The Latest Cardiac and Vascular News
BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (CorFlow) is pleased to announce the appointment of Chris O’Connell as Chairman of the Board of Directors, replacing Rick Geoffrion who remains as a Director on the Board. Chris is a highly regarded senior executive, board member and advisor across the medical devices, life sciences and global […]
MIAMI, May 06, 2025 (GLOBE NEWSWIRE) — RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS), announced patient enrollment has started in the Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. Researchers at Vall d’Hebron University Hospital, Bellvitge University Hospital, and Germans Trias i Pujols University Hospital in Barcelona Spain have begun using the patented RapidPulse® system as part of the trial.
PLANTATION, Fla., May 6, 2025 /PRNewswire/ – Akumin, a leader in managed radiology and oncology services, is pleased to announce the appointment of Dr. Nasir Siddiqui as Chief Medical Officer (CMO). As Chief Medical Officer, Dr. Siddiqui will lead Akumin’s clinical strategic priorities…
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 […]
KardiaMobile 6L Max is powered by advanced AI to offer a wider range of arrhythmia detection, more insights, and ongoing access to board-certified cardiologist ECG reviews. KardiaAlert is a first-of-its-kind feature to alert customers of potential changes in their ECGs that may indicate…
Adoption of this emerging technology requires data integration with existing modalities and clinical IT systems. PLEASANTON, Calif., May 6, 2025 /PRNewswire/ — Altamont Software, a provider of enterprise medical imaging connectivity solutions, announces the successful integration of…
FORT MILL, S.C., May 06, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that its 82% owned subsidiary has acquired certain heart failure related assets of Cardionomic, Inc.
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
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
Angelini Ventures marks its first investment in the cardiovascular and gene therapy space – and first in Asia, further diversifying its strong and growing portfolio Rome, Italy – 6 May 2025 – Angelini Ventures, the corporate venture firm of Angelini Industries focused on investing in companies developing innovative solutions in BioTech and Digital Health, today announces that it has co-led a $45 million Series B financing round in Nuevocor, an IND-stage biotechnology company specialized in the development of transformative therapies for patients with genetic cardiomyopathy, a largely unaddressed condition, by targeting the underlying mechanical defects. Founded in 2021, Nuevocor is pioneering a new generation of pathway-specific genetic medicines using its PrOSIA mechanobiology platform, with the potential to benefit patients across multiple cardiac genetic disorders. The company is dedicated to transforming the treatment of genetic cardiomyopathies by addressing the biomechanical root causes of the disease. Proceeds from the financing will be used to achieve clinical proof-of-concept for its lead candidate NVC-001 in patients with LMNA DCM, a rare genetic heart condition caused by mutations in the LMNA gene. Angelini Ventures co-led the financing with Kurma Partners and participation from Highlight Capital as well as continued significant support from existing investors Boehringer Ingelheim Venture Fund, ClavystBio, EDBI, SEEDS Capital and Xora Innovation. Dr. Elia Stupka, Managing Director at Angelini Ventures, will join Nuevocor’s Board of Directors as Board member, together with Dr. Lola Buono, Senior Associate, who will join as a Board Observer. Angelini Ventures has partnered with Nuevocor, reflecting its vision to support transformative global biotech companies with the potential to become the next generation of biopharma leaders. This collaboration marks Angelini Ventures first investment in the cardiovascular space and in gene therapy as well as the first investment in Asia – unlocking access to cutting edge innovation and transformative potential for patient outcomes. Dr. Elia Stupka, Managing Director at Angelini Ventures said, “This investment represents a significant strategic milestone for Angelini Ventures. It not only broadens our global footprint to a strategic Asian Life Sciences Hub such as Singapore but also accelerates our mission to back transformative science with the potential to impact patients worldwide. We’re excited by Nuevocor’s novel approach to treating genetic dilated cardiomyopathy by targeting mechanobiological pathways rather than simply replacing genes. This one-time therapy has the potential to transform patient outcomes and ease healthcare burdens. We’re proud to support Nuevocor’s mission and join the board – alongside Kurma Partners – as the company expands its global presence and advances clinical development in Europe.” “We are delighted to secure this significant financing milestone and build global collaborations with such an experienced syndicate of life sciences investors. Their support will enable Nuevocor to continue its strong momentum and advance NVC-001 into the clinic,” said Dr. Yann Chong Tan, PhD, CEO and Co-Founder of Nuevocor. “There exists a huge unmet need for patients suffering from cardiomyopathies, and with the help of our powerful mechanobiology platform, we continue to build our pipeline of targeted life-changing medicines for these patients.” Notes to EditorsAbout Angelini Ventures Angelini Ventures, the venture capital arm of Angelini Industries, is a Series A and Series B investment firm focused on accelerating disruptive innovations and trends in BioTech and Digital Health. Angelini Ventures will invest €300 million across a global portfolio in Europe and North America, drawing on a global team, strategic advisors and partners to help entrepreneurs scale their businesses into transformative category-leading companies. To date, Angelini Ventures has invested around €100 million into 18 companies covering a range of therapeutic areas and modalities. Angelini Ventures’ BioTech portfolio includes Neumirna, Cour Pharmaceuticals, Nouscom, Pretzel Therapeutics and Freya Biosciences. The Company’s Digital Health portfolio includes Vantis Health, Avation, Cadence Neuroscience, Nobi, Noctrix and Serenis. www.angeliniventures.com About Angelini Industries Angelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over two billion euros, generated in the health, industrial technology and consumer goods sectors. A targeted investment strategy for growth, constant commitment to research and development, deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates.www.angeliniindustries.com About Nuevocor Nuevocor is a biotechnology company pioneering innovative pathway-centric approaches to developing functional cures for heart conditions known as cardiomyopathies. Nuevocor designs life-changing medicines to target the biomechanical root-cause of these diseases by harnessing its PrOSIATM mechanobiology platform. Nuevocor’s approach surpasses the limitations of traditional gene therapy, which focuses on individual gene mutations, to treat defects within shared disease pathways across multiple cardiomyopathies. This enables us to expand our impact to broader patient populations. ContactsAngelini VenturesMartina Palmese, Communications Coordinatormartina.palmese@angeliniventures.com Media contacts for Italy – SEC Newgate ItaliaDaniele Pinosa, daniele.pinosa@secnewgate.it; Tel. +39 3357233872Fausta Tagliarini; fausta.tagliarini@secnewgate.it; Tel. +39 3476474513Daniele Murgia; daniele.murgia@secnewgate.it; Tel. +39 3384330031 Media contacts outside Italy – MEDiSTRAVA Sylvie Berrebi, Sandi Greenwood, Mark Swallowangeliniventures@medistrava.com
