Key Topics Covered:

1. FLUNITRAZEPAM

1.1. General information, synonyms

1.2. Composition, chemical structure

1.3. Safety information

1.4. Hazards identification

1.5. Handling and storage

1.6. Toxicological & ecological information

1.7. Transport information

2. FLUNITRAZEPAM APPLICATIONS

3. FLUNITRAZEPAM MANUFACTURING METHODS

4. FLUNITRAZEPAM PATENTS

5. FLUNITRAZEPAM WORLD MARKET ANALYSIS

5.1. Flunitrazepam market constraints, drivers and opportunities in 2019-2024

5.2. Flunitrazepam supply/demand in 2019-2024

5.3. Flunitrazepam market overview by region – Europe, Asia, North America, etc.

6. MANUFACTURERS OF FLUNITRAZEPAM

6.1. Flunitrazepam manufacturers in Europe

6.2. Flunitrazepam manufacturers in Asia

6.3. Flunitrazepam manufacturers in North America

6.4. Flunitrazepam manufacturers in RoW

7. SUPPLIERS OF FLUNITRAZEPAM

7.1. Flunitrazepam suppliers in Europe

7.2. Flunitrazepam suppliers in Asia

7.3. Flunitrazepam suppliers in North America

7.4. Flunitrazepam suppliers in RoW

8. FLUNITRAZEPAM WORLD MARKET FORECAST

8.1. Future trends in global Flunitrazepam market

8.2. Flunitrazepam supply/demand forecast to 2029

8.3. Flunitrazepam market forecast to 2029 by region (Europe, Asia, North America, etc.)

9. FLUNITRAZEPAM MARKET PRICES

9.1. Flunitrazepam prices in Europe

9.2. Flunitrazepam prices in Asia

9.3. Flunitrazepam prices in North America

9.4. Flunitrazepam prices in RoW

10. FLUNITRAZEPAM END-USE SECTOR

For more information about this report visit https://www.researchandmarkets.com/r/sakwc2

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com




Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.

This report on Flumazenil provides comprehensive insights, including general information, synonyms, chemical composition, safety, hazards, handling, storage, and toxicological and ecological details, along with transport information. This in-depth study serves as a vital resource for understanding the Flumazenil market landscape and its growth potential worldwide.

It explores various applications and examines manufacturing methods, supported by an analysis of relevant patents. The global market analysis covers constraints, drivers, and opportunities from 2019 to 2024, supply and demand dynamics, suppliers and regional overviews across Europe, Asia, North America, and other regions.

The report forecasts future trends and supply-demand scenarios up to 2029, with detailed market predictions by region. Additionally, it analyzes market prices across different regions and evaluates the end-use sectors for Flumazenil.

The Flumazenil global market report covers the following key points:

• Flumazenil description, applications and related patterns
• Flumazenil market drivers and challenges
• Flumazenil manufacturers and distributors
• Flumazenil prices
• Flumazenil end-users
• Flumazenil downstream industries trends

Key questions answered in the report:

• What were the main trends of the global Flumazenil market in 2019-2024?
• What was the size of the global Flumazenil market in 2019-2024?
• Who are the main players in the global Flumazenil market?
• Which drivers and challenges will determine the development of the global Flumazenil market during 2025-2029?
• What will the CAGRs be for the global product industry?

Key Topics Covered:

1. FLUMAZENIL

1.1. General information, synonyms

1.2. Composition, chemical structure

1.3. Safety information

1.4. Hazards identification

1.5. Handling and storage

1.6. Toxicological & ecological information

1.7. Transport information

2. FLUMAZENIL APPLICATIONS

3. FLUMAZENIL MANUFACTURING METHODS

4. FLUMAZENIL PATENTS

5. FLUMAZENIL WORLD MARKET ANALYSIS

5.1. Flumazenil market constraints, drivers and opportunities in 2019-2024

5.2. Flumazenil supply/demand in 2019-2024

5.3. Flumazenil market overview by region – Europe, Asia, North America, etc.

6. MANUFACTURERS OF FLUMAZENIL

6.1. Flumazenil manufacturers in Europe

6.2. Flumazenil manufacturers in Asia

6.3. Flumazenil manufacturers in North America

6.4. Flumazenil manufacturers in RoW

7. SUPPLIERS OF FLUMAZENIL

7.1. Flumazenil suppliers in Europe

7.2. Flumazenil suppliers in Asia

7.3. Flumazenil suppliers in North America

7.4. Flumazenil suppliers in RoW

8. FLUMAZENIL WORLD MARKET FORECAST

8.1. Future trends in global Flumazenil market

8.2. Flumazenil supply/demand forecast to 2029

8.3. Flumazenil market forecast to 2029 by region (Europe, Asia, North America, etc.)

9. FLUMAZENIL MARKET PRICES

9.1. Flumazenil prices in Europe

9.2. Flumazenil prices in Asia

9.3. Flumazenil prices in North America

9.4. Flumazenil prices in RoW

10. FLUMAZENIL END-USE SECTOR

For more information about this report visit https://www.researchandmarkets.com/r/9qmow7

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

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For E.S.T Office Hours Call 1-917-300-0470

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Prodalim Expands SOLOS Capabilities with New Dealcoholization Site in Spain




Prodalim Expands SOLOS Capabilities with New Dealcoholization Site in Spain

VALENCIA, Spain–(BUSINESS WIRE)–Prodalim, a global leader in juice and specialty ingredients solutions, announced today the expansion of its SOLOS division with the opening of a dedicated dealcoholization and aroma recovery site in Valencia, Spain. The new facility is fully operational and strengthens Prodalim’s ability to support the rapidly growing no- and low-alcohol (NoLo) beverage market across Europe. During the coming months, an additional SOLOS site in California is planned to be inaugurated, further expanding overall capacity.

The global NoLo category continues to expand, driven by consumer demand for mindful drinking and healthier lifestyle choices. Industry forecasts estimate the NoLo global market at approximately USD 25 billion in 2025, with expected annual growth of 8–10% as the category expands across beers, wines, spirits, and functional beverages.

Preserving aroma, flavor, and authenticity during dealcoholization remains one of the industry’s most complex technical challenges. SOLOS addresses this challenge, enabling producers to create NoLo wines, beers, and spirits that remain true to their original sensory profiles. At the core of the SOLOS platform is its proprietary, patent-based Aroma Recovery System (ARS), developed over more than a decade of research to capture and reintegrate a beverage’s original aromatic profile during alcohol removal.

The Valencia site forms a complementary SOLOS platform, offering full-service dealcoholization, aroma recovery, pilot-scale trials, and white-label development. Designed for close technical collaboration, the facility enables customers to move efficiently from concept to commercial production, supported by Prodalim’s global infrastructure and expertise.

The expansion of SOLOS reflects Prodalim’s broader transformation into a purpose-driven, vertically integrated ingredient solutions group. As part of this transformation, Prodalim has reorganized its operations into three divisions:

• Juice Solutions – a one-stop-shop for juice producers, covering sourcing, logistics, formulation, and blending
• Specialty Ingredients & Solutions – including flavors, aromatic fruit-based essences (FTNF), essential oils, citrus fibers, natural colors, and beverage compounds
• SOLOS – a premium, patent-based dealcoholization and aroma recovery platform serving the fast-growing NoLo industry

All divisions are supported by Prodalim’s vertically integrated, regenerative supply chain, anchored in circular economy principles. Through this integrated approach, Prodalim empowers food and beverage brands to innovate with authenticity, sustainability, and performance at their core.

About Prodalim

Prodalim is a global leader in juice and specialty ingredients solutions, harnessing nature’s essence to craft healthier creations. With its tree-to-table supply chain and global footprint, the company develops sustainable, innovative solutions for the food and beverage industry, making a meaningful impact for people and planet.

Visit Prodalim at: www.prodalim.com

Contacts

sales@prodalim.com

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer




ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

• Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significantly improved progression-free survival versus current first-line standard of care in HER2 positive metastatic breast cancer

TOKYO & MUNICH–(BUSINESS WIRE)–The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU^® (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer.

“This validation in the EU is an important step in moving us closer to offering ENHERTU in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following the recent approval in the U.S. for this indication, we look forward to working closely with the EMA to bring ENHERTU to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade.”

About DESTINY-Breast09

DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.¹ In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths.¹ While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or that have progressed to metastatic disease are expected to live five years following diagnosis.²

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.³ HER2 protein overexpression may occur as a result of HER2 gene amplification.³ Approximately one in five cases of breast cancer are considered HER2 positive.⁴

HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.⁴ While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.^5,6,7 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.^8,9

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02, DESTINY-Gastric04 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY^® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of six ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 is being developed by Daiichi Sankyo.

Additional ADCs being developed by Daiichi Sankyo include DS-9606, which consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload and DS3610, which consists of an antibody attached to a novel immunomodulatory payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS-9606 and DS-3610 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

Contacts

Media Contacts:

Global:
Jennifer Brennan

Daiichi Sankyo, Inc.

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

EU:
Simone Jendsch-Dowé

Daiichi Sankyo Europe GmbH

simone.jendsch-dowe@daiichisankyo.com
+49 (89) 78080 (office)

Japan:

Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com

Median Technologies Reports Landmark 2025 Performance With Major Regulatory and Commercial Milestones Ahead in 2026




Median Technologies Reports Landmark 2025 Performance With Major Regulatory and Commercial Milestones Ahead in 2026

• Record iCRO bookings in 2025; order backlog at an all-time high of €76.6 million despite negative forex impact of € (6.5) million
• 2025 revenue of €23.5 million, up 2.6% vs 2024 despite negative forex impact of € (0.8) million
• FDA decision for eyonis® LCS expected in the coming weeks; CE marking anticipated in Q2 2026
• First U.S. and European distribution agreement for eyonis® LCS signed in December 2025
• 2026 set to accelerate commercial deployment of eyonis® LCS and expand the eyonis® portfolio
• As of December 31, 2025, cash position at €18.2 million after 2025 refinancing operations

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 2025 key business results (including unaudited figures) and provides an outlook on its critical milestones in 2026.

Management Statement

“Median made outstanding progress in 2025 which provides the foundations to deliver significant achievements in the coming years. We have achieved key regulatory, commercial, and operational milestones, providing significant momentum for further accelerating our growth trajectory to create long term value for our shareholders and clients,” said Fredrik Brag, CEO and Founder of Median Technologies.

Thomas Bonnefont, COO and CCO of eyonis®, said: “We expect a pivotal year for eyonis® in 2026. The FDA’s decision on 510(k) clearance for eyonis® LCS is expected in the coming weeks, followed by a European decision on CE marking, which we expect in the second quarter. The U.S., where lung cancer screening is already established with 14.5 million eligible patients, is our primary commercial target. We are actively building our commercial operations, starting with a first distribution agreement in December 2025 and with more to follow. The successful pivotal studies with eyonis® LCS demonstrate its potential as the new standard-of-care in lung cancer screening both in the U.S. and in Europe, and Median is determined to deliver on that.”

Nicolas Dano, COO and CCO of iCRO, said: “Our iCRO business enters 2026 with strong momentum. With an order backlog of 76.6 million euros as of December 31, 2025 (€83.1 million at constant forex) supported by exceptional fourth-quarter booking, we expect to accelerate revenue growth in 2026. At the same time, we will continue executing the optimization of our organization, and automation of our operations to further enhance iCRO business profitability. The initiatives launched in 2024 have already delivered significant gains, positioning iCRO for sustained and profitable growth in the year ahead.”

eyonis®LCS Software as a Medical Device: AI-driven Innovation for Lung Cancer Screening

2025 Key Achievements

2025 was a major milestone for the eyonis® program, with the completion of pivotal studies for eyonis® LCS, Median’s proprietary AI-based SaMD for lung cancer screening, followed by regulatory submissions for both FDA 510(k) clearance and European CE marking, respectively in May and June 2025.

To support the U.S. launch, Median completed a comprehensive mapping of lung cancer screening channels nationwide and has a well-defined strategy to deploy its organization and operations. Median is actively implementing its plan, laying the foundation for an accelerated successful commercial launch post FDA clearance.

In December 2025, the Company signed its first non-exclusive agreement with a leading U.S. healthcare company for the distribution of eyonis® LCS in the United States and Europe. Both organizations are now collaborating to ensure strong market impact following regulatory clearance.

Median further strengthened its network of key opinion leaders across radiology, pulmonology, and thoracic oncology, increasing visibility among early adopters and advancing the design of upcoming health-economic studies. Engagement with patient advocacy groups also intensified throughout the year.

2026 Strategic Outlook and Key Milestones

eyonis® LCS remains under regulatory review in both the U.S. and Europe. The FDA’s response regarding the 510(k) submission is expected in the coming weeks, while feedback for CE marking is anticipated in Q2.

Median is engaged in advanced discussions with additional industry leaders to widen its commercial reach across the U.S., Europe and possibly Asia.

In 2026, alongside the commercial rollout of eyonis® LCS, the Company will accelerate development of additional SaMD within the eyonis® portfolio, with a focus on eyonis® IPN (Incidental Pulmonary Nodules) and eyonis® HCC (Hepatocellular Carcinoma). The expansion of this portfolio will leverage current commercial efforts and reinforce Median’s global position in early cancer diagnosis.

iCRO: AI-driven and central imaging services for oncology drug development

2025 Key Achievements (unaudited figures)

Median’s order backlog¹ and revenue come entirely from the iCRO Business Unit, which provides AI-based image analyses and central imaging services for industry-sponsored oncology clinical trials.

As of December 31, 2025, the Company’s order backlog reached €76.6 million (€83.1 million at constant forex), an all-time high, providing strong revenue visibility over the next several years. This represents an increase of 4.1% compared to September 2025 (€73.6 million) and 7.9% (+17% at constant forex) compared to December 31, 2024.

2025 marked the strongest booking year in Median’s history, driven primarily by activity in the United States.

Q4 2025 revenue totaled €6.3 million, up 6.8% versus €5.9 million in Q4 2024 and up 6.8% versus €5.9 million in Q3 2025.

Full-year 2025 revenue reached €23.5 million (€24.3 million at constant forex), representing a 2.6% increase compared to €22.9 million in 2024.

Since late 2024, Median has implemented major operational improvements to increase iCRO’s profitability, delivering a surge in operating contribution of approx. €3.6 million in 2025 (unaudited figures).

Throughout the year, iCRO deepened its relationships with key top-3 and top-10 oncology pharmaceutical companies, significantly increased its market share in China, and expanded its client base with numerous biotech organizations.

2026 Strategic Outlook

In 2026, Median’s iCRO business will continue to execute its global key account strategy across the three major industry regions: North America, Europe and Asia.

Leveraging its recognized expertise in oncology imaging and artificial intelligence, Median’s iCRO business is well positioned to attract new clients across both large pharmaceutical companies and emerging biotech organizations, while expanding the scope of services provided to support drug development.

iCRO business profitability is expected to continue to improve throughout 2026, driven by Median’s highly differentiated, high-value imaging technology.

Strengthened Cash Position in 2025

As of December 31, 2025, cash and cash equivalents stood at €18.2 million, compared with €8.1 million one year earlier.

In July and August 2025, Median completed refinancing operations totaling up to €61.4 million. This included:

• a €23.9 million gross capital increase through the issuance of ABSA announced on August 1, 2025;
• a new €37.5 million financing facility from the European Investment Bank announced on July 11, 2025, with the first €19 million tranche drawn on October 21, 2025, following the €20.7 million repayment of the 2019 EIB loan tranche on October 17, 2025.

These transactions extend the Company’s cash runway through Q4 2026—and potentially well beyond, depending on the full exercise of 13,340,551 share warrants remaining as of December 31, 2025, which could generate an additional €47.8 million upon exercise.

The first €4 million tranche of the €10 million equity line subscribed with IRIS in January 2025, which was intended as bridge financing, has been fully repaid. Median has suspended drawdowns from the remaining tranches until further notice.

Next financial release on April 23, 2026, after the market close:

2025 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 www.mediantechnologies.com.

Disclaimer

eyonis® LCS is pending 510(k) clearance and CE marking is not yet available for sale in the United States and in Europe.

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.

Contacts

MEDIAN TECHNOLOGIES
Emmanuelle Leygues
VP, Corporate Marketing & Financial

Communications

+33 6 10 93 58 88

emmanuelle.leygues@mediantechnologies.com

Investors – SEITOSEI ACTIFIN
Ghislaine Gasparetto
+33 6 85 36 76 81

ghislaine.gasparetto@seitosei-actifin.com

Press – MAARC
Bruno Arabian
+33 6 87 88 47 26

bruno.arabian@maarc.fr
Nicolas Entz
+33 6 33 67 31 54

nicolas.entz@maarc.fr