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Cytokinetics Announces Positive Results from ACACIA-HCM Presented in Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 and Published in The New England Journal of Medicine

ACACIA-HCM is the First Phase 3 Clinical Trial to Successfully Demonstrate Statistically Significant Improvements Across Both Patient-Reported and Physician-Assessed Endpoints in Non-Obstructive HCM Supplemental New Drug Application to be Submitted to FDA in Fourth Quarter Company to Host Investor Event and Webcast Today at 2:00 PM Central European Summer Time (8:00 AM Eastern Time) SOUTH SAN FRANCISCO, Calif., Aug. 28, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the primary results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, and simultaneously published in The New England Journal of Medicine.1 ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). Results for the dual primary endpoint analysis consistently favored aficamten across prespecified subgroups studied. Based on the positive results from ACACIA-HCM, Cytokinetics plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for aficamten for the treatment of adult patients with symptomatic nHCM in the fourth quarter of 2026. “ACACIA-HCM is the first-ever positive clinical trial in non-obstructive HCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “As shown in presentation and publication, the results from ACACIA-HCM are both statistically robust, consistent across prespecified subgroups and other secondary endpoints, and clinically impactful for these patients with non-obstructive HCM. As such, these data may potentially translate into a new treatment option for patients with HCM with no available medical treatments that directly address their underlying disease. If approved, we look forward to seeing aficamten become the first cardiac myosin inhibitor to treat the full spectrum of symptomatic HCM.” “We are grateful to the patient community and the clinical trial team who contributed to the successful completion of ACACIA-HCM, a fitting tribute to the patients and families who have struggled with this disease for many years and across generations. We are also pleased that most of the eligible patients from ACACIA-HCM are continuing treatment with aficamten in FOREST-HCM,” said Ahmad Masri, M.D., M.S., Director, Hypertrophic Cardiomyopathy Center and Cardiac Amyloidosis Program, Oregon Health & Science University and Principal Investigator of ACACIA-HCM. “We look forward to applying this study’s groundbreaking scientific knowledge into clinical practice upon potential approval, addressing this area of HCM where patients do not have adequate treatment options.” ACACIA-HCM: Efficacy The baseline characteristics of patients enrolled in ACACIA-HCM were well-matched between treatment groups and consistent with a symptomatic nHCM phenotype with substantial disease burden despite normal left ventricular ejection fraction (LVEF). There were two pre-specified primary endpoints, KCCQ-CSS and pVO₂, evaluated in parallel. For each endpoint, a p-value of 0.025 or less was considered statistically significant. Compared to placebo, treatment with aficamten demonstrated statistically significant improvements in both dual primary endpoints at 36 weeks (Table 1). Table 1: Dual Primary Endpoint Results PrimaryEndpointsChange from Baseline to Week 36LSM [95% CI]Aficamtenvs PlaceboLSM (95% CI)P-value AficamtenPlacebo  KCCQ-CSS11.4 [9.6 – 13.2]8.4 [6.6 – 10.2]3.0 (0.5 – 5.5)0.021pVO2 (ml/kg/min)0.64 [0.32 – 0.95]-0.03 [-0.35 – 0.28]0.67 (0.22 – 1.1)0.003LSM = least square mean; CI = confidence interval Improvements in KCCQ-CSS relative to placebo were noted beyond titration and throughout the treatment period in participants treated with aficamten, such that patients remaining on treatment at 72 weeks demonstrated a least square mean (LSM) change from baseline in KCCQ-CSS of 7.0 points. Of note, following a washout of aficamten for four weeks, the KCCQ-CSS declined from the end of treatment for participants on aficamten to match that in the placebo group (Figure 1). Figure 1: Assessment of KCCQ-CSS The figure is based on the observed data, except that the inset box of Week 36 LSM difference and p-value are from the primary analysis imputed data. At Week 36, pVO2 increased for participants on aficamten while it remained unchanged for participants on placebo (Figure 2). Figure 2: Assessment of pVO2 The treatment effect of aficamten on both dual primary endpoints was consistent across all prespecified subgroups, including baseline LVEF, atrial fibrillation status, genotype, age, sex, whether patients were receiving background beta-blocker therapy and whether patients had intracavitary obstruction at baseline (Figure 3). Figure 3: Pre-Specified Subgroups for KCCQ-CSS and pVO2 Statistically significant improvements compared to placebo were observed in key ranked secondary endpoints, including New York Heart Association (NYHA) Functional Class, the composite z-score of two cardiopulmonary exercise testing (CPET) parameters (VE/VCO2 and pVO2), and NT-proBNP, a biomarker of cardiac wall stress. Statistical significance was not met on the endpoints of change from baseline in left atrial volume index or the time to first cardiovascular event for aficamten compared to placebo (Table 2). Table 2: Secondary Endpoints SecondaryEndpointsChange from Baseline to Week 36LSM (95% CI)Aficamten vsPlaceboTreatmentDifference (95% CI)P-value AficamtenPlacebo  Improvement of ≥1 NYHA class at week 36 – n (%)108 (41.9)72 (27.8)14.1 (6.0 to 22.2)

New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk

MUNICH–(BUSINESS WIRE)–Daiichi Sankyo (TSE:4568) today announced new results from the MILOS study that demonstrate the real-world impact of bempedoic acid administered either alone or as a fixed-dose combination with ezetimibe, in the management of dyslipidaemia. Presented at the European Society of Cardiology Congress 2026 in Munich, the findings show that the clinically relevant reductions in low-density lipoprotein cholesterol (LDL-C) achieved within the first year of treatment are estimat

Late Breaking Data from Independent Government-Funded Trial at ESC Shows Heartflow FFRCT Analysis Reduces Unnecessary Invasive Heart Procedures by Nearly Half

FUSION trial presented at ESC and published in Journal of the American College of Cardiology demonstrates adding non-invasive lesion-specific physiology resolves critical diagnostic uncertainty, supporting Appropriate Use Criteria for cath lab referralsSAN FRANCISCO, Aug. 28, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced late-breaking one-year results from an independent randomized clinical trial proving the Heartflow FFRCT Analysis safely and significantly reduced unnecessary invasive heart procedures by 44% (p < 0.001). Presented as Late-Breaking Science at the European Society of Cardiology (ESC) Congress 2026, FUSION trial, funded by the Dutch National Health Care Institute, demonstrates that standard coronary computed tomography angiography (CCTA) alone drives overutilization of invasive catheterizations.1 By adding Heartflow FFRCT Analysis to standard CCTA scans, clinicians dramatically reduced diagnostic catheter lab procedures. The FUSION study has been published simultaneously in the Journal of the American College of Cardiology (JACC). CCTA is the primary first-line test recommended by both European (ESC) and U.S. (ACC/AHA) guidelines for evaluating patients with suspected CAD. However, visual assessment of CCTAs is limited to assessing anatomy and whether plaque is present; it cannot determine lesion-specific physiology or whether a blockage significantly restricts blood flow to the heart. This diagnostic uncertainty frequently leads physicians to refer patients for invasive coronary angiography (ICA), a hospital procedure where a catheter is threaded through an artery, normally in the groin or arm, to get into the heart to assess blocked or narrowed blood vessels.1,2,3,4 These findings show Heartflow FFRCT – the only AI platform prospectively validated against invasive gold standard – bridges this critical diagnostic gap. By applying advanced AI and computational fluid dynamics to standard CT scans with documented narrowings, Heartflow creates a personalized 3D model that quantifies blood flow within the coronary arteries.5 “CCTA is established as the optimal first-line diagnostic test for coronary artery disease as it is noninvasive, but when anatomical scans show intermediate stenosis, determining whether that blockage is clinically significant remains a critical challenge,” said Alexander Hirsch, M.D., principal investigator of the FUSION trial and associate professor of cardiology at Erasmus MC in Rotterdam, Netherlands. “The FUSION trial shows that adding Heartflow lesion-specific physiology makes CCTA even more powerful and improves diagnostic efficiency. It gives clinicians the clarity to know which patients require further invasive testing, safely avoiding unnecessary invasive catheterizations while maintaining excellent patient outcomes.” One-Year FUSION Results Enrolling 528 patients with stable chest pain across twelve hospitals in the Netherlands, FUSION is an independent randomized controlled trial funded through the Dutch government’s Zorginstituut Nederland ‘Potentially Promising Care’ program. The study evaluated Heartflow FFRCT Analysis across diverse scanner vendors in both academic and community hospital settings, with blinded, independent clinical event adjudication. Key 1-year findings include: A sustained 44% relative reduction in unnecessary ICA was demonstrated at one year in the Heartflow pathway compared to the CCTA-only group (22% [57/263] Heartflow vs. 39% [103/265] CCTA alone; p < 0.001), consistent with the 90-day primary endpoint results (18% [48/263] vs. 33% [87/265] CCTA alone; p < 0.001).Overall rates of ICA were significantly lower at one year in the Heartflow pathway compared to the CCTA-only group (43% [114/263] Heartflow vs. 61% [161/265] CCTA alone; p 50% non-obstructive rate in usual care elective caths).2 Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCAI Guideline for the Evaluation and Diagnosis of Chest Pain. Circulation 2021; 144:e368–e454.3 Vrints C, et al. 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. Eur Heart J 2024; 00:1–105.4 Tonino PA, et al. Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME). N Engl J Med 2009; 360:213-224.5 Taylor CA, et al. Computational Fluid Dynamics Applied to Coronary Computed Tomography Angiography. J Am Coll Cardiol 2013; 61(22):2233-2241.6 Curzen N, et al. Fractional Flow Reserve Derived From Computed Tomography in Suspected Stable Angina: The FORECAST Trial. Eur Heart J 2021; 42(37):3807-3818.7 Douglas PS, et al. A Clinical Pathway to Optimize the Diagnostic Workup of Patients With Suspected CAD: The PRECISE Randomized Trial. JAMA Cardiol 2023; 8(7):643–652.8 15-Year Evidence Base includes DISCOVER-FLOW (JACC 2011), DeFACTO (JAMA 2012), NXT (JACC 2014), PLATFORM (Eur Heart J 2015), and ADVANCE Registry (Eur Heart J 2019).9 Narula, et al. EHJ CVI 2024.10 Danad, et al. JAMA Cardiol 2017.11 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI).12 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024. (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years).

Philips and Imricor launch cardiac interventional MR lab solution, expanding longstanding collaboration

Philips MR

Philips and Imricor’s new iMR lab solution combines 1.5T MRI with MR-compatible systems and tools to support MR-guided cardiac interventions.

August 27, 2026 The solution combines Philips’ high-performance 1.5T MRI platform and advanced interventional workflow capabilities with Imricor’s exclusive portfolio of systems and consumables for MR-guided cardiac interventions. Amsterdam, the Netherlands – August 27, 2026: Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Imricor Medical Systems (ASX: IMR), a pioneer and world-leading developer of MR-compatible products for interventional MR procedures, today announced a new Interventional MR (iMR) lab solution for Philips 1.5T MR. The first commercially available configuration [1] combines Philips’ 1.5T MRI platform and Imricor’s portfolio of iMR systems and consumables, enabling an MR-guided workflow for cardiac intervention, without compromising on MR field strength.  Meeting the need for greater tissue insight during cardiac intervention Cardiac arrhythmias affect millions of people worldwide, and catheter ablation is an established and increasingly utilized treatment for many complex cardiac arrhythmias. Yet today, these procedures continue to rely primarily on X-ray fluoroscopy, which provides only indirect visualization of soft tissue while exposing patients and clinical teams to ionizing radiation.  MRI has already transformed cardiac diagnosis by enabling clinicians to visualize cardiac anatomy and tissue in exceptional detail. Bringing that same level of tissue insight into intervention has the potential to help physicians guide therapy more precisely, assess treatment response during procedures and identify potential therapy gaps before a patient leaves the procedure room – all within a radiation-free work environment of an iMR.  “Our ambition is not only to advance what clinicians can see with MRI, but also what they can do with it,” said Ioannis Panagiotelis, PhD, Business Leader, Magnetic Resonance at Philips. “Philips has a long history of helping clinicians perform image-guided procedures with confidence, and we believe MRI can play an even greater role in providing care. With this new iMR lab solution, enabled through our collaboration with Imricor, we’re expanding the role of cardiac MRI from diagnosis into the treatment environment.”  Panagiotelis added, “Cardiac electrophysiology is just the beginning. This iMR lab solution represents an important step in Philips’ strategy to advance MRI across the care continuum, creating a platform that can expand into additional clinical areas while helping clinicians deliver the best possible care for their patients.” iMR built on Philips’ leading cardiac 1.5T MRI platform The iMR lab solution combines Philips’ high-performance 1.5T MRI platform with Imricor’s portfolio of MR-compatible systems and consumables to create a complete, connected environment for MR-guided cardiac intervention – marking the next milestone in the companies’ long-standing collaboration to bring MR-guided cardiac intervention into routine clinical practice.  The first commercially available configuration includes Philips’ Cardiac MR Suite, featuring SmartHeart AI-powered cardiac planning and advanced cardiac imaging applications alongside Imricor’s NorthStar® iMR mapping and guidance system, Advantage-MR® EP Recorder/Stimulator and Vision-MR® family of electrophysiology catheters [2]. Together, these technologies enable physicians to visualize cardiac anatomy and arrhythmia substrate, actively track catheters, perform electroanatomical mapping, assess lesion formation and evaluate treatment response throughout procedures within Philips’ 1.5T MR environment.  For hospitals, the iMR lab solution provides a turnkey platform for MR-guided cardiac intervention, bringing together advanced imaging, intelligent workflows and MR-compatible interventional technologies. The solution is built on Philips’ BlueSeal helium-free MRI technology[3], reducing siting complexity and enabling installation closer to cardiology departments, helping support adoption today while establishing a scalable foundation for future iMR-guided procedures.  “With interventional MR, the idea is not to move procedures into diagnostic MRI suites, but rather to bring MR imaging into the procedure room, a room we call an iMR lab,” said Steve Wedan, Founder and CEO of Imricor. “Our collaboration with Philips has always been driven by this shared vision, and with our combined iMR lab solution, that vision becomes a reality today. Pairing Philips’ world-class 1.5T MR platform with Imricor’s exclusive portfolio of advanced iMR systems and interventional tools creates the world’s first state-of-the-art high-performance iMR lab solution. We believe the future is about advanced image guidance for therapies and interventions, and the future is here now.”  The iMR lab solution will be showcased in Munich at ESC Congress 2026 and is commercially available immediately in CE-marked markets and, in some configurations, the U.S. Further Imricor configurations are expected to become available in the U.S. and additional markets, subject to regulatory clearances.  [1] Philips issued a Third-Party Product Compatibility Declaration for Imricor’s interventional MRI (iMR) equipment and consumables.  [2] NorthStar and the Vision-MR Diagnostic Catheter are commercially available in the U.S. Other Imricor products are not yet cleared/approved for sale in the U.S. [3] Helium-free operations. 7 liters of helium is permanently enclosed in the cryogenic circuit.  For further information, please contact: Name Jayme ManiatisPhilips Global External RelationsTel.: +16178948368E-mail: jayme.maniatis@philips.com About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.Headquartered in the Netherlands, the company is a leader in image-guided therapy, diagnostic imaging, ultrasound, monitoring, enterprise informatics and personal health. Philips generated 2025 sales of approximately EUR 18 billion and employs approximately 63,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter. About Imricor Imricor Medical Systems, Inc. (ASX:IMR) is striving to make interventional medical procedures better, safer, and more cost effective by making it possible for these procedures to be performed under real-time magnetic resonance (MR) guidance, rather than under x-ray fluoroscopy guidance, thus taking advantage of MR’s superior imaging capabilities.
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Philips MR

Vascular Technology, Incorporated Appoints David Pierce to Board of Directors

NASHUA, N.H.–(BUSINESS WIRE)–Vascular Technology, Incorporated (“VTI” or the “Company”), a medical device company specializing in the development, manufacturing and sale of surgical devices, today announced the appointment of David Pierce to its Board of Directors. Pierce brings more than three decades of experience leading innovation, transformation and sustainable growth across global medical device and healthcare technology markets. He currently serves on the boards of Neuraptive Therapeut

Wellness Insights in Your Hands in 60 Seconds: EYVA to Introduce Unique Touch-Based Metabolic Wellness Tracker to U.S. Market – EYVA Pro

The EYVA Pro experience brings together six key wellness indicators with personalized AI-powered insights to help consumers explore the bigger picture across their metabolic, cardiovascular, and respiratory wellness HYDERABAD, India, Aug. 27, 2026 /PRNewswire/ — What if gaining a better…