The Latest Cardiac and Vascular News
SAN FRANCISCO–(BUSINESS WIRE)–Barnes-Jewish Hospital (BJH), a recognized regional leader in advanced cardiovascular services, partnered with Biome Analytics to leverage sophisticated data analytics and reporting tools to improve clinical outcomes for patients undergoing interventional cardiology procedures. Results from their efforts underscore both organizations’ steadfast commitment to delivering better care while simultaneously reducing unwarranted […]
SUNNYVALE, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the completion of source data verification and freezing of primary outcomes data in the double-blind randomized placebo-controlled Phase 3 CardiAMP HF study of its autologous minimally invasive cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). Data from the 115 randomized patients in the study has been transferred to the Statistical Data Analysis Center core laboratory for analysis. Results are scheduled to be presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) 2025 Scientific Sessions in Chicago on March 30, 2025. We believe this data represents the largest ischemic HFrEF patient cohort studied in a randomized trial of an autologous cell therapy, and the first to use a precision medicine approach to identify patients likely to respond to therapy based on the nature of their cells. Should the results presented at ACC confirm the interim analysis, the trial will provide evidence of meaningful therapeutic benefit of this cell therapy for HFrEF patients insufficiently responsive to medication as characterized by elevated NT-proBNP. “This clinical study is intended to provide evidence supporting the safety and effectiveness of our CardiAMP cell therapy system for future approvals in the United States and Japan,” said Peter Altman, PhD, BioCardia President and CEO. “The results are also expected to support the safety and effectiveness of the Helix biotherapeutic delivery system for standalone approval for the intramyocardial delivery of agents to the heart.” About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially 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 autonomic 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: https://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 the Company’s investigational product candidates, the timing of availability of data from this trial, the likelihood of safety and patient benefit, statements related to the mechanisms of action of the CardiAMP Cell Therapy, references to the presentation at the American College of Cardiology and potential future regulatory approvals. These forward-looking statements are made as of the date of this press release. 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 27, 2024, 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. Media Contact: Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
MyOme Launches Integrated Risk Tool for Coronary Artery Disease MENLO PARK, Calif., Feb. 27, 2025 /PRNewswire/ — MyOme, Inc., a leading clinical whole genome testing and polygenic risk modelling (PRS) company, is proud to announce the launch of its coronary artery disease (CAD) PRS…
FORT MILL, S.C., Feb. 27, 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 their attendance at the 18th Western Atrial Fibrillation Symposium from February 27 – March 1 in Salt Lake City, Utah.
TAMPA, Fla., Feb. 26, 2025 /PRNewswire/ — The Patel Children’s Heart Institute at St. Joseph’s Children’s Hospital is the first in the southeastern United States and one of only a handful of programs in the world to implant a new stent specifically created to enlarge narrowed blood…
New Brand Identity Reaffirms Commitment to Transforming the World’s Leading Cause of Death Into a Manageable Condition
We’ve entered a new era at Heartflow – reaffirming our commitment to transforming coronary artery disease into a manageable condition. Discover what it means to see CAD clearly and manage it for life.
MOUNTAIN VIEW, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the global leader in AI technology for coronary artery disease (CAD) management, today introduced its new brand identity reflecting its focus on delivering clarity, precision, and confidence in the prevention, diagnosis, and treatment of CAD. This updated identity represents a new era for Heartflow, reinforcing the company’s leadership in providing clinicians with decisive insights to manage CAD throughout patients’ lives. Heartflow has helped clinicians manage over 400,000 patients worldwide and is striving to make a difference for the millions of patients whose lives are impacted by CAD every year. “At Heartflow, we are working toward a new vision to transform coronary artery disease from the leading cause of death to a disease that can be managed for life,” said John Farquhar, president and CEO of Heartflow. “With our AI-driven technology, we’re doing more than diagnosing CAD – we’re equipping clinicians with the insights needed to develop personalized treatment plans to provide the best possible care to each patient. We’re excited about the future, where Heartflow is positioned to help physicians identify CAD earlier and guide patients toward a lifetime of better health.” Heartflow’s new branding will be rolled out across all company materials, product interfaces, social media channels, and the Heartflow.com website beginning today. Importantly, the new brand identity and materials reflect input collected from Heartflow customers and cardiovascular community stakeholders. A key element of Heartflow’s approach is close collaboration with clinical teams to improve patient experiences, create efficient care pathways, and reach more patients with personalized insights, ensuring the best possible outcomes. In the U.S., CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.1 Many of the estimated 18 million adults in the U.S. and 315 million people globally living with CAD either have no symptoms or symptoms that go unrecognized.2, 3 Heartflow is working to ensure that its technology not only helps clinicians see CAD earlier but also transforms how they understand and manage the disease. Coronary computed tomography angiography (CCTA) was a major advancement in CAD diagnostics, helping physicians estimate if a stenosis was significant and requiring intervention. Technologies like Heartflow fractional flow reserve computed tomography (FFRCT) provide lesion-specific physiology, which enhances CCTA’s diagnostic accuracy. Now Heartflow Plaque Analysis leverages AI to quantify and characterize the amount and type of plaque present in the arteries from a single CCTA scan. 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 and without symptoms of CAD. Heartflow is dedicated to defeating CAD by partnering with physicians to generate robust, high-quality clinical evidence. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make its cutting-edge solutions more widely available to an increasingly diverse patient population worldwide. 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. References Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats. Accessed Feb. 18, 2025.Cleveland Clinic. Coronary Artery Disease. https://my.clevelandclinic.org/health/diseases/16898-coronary-artery-disease. Accessed Feb. 21, 2025.Stark, B, Johnson, C, Roth, G. Global Prevalence of Coronary Artery Disease: An Update From The Global Burden of Disease Study. JACC. 2024 Apr, 83 (13_Supplement) 2320. https://doi.org/10.1016/S0735-1097(24)04310-9 Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bcb78bab-c373-4d0e-98f6-de83872371f6
BOSTON, Feb. 24, 2025 /PRNewswire/ — At the THT conference, Dr. Jesus Alvarez-Garcia, MD, PhD, head of Advanced Heart Failure Unit at Ramón y Cajal Hospital in Madrid, announced the launch of ReDS-SAFE HF II, a large-scale investigator-initiated trial designed to validate the benefits of…
BOSTON, Feb. 21, 2025 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced that Kurt Gunter, M.D., Senior Vice President and Chief Medical Officer, will present recently announced data from the company’s Expanded Access Program (EAP) evaluating INZ-701 in infants and children with ENPP1 Deficiency at the CHOP Cardiology Annual Meeting, held February 19-23, 2025, in Orlando, Florida. Presentation Details: Title: Impact of the Enzyme Replacement Therapy, INZ-701, in Children with ENPP1 Deficiency: Experience from an Expanded Access ProgramPresentation Number: 10 – Poster SessionDate: Saturday, February 22, 2025Time: 10:00 – 11:00am ETPresenter: Kurt Gunter, M.D., Senior Vice President and Chief Medical Officer About ENPP1 Deficiency ENPP1 Deficiency is a serious and progressive rare disease that affects blood vessels, soft tissues, and bones. Individuals who present in utero or in infancy are typically diagnosed with generalized arterial calcification of infancy (GACI Type 1), with about 50% of these infants not surviving beyond six months. Children with this condition typically develop autosomal-recessive hypophosphatemic rickets type 2 (ARHR2), while adolescents and adults may develop osteomalacia, or softened bones. ARHR2 and osteomalacia cause pain and difficulty with movement. Additionally, patients may experience hearing loss, calcification in arteries and joints, and heart problems. ENPP1 Deficiency is an autosomal recessive disease and biallelic mutations are estimated to occur in approximately 1 in 64,000 pregnancies worldwide. Many individuals with just one copy of the mutated gene (monoallelic ENPP1 Deficiency) exhibit severe symptoms, suggesting that the worldwide prevalence of ENPP1 Deficiency is much higher than current estimates. Currently, there are no approved therapies for ENPP1 Deficiency. About Inozyme Pharma Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL). Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases. For more information, please visit https://www.inozyme.com/ or follow Inozyme on LinkedIn, X, and Facebook. Contacts Investors:Inozyme PharmaStefan Riley, Senior Director of IR and Corporate Communications(617) 461-2442stefan.riley@inozyme.com Media:Biongage CommunicationsTodd Cooper(617) 840-1637todd@biongage.com
ROCKVILLE, Md., Feb. 20, 2025 (GLOBE NEWSWIRE) — The National Board of Echocardiography (NBE) and Inteleos have established the Cardiovascular Imaging Coalition (CVIC) to streamline the maintenance of certification (MOC) process for physicians specializing in multiple cardiac imaging modalities. This groundbreaking initiative addresses the challenges of time and expense physicians face in maintaining multiple certifications across cardiovascular computed tomography (CT), nuclear cardiology (NC), cardiovascular magnetic resonance imaging (CMR), and echocardiography. The CVIC is developing an integrated, case-based MOC process that will provide immediate feedback and learning opportunities to enhance patient care. While this new program is under early development, NBE will continue to offer its annual longitudinal assessment process for Maintenance of Certification in Echocardiography (MOCE), ensuring flexibility for physicians who specialize in single imaging modalities. Additionally, Inteleos will enhance its MOC experience for physicians certified in individual cardiovascular imaging specialties. “We are thrilled to help physicians who use multiple cardiovascular imaging modalities streamline their certification maintenance process,” says NBE President Roberto Lang, MD. Luciana Young, MD, Chair of the Inteleos Board of Directors, adds, “Inteleos is committed to modernizing cardiovascular imaging certification maintenance through the CVIC, implementing meaningful evaluations that reflect the daily practice of multimodality imagers.” The CVIC plans to have an initial MOC for multi-modality cardiovascular imagers assessment in the near future, but will keep the community fully informed on development progress. CVIC will also establish a centralized hub for efficient management of multiple imaging specialty certifications, benefiting both testamurs and certified physicians. About the National Board of Echocardiography Founded in 1996, the NBE is a non-profit organization advancing excellence in clinical echocardiography through certification examinations. The organization has administered over 42,000 exams across its programs, including ASCeXAM®, Advanced PTEeXAM®, Basic PTEeXAM®, and CCEeXAM®, with more than 17,000 physicians worldwide achieving NBE Diplomate status. About Inteleos Inteleos™ is a non-profit organization dedicated to ensuring equitable access to quality healthcare globally. It oversees the American Registry for Diagnostic Medical Sonography® (ARDMS®), the Alliance for Physician Certification & Advancement™ (APCA™), and the Point-of-Care Ultrasound Certification Academy™ (PCA), collectively representing 150,000 certified medical professionals worldwide. The APCA Council’s Cardiovascular Imaging certification examinations include the Certification Board of Cardiac Computed Tomography (CBCCT), the Certification Board of Cardiac Magnetic Resonance (CBCMR), and the Certification Board of Nuclear Cardiology (CBNC). The Inteleos Foundation manages the organization’s philanthropic initiatives. CONTACT: Contact Information:
Lisa Jordan (240) 386-1579
Taryn Reed (240) 386-1627
Customer Care (240) 386-1710
To further support momentum in special needs Medicare Advantage plans, Zing will also tap into a portion of Karoo’s national network of 700-plus cardiology provider partners CHICAGO and ALBUQUERQUE, N.M., Feb. 20, 2025 /PRNewswire/ — Zing Health, a leading Medicare Advantage insurer…
