The Latest Cardiac and Vascular News
NEW BRUNSWICK, N.J. – April 24, 2026 – Johnson & Johnson (NYSE: JNJ) has entered into a definitive agreement to acquire Atraverse Medical, Inc., a privately-held medical device company pioneering next-generation left-heart access and radiofrequency (RF) technology. Achieving safe and precise access to the left atrium remains one of the most critical steps […]
LIVERMORE, Calif., April 27, 2026 /PRNewswire/ — Advanced Bifurcation Systems Inc. (“ABS”), a leader in innovative solutions for bifurcation lesions in coronary angioplasty, today announced that it has recently acquired all assets of Svelte Medical Systems, Inc. (“Svelte”). The acquired…
Readout to Include One-Year Cohort 1 Results and Early Cohort 2 Data; Webcast Conference Call Planned to Review RIDGE-1 Data at ASGCT Additional Presentations at ASGCT Showcase Tenaya’s Work with Patients to Advance Gene Therapy and Early-Stage Pipeline Innovations in Cardiac Gene Editing SOUTH SAN FRANCISCO, Calif., April 27, 2026 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced the acceptance of multiple abstracts for presentation at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, taking place May 11-15, 2026, in Boston, Massachusetts. Of note, new clinical data from both dose cohorts of the RIDGE-1 Phase 1b/2 trial of TN-401 will be featured as a late-breaking oral presentation. TN-401 is being developed for the potential treatment of adults with arrhythmogenic right ventricular cardiomyopathy (ARVC), a form of arrhythmogenic cardiomyopathy (ACM) that primarily impacts the right ventricle, caused by mutations in the plakophilin-2 (PKP2) gene. PKP2 gene mutations result in insufficient levels of critical proteins needed to maintain the structural integrity and cell-to-cell electrical signaling of heart muscle cells. TN-401 gene replacement therapy is designed to address the underlying cause of disease by delivering a functional PKP2 gene into heart muscle cells using an adeno associated virus serotype 9 (AAV9) capsid. The ASGCT presentation will include new safety, biopsy and efficacy data from patients treated at both the 3E13 vg/kg and 6E13 vg/kg dose levels. Details of the TN-401 clinical data presentation are as follows: Presentation Date & Time: Friday, May 15, 2026, from 8:00 am – 9:00 am EDT Abstract Title: Interim Data from RIDGE-1: A Phase 1b/2 Interventional Study to Evaluate Safety and Efficacy of TN-401, an AAV9 Investigational Gene Replacement Therapy, in Adults with PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)Presenting Author: John Giudicessi, M.D., Departments of Cardiovascular Medicine and Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, New York Two other Tenaya abstracts have been accepted for poster presentations during ASGCT 2026. The first poster will detail results of a survey exploring parental perceptions of gene therapy treatment for children with cardiomyopathies conducted in partnership with DDC Clinic and the patient advocacy group, Children’s Cardiomyopathy Foundation. Presentation Session Date & Time: Tuesday, May 12, 2026, from 5:00 pm – 6:30 pm EDT Abstract Title: Perceptions and attitudes towards gene replacement therapy in parents of children with cardiomyopathy (#1372)Location: MCEC Exhibit and Poster HallPresenting Author: Kimberly Cohee, Executive Director, Patient Advocacy at Tenaya The second poster accepted for presentation builds on research previously presented for TN-501, a gene editing therapeutic candidate intended for the treatment of PLN-R14del-associated dilated cardiomyopathy (DCM). TN-501 is uniquely designed to specifically inactivate the pathogenic phosolamban (PLN) R14del allele while preserving healthy function. Presentation Session Date & Time: Thursday, May 14, 2026, from 5:00 pm – 6:30 pm EDTAbstract Title: Development of TN-501, an AAV-Delivered Gene Editing Therapy for PLN-R14del Cardiomyopathy (#3432) Location: MCEC Exhibit and Poster HallPresenting Author: Huanyu Zhou, PhD, Associate Director, Gene Therapy at Tenaya Therapeutics The posters presented at ASGCT will be available in the “Our Science” section of the company’s website at the time of the live presentation. Conference Call and WebcastTenaya management plans to host a webcast conference call to discuss the TN-401 data being presented at the upcoming ASGCT Annual Meeting 2026. Details will be posted to the “Events & Presentations” page in the investor section of the Tenaya website at www.tenayatherapeutics.com. About PKP2-Associated ARVCPlakophilin-2 (PKP2) mutations are the most common genetic cause of arrhythmogenic right ventricular cardiomyopathy (ARVC, also known as arrhythmogenic cardiomyopathy or ACM), occurring in approximately 40 percent of the overall ARVC population. The prevalence of PKP2-associated ARVC is estimated at more than 70,000 people in the U.S. alone. In PKP2-associated ARVC, mutations of the PKP2 gene results in insufficient expression of a protein needed for the proper functioning of the desmosomal complex that maintains physical connections and electrical signaling between heart muscle cells. As the desmosome structure degrades, cardiac muscle cells are replaced by fibrofatty tissue and electrical impulses in the heart become unstable, resulting in irregular heart rhythms that can be fatal. ARVC symptoms include arrhythmias, palpitations, lightheadedness, dizziness and fainting. It is typically diagnosed before age 40, and sudden cardiac arrest due to life-threatening ventricular arrhythmias is frequently the first manifestation of disease. Current treatments include anti-arrhythmic medications, implantable cardioverter-defibrillators (ICDs) and ablation procedures, which do not address the underlying genetic cause of disease. About TN-401 Gene Therapy and the RIDGE-1 Clinical TrialTN-401 is an investigational AAV9-based gene therapy being developed for the treatment of ARVC due to mutations in the PKP2 gene. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record and demonstrated ability to target heart muscle cells. TN-401 has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration. Tenaya’s development of TN-401 is supported in part by a grant from the California Institute for Regenerative Medicines (CIRM). The RIDGE-1 Phase 1b/2 clinical trial of TN-401 in patients with PKP2-associated ARVC is a multi-center, open-label, dose escalation study being conducted in the U.S. and UK. RIDGE-1 is intended to assess the safety, tolerability and preliminary clinical efficacy of a one-time intravenous infusion of TN-401. RIDGE-1 will seek to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC, have an ICD and have high counts of premature ventricular contractions (PVCs) during screening, indicating electrical instability and increased risk of fatal arrhythmias. To learn more about gene therapy for ARVC and the RIDGE-1 clinical trial, please visit ARVCstudies.com or ClinicalTrials.gov (NCT06228924). About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) and TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, such as Duchenne’s muscular dystrophy. Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. Tenaya is also leveraging this expertise through a research collaboration with Alnylam Pharmaceuticals to discover novel human genetic targets for the potential development of disease-modifying treatments for cardiovascular diseases. For more information, visit www.tenayatherapeutics.com. Forward-Looking StatementsThis press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “planned,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the therapeutic potential of TN-401 as a treatment for ARVC caused by mutations in the PKP2 gene; the timing and content of the RIDGE-1 data presentation and related conference call, as well as Tenaya’s other ASGCT poster presentations; and TN-501 as a potential treatment for PLN R14del-associated DCM. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of data at the referenced times; the timing and progress of RIDGE-1 and Tenaya’s other ongoing clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; risks associated with the process of discovering, developing and commercializing therapies that are safe and effective for use as human therapeutics; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Tenaya ContactsMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com InvestorsAnne-Marie FieldsPrecision AQannemarie.fields@precisionaq.com MediaWendy RyanTen Bridge Communicationswendy@tenbridgecommunications.com
DURHAM, N.C., April 27, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it will host a virtual key opinion leader (KOL) event on Tuesday, April 28, 2026 at 8:00 AM ET featuring Prabir Roy-Chaudhury MD, PhD, FASN (University of North Carolina (UNC) Kidney Center, Salisbury VA Medical Center), and Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS (Brigham & Women’s Hospital, Center for Surgery and Public Health, Harvard Medical School), who will join company management to discuss the unmet need and current treatment landscape for hemodialysis patients with End-Stage Renal Disease (ESRD). To register, click here. The event will provide an overview of the Company’s Acellular Tissue Engineered Vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients. The current standard of care for providing AV access involves connecting the patient’s artery with a vein, known as an arteriovenous fistula or AV fistula (AVF). Humacyte’s ATEV is designed to provide an alternative to the current standard of care for hemodialysis patients with ESRD, as AVFs can take weeks or months to mature and become usable for hemodialysis, and in many patients fail to mature at all. One Phase 3 trial has already been completed showing the potential advantages of the ATEV in AV Access compared to autologous AV fistula in patients at high risk for fistula failure. Company management will also review the ongoing V012 Phase 3 trial in hemodialysis for which interim top-line results are expected this quarter. A live question and answer session will follow the formal presentations. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Prabir Roy-Chaudhury MD, PhD, FASNPrabir Roy-Chaudhury MD, PhD, FASN is the Drs. Ronald and Katherine Falk Eminent Professor and Co-Director of the University of North Carolina (UNC) Kidney Center. He is also a Staff Nephrologist at the Salisbury VA Medical Center. After graduating from the Armed Forces Medical College, Pune, India, he trained in Internal Medicine and Nephrology at the University of Aberdeen, Scotland and at the Beth Israel Hospital, Harvard Medical School, Boston, USA. In addition to being an active transplant nephrologist, Dr. Roy-Chaudhury’s main research interest is in uremic vascular biology (including both dialysis vascular access dysfunction and cardiovascular complications in kidney disease patients). Dr. Roy-Chaudhury has been the recipient of extensive NIH, VA, and industry research grant funding (over 20 million USD) has published over 250 manuscripts and book chapters (h index = 65), and has delivered over 450 lectures (including multiple named and plenary presentations) across the globe. He is also the recipient of many national and international awards including the ASDIN Lifetime Achievement Award and the KS Chugh Memorial Oration. Dr. Roy-Chaudhury has also been actively involved in the public policy and administrative aspects of dialysis vascular access care and hemodialysis through leadership roles in multiple societies such as ASN, ASDIN and VASA, and is a Past President of the American Nephrologists of Indian Origin (ANIO). Dr. Roy-Chaudhury was also the founding ASN co-chair of the Kidney Health Initiative, a public-private partnership between ASN and the US FDA and is a regular member of the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC). He is also currently the Immediate Past President of the American Society of Nephrology, which is the largest professional kidney organization in the world with over 21,000 members in 141 countries across the globe. About Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACSMohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS is a Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Associate Professor of Surgery at Harvard Medical School in Boston. He is board certified in vascular surgery by both the American Board of Surgery and the Royal College of Physicians and Surgeons of Canada. He obtained his medical degree from the Michael G. DeGroote School of Medicine at McMaster University. He completed vascular surgery residency and a PhD in clinical epidemiology and health services research through the Surgeon Scientist Training Program at the University of Toronto. He also completed a cardiovascular research fellowship at the Brigham. Dr. Hussain’s clinical practice is focused on general vascular and endovascular surgery, with special interests in complex hemodialysis access, aortic dissections and aneurysms, and thoracic outlet syndrome. He also co-directs the Heart & Vascular Hemodialysis Access workgroup across the MGB health system. Dr. Hussain’s research lab VESEL (Vascular & Endovascular Surgery Epidemiology Lab) conducts observational and clinical research to improve the care of patients with vascular diseases with special interests in population-based health services research, prediction with machine learning, enhancing causal inference research using target trial emulation, and clinical trials. Dr. Hussain also serves as the Associate Program Director of Surgical Residency and Associate Clerkship Director in the Department of Surgery at the Brigham. About HumacyteHumacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking StatementsThis press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our V007 and V012 Phase 3 clinical trials; the anticipated characteristics and performance of our ATEVs and the public perception thereof; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com
CAMBRIDGE, England–(BUSINESS WIRE)–PlaqueTec, a medtech company pioneering intracoronary liquid biopsy to identify inflammatory drivers of cardiovascular disease (CVD), today announced it has raised $5 million. The oversubscribed financing round was funded entirely by the Company’s existing investor base. The investment will support the continued build-out of PlaqueTec’s proprietary cardiovascular data lake, BioCarta, a growing repository of unique intracoronary proteomic and clinical data. B
LAGUNA HILLS, Calif.–(BUSINESS WIRE)—- $ADGM #Arrhythmia–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today reported six month results from its FULCRUM-VT Investigational Device Exemption (“IDE”) clinical trial, which will be used to support the Company’s application for Food and Drug Administration (“FDA”) Premarket Approval of the vCLAS Ventricular Ablation System. The results were prese
BOSTON, April 24, 2026 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced the publication of a new study comparing its VASCADE MVP® XL vascular closure…
VILLEPINTE, France, April 24, 2026 /PRNewswire/ — GUERBET (FR0000032526 GBT): Guerbet, a global leader in medical imaging, announces a positive outcome from a worksharing procedure, involving several EU member states, for a new Lipiodol® indication in interventional radiology procedures…
SAN CLEMENTE, Calif.–(BUSINESS WIRE)– #coraflex–Reflow Medical announces US launch of next-generation Cora Flex® and Cora Force® Torqueable Microcatheters for complex coronary interventions.
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended March 31, 2026. Highlights and Outlook Q1 sales grew 16.7% to $1.65 billion1, constant currency2 sales grew 12.7% Q1 TAVR sales grew 14.4% to $1.20 billion1; constant currency2 sales grew 11.0% Q1 TMTT sales of $173 million1,3, driven by repair and replacement therapies Q1 EPS of $0.661; adjusted2 EPS of $0.781 Raising FY 2026 constant currency2 sales growth guidance to 9% to
