Coronary/Structural Heart

CorVista Health Announces European Respiratory Journal Publication Detailing Validation of its Non-Invasive Test for Pulmonary Hypertension

Data demonstrates CorVista’s proprietary machine-learned algorithm detects elevated mean pulmonary artery pressure (mPAP) with strong sensitivity and specificity across diverse patient populations BETHESDA, Md., May 07, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced the publication of data in European Respiratory Journal (ERJ) Open Research, a leading peer-reviewed journal. The study validates CorVista’s machine learned, non-invasive algorithm for aiding in the diagnosis of pulmonary hypertension (PH) using signals collected by the CorVista System®, the world’s first non-invasive point-of-care solution for evaluating both coronary artery disease and pulmonary hypertension. The published article, titled “Clinical validation of a machine-learned, point-of-care system to IDENTIFY pulmonary hypertension,” provides compelling evidence that the CorVista System can accurately detect elevated mean pulmonary artery pressure (mPAP) – a hallmark of PH – with diagnostic performance comparable to, or surpassing, current standard-of-care modalities. “Pulmonary hypertension remains vastly underdiagnosed, with patients waiting an average of two and a half years from symptom onset to accurate diagnosis—often after disease progression has already compromised outcomes,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “The findings published in ERJ Open Research demonstrate the clinical power of our machine-learned, non-invasive test to identify PH in just minutes at point of care. The CorVista System can transform our approach to PH diagnosis as a frontline diagnostic tool. Now that highly effective new treatment options exist for most patients with PH, earlier detection has become critically important.” Currently, PH is primarily diagnosed through right heart catheterization (RHC), an invasive and resource-intensive procedure. Transthoracic echocardiography (TTE), while commonly used as a screening tool, can have significant limitations – particularly the inability to measure tricuspid regurgitant velocity in up to 41% of patients. The CorVista System offers a non-invasive, stress-free test option conducted in under five minutes, making it a powerful tool to address the critical unmet need for earlier and broader diagnosis of PH. Key findings from the publication include: The algorithm achieved 82% sensitivity and 92% specificity for detecting mPAP ≥25 mmHg (95% CI: 0.78–0.87 and 0.87–0.96, respectively), meeting the study’s pre-specified primary endpoints.Performance remained high at the updated PH threshold of mPAP ≥21 mmHg, with 78% sensitivity and 92% specificity.ROC-AUC was 0.95 and 0.93 at the 25 mmHg and 21 mmHg thresholds, respectively.Diagnostic accuracy was consistent across PH subtypes (pre-capillary, combined pre-/post-capillary, and isolated post-capillary), as well as across sex, age, BMI, and key comorbidities such as diabetes and COPD.Negative predictive value (NPV): > 99%. The study enrolled 462 symptomatic patients across 18 U.S. clinical sites and was conducted under a rigorous, blinded design. Patients underwent signal acquisition using the CorVista System prior to RHC or – in PH-negative controls – to CT angiography and echocardiography. Importantly, the system’s performance was validated using a dataset independent of the one used in algorithm development, supporting its real-world applicability and generalizability. About CorVista System® The CorVista System is a point-of -care digital health solution that can aid in diagnosis of multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze physiological signals and detect signs of serious cardiovascular diseases – all in under 30 minutes, allowing clinicians to interpret results and help guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including Pulmonary Capillary Wedge Pressure (PCWP), in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking a major advancement in PH diagnostics and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care.   For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com

NewAmsterdam Pharma Announces Late-Breaking Data from BROADWAY and TANDEM Pivotal Studies Published in Leading Medical Journals and Presented at the European Atherosclerosis Society (EAS) Congress 2025

– Late Breaking BROADWAY and TANDEM data presented at EAS 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM) – – Phase 3 data showed that obicetrapib as an adjunct to statins, whether in combination with ezetimibe or as monotherapy, reduced LDL-C by 50% and 35%, respectively; in addition, Phase 2 data of obicetrapib in combination with moderate-dose statins showed LDL-C reductions of approximately 70% – – 21% observed reduction in major adverse cardiovascular events (HR=0.79, CI 0.54-1.15) in BROADWAY trial – – Pooled Phase 3 data showed Lp(a) reductions of 45% across BROADWAY, TANDEM, and BROOKLYN trials for patients with increased risk levels of Lp(a) from 50-150 nmol/L at baseline – NAARDEN, The Netherlands and MIAMI, May 07, 2025 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam,” “we,” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced additional data from the BROADWAY and TANDEM pivotal Phase 3 studies were presented as late-breaking oral presentations at the European Atherosclerosis Society Congress (“EAS”) 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM). “We are proud to share what we believe to be compelling clinical data from two comprehensive clinical trials conducted in the CVD space, now published in leading peer-reviewed journals and as late-breaking presentations at EAS 2025,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “We believe the additional data presented today further supports obicetrapib as a meaningful advancement in the development of an oral medication to be used adjunctively to statins. These results will support global regulatory filings and reinforce our belief that obicetrapib has the potential to be an effective, once-daily, oral treatment that significantly reduces LDL-C.” Key previously-reported findings from the BROADWAY clinical trial evaluating obicetrapib in patients with atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia (“HeFH”): Achieved primary endpoint showing a 33% (p

Family Heart Foundation Announces Results of Real-World Study in 273,770 Individuals with Cardiovascular Disease Demonstrating that Risk of Subsequent Cardiovascular Event Increases with Rising Lipoprotein(a) Levels

-Study showed that every increase in Lp(a) is associated with increased risk of a cardiovascular event; individuals with the highest levels ( >300 nmol/L) were 40% more likely to have a cardiovascular event compared to people at lower levels (

Sensydia Appoints Rusty Page as President and Chief Operating Officer to Support Growth and Commercialization of the Cardiac Performance System (CPS™)

LOS ANGELES–(BUSINESS WIRE)–Sensydia, a medical technology company advancing non-invasive cardiac assessment, today announced the appointment of Rusty Page as President and Chief Operating Officer. Page joins Sensydia from publicly traded Neuronetics, Inc., where he served as SVP, Chief Information & Operations Officer. He brings more than two decades of senior […]

AI Meets Value-Based Care: Cleerly and Cardiac Care Alliance Join Forces to Revolutionize Heart Disease Detection

DENVER–(BUSINESS WIRE)–Cleerly, the leader in cardiovascular imaging, and Cardiac Care Alliance, leader in value-based cardiovascular care solutions, today announced a strategic partnership to enhance cardiovascular care delivery across the healthcare ecosystem. This collaboration will integrate Cleerly’s advanced AI-powered coronary artery assessment technology with Cardiac Care Alliance’s cardiovascular care network. This collaboration […]

BioCardia Initiates Patient Enrollment at University of Wisconsin at Madison for Ongoing CardiAMP HF II Pivotal Study

CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF) and Elevated Markers of Cardiac Stress Dr. Amish Raval, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, to serve as Site Principal Investigator and Co-National Principal Investigator SUNNYVALE, Calif., May 06, 2025 (GLOBE NEWSWIRE) —  BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that University of Wisconsin in Madison, Wisconsin is now enrolling patients with ischemic HFrEF in the Company’s ongoing pivotal Phase 3 CardiAMP HF II trial. “In CardiAMP HF II, we aim to add to the evidence that this cell therapy can safely and significantly improve survival and quality of life for heart failure patients having elevated NTproBNP, a marker of heart stress, encompassing a large group of patients we see in daily practice,” said Dr. Amish Raval. “Importantly, this minimally invasive autologous approach has shown great results to date, avoids the need for immune suppression, and preserves all therapeutic options including heart transplant for patients.” About the CardiAMP Heart Failure II Study CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic HFrEF on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to CardiAMP HF, with tier 1 all cause death, tier 2 nonfatal major adverse cardiac events, but with tier 3 using a validated quality of life patient self-assessment instrument. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02). Advances in this therapeutic approach in CardiAMP HF II include using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, which include the introduction of the FDA approved Morph DNA steerable platform. About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: www.BioCardia.com.  Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com 
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com 
Phone: 650-226-0120

New Analysis Published in Nature Medicine Demonstrates Advantages of Nationwide Coronary CTA Strategy with Heartflow FFRCT in Over 90,000 Patients with Coronary Artery Disease

Two-year data from England’s National Health Service show improved care efficiency with reduction in unnecessary invasive and noninvasive cardiac tests using CCTA and Heartflow FFRCT versus CCTA aloneMOUNTAIN VIEW, Calif., May 06, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced two-year data from FISH&CHIPS, a real-world, multicenter, retrospective study, conducted by the National Health Service (NHS) in England, were published in Nature Medicine. The study, which analyzed the impact of adding Heartflow fractional flow reserve (FFRCT) derived from coronary computed tomography angiography (CCTA) to a CCTA pathway for the evaluation of CAD, showed improved care efficiency and reduction in unnecessary tests with CCTA+FFRCT versus CCTA alone. “New findings from the FISH&CHIPS study demonstrate that a CCTA+FFRCT pathway at a national level can positively impact individual patient care, improving the suspected coronary artery disease patient’s journey,” said Dr. Timothy Fairbairn, principal investigator for the study, Liverpool Heart and Chest Hospital NHS Foundation Trust, and associate professor at the University of Liverpool, U.K. “FFRCT is a major AI-driven advancement in the management of cardiac disease that is helping to ensure that patients receive more precise, improved care, by reducing unnecessary invasive procedures and additional tests whilst identifying those who need intervention.” The overarching results of the more than 90,000-patient study, covering the breadth of NHS England, showcased the positive impact of a CCTA+FFRCT diagnostic pathway using Heartflow technology versus CCTA alone. Key outcomes outlined in the published data include: The CCTA+FFRCT cohort reduced the need for an invasive coronary angiography (ICA) procedure by 7% and led to a reduction in inappropriate ICA procedures that did not result in treatment by 16%.CCTA+FFRCT helped to identify more patients that would benefit from revascularization, with one additional appropriate percutaneous coronary intervention (PCI) identified for every two negative diagnostic catheterizations that were avoided.CCTA+FFRCT showed a 12% relative reduction in the need for a secondary non-invasive test after CCTA, for example requiring a repeat CCTA or nuclear stress test. “By implementing a nationwide CCTA-first strategy for assessing patients with potential cardiovascular disease, NHS has set the standard for both clinical efficacy and efficiency — an approach now reflected in clinical guidelines worldwide,” said Campbell Rogers, M.D., FACC, Heartflow’s chief medical officer. “The FISH&CHIPS data underscore how the addition of Heartflow’s FFRCT technology can improve upon the CCTA-first approach for many patients and optimize the use of both noninvasive testing and treatment.” Heartflow is the only company to offer a complete non-invasive, precision coronary care platform designed to manage CAD for life. With Heartflow One, a CCTA scan is transformed into a dynamic and personalized 3D model of the heart. Within the platform, Heartflow FFRCT provides lesion-specific physiology, enhancing CCTA’s diagnostic accuracy and helping determine whether there is benefit to revascularization. Heartflow Plaque Analysis leverages AI to quantify and characterize the amount and type of plaque in the coronary arteries to determine appropriate medical management. These advancements provide physicians with more precise, personalized insights into heart health, aiding in treatment planning and identifying individuals at high risk of major adverse cardiovascular events (MACE), such as heart attacks, which can occur in patients with or without symptoms of CAD. Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life by partnering with physicians and institutions to generate robust, high-quality clinical evidence. Heartflow has been adopted by more than 1,400 institutions globally. About FISH&CHIPSFISH&CHIPS is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFRCT to a CCTA-first diagnostic paradigm for CAD at a national level. The study analyzed data from 27 NHS hospital sites in England, including 90,553 patients followed for at least two years. The primary objective was to determine whether introducing a CCTA+FFRCT diagnostic pathway was clinically useful and safe compared to a standard-of-care CCTA diagnostic chest pain pathway. The study was funded by the UK Medical Research Council (MRC) and supported by the National Institute for Health and Care Research (NIHR) Research Delivery Network. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including RoadMap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com

Saddleback Medical Center Expands Cardiac Surgical Capabilities With Recruitment of Renowned Cardiothoracic Surgeons

Asad Shah, M.D. and Timothy Lee, M.D., two nationally esteemed cardiothoracic surgeons join the MemorialCare Heart & Vascular Institute to bring advanced robotic cardiac surgery capabilities to the South Orange County community, helping to fill a gap in care LAGUNA HILLS, Calif., May 5,…

Primary Care Physician Use of Counterpart Assistant Technology Associated with Better Health Outcomes in Patients with Congestive Heart Failure

New whitepaper highlights how a relationship with a Primary Care Physician (“PCP”) that uses Counterpart Assistant is associated with better clinical management, and fewer hospitalizations (18% lower) and readmissions (25% lower) in heart failure patients New whitepaper highlights how a relationship with a Primary Care Physician (“PCP”) that uses Counterpart Assistant is associated with better clinical management, and fewer hospitalizations (18% lower) and readmissions (25% lower) in heart failure patients

Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy

SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA. “We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to continuing our constructive engagement with the FDA regarding the NDA for aficamten.” About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, and statements regarding our expectation that aficamten will be approved with a differentiated label and REMS. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including FDA’s on-going review of our NDA for aficamten in obstructive hypertrophic cardiomyopathy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757