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Monebo and Innolitics Secure FDA 510(k) Clearance for a Cross-Platform ECG Arrhythmia Analysis Library

AUSTIN, Texas–(BUSINESS WIRE)–Monebo Technologies, Inc. and Innolitics today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Kinetic Software Library (K260640), Monebo’s ECG analysis library for medical device manufacturers. The Kinetic Software Library provides ECG signal processing and analysis, including QRS detection, ectopic beat detection, QRS feature extraction, heart rate measurement and rhythm analysis. It is intended for use by qualified med

vRad Study Finds Radiologists Miss 40.7% of Superior Mesenteric Artery Occlusions Across 79,163 CT Exams

MINNEAPOLIS–(BUSINESS WIRE)–New research published in Clinical Imaging suggests that superior mesenteric artery occlusion (SMAO), a life-threatening vascular emergency requiring rapid diagnosis and treatment, may be overlooked on CT interpretation more often than previously recognized. The findings highlight a significant opportunity for radiologists and radiology practices to strengthen evaluation of the superior mesenteric artery and potentially improve patient outcomes. Conducted by resear

Powerful Medical Granted CPT Code for AI ECG Heart Attack Detection, Weeks After FDA De Novo Authorization of Queen of Hearts™

NEW YORK–(BUSINESS WIRE)– #AI–Powerful Medical, a leader in AI-driven cardiovascular diagnostics, today announced that the American Medical Association (AMA) CPT® Editorial Panel has established a new Category III CPT code, 1139T, for the noninvasive identification of ST-elevation myocardial infarction (STEMI), STEMI equivalents, and acute or subacute myocardial ischemia by assistive algorithmic analysis of the electrocardiogram (ECG). This is the service performed with Queen of Hearts™, which rec

Microbot Medical® Secures its First Office-Based Lab (OBL) Customer for the LIBERTY® Endovascular Robotic System

ELMNT IR also became the first account on the West Coast, marking a geographic expansion which aligns with the Company’s Full Market Release strategy.  The Company believes the OBLs represent a rapidly growing healthcare segment and opportunity as many endovascular procedures are being done outside traditional hospital settings and Ambulatory Surgery Centers. HINGHAM, Mass., Oct. 27, 2026 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY Endovascular Robotic System, today announced that ELMNT IR, a multisite outpatient interventional radiology practice in California, has signed an order to purchase up to a 12-month supply of LIBERTY devices. ELMNT IR became the first Office-Based Laboratory (OBL) customer in the world to utilize the LIBERTY Endovascular Robotic System, and the Company’s first customer on the West Coast. An OBL is an outpatient care setting that enables physicians to perform minimally invasive, image-guided procedures outside of the traditional hospital environment. Jonathan Steinberger, M.D., co-founder of ELMNT IR and a board-certified interventional radiologist specializing in minimally invasive, image-guided treatments for vascular disease, cancer, men’s health conditions, and complex venous disorders, has already performed multiple procedures using the LIBERTY System, including Y90 mapping, which is a planning procedure performed before Y-90 radioembolization, for the treatment of liver tumors, Prostate Artery Embolization (PAE) for the treatment of benign prostatic hyperplasia (BPH), and Genicular Artery Embolization (GAE) for symptomatic knee osteoarthritis. “Having used LIBERTY for multiple procedures, I’ve found that the combination of a compact footprint, efficient workflow, and the elimination of upfront capital costs and expenses associated with traditional equipment makes LIBERTY an optimal system for establishing an Endovascular Robotic Program in an OBL,” said Jonathan Steinberger, M.D., Co-Founder and Interventional Radiologist at ELMNT IR. “We have seen firsthand the value it can bring to physicians and patients. Based on our experience to date, LIBERTY is well positioned to become a standard for the use of robotics in endovascular intervention procedures.” “This is a significant milestone for us, and we believe it supports the value that LIBERTY brings across multiple sites of care settings, especially in OBLs, as we believe they are an important and growing segment of the market,” commented Harel Gadot, Chairman, CEO, President. “Our relationship with ELMNT IR, which has already resulted in advance orders of the LIBERTY System from ELMNT IR, continues a trend in which every customer that has utilized its initial LIBERTY inventory has subsequently reordered additional systems. We believe this reflects high satisfaction among physicians, as well as the acceptance by hospital administration, as they recognize the value of the system. Furthermore, in addition to expanding access to healthcare networks, this represents an additional revenue opportunity for the LIBERTY System as we expect the number of peripheral vascular interventions performed in OBLs to continue to increase.” LIBERTY is the only FDA cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain. About Microbot MedicalMicrobot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care. Learn more at www.microbotmedical.com and connect on LinkedIn and X. Safe Harbor Statements relating to future financial and/or operating results, future adoption of products, future growth in research, technology, clinical development, commercialization and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, market acceptance of the LIBERTY system, the length and outcome of hospital Value Analysis Committee and purchasing processes and the Company’s ability to convert sales leads into orders, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical® can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical® disclaims any intent or obligation to update these forward-looking statements, except as required by law. Contacts: IR@microbotmedical.comMedia@microbotmedical.com

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Vincora Receives FDA Approval to Initiate U.S. Early Feasibility Study of Transcatheter Chordal Repair System

MAPLE GROVE, Minn., Oct. 27, 2026 /PRNewswire/ — Vincora (NeoChord, Inc. d/b/a Vincora), a medical technology company developing transcatheter therapies for mitral valve repair, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational…

Anteris Announces Upcoming Data Release for Medium-Size DurAVR THV from EMBARK Study at TCT 2026

MINNEAPOLIS and BRISBANE, Australia, Oct. 27, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) today announced that Azeem Latib, MD, will present the first 30-day clinical and hemodynamic outcomes for its medium-size DurAVR® Transcatheter Heart Valve (THV) at TCT® 2026 – The 38th Annual Transcatheter Cardiovascular Therapeutics Conference, taking place in San Diego, California, October 31-November 3, 2026. The presentation will report 30-day outcomes in patients with severe aortic stenosis who received the medium-size DurAVR THV in the ongoing EMBARK study. Since 2021 over 130 patients have been treated with the DurAVR THV across different valve sizes in the Company’s EMBARK study and Early Feasibility Study (EFS). In a separate session on emerging TAVR technologies, Santiago Garcia, MD, will present “DurAVR TAVR (ANTERIS): Technology and Case-in-a-Box”, featuring the biomimetic DurAVR THV, a new class of transcatheter aortic valve replacement (TAVR). Session details are as follows: 1)   TCT Innovation 3: Emerging Concepts and Innovations in TAVR Sunday, November 1, 2026, 10:45 AM – 12:15 PM PST Room: Innovation Theater The Novel Biomimetic Medium DurAVR THV Balloon-Expandable Valve (Anteris): First Report of the 30-Day Clinical and Hemodynamic Outcomes Presenter: Azeem Latib, MD 2)   TCT Innovation 15: Live Case-in-a-Box Innovation: Emerging TAVR Technologies Tuesday, November 3, 2026, 8:35 – 9:35 AM PST Room: Innovation Theater DurAVR TAVR (ANTERIS): Technology and Case-in-a-Box Presenter: Santiago Garcia, MD About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information:   Global Investor Relationsinvestors@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D.Blueprint Life Science Group+1 917 330 4269   Websitewww.anteristech.com X@AnterisTech LinkedInhttps://www.linkedin.com/company/anteristech       

RadNet, Inc. Announces Agreement to Acquire ONRAD, Inc.

RadNet, Inc. Announces Agreement to Acquire ONRAD, Inc.

RadNet, Inc. Announces Agreement to Acquire ONRAD, Inc.

RadNet, Inc. Announces Agreement to Acquire ONRAD, Inc.

Adds a radiology professional services platform offering teleradiology and in-hospital staffing for hospitals and health systemsEnables RadNet to seamlessly combine radiology professional services, AI-powered technology solutions and outpatient imaging operations into an integrated offering, transforming radiology workflows and ultimately improving patient careUniquely positions RadNet with an expanded offering to address the full range of care settings where imaging is performed inside and outside of hospitalsAcquisition adds to RadNet a capital-light, high-margin management services platform supporting more than 225 hospital facilities across 26 states with more than 130 contracted radiologistsONRAD is expected to add $190 million to $200 million of Revenue and $60 million to $65 million of Adjusted EBITDA(1) to RadNet in its first year of operation after closingRadNet and ONRAD management will host a conference call and webcast to discuss the transaction in more detail on Tuesday, October 27  LOS ANGELES, Oct. 26, 2026 (GLOBE NEWSWIRE) — RadNet, Inc. (NASDAQ: RDNT) (“RadNet” or the “Company”), a national leader in providing high-quality, cost-effective outpatient diagnostic imaging services and a global developer of digital health solutions, today announced that it has entered into a definitive agreement to acquire ONRAD, Inc. (ONRAD).  ONRAD, through its more than 130 contracted radiologists, is a provider of teleradiology and in-hospital professional radiology staffing services for hospitals, health systems and other diagnostic imaging sites of care.  The transaction is expected to close in early 2027 and is subject to customary regulatory review and closing conditions.  Upon closing, ONRAD shareholders will receive a cash payment of $350 million and 5 million shares of RadNet, Inc. common stock, subject to customary adjustments.  In addition, an earnout of up to $210 million in value will be payable upon achievement of target EBITDA for 2027.  The earnout is payable in cash, RadNet common stock, or a combination thereof, at RadNet’s election. “This is the next step in building an imaging company with comprehensive solutions that brings technology, radiology professional services and imaging operations together to address some of healthcare’s most pressing challenges and needs,” said Dr. Howard Berger, President and CEO of RadNet.  “Connecting RadNet’s established AI-enabled digital health technology and imaging center operational expertise with ONRAD’s teleradiology and professional staffing solutions unites the capabilities needed to address the entire continuum of diagnostic imaging under one company.  The acquisition will enhance RadNet’s portfolio of solutions for hospitals and health systems, outpatient freestanding centers, urgent care facilities, freestanding emergency departments and physician offices.” Dr. Berger continued, “I welcome ONRAD’s executive team, its contracted radiologists and all other ONRAD team members into the RadNet family.  This transaction is a significant additional step in leading our industry forward and demonstrating the impact that a transformation to workflow solutions in diagnostic imaging can have in advancing early detection, population health and improved patient outcomes.” Through its contracted radiologists, ONRAD provides remote teleradiology final-read interpretations across many healthcare settings and in-hospital professional radiology staffing services, including interventional radiology, for hospitals and health systems.  Upon closing, ONRAD will become the foundation for RadNet’s third reportable operating segment, Radiology Professional Services.  With the addition of this third operating segment, RadNet becomes a comprehensive radiology services and solutions provider, addressing the imaging continuum across the full range of care settings, including hospitals, freestanding ambulatory outpatient centers, primary and specialty care physician offices and standalone urgent care and emergency department facilities. Strategic Rationale Connects three complementary businesses to provide comprehensive imaging solutions.  Combining RadNet outpatient imaging operations and DeepHealth AI-enabled digital health solutions with the ONRAD radiology professional services platform will bring together comprehensive expertise in the diagnostic imaging industry within one company.  Integrating these capabilities for customers and partners across all diagnostic imaging settings is expected to create efficiencies, improve patient care and lower costs in an unequaled approach.Expands RadNet into hospital-based radiology.  Hospitals and health systems account for more than 50% of U.S. diagnostic imaging volume.(2)  ONRAD will provide RadNet with an established platform to support in-hospital and remote professional radiology interpretation services while also expanding the RadNet offerings to its existing joint venture partners.Addresses growing market demand.  U.S. imaging demand growth is outpacing the supply of trained radiologists.  With ONRAD, RadNet will be positioned to further help address this gap by integrating AI-enabled technology with teleradiology and professional staffing services, creating opportunities to transform workflows, support case prioritization and better match interpretation capacity to demand.Adds a fast-growing, high-margin capital-light business.  ONRAD has demonstrated consistent annual revenue growth between 10% and 20% over the last several years with Adjusted EBITDA(1) margins exceeding 30%.  RadNet believes ONRAD will require very little capital to maintain and grow organically. “For 20 years, ONRAD has built long-standing relationships with hospitals and health systems delivering reliable, high-quality radiology coverage,” said Dave Engert, President and CEO of ONRAD.  “Joining RadNet not only gives us the scale, resources and technology to meet the growing needs of our current and prospective customers, but it also enables us to offer a unique imaging model that addresses the full continuum of care from outpatient imaging centers to the acute care environment.  The potential to further meet the ever-increasing demand for imaging services along with improving patient outcomes is what excites me most about our future together.” Conference Call and WebcastRadNet will host a conference call and webcast at 8:00 a.m. Eastern Time on Tuesday, October 27, 2026 to discuss the transaction in further detail.  To join by phone, dial 1-844-744-1280 for the U.S. and Canada and 1-412-564-6465 for international callers. A live webcast will be available at https://viavid.webcasts.com/starthere.jsp?ei=1780997&tp_key=417a069370. Robert W. Baird & Co. is serving as exclusive financial advisor to ONRAD, which is a portfolio company of Housatonic Partners.  About RadNet, Inc.RadNet, Inc. is a leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue.  RadNet has a network of owned and/or operated outpatient imaging centers.  RadNet’s imaging center markets include Arizona, California, Delaware, Florida, Idaho, Indiana, Maryland, New Jersey, New York, Texas and Virginia.  In addition, RadNet provides radiology information technology and artificial intelligence solutions marketed under the DeepHealth brand, teleradiology professional services and other related products and services to customers in the diagnostic imaging industry globally.  Together with contracted radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has over 12,000 team members.  Learn more at radnet.com.    About ONRAD, Inc. ONRAD, Inc. is a leading radiology services company, delivering remote teleradiology final-read impressions and full-service radiology solutions for hospitals, radiology practices, outpatient clinics and imaging centers. Its spectrum of services includes reading remote and onsite diagnostic studies, interventional radiology, medical directorship, analytics, peer review, billing and quality oversight — all on the industry’s most advanced, integrated, AI-powered technology platform. ONRAD reads all modalities and has been Joint Commission accredited since its inception.  Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included in this press release that address activities, events or developments that RadNet expects, believes or anticipates will or may occur in the future are forward-looking statements. Terminology such as “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the transaction discussed herein, the expected timing and completion of such transaction, the anticipated benefits of such transaction, the potential earnout amount, the expected financial impact of the transaction on RadNet and other statements that are not historical facts. Forward-looking statements are based on current plans, estimates, expectations and assumptions as of the time they are made, are not guarantees of future performance and should not be relied on as predictions of future events, and there can be no assurance that such estimates, assumptions and expectations will prove to have been correct. These forward-looking statements involve risks and uncertainties, many of which are difficult to predict and are generally outside RadNet’s control, and other factors that could cause RadNet’s actual results or financial condition to differ materially from those expressed or implied by forward-looking statements, including (i) the risk that the conditions to the closing of the transaction, including required regulatory approvals, are not satisfied or waived on a timely basis or at all, and the risk that the transaction may not be completed on the anticipated terms, in the anticipated timeframe or at all, (ii) the occurrence of any event that could give rise to the termination of the definitive agreement for the transaction, (iii) the risks and costs associated with the transaction and integrating ONRAD and achieving the anticipated benefits of the transaction, (iv) potential disruption to the businesses of RadNet and ONRAD, including the ability to retain and hire key personnel and to maintain relationships with customers, suppliers and other business partners, as well as diversion of management’s time and attention from ordinary course business operations to completion of the transaction and integration matters, (v) potential litigation or regulatory action relating to the transaction, (vi) the effect of the transaction on RadNet’s indebtedness and leverage, credit ratings and liquidity, (vii) legislative, regulatory and economic developments, including in the healthcare industry, (viii) the effect of the announcement, pendency or completion of the transaction on the market price of RadNet’s common stock, and (ix) the other risks described under “Risk Factors” in RadNet’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. There may be additional risks, uncertainties and factors that we do not currently view as material or that are not necessarily known. Please read the Company’s filings with the SEC, which are available on the SEC’s website at https://www.sec.gov, for a discussion of risks and uncertainties that could cause actual results to differ from those in such forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements in this press release are qualified in their entirety by these cautionary statements. Except as required by law, RadNet undertakes no obligation and does not intend to update or revise any forward-looking statements, whether as a result of new information, future results or otherwise.  No Offer or Solicitation This press release is for informational purposes only and shall not constitute or form part of, an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities, in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.  References (1)The Company defines Adjusted EBITDA as earnings before interest, taxes, depreciation and amortization, each from continuing operations and adjusted for losses or gains on the sale of equipment, other income or loss, debt extinguishments and non-cash equity compensation.  Adjusted EBITDA includes equity earnings in unconsolidated operations and subtracts allocations of earnings to non-controlling interests in subsidiaries, and is adjusted for non-cash or extraordinary and one-time events taken place during the period.     Adjusted EBITDA is a non-GAAP financial measure used as analytical indicator by RadNet management and the healthcare industry to assess business performance, and is a measure of leverage capacity and ability to service debt.  Adjusted EBITDA should not be considered a measure of financial performance under GAAP, and the items excluded from Adjusted EBITDA should not be considered in isolation or as alternatives to net income, cash flows generated by operating, investing or financing activities or other financial statement data presented in the consolidated financial statements as an indicator of financial performance or liquidity. As Adjusted EBITDA is not a measurement determined in accordance with GAAP and is therefore susceptible to varying methods of calculation, this metric, as presented, may not be comparable to other similarly titled measures of other companies.   The Company’s guidance or target for ONRAD’s addition to Adjusted EBITDA is also a non-GAAP financial measure that excludes or otherwise has been adjusted for non-GAAP adjustment items from the Company’s GAAP financial statements. When the Company provides guidance or its target for ONRAD’s addition to Adjusted EBITDA, it does not provide a reconciliation of the GAAP measure as it is unable to predict with a reasonable degree of certainty the actual impact of the non-GAAP adjustment items. By their very nature, non-GAAP adjustment items are difficult to anticipate with precision because they are generally associated with unexpected and unplanned events that impact the Company and its financial results. Therefore, the Company is unable to provide a reconciliation of these measures without unreasonable efforts.   (2)Based on a Signify analysis.    RadNet Media Contacts  Jane Mazur  Senior Vice President, Corporate Communications  +1 585-355-5978  jane.mazur@radnet.com     Mark Stolper Executive Vice President and Chief Financial Officer +1 310-445-2800 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/05e518ec-4d83-4fcc-a69f-3e80e67f4d30

Parasol Med Tech Secures $2.75M to Improve Stroke Prevention in Atrial Fibrillation

Parasol Med Tech, a Chicago-based medical device company, today announced that it has closed an oversubscribed $2.75 million pre-seed funding round. The round included participation from Harper Court Ventures, UChicago Medicine Ventures, a venture investment vehicle of the University of Chicago Medical Center, and Cardiovascular Innovation Ventures, the venture arm […]

Amarin Provides Update on University of Leeds Sponsored Phase 3 EPA for Metastasis Trial 2 (EMT2) Evaluating VAZKEPA®/VASCEPA® (icosapent ethyl) Capsules on Top of Standard of Care Treatment in Patients Undergoing Liver Resection for Colorectal Cancer Liver Metastases (CRCLM)

Pre-specified and Statistically Powered Key Endpoints Included Progression-free Survival (PFS) and Overall Survival (OS). Although Primary Endpoint of PFS Was Not Met, The Key Secondary Endpoint of OS Was Improved With VAZKEPA/VASCEPA Patients Taking VASCEPA Prior to and Following Liver Resection for CRCLM Were Estimated to Have an Approximately 32% Reduction in the Risk of Death at 5 Years Relative to the Control Arm DUBLIN and BRIDGEWATER, N.J., Oct. 25, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today highlighted findings from the EPA for Metastasis Trial 2 (EMT2), a randomized, double-blind, placebo-controlled, multi-center, Phase 3 investigator-initiated trial sponsored by the University of Leeds and presented as a late breaker at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain. The research presented by the Chief Investigator, Professor Mark Hull, added to the scientific understanding of VAZKEPA®/VASCEPA® (icosapent ethyl or IPE), a highly purified ethyl ester form of eicosapentaenoic acid (EPA), and its potential role as an add-on therapy in improving outcomes for patients undergoing liver resection and standard of care treatment for colorectal cancer liver metastases (CRCLM). The investigational medicinal product used in EMT2 was the same prescription IPE clinical formulation and dosage utilized in the landmark REDUCE-IT cardiovascular outcomes trial.  The presented results showed the trial did not meet its pre-specified primary endpoint of progression-free survival (PFS) in the intent-to-treat (ITT) population: median PFS was 13.5 months with IPE versus 12.9 months with placebo (adjusted HR 0.89; 95% CI 0.70–1.13; p=0.329). However, the pre-specified key secondary endpoint of overall survival (OS) demonstrated a statistically significant benefit in the ITT population. The 5-year OS estimate was 62.0% with IPE versus 45.1% with placebo, corresponding to an approximately 32% reduction in the risk of death (adjusted HR 0.68; 95% CI 0.48–0.96; p=0.030). IPE was reported to be safe and well tolerated, with no excess of total adverse events, bleeding episodes, atrial fibrillation, or deterioration in quality of life.i “Today’s presentation reflects years of commitment from the funder (Yorkshire Cancer Research), investigators, research teams, and, most importantly, the patients who took part in EMT2, helping to advance our understanding of whether IPE could improve outcomes in patients with metastatic colorectal cancer,” said Professor Mark A. Hull, Chief Investigator, University of Leeds. “An overall survival benefit without a corresponding progression-free survival benefit is not an unprecedented finding in oncology. This type of oncology endpoint pattern can be observed where delayed effects on host anti-tumor immunity may influence long-term outcomes. There are also several biologically plausible hypotheses, including direct anti-inflammatory or anti-neoplastic activity of prescription IPE and potential augmentation of host anti-tumor immune surveillance through effects on the gut microbiome. These potential mechanisms remain investigational and require further analyses of the EMT2 dataset as well as further study.”  The study investigators concluded that high-dose, high-purity prescription IPE did not alter subsequent cancer progression but did reduce mortality in patients undergoing liver resection for CRCLM. Colorectal cancer is the second leading cause of cancer-related death globally. Approximately half of all CRC patients develop liver metastases and, even after curative-intent liver resection with contemporary multimodality treatment, five-year survival rates remain between 40 to 60%, with outcomes dependent on several factors.ii There remains a critical and largely unmet need for safe, affordable adjunctive therapies that can extend survival in this population. “We would like to acknowledge and thank the University of Leeds, as well as the other institutions that were part of the EMT2 trial team, and all patients for their dedication and multi-year commitment to conducting and participating in this important research exploring a new potential way of positively impacting survival in colorectal cancer with liver metastases on top of current standard of care therapy and surgery,” said Steve Ketchum, President R&D and Chief Scientific Officer of Amarin. “We are encouraged by the presented findings, including the significant improvement in overall survival, a clinically important and meaningful endpoint in oncology and a key result that warrants further scientific evaluation. These findings add to clinical and mechanistic evidence suggesting that highly purified prescription IPE may have biological effects of relevance to areas beyond cardiovascular disease.”  “Perhaps the most exciting part of these findings is the new questions they allow us to ask regarding potential novel therapeutic pathways for VAZKEPA/VASCEPA,” said Aaron Berg, Chief Executive Officer of Amarin. “These results give us an opportunity to explore whether this safe and proven therapy for cardiovascular risk reduction – which has been prescribed approximately 32 million times – could make a meaningful difference in the adjunctive care of colorectal cancer patients with liver metastases eligible to undergo liver surgery. Our team will continue to collaborate with the study sponsor to better understand the results and develop a clearer perspective on the potential opportunity. Patent protection in Europe through 2039 for VAZKEPA/VASCEPA provides a substantial runway to evaluate this type of opportunity and its potential to deliver long-term value for patients and shareholders.” The study investigators reported that prescription IPE was well tolerated throughout the trial. There was no excess of total adverse events, serious adverse events, atrial fibrillation, bleeding episodes, or clinically meaningful quality-of-life detriment versus placebo. The safety findings were consistent with the known safety profile of prescription IPE. Serious bleeding events requiring transfusion or re-operation were numerically lower in the IPE arm than in the placebo arm.  While REDUCE-IT established VAZKEPA/VASCEPA as a foundational add-on therapy for cardiovascular risk reduction, published cancer literature,iii including recent mechanistic data reporting the incorporation of EPA in colorectal tissue after IPE administration,iv as well as the recent EMT2 findings provide additional clinical evidence supporting continued scientific investigation into the broader biological effects of prescription IPE and its potential role in areas of significant unmet medical need.  About The EMT2 TrialThe EPA for Metastasis Trial 2 (EMT2; ClinicalTrials.gov NCT03428477) is a randomized, double-blind, placebo-controlled, multicenter Phase 3 investigator-initiated trial funded by Yorkshire Cancer Research and sponsored by the University of Leeds, along with involvement from Leeds Teaching Hospitals NHS Trust, University of Bradford, University of Liverpool, and University of Edinburgh. The trial enrolled 418 patients across 13 hepatobiliary surgery centers in England and Wales between 2018 and 2023. Patients undergoing liver resection for colorectal cancer liver metastases were randomized 1:1 to highly purified prescription EPA ethyl ester 4 g/day or matched mineral oil placebo. Treatment was initiated before surgery and continued for up to a maximum of four years. Investigational product was supplied by Amarin Corporation free of charge. A link to the published rationale and design of EMT2 can be found here: https://bmjopen.bmj.com/content/13/11/e077427  About Amarin At the Heart of Amarin Corporation is a singular focus on advancing cardiovascular disease prevention worldwide. Our flagship oral prescription therapy, VASCEPA® (icosapent ethyl or IPE), is the U.S. market leader across all available IPE products and has been prescribed approximately 32 million times globally. Through our independent U.S. commercial operations and global commercial partnerships, Amarin supports access to VASCEPA/VAZKEPA® across nearly 100 markets worldwide. For more information, visit www.amarincorp.com and follow Amarin on LinkedIn, X, Facebook. To be added to the Company’s email list and receive news directly, please visit https://investors.amarincorp.com/email-alerts. About REDUCE-IT®REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.v The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.vi The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.vii  About VASCEPA®/VAZKEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, the Netherlands, Scotland, Greece, Portugal, Italy, Slovenia, Romania, Denmark and Austria.  United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.  The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.  Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf Globally, prescribing information varies; refer to the individual country product label for complete information.  Forward-Looking StatementsThis press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin Contact InformationMedia Inquiries:Amarin Corporation plcPR@amarincorp.com Investor Inquiries:Devin Sullivan & Conor RodriguezThe Equity Group on Behalf of Amarindevin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.comInvestor.relations@amarincorp.com _________________________i https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/session/calendar?q=eicosapentaenoic ii Hull MA, Ow PL, Ruddock S, et al. Randomised, placebo-controlled, phase 3 trial of the effect of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) on colorectal cancer recurrence and survival after surgery for resectable liver metastases: EPA for Metastasis Trial 2 (EMT2) study protocol. BMJ Open. 2023;13:e077427. doi: 10.1136/bmjopen-2023-077427 iii Song M, Ou FS, Zemla TJ, Hull MA, Shi Q, Limburg PJ, Alberts SR, Sinicrope FA, Giovannucci EL, Van Blarigan EL, Meyerhardt JA, Chan AT. Marine omega-3 fatty acid intake and survival of stage III colon cancer according to tumor molecular markers in NCCTG Phase III trial N0147 (Alliance). Int J Cancer. 2019;145(2):380-389. doi: 10.1002/ijc.32113.iv Chen Y, Bae S, Wang K, et al. Effect of icosapent ethyl treatment on colorectal tissue marine ω-3 polyunsaturated fatty acid levels among patients with a history of adenoma: a prospective, single-arm clinical trial. Am J Clin Nutr. 2026;124(3):101419. doi: 10.1016/j.ajcnut.2026.101419. v Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148vi Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792 vii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.