Published study reports PulseAI model delivers up to 10x performance improvement when used with leading wearables BELFAST, Northern Ireland, Nov. 5, 2026 /PRNewswire/ –PulseAI, a medical technology company developing artificial intelligence for cardiac diagnostics, today announced U.S….
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Evident Vascular Receives FDA Clearance for High-Fidelity AI Powered IVUS Imaging Platform
SAN JOSE, Calif.–(BUSINESS WIRE)–Evident Vascular, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Evident Vascular® Guidance System and Evident® peripheral imaging catheters. The Evident Vascular Guidance System is intended for ultrasound examination of intravascular pathology during peripheral vascular interventions. The Evident platform is designed to transform the IVUS imaging experience by bringing together high-fidelity imaging, purpose-built AI, an
FDA Confirms SeaStar Medical Has Fulfilled the Post-Approval Study Requirements for QUELIMMUNE® for the Treatment of Sepsis-Associated Acute Kidney Injury (AKI) in Pediatric Patients
DENVER, Nov. 03, 2026 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry (SAVE Registry) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption (HDE) approval of QUELIMMUNE. “We are grateful for this decision by FDA and believe it will enable us to expand the potential life-saving benefits of our QUELIMMUNE therapy to more critically ill children with life-threatening AKI,” stated Eric Schlorff, CEO of SeaStar Medical. “These kids typically have about a 50% survival rate with traditional supportive care alone, and we believe this decision will be a win-win for patients, their families, health care providers, and the overall health care system.” Results from the SAVE Registry were recently presented at a late-breaking presentation at ASN Kidney Week 2026. The presentation highlighted the clinically meaningful and statistically significant improved survival of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening AKI and sepsis requiring renal replacement therapy (RRT). Data from the SAVE Registry patients showed no device-related adverse events. This late-breaking presentation at ASN Kidney Week 2026 reported a clinically meaningful and statistically significant improvement in 90-day survival of 65.1% for the QUELIMMUNE (SCD-PED) patients (N=43) versus only 47.5% (P = 0.043) for patients from clinically aligned cohorts from the Kids’ Inpatient Database (KID) (N=196). Statistically significant increases for both in-hospital and 60-day survival were also seen in the primary analysis for patients treated with QUELIMMUNE (SCD-PED) compared to the KID cohorts. KID is the largest publicly available, all-payer pediatric inpatient care database in the United States representing a broad range of diagnoses, procedures, and clinical severity. The ASN Kidney Week 2026 late-breaking poster presentation is available on the Healthcare Professional section of the SeaStar Medical website. “It is hard to describe how sick these children really are. Many are fighting sepsis and multi-organ failure at the same time,” stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The SAVE Registry gives us crucial real-world evidence on both safety and probable benefits in these patients, and we are grateful to the pediatric teams and families who made it possible. We remain committed to collecting data wherever feasible, so that we keep learning how best to use QUELIMMUNE for the children who need it most.” FDA’s decision now enables hospitals to employ the QUELIMMUNE therapy without the research infrastructure that the SAVE Registry demanded, which will expand access to critically ill pediatric patients with sepsis-associated AKI on RRT at medical centers that previously could not participate. SeaStar Medical will continue to voluntarily enroll patients in the SAVE Registry at medical centers that choose to take part to continue to build on the real-world evidence for the use of QUELIMMUNE. The QUELIMMUNE therapy has been adopted by many of the highest rated children’s medical centers in the United States. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy that has broad potential applications for the treatment of destructive hyperinflammation that shuts down organ function and causes loss of life. About QUELIMMUNE The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more and aged ≤22 years who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. QUELIMMUNE was approved by FDA under a Humanitarian Device Exemption based on safety and probable benefit. The effectiveness of this device for this use has not been demonstrated. Adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia. Additional risks may include blood loss or extracorporeal circuit complications. QUELIMMUNE must be used with citrate anticoagulation. For complete risk information, please see: https://seastarmedical.com/quelimmune About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing CRRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future CRRT, including dialysis, and prevent loss of life. About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous RRT, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to the potential benefits from the SCD therapy; anticipated improved survival in real-world critical care practice; anticipated adoption of SeaStar’s products; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: IR@SEASTARMED.COM QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.
Abbott’s TECTONIC clinical trial demonstrates strong 30-day outcomes and high procedural success for its investigational SonicForce™ Coronary Intravascular Lithotripsy System
SonicForce is an investigational coronary intravascular lithotripsy (IVL) system that uses acoustic pressure waves, similar to those used to break up kidney stones, to crack calcium in coronary arteries and restore blood flow The system is designed to bring purposeful innovation to…
Instylla’s Embrace® Hydrogel Embolic System Receives FDA Approval for Peripheral Arterial Bleeds
First and Only Liquid Embolic Approved for Both Peripheral Arterial Bleeds and Hypervascular Tumors Supported by Two Prospective, Multicenter Pivotal Clinical Trials BURLINGTON, Mass., Oct. 29, 2026 /PRNewswire/ — Instylla, Inc., a privately held company advancing resorbable embolics for…
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
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…
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.
Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S.
Secures its 13th FDA 510(k) clearance, expanding its U.S. portfolio from lung nodule detection and coronary artery calcium (CAC) analysis to quantitative aortic assessment Enables automated aortic segmentation and diameter measurements across anatomical regions, broadening the…
CorWave Completes Enrollment in Feasibility Study and Presents First Clinical Data on Adaptive Support with its Wave Membrane LVAD
CLICHY, France–(BUSINESS WIRE)–CorWave SA, a clinical-stage medical technology company pioneering innovative cardiac assist devices, announces the completion of enrollment in its feasibility study of the CorWave Left Ventricular Assist System (LVAS). The company also presented the first clinical data on the device’s adaptive control algorithm at the 18th Branislav ‘BRANO’ Radovancevic Heart Failure Forum, held jointly with the 19th Innovations and New Treatment Strategies in Heart Failure sym



