Coronary/Structural Heart

Ancora Heart Inc. Reports Two-Year Results Demonstrating Sustained Benefits of AccuCinch® System in Heart Failure Patients

SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a medical device company developing a transcatheter device-based therapy to address heart failure (HF), today announced that two-year results from an analysis of early clinical studies evaluating the AccuCinch® Transcatheter Left Ventricular Restoration System were published in Structural Heart. The findings demonstrate that reverse remodeling achieved […]

Emboline, Inc. Completes Enrollment in U.S. Pivotal IDE Trial of the Emboliner® Embolic Protection Catheter Designed to Protect Patients from Embolic Injury During Transcatheter Aortic Valve Replacement

SANTA CRUZ, Calif., Oct. 23, 2025 /PRNewswire/ — Emboline, Inc., a leading innovator in full-body embolic protection devices for transcatheter procedures, today announced completion of patient enrollment in its Protect the Head to Head (ProtectH2H) Clinical Trial, a pivotal…

Conavi Medical to Highlight Novasight Hybrid™ Imaging at TCT 2025

Company to Participate in Educational Imaging Sessions and Feature Hybrid IVUS/OCT Imaging TechnologyTORONTO, Oct. 23, 2025 (GLOBE NEWSWIRE) — Conavi Medical Inc. (TSXV: CNVI) (OTCQB: CNVIF), a commercial-stage medical device company focused on intravascular imaging solutions, today announced that it will participate in the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference, taking place October 25 – 28, 2025, at the Moscone Center in San Francisco, California. Attendees will have the opportunity to learn more about Conavi’s hybrid intravascular imaging technology, which combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to provide complementary insights into coronary anatomy. Conavi will share clinical images acquired using its first-generation Novasight Hybrid™ imaging system and provide information on the potential role of hybrid IVUS/OCT imaging in guiding complex percutaneous coronary interventions (PCI). “TCT provides an important forum for clinical education and scientific exchange in interventional cardiology,” said Thomas Looby, President and CEO of Conavi Medical. “We look forward to engaging with physicians and thought leaders to discuss how hybrid intravascular imaging can enhance procedural decision-making and improve patient outcomes.” The next-generation version of Conavi’s Novasight Hybrid system was submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance in September 2025. Conavi’s first-generation version previously received FDA 510(k) clearance and Health Canada approval and was used at seven luminary cardiovascular care hospitals in North America. Intravascular Imaging Education SessionsConavi will also participate in the Intravascular Imaging & Training sessions at the Imaging & Training Center, held throughout the day on Sunday, October 26, and Monday, October 27. These physician-led sessions will feature expert case presentations illustrating how intravascular imaging can be used to guide challenging PCI procedures, including those involving calcified lesions, acute coronary syndrome (ACS), and in-stent restenosis (ISR). Conference Details Event: Transcatheter Cardiovascular Therapeutics (TCT) 2025Dates: October 26 – 29, 2025Location: Moscone Center, San Francisco, CaliforniaConavi Medical Booth: #2126 About TCT The Transcatheter Cardiovascular Therapeutics (TCT) conference, organized by the Cardiovascular Research Foundation (CRF), is the world’s leading educational meeting specializing in interventional cardiovascular medicine. TCT brings together thousands of physicians, scientists, and industry leaders from around the globe to present the latest research, live cases, and innovations in device-based therapies for coronary, structural, and endovascular disease. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System received regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com. Cautionary Statement Regarding Forward-Looking Information This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S. These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Contact:Stefano PiconeChief Financial Officer(416) 483-0100

New Heartflow PCI Navigator to Equip Interventional Cardiologists with Pre-procedural Insights to Enable PCI Planning

Heartflow PCI Navigator

Heartflow PCI Navigator is the only integrated, AI-driven percutaneous coronary interventions planning tool that gives interventional cardiologists a patient-specific 3D model—detailing anatomy, plaque composition, and lesion-specific physiology—all aligned to optimize potential stent placement.

PLAN CALCIUM study to be presented at TCT 2025 conference highlights how AI-powered plaque analysis can inform lesion preparation and calcium modification planning NAVIGATE-PCI registry to enroll approximately 2,500 patients across approximately 30 sites to evaluate the impact of CT-guided PCI planning in real-world practice MOUNTAIN VIEW, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today introduced Heartflow PCI Navigator, the newest addition to the Heartflow One platform. PCI Navigator is the only integrated, AI-driven percutaneous coronary interventions (PCI) planning tool that gives interventional cardiologists a patient-specific 3D model — detailing anatomy, plaque composition, and lesion-specific physiology — all aligned to optimize potential stent placement. For the first time, interventional cardiologists can plan PCIs with relevant information brought together in one intuitive view before their patients are in the cath lab. Heartflow will showcase PCI Navigator with live demonstrations at Heartflow’s exhibit booth (#2155) at the upcoming Transcatheter Cardiovascular Therapeutics (TCT®) conference, taking place from October 25-28, 2025, in San Francisco. The company will also present the PLAN CALCIUM study (abstract TCT 417) at the conference on October 26 at 8:30 a.m. PDT. PCI Navigator delivers a streamlined view of essential information for cath lab decision-making by integrating all relevant measurements — including IVUS-like and FFR-like pullback visualizations — into one seamless experience, which typically requires significant time and effort to obtain in the cath lab. “Interventional cardiologists make some of the most critical decisions in coronary care, often with limited information before a case begins. CT-guided PCI addresses that information gap, harnessing insights from the CCTA pathway into a pre-procedural plan to provide physicians the clarity they need for each case. PCI Navigator puts Heartflow at the forefront of that shift,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of Heartflow. “CCTA with Heartflow analysis helps ensure that all patients warranting invasive management are directed to the cath lab, while also reducing invasive angiograms and improving efficiency. PCI Navigator enhances planning for these patients by integrating anatomy, plaque, and lesion-specific physiology for the interventionalist’s review and input before the procedure.” PCI Navigator Will Deliver a Streamlined View of Essential Information for Cath Lab Decision-making This includes: Procedural Complexity: Lesion-specific FFRCT values, stenosis, plaque location and composition, as well as percent myocardium fed by a vessel, to help understand lesion significance in context.Stent Landing Zones: Cross-sectional and longitudinal reconstructions providing lumen diameter and length measures alongside plaque morphology and stenosis severity to help precisely plan and guide procedures.Planning for Optimal Outcomes: Physiology changes along the lesion (ΔFFRCT) to ensure the stenting procedure addresses the maximal flow gradient for optimal outcomes. By bringing together information that interventional cardiologists need to plan procedures into a web-based interface, PCI Navigator may help streamline procedures with increased efficiency and clinical confidence for both patients and staff. PLAN CALCIUM Study Data to Be Presented at TCT 2025 Heartflow’s technology will be featured in new data from the PLAN CALCIUM Study. The study evaluated how pairing Heartflow Plaque Analysis insights with coronary CTA imaging and FFRCT analysis influenced the decisions of interventional cardiologists undertaking PCI in highly calcified lesions. The addition of AI-powered plaque analysis to coronary CTA, FFRCT and angiography altered plans for calcium modification in over half of lesions, demonstrating the growing potential for CT-guided planning to drive more precise coronary interventions. “Incorporating AI-driven plaque analysis into coronary CTA and lesion-specific FFRCT workflows has great potential to change how we think about lesion preparation,” said Ankitkumar Patel, M.D., M.P.H., Medical Director of the Cardiac Catheterization Laboratory at Hackensack Meridian Mountainside Medical Center, Montclair, NJ. “PLAN CALCIUM data suggest that having information about plaque composition and distribution available ahead of time can help clinicians make more informed decisions about calcium modification and device selection for our patients.” Heartflow to Initiate NAVIGATE-PCI Registry in 2026 The NAVIGATE-PCI Registry will enroll more than 2,500 patients across approximately 30 U.S. sites to assess how PCI Navigator influences physician confidence, procedural safety and efficiency, strategy and patient outcomes compared to standard care. “The NAVIGATE-PCI study is designed to address a major unmet need in how we plan and perform PCI in clinical practice,” said Ziad Ali, M.D., D.Phil., Director of the DeMatteis Cardiovascular Institute at St. Francis Hospital & Heart Center, and Co-Principal Investigator of the study. “By evaluating CT-guided PCI planning using Heartflow PCI Navigator, we aim to better understand how this technology can reshape everyday interventional practice and elevate patient care.” Broader clinical use of PCI Navigator is expected to begin with the NAVIGATE-PCI registry, followed by commercial availability later in 2026. About Heartflow’s Technology and ResearchBacked by ACC/AHA guidelines and over 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for nearly 500,000 patients worldwide. Our continuous innovation is driven by an unmatched proprietary data pipeline built from over 110 million annotated CTA images. Heartflow’s AI-driven solutions have been extensively validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 96%. Heartflow’s integrated workflow delivers analysis instantly upon order, enabling clinicians to move from diagnosis to decision without delay. To uphold the highest security and patient-data integrity standards, Heartflow fully complies with leading global security regulations, including HITRUST, SOC2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8d62cfec-2cb8-4c89-81bc-eac3f7c1ec44

SpectraWAVE Receives 510(k) Clearance for X1™-FFR, an AI-enabled, Wire-Free, Drug-Free, Single Angiogram Physiology Solution

BEDFORD, Mass.–(BUSINESS WIRE)–SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its wire-free, drug-free, single angiogram derived physiology product, X1TM-FFR. X1-FFR provides physicians physiology results from a single […]

Cordis to Unveil 12-Month Results from Two SELUTION SLR™ DEB Randomized Clinical Trials at TCT 2025 Late-Breaking Clinical Trials Session

12-month data from pivotal randomized studies underscore Cordis’ commitment to shaping the future of cardiovascular care. MIAMI LAKES, Fla., Oct. 21, 2025 /PRNewswire/ — Cordis, a global leader in interventional cardiovascular technologies, will share late-breaking 12-month results from…

AskBio Announces Publication in Nature Medicine of 12-month data from Phase 1 Trial of AB-1002 Gene Therapy in Participants with Congestive Heart Failure

Research Triangle Park, N.C., Oct. 21, 2025 (GLOBE NEWSWIRE) — First-in-human trial of investigational gene therapy AB-1002 designed to evaluate safety and preliminary efficacy in participants with New York Heart Association (NYHA) Class III heart failureNo adverse events were deemed related to AB-1002, and clinically meaningful improvement of several efficacy assessments was seen in participants with non-ischemic congestive heart failure (CHF)Phase 2 GenePHIT trial is currently enrolling in Canada, Europe, the United Kingdom, and the United States AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced the publication in peer-reviewed journal Nature Medicine of 12-month data from its Phase 1 trial of AB-1002 investigational gene therapy in participants with congestive heart failure (CHF).1 This non-randomized, sequential dose-escalation trial (NCT04179643) includes escalating dose cohorts to evaluate the safety and preliminary efficacy of investigational gene therapy AB-1002 in participants with New York Heart Association (NYHA) Class III non-ischemic heart failure with reduced ejection fraction (HFrEF).1 It is estimated that 64 million people worldwide are living with heart failure, and despite standard of care, mortality and morbidity remain very high.2,3 The publication, which is available online, confirms that no adverse events were deemed related to AB-1002 in this trial and that clinically meaningful improvements were recorded across several efficacy assessments in participants with non-ischemic CHF.1 The data further support that the AB-1002 capsid may be highly cardiotrophic when administered as a single intracoronary injection. AskBio thanks the participants who volunteered for this important clinical trial, the sites that made this effort possible, and the skilled investigators who conducted this invaluable research and contributed to the scientific body of knowledge related to AB-1002. “We believe there is a critical need to progress innovative therapies that target the root causes of congestive heart failure, so we’re pleased to see these data for AB-1002 published and shared with the scientific community via Nature Medicine, a high-impact peer-reviewed journal,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer at AskBio. “We’re eager to further assess the safety and efficacy of AB-1002 in our ongoing Phase 2 trial, GenePHIT, which is currently enrolling in Canada, Europe, the United Kingdom, and the United States, and look forward to sharing those results once available.” GenePHIT is a Phase 2, adaptive, randomized, double-blind, placebo-controlled trial investigating the safety and efficacy of AB-1002 in non-ischemic heart failure.   About AB-1002 AB-1002 is an investigational one-time gene therapy administered to the heart to promote production of a modified version of the therapeutic inhibitor 1 (I-1c) protein designed to block the action of protein phosphatase 1, which is linked to CHF.4,5 This investigational gene therapy has not been approved by any regulatory authority, and its efficacy and safety have not yet been established or fully evaluated. About Congestive Heart Failure Heart failure occurs when the heart cannot pump blood efficiently enough to meet the body’s needs, including providing sufficient oxygen to the organs.6 Congestive heart failure results in the slowing of the blood flow out of the heart, which causes the blood returning to the heart through the veins to back up.7 This causes congestion in the body’s tissues.8 Symptoms may include shortness of breath, swelling in the legs and ankles caused by fluid retention, and fatigue.8 More than 64 million people worldwide are estimated to be living with heart failure.2 About GenePHIT GenePHIT is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial conducted to evaluate the safety and efficacy of the one-time administration of investigational gene therapy AB-1002, via antegrade intracoronary artery infusion, in males and females age >18 years with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms.9 For more information, please visit euclinicaltrials.eu (EUCT#2024-510581-17-00), clinicaltrials.gov (NCT#05598333), or askbio.com. GenePHIT is being conducted at 46 locations across the United States, Austria, Germany, the Netherlands, Spain, and the United Kingdom.   About AskBio  AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to steering gene therapy into a new era where it can transform the lives of a wider range of people living with rare and more common diseases. The company maintains a portfolio of clinical programs across a range of disease indications related to a single gene or multiple factors across cardiovascular, central nervous system, and neuromuscular conditions, with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s end-to-end gene therapy platform includes our Pro10™ technology, which makes gene therapies more accessible by making research and commercial grade manufacturing more affordable. With global headquarters in Research Triangle Park, North Carolina, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. An early innovator in the gene therapy field with over 900 employees in five countries, the company holds more than 600 patents and patent applications in areas such as AAV production and chimeric capsids. Learn more at http://www.askbio.com/ or follow us on LinkedIn. About Bayer  Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to http://www.bayer.com. AskBio Forward-Looking Statements  This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding AskBio’s clinical trials. These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned clinical and regulatory milestones and timelines, its reliance on third-parties, clinical development plans, manufacturing processes and plans, and bringing its product candidates to market, due to a variety of reasons, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office. Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.  References [1] Hajjar, R. Cardiotropic AAV gene therapy for heart failure: a phase 1 trial. Nature Medicine. 2025 Oct 21; 10.1038/s41591-025-04011-z. [2] Savarese G, et al. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287.  [3] Myhre P, et al. Digital tools in heart failure: addressing unmet needs. Lancet Digit Health. 2024 Oct;6(10):e755-e766. [4] Henry T, et al. Preliminary safety and efficacy of a Phase 1 clinical gene therapy trial in patients with advanced heart failure using a rationally designed cardiotropic AAV vector targeting Protein Phosphatase Inhibitor-1. Presented at American Heart Association Scientific Sessions, November 2023. [5] Nicolaou P & Kranias E. Role of PP1 in the regulation of Ca cycling in cardiac physiology and pathophysiology. Front Biosci (Landmark Ed). 2009 Jan 1;14(9):3571-85. [6] Centers for Disease Control and Prevention. Heart failure. Published 2022. Available at: https://www.cdc.gov/heart-disease/about/heart-failure.html. Accessed October 2025. [7] American Heart Association. Types of Heart Failure. Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/types-of-heart-failure. Accessed October 2025. [8] American Heart Association. Heart Failure Signs and Symptoms. Available at: https://www.heart.org/en/health-topics/heart-failure/warning-signs-of-heart-failure. Accessed October 2025. [9] Clinical trials.gov. AB-1002 in Patients With Class III Heart Failure (NAN-CS101). Available at: https://clinicaltrials.gov/study/NCT04179643. Accessed October 2025. CONTACT: Phil McNamara
AskBio Inc. (AskBio)
+1 (984) 5207211
pmcnamara@askbio.com