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Abbott’s TECTONIC clinical trial demonstrates strong 30-day outcomes and high procedural success for its investigational SonicForce™ Coronary Intravascular Lithotripsy System

SonicForce is an investigational coronary intravascular lithotripsy (IVL) system that uses acoustic pressure waves, similar to those used to break up kidney stones, to crack calcium in coronary arteries and restore blood flow The system is designed to bring purposeful innovation to…

Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026

MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR® Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 ± 38 mm2). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch* (PPM) in a cohort of medium annuli patients from the EMBARK Study. The 30-day Medium-size DurAVR THV results were presented by Azeem Latib, MD during the Emerging Concepts and Innovations in TAVR session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego, California. 30-day Results Highlights DurAVR THV delivered a favorable hemodynamic profile with a large EOA of 2.64 ± 0.19 cm2 (baseline 0.8 ± 0.2 cm2) and a single digit mean pressure gradient (MPG) of 6.17 ± 1.40 mmHg (baseline 45.5 ± 11.7 mmHg). At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).No moderate or severe prosthesis–patient mismatch was observed at 30 days. “These are exceptional 30-day hemodynamics for medium annuli, with large effective orifice areas, single-digit gradients, and no moderate or severe PPM or paravalvular leak. That matters because prosthesis-patient mismatch is not just a small-annulus problem. A recent study in younger, lower-risk TAVR patients found PPM was associated with higher mortality and substantially more heart failure hospitalization at five years.¹ As TAVR moves to patients who will live with their valve for decades, this is the hemodynamic profile we designed DurAVR to deliver, and we look forward to PARADIGM confirming it in a randomized setting,” said Chris Meduri, M.D., Anteris Chief Medical Officer. The DurAVR THV is being evaluated in the ongoing global PARADIGM pivotal trial (ClinicalTrials.gov ID NCT07194265), which is actively enrolling patients and will include use of the Medium-size DurAVR THV. This prospective, randomized controlled trial (RCT) is designed to evaluate the safety and effectiveness of DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis. ¹Suruga K, et al. Prosthesis-Patient Mismatch in Young and Low-Risk Patients After Newer Generation Balloon-Expandable Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2025;18(12). *Prosthesis‐patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn’t have a large enough opening (EOA) to accommodate the patient’s blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR). **As defined in VARC-3 About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR® Delivery System. DurAVR THV is intended for INVESTIGATIONAL USE ONLY. Not available for commercial use or sale worldwide. CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.    For more information: Global Investor RelationsInvestor Relations (US)investors@anteristech.commchatterjee@bplifescience.comDebbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269 Websitewww.anteristech.comX@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech

TCT 2026: CT-guided PCI Matches IVUS Outcomes in Randomized P4 Trial; Heartflow PCI Navigator Changes PCI Plans in Approximately 70% of Patients

Late-Breaking P4 study, simultaneously published in NEJM, shows CT guidance delivers matched one-year clinical outcomes with shorter procedures, demonstrating pre-procedural CCTA can guide key PCI planning decisions NAVIGATE-PCI shows Heartflow PCI Navigator drove modifications to stent length and lesion prep compared to angiography alone SAN FRANCISCO, Nov. 01, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced new landmark randomized clinical data presented at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, demonstrating computed tomography (CT)-guided percutaneous coronary intervention (PCI) matches gold-standard imaging outcomes with greater efficiency. These data are supported by registry insights on the procedural impact of Heartflow PCI Navigator. In a late-breaking presentation simultaneously published in the New England Journal of Medicine (NEJM), the 1,105-patient P4 randomized clinical trial met its primary endpoint, demonstrating that CT-guided PCI planning was non-inferior to gold-standard intravascular ultrasound (IVUS) for one-year clinical outcomes. In the largest randomized trial of its kind, CT guidance achieved these matched results compared to IVUS while significantly improving procedural efficiency, delivering faster procedure times and utilizing lower contrast volume. Data from the NAVIGATE-PCI registry showed that interventional cardiologists altered their procedural strategy in approximately 70% of cases after incorporating 3D anatomic, plaque, and physiologic insights from Heartflow PCI Navigator compared to standard invasive coronary angiography alone. “CT has already become routine for planning structural procedures like TAVR. The data presented at TCT show coronary intervention is ready to follow the same path with advanced pre-procedural imaging and Heartflow’s AI-powered analysis to deliver precision and efficiency,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “What we learned planning P4 cases across six separate tools shaped Heartflow PCI Navigator, which brings anatomy, plaque and physiology together in the first and only PCI planning tool backed by prospectively validated accuracy and randomized clinical trial data. Together, P4 and NAVIGATE-PCI support a paradigm shift in coronary intervention, bringing non-invasive CT-guided PCI planning into routine cath lab practice.” P4 Trial: Validating CT-guided PCI Against IVUS with Greater Efficiency Main Arena 4, November 1 The Heartflow-supported, investigator-initiated P4 trial directly evaluated the clinical efficacy of non-invasive CT-guided PCI planning against invasive IVUS guidance. Enrolling 1,105 patients across 23 centers in the U.S., Europe, and Japan, P4 randomized stable CAD patients to either CT-guided PCI planning, including Heartflow FFRCT Analysis and Heartflow Planner (an earlier version of Heartflow PCI Navigator), or intra-procedural IVUS guidance. Key P4 trial one-year findings showed CT-guided PCI matched IVUS on outcomes while enabling a faster procedure and lower contrast use, including: CT-guided PCI matched IVUS for the primary endpoint of 12-month target-vessel failure (4.1% vs. 4.6%).CT-guided PCI had a 17-minute shorter median procedure time than IVUS (46 minutes vs. 63 minutes, a 27% reduction).Contrast volume was reduced by approximately 12% in the CT-guided arm (median 150 mL vs. 170 mL).CT-guided PCI more than doubled the use of advanced calcium modification (9.2% vs. 3.8%). “Intravascular ultrasound is an established benchmark, but performing assessments inside the cath lab adds procedural time and requires expertise,” said Carlos Collet, M.D., Ph.D., principal investigator of the P4 trial and Director of Cardiovascular Imaging, Physiology and Translational Therapeutics at the Cardiovascular Research Foundation in New York. “P4 shows that non-invasive CT-guided PCI planning achieves comparable clinical outcomes with shorter procedure times and less contrast, enabling interventionalists to anticipate challenges, tailor their strategy, and enter the cath lab better prepared.” NAVIGATE-PCI Registry: Optimizing Strategy Before Entering the Cath Lab TCT AI Lab 3, November 1 NAVIGATE-PCI is a prospective, multi-center registry evaluating the real-world utility of Heartflow PCI Navigator, the first and only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to streamline procedures with increased efficiency and clinical confidence. In the 203-patient cohort presented at TCT, investigators evaluated how access to integrated pre-procedural insights altered treatment strategies established immediately after invasive angiography. Key NAVIGATE-PCI findings include: Treatment plans were modified in approximately 70% of patients after physicians reviewed Heartflow PCI Navigator prior to intervention, compared to angiography alone. The most frequent changes included stent length (41%) and lesion preparation technique (12%).Physicians rated their PCI Navigator plans with higher confidence than their angiography-based plans. “Angiography only shows a two-dimensional silhouette, leaving critical blind spots around plaque burden, calcium and true vessel size,” said Ziad A. Ali, M.D., D.Phil., principal investigator of the NAVIGATE-PCI registry and Director of the DeMatteis Cardiovascular Institute at St. Francis Heart Center in New York. “Heartflow PCI Navigator fundamentally changes our approach, providing the comprehensive 3D and physiologic clarity needed to tailor treatment plans with greater confidence before entering the cath lab.” The BRAVEHEART Registry: Revealing High CAD Burden in Firefighters to Accelerate Prevention TCT 1488, November 3 Highlighting the impact of Heartflow’s technology across the entire continuum of care, investigators will also present data from the prospective BRAVEHEART registry. The study evaluated the use of AI-powered Heartflow Plaque Analysis and Heartflow FFRCT Analysis to identify hidden coronary risk and encourage earlier preventive therapy in 96 asymptomatic firefighters with at least 10 years of occupational smoke exposure. Key BRAVEHEART findings include: Subclinical coronary plaque was identified in 72% of asymptomatic firefighters (mean age 48.1 years), with 16% presenting with severe total plaque volume ( >250 mm³).Willingness to initiate lipid-lowering medical therapy was reported by 68% of participants following review of their CCTA and Heartflow Analysis insights, while 93% committed to lifestyle modifications. Experience Heartflow PCI Navigator at TCT 2026 TCT 2026 attendees are invited to visit Heartflow at exhibit booth #3819 for live demonstrations of Heartflow PCI Navigator. See the full schedule of other Heartflow programs, including a lunch symposium, hands-on training workshops, and more at event.heartflow.com/tct2026. About Heartflow PCI Navigator Heartflow expanded the Heartflow One platform with the addition of Heartflow PCI Navigator to support diagnosing, managing and guiding treatment for patients throughout the spectrum of CAD care. PCI Navigator is the only integrated, AI-driven percutaneous coronary intervention (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. Heartflow introduced PCI Navigator to close the critical information gaps interventional cardiologists face before entering the cardiac catheterization lab. About Heartflow Plaque Analysis with Plaque Staging Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with 95% agreement against the gold standard, intravascular ultrasound (IVUS), in a prospective, international trial.1 Heartflow Plaque Staging builds on this foundation, categorizing plaque burden into clinical risk stages to guide actionable risk stratification.2,3 The framework is validated in 23,000 patients with up to 16 years of follow-up, offering the reproducibility clinicians need for serial monitoring and individualized preventive care. About Heartflow’s Technology and Research Heartflow’s technology is redefining precision diagnostic testing and management for coronary artery disease (CAD) through clinically proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 750,000 patients worldwide.4 Key benefits include: Unmatched proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible diagnostic insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.3,5,6,7 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST r2, SOC 2 Type 2, MDSAP, 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 Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com _____________________________1 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.2 Rinehart, et al. JACC Imaging. 2025.3 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)h4 Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCAI Guideline for the Evaluation and Diagnosis of Chest Pain. Circulation 2021; 144:e368–e454.5 Narula, et al. EHJ CVI 2024.6 Danad, et al. JAMA Cardiol 2017.7 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024. (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years).

GE HealthCare debuts Allia Celeo, a ceiling-mounted interventional system designed for smooth procedural flow and AI-powered precision imaging

CHICAGO–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) today introduced Allia™ Celeo,* a ceiling-mounted image guiding system, at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference in San Diego. Developed around the principle of smooth procedural flow and built for interventional suites that prioritize high patient throughput and versatility across many indications, Allia Celeo pairs an extra-wide-bore C-arm with intuitive user interface, an AI-powered image chain, and compatib

Reflow Medical Reports One-Year Results from DEEPER CORONARY Study of Investigational Coronary Spur® Elute Sirolimus-Eluting Retrievable Stent System

SAN CLEMENTE, Calif.–(BUSINESS WIRE)– #TCT2026–Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the presentation of one-year clinical results from the first-in-human DEEPER CORONARY study at Transcatheter Cardiovascular Therapeutics (TCT) 2026, the annual scientific symposium of the Cardiovascular Research Foundation (CRF), in San Diego. The study evaluates the investigational coronary Spur® Elute Sirolimus-Eluting Retrievable Stent

Data Show Positive Survival and Patient Outcomes with Best-Practice Impella Support in HRPCI, in Contrast to CHIP-BCIS3 Study Results

SAN DIEGO–(BUSINESS WIRE)– #PressRelease–Johnson & Johnson announced results from three clinical analyses being presented during the Transcatheter Cardiovascular Therapeutics annual scientific symposium (TCT 2026) that report positive survival and patient outcomes data when Impella™ heart pumps are used to support a patient’s heart during and after high-risk percutaneous coronary intervention (HRPCI). Real-world and observational registry data from 1,379 HRPCI patients across hospitals in the U.S. and E

Philips launches HyperVue Integrated System in the U.S., bringing advanced coronary imaging and physiology into the cathlab

New fixed, single-room configuration is designed to make DeepOCT+NIRS Imaging and X1-FFR physiology readily available for efficient cath lab workflows At TCT 2026, Philips will showcase its broader full picture portfolio, bringing together imaging, physiology and procedural guidance Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced U.S. commercial availability of the HyperVue Integrated System1, a new single room-based configuration of its HyperVue Imaging System for DeepOCT+NIRS imaging and X1-FFR physiology assessment. It is designed to keep advanced coronary imaging and physiology tools connected and readily available in the interventional suite. The system will be showcased at TCT 2026 in San Diego, California, October 31–November 3, alongside Philips’ broader portfolio of imaging, physiology and procedural guidance solutions for precision PCI. “Every procedure is an opportunity to help a patient return to a fuller life, and physicians need technology that supports confident clinical decisions without adding unnecessary complexity or time,” said Stacy Beske, Business Leader, Image Guided Therapy Devices at Philips. “For advanced intravascular imaging to become part of everyday practice, it has to fit naturally into the high-volume workflow of the interventional suite. Part of what Philips will showcase at TCT is how this approach extends across our portfolio, bringing imaging, physiology and procedural guidance closer together so physicians can access the information they need throughout the PCI procedure.” Bringing physiology and intravascular imaging togetherHyperVue with X1-FFR1 brings together angiography derived, drug-free coronary physiology with DeepOCT+NIRS intravascular imaging on a single platform.  X1-FFR is an FDA cleared, AI powered, angiography derived platform designed to simplify and speed up FFR results at the patient’s bedside.2 X1-FFR is the only FDA cleared angiogram-derived FFR solution to use a single angiographic view, rather than two or three, to provide an FFR value.2 At TCT Philips will showcase both X1-FFR and HyperVue’s DeepOCT+NIRS imaging. An integrated system designed around interventional suite workflowAs coronary interventions become more complex, physicians need timely, meaningful information to assess disease, plan treatment and confirm results without adding unnecessary complexity for the clinical team. Unlike the mobile configuration of the HyperVue Imaging System that must be brought into the procedure room, powered and connected for each case, HyperVue Integrated is permanently installed in a dedicated interventional suite, keeping this imaging capability readily available when clinicians need it. “In a high-volume cath lab, imaging technology needs to be readily available, simple to operate and easy to use at the point of care,” said Richard Shlofmitz, MD, Chief of Cardiology, St. Francis Hospital & Heart Center, Catholic Health. “We were encouraged by the HyperVue technology and look forward to continuing our collaboration with Philips to explore how a more integrated workflow can support efficient, patient-focused care.” By eliminating the need to move, connect and prepare a mobile system for each procedure, HyperVue Integrated is designed to reduce setup steps and make advanced imaging and physiology more accessible in the everyday cathlab workflow. HyperVue Integrated provides continuous connectivity in the cath lab for both HyperVue’s DeepOCT+NIRS Imaging and X1-FFR, Philips’ angiography-based coronary physiology solution. A table-mounted touchscreen enables bedside system control within the sterile field. The new configuration also introduces updates to the controller to further simplify the setup and user experience. A broader Philips portfolio for precision PCIHyperVue Integrated expands Philips’ coronary guidance portfolio alongside its IVUS and physiology solutions. The portfolio gives clinicians options to assess coronary disease, plan and guide treatment, and confirm procedural results using the imaging and physiology tools most appropriate for the patient and lesion.At TCT, Philips will also showcase HyperVue Integrated alongside IntraSight Plus, its U.S.-available interventional guidance platform. IntraSight Plus brings IVUS, iFR/FFR physiology, co-registration, tri-registration and real-time device visualization together in a single platform, supporting assessment, treatment planning, device guidance and result verification in PCI. By bringing key diagnostic and treatment-planning tools together at the bedside, IntraSight Plus is designed to simplify the workflow of complex coronary interventions. Experience Philips at TCT 2026Attendees can experience HyperVue Integrated, IntraSight Plus and Philips’ wider image-guided therapy portfolio at the Philips Hub at TCT 2026. For further information, please contact: Joost Mi-MalthaPhilips Global External RelationsTel.: +31 6 1055816E-mail: joost.maltha@philips.com About Royal Philips  Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.Headquartered in the Netherlands, the company is a leader in image-guided therapy, diagnostic imaging, ultrasound, monitoring, enterprise informatics and personal health. Philips generated 2025 sales of approximately EUR 18 billion and employs approximately 63,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter. HyperVue Integrated System, HyperVue with X1-FFR, HyperVue mobile and HyperVue integrated refer to different form factors of the FDA cleared HyperVue Imaging System – Integrated product, 510(k) K253101 Shlofmitz E, Shin D, Alasnag M, Angiography-Derived Physiology for Coronary Artery Disease Assessment: Expert Opinion From a SCAI Roundtable, Journal of the Society for Cardiovascular Angiography & Interventions, 2026; 5. URL: https://www.jscai.org/article/S2772-9303(25)01602-3/fulltext
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03 – X1-FFR UI image – YES Press Release

01 – Imaging System wide shot – YES Press Release

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HyperVue UI 1

02 – DeepOCT closeup – YES Press Release

Canon Medical and Stereotaxis Collaborate to Advance Robotic Electrophysiology

Collaboration brings together Canon’s Alphenix interventional fluoroscopy system and Stereotaxis’ GenesisX robotic technologyTechnologies will be presented at TCT 2026 in the Canon booth TUSTIN, Calif. and ST. LOUIS, Oct. 30, 2026 (GLOBE NEWSWIRE) — Canon Medical Systems USA, a leader in innovative diagnostic imaging solutions, and Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced a technology compatibility and commercial collaboration to pair Canon Medical’s Alphenix interventional imaging platform with Stereotaxis’ GenesisX Robotic Magnetic Navigation system. Canon and Stereotaxis are collaborating to offer their respective systems in a compatible fashion alongside each other. Canon Medical’s Alphenix platform provides advanced imaging, visualization, dose-management and workflow capabilities for interventional cardiology, with flexible configurations designed to support complex procedures. GenesisX enables precise robotic navigation of interventional catheters, with a semi-mobile architecture designed to facilitate adoption broadly within existing catheterization labs without any construction. The combination of these two advanced technologies aims to expand access to next-generation robotic electrophysiology technology. The collaboration will enable the companies to enhance customer knowledge regarding their respective technologies, providing healthcare organizations greater flexibility when planning advanced robotic electrophysiology labs. The companies will further explore opportunities for Alphenix and GenesisX to improve workflow and introduce advanced capabilities in electrophysiology. Such efforts may apply beyond electrophysiology to support the advancement of robotic technology in interventional cardiology and neurointerventional procedures. “As electrophysiology continues to evolve, customers need the flexibility to build advanced labs around the technologies and workflows that best meet their needs,” said Tsuneo “Neo” Imai, President & CEO of Canon Medical Systems USA. “Our collaboration with Stereotaxis reinforces Canon Medical’s commitment to customer choice and creates an exciting opportunity to bring Alphenix imaging together with Robotic Magnetic Navigation.” “We are delighted to collaborate with Canon Medical to bring together two complementary technologies for the modern EP lab,” said David Fischel, Chairman and CEO of Stereotaxis. “More tightly coordinating the delivery of advanced interventional imaging and robotic technologies offers hospitals an exciting approach to building their robotic electrophysiology programs.” About Canon Medical Systems USA, Inc.Canon Medical Systems USA, Inc. markets, sells, distributes and services radiology and cardiovascular systems, including CT, MR, molecular imaging, ultrasound, X-ray, and interventional X-ray equipment. For more information, visit Canon Medical Systems’ website: https://us.medical.canon/ About Canon Medical GroupCanon Medical Group provides a comprehensive range of medical imaging solutions, including CT, diagnostic and interventional X-ray, MRI, ultrasound, service solutions, and advanced Healthcare IT. In line with Canon Medical Group’s continued Made for Life philosophy, patients are at the heart of everything we do. Our mission is to equip healthcare professionals with innovative solutions that enhance clinical performance, safety, comfort, and outcomes—helping deliver better health opportunities for patients worldwide. We invest in research and product development that directly addresses the real clinical, operational, and business needs of our customers. By improving accessibility, enabling cross-platform integration, and supporting patient-centered care pathways, we aim to deliver solutions that are both meaningful and impactful. Working hand in hand with our medical, academic, and research partners, we build relationships founded on transparency, trust, and respect. Together, we strive to create industry-leading innovations that improve patient outcomes and enrich quality of life for communities around the world. https://global.medical.canon/ About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com. Cautionary Note Regarding Forward-Looking StatementsThis press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, our overall liquidity and our ability to fund operations, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, our ability to manage and integrate recent acquisitions, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. Stereotaxis Contacts:David L. FischelChairman and Chief Executive OfficerKimberly PeeryChief Financial Officer314-678-6100Investors@Stereotaxis.comCanon Medical Systems USA Contacts:Olivia DuarteDirector of Corporate Communications(800) 421-1968

Merit Medical Acquires Solo Pace, Inc., Expanding Its Cardiac Therapies Platform with Innovative TAVR Pacing Technology

Solo Pace, Inc. specializes in temporary pacing solutions and systems designed for transcatheter heart valve procedures, including transcatheter aortic valve replacement proceduresSOUTH JORDAN, Utah, Oct. 29, 2026 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced its acquisition of Solo Pace, Inc. (Solo Pace). Located in Minneapolis, Minnesota, Solo Pace manufactures temporary pacing technology designed to help physicians treat patients with aortic stenosis. Merit had previously invested in Solo Pace and on October 13, 2026, Merit acquired all remaining outstanding equity of Solo Pace for purchase consideration of approximately $45 million. The acquisition expands Merit’s Cardiac Therapies platform with differentiated technologies, including SOLO PACE CONTROL™ and SOLO PACE FUSION™ systems, exclusively engineered for transcatheter aortic valve replacement (TAVR) and other transcatheter heart valve (THV) procedures. Prior to the acquisition, Merit served as the exclusive distributor of Solo Pace’s precision intraprocedural pacing technology. The acquisition builds on this existing commercial relationship and supports Merit’s strategy to expand its structural heart portfolio, with a focus on technologies designed to simplify procedural workflows and support physicians performing transcatheter heart valve procedures. TAVR is a minimally invasive THV procedure that replaces the aortic valve in the heart. A treatment for aortic stenosis, or narrowing of the valve opening, TAVR is a rapidly growing procedure, with more than 100,000 performed annually in the United States alone.1 Temporary pacing is a critical component of TAVR procedures, supporting accurate valve deployment and helping physicians perform the procedure safely and efficiently. SOLO PACE CONTROL and FUSION systems are designed to help physicians treat patients by simplifying pacing setup,2 reducing workflow variability,2,3 and standardizing pacing strategies for TAVR procedures.2–4 The systems can help physicians minimize communication-related pacing errors2–4 and decrease the risk of vascular complications.2,4,5–7 SOLO PACE FUSION is a single-use, sterile kit designed for temporary intracardiac pacing for TAVR and other THV procedures. Combining guide wire functionality, left ventricular pacing, and patient grounding in one device, SOLO PACE FUSION is designed to provide stable, reliable temporary pacing throughout pacing setup and delivery.2,8 Designed for use with the existing SOLO PACE CONTROL external pulse generator, SOLO PACE FUSION is engineered to improve procedural efficiency during TAVR procedures.8 In addition, it supports temporary pacing with operator-specific protocols, automated pace capture checks, sterile remote-control operation, and simple visual indicators. “SOLO PACE CONTROL and FUSION systems have the potential to redefine pacing in transcatheter valve procedures,” said David V. Daniels, MD, Interventional Cardiologist and Founder of Solo Pace. “Seeing the technology embraced by physicians and having a meaningful impact on procedural efficiency has been incredibly gratifying. With Merit taking the lead, I’m excited for the difference the Solo Pace products can make in advancing patient care and market adoption.” Solo Pace announced U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial release of the SOLO PACE FUSION system on April 17, 2025, and March 31, 2026, respectively. “This acquisition expands our Cardiac Therapies platform and further strengthens our position in the structural heart market,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “Through our exclusive distribution relationship, we have seen a favorable response from clinicians. That experience reinforces our confidence in the technology and the opportunity to support its next phase of growth. We look forward to leveraging our commercial, clinical, and physician education capabilities to expand adoption in the United States and, over time, bring these solutions to more physicians and patients worldwide.” Learn more about SOLO PACE CONTROL and SOLO PACE FUSION. 1. Cleveland Clinic. 2025. “How and Why Volumes Matter In Aortic Valve Replacement.” Last modified January 22, 2025.2. Data on file. 3. Blusztein et al. 2023. Struct Heart. doi: 10.1016/j.shj.2023.100213.4. Berman et al. 2024. Struct Heart. doi: 10.1016/j.shj.2024.100306.5. Faurie et al. 2019. JACC Cardiovasc Interv. doi: 10.1016/j.jcin.2019.09.029.6. Regueiro et al. 2023. JACC Cardiovasc Interv. doi: 10.1016/j.jcin.2023.10.035.7. Arnold et al. 2014. Circ Cardiovasc Interv. doi: 10.1161/CIRCINTERVENTIONS.114.001395.8. Pasupati. “First-in-Human Experience with LV Guidewire Pacing.” TCT, October 2025. FINANCIAL SUMMARYOn October 13, 2026, Merit paid purchase consideration of approximately $45 million to acquire all remaining outstanding equity of Solo Pace. Merit previously owned approximately 18% of Solo Pace pursuant to various agreements executed between January 2023 and December 2025 under which Merit paid a total of $5 million to acquire shares of Solo Pace, an option to acquire all remaining outstanding equity of Solo Pace based on certain commercialization milestones, and exclusive rights to distribute the Solo Pace products upon commercialization. From the acquisition effective date of October 13, 2026, through December 31, 2026, the acquisition is projected to be immaterial to Merit’s previously forecasted full-year 2026 total revenue, non-GAAP net income and non-GAAP earnings per share. The acquisition is expected to be immaterial to Merit’s previously forecasted full-year 2026 GAAP net income and GAAP earnings per share. For the twelve months ending December 31, 2027, the acquisition is projected to be slightly accretive to non-GAAP net income and non-GAAP earnings per share, inclusive of approximately $1.5 million of lower interest income on cash balances used for the total purchase consideration and excluding approximately $3.2 million of non-cash and non-recurring transaction-related expenses. The acquisition is projected to be slightly dilutive to Merit’s GAAP net income and GAAP earnings per share in 2027 and accretive thereafter. NON-GAAP FINANCIAL MEASURESMerit generally does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of various items which could impact Merit’s future financial results, such as expenses attributable to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reliably predict the impact of these items, and Merit believes inclusion of a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance. Only information on the impacts to such measures from the proposed acquisition is included in this release. A reconciliation of the impacts on such financial measures to the impacts on their GAAP counterparts is not available without unreasonable effort. ADVISORSParr Brown Gee & Loveless served as legal advisor to Merit in connection with the transaction. ABOUT MERIT MEDICALFounded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling approximately 900 individuals. Merit employs approximately 7,500 people worldwide. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others: Statements proceeded or followed by, or that include the words, “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “projects,” “forecasts,” “potential,” “target,” “continue,” “upcoming,” “optimistic” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology;Statements that address Merit’s future operating performance or events or developments that Merit’s management expects or anticipates will occur, including, without limitation, any statements regarding Merit’s projected revenues, revenue growth or other financial measures, Merit’s plans and objectives for future operations, Merit’s proposed new products or services, the integration, development or commercialization of the business or any assets acquired from other parties, future economic conditions or performance, the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives Program or other business optimization initiatives, and any statements of assumptions underlying any of the foregoing; andStatements regarding Merit’s past performance, efforts, or results about which inferences or assumptions may be made, including statements proceeded or followed by the words “preliminary,” “initial,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications,” or “early feedback” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. The forward-looking statements contained in this release are based on Merit management’s current expectations and assumptions regarding future events or outcomes. If underlying expectations or assumptions prove inaccurate, or risks or uncertainties materialize, actual results will likely differ, and could differ materially, from Merit’s expectations reflected in any forward-looking statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Investors are cautioned not to unduly rely on any such forward-looking statements. The following are some of the important risks and uncertainties that could cause Merit’s actual results to differ from Merit’s expectations in any forward-looking statements: risks and uncertainties associated with Merit’s acquisition of Solo Pace and SOLO PACE CONTROL and FUSION systems and related technology; risks and uncertainties associated with Merit’s integration of the Solo Pace business, assets and operations into its operations and its ability to achieve anticipated financial results, product development and other anticipated benefits of the acquisition; uncertainties as to whether Merit will achieve revenue or other financial performance consistent with its forecasts projected for the Solo Pace acquisition; risks and uncertainties regarding trade policies or related actions implemented by the United States or other countries, including existing, proposed, prospective or invalidated tariffs, duties or other measures; risks and uncertainties associated with Merit’s integration of businesses or assets acquired from third parties, including View Point Medical, Inc. in April 2026, the business and assets related to the C2 CryoBalloon™ device acquired from Pentax of America, Inc. in November 2025 and Biolife Delaware, L.L.C. in May 2025, and Merit’s ability to achieve the anticipated operating and financial results, product development and other anticipated benefits of such acquisitions; effects of Merit’s 3.00% Convertible Senior Notes due 2029 on Merit’s net income and earnings per share performance; disruptions in Merit’s supply chain, manufacturing or sterilization processes; U.S. and global political, economic, competitive, reimbursement and regulatory conditions; risks and uncertainties associated with Merit’s executive succession and leadership transition; modification or limitation of, or policies and procedures associated with, governmental or private insurance reimbursement policies; reduced availability of, and price increases associated with, components and other raw materials; increases in transportation expenses; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; prospective financial obligations or other uncertainties associated with Merit’s divestiture of its DualCap® anti-microbial cap product line in February 2026; fluctuations in interest or foreign currency exchange rates and inflation; cybersecurity events; government scrutiny and regulation of the medical device industry; difficulties relating to development, testing and regulatory approval, clearance and maintenance of Merit’s products; the safety, efficacy and patient and physician adoption of Merit’s products; the ability to fully enroll and the outcomes of ongoing and future clinical trials and market studies relating to Merit’s products; litigation and other legal proceedings affecting Merit; the risk and possible effects of any failure to comply with U.S. and foreign laws and regulations; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; potential for significant adverse changes in governing regulations;, changes in tax laws and regulations in the United States or other jurisdictions or exposure to additional tax liabilities which may adversely affect Merit’s effective tax rate; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; failure to comply with applicable environmental laws; changes in key personnel; labor shortages and increases in labor costs; price and product competition; extreme weather events; and geopolitical events. For a further discussion of the risks and uncertainties that may affect Merit’s business, operations and financial condition, see Part I, Item 1A. “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the SEC and Merit’s other filings with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. TRADEMARKSUnless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTS PR/Media Inquiries Sarah ComstockMerit Medical +1-801-432-2864 | sarah.comstock@merit.com  Investor Inquiries Mike Piccinino, CFA, IRC ICR Healthcare +1-443-213-0509 | mike.piccinino@icrhealthcare.com