The Latest Cardiac and Vascular News
The analysis, published simultaneously in JACC, found that moderate AS patients with at least one at-risk feature had a two-fold increase in mortality and hospitalization with heart failure compared with moderate AS patients with no at-risk features over two years. Dr. Philippe Généreux…
Both post-implant monotherapies in the trial achieved non-inferiority compared to dual anti-platelet therapy (DAPT) supporting the potential to simplify post-procedure drug regimens MARLBOROUGH, Mass. and SAN DIEGO, Nov. 2, 2026 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX)…
SAN DIEGO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced results from the PROGRESS Trial, marking a turning point in the management of moderate aortic stenosis (AS). The trial demonstrated that transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance in the primary composite endpoint of death or heart failure events at two years in moderate AS patients with at-risk features. The late-breaking results were presented at Transcatheter Cardiovascular Th
MENLO PARK, Calif.–(BUSINESS WIRE)– #AVENTUSThrombectomy–Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced the launch of SENSE-PE, an all-comer post-market registry evaluating the safety and efficacy of the AVENTUS™ Thrombectomy System in patients treated for acute pulmonary embolism (PE). Cleared by the FDA for the treatment of PE in June 2025, AVENTUS is the only thrombectomy platform combining integrated tissue-sensing technology and directional aspiration
Late-breaking one-year VERITAS study results were presented at the Transcatheter Cardiovascular Therapeutics conference and simultaneously published in JACC: Cardiovascular Interventions; data show the device achieved high closure rates of the left atrial appendage (LAA) and a low…
100% clinical success and no device-related adverse events in 20 First-in-Human Percutaneous Coronary Intervention procedures with next-generation robotic systemRobocath system demonstrates ability to efficiently and effectively support the full range of coronary interventions including in complex coronary artery disease patientsPrincipal investigator, Dr. Nejjari, shared the findings during the “Innovations in Robotics for Transcatheter Heart Interventions” session at TCT on November 1, 2026 ST. LOUIS and ROUEN, France, Nov. 02, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the findings from the first-in-human clinical results for Robocath’s next-generation robotic system during the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. The findings support a favorable performance profile for the system, with 100% clinical success rate and no device-related complications. The study was conducted by Dr. Mohammed Nejjari and Dr. Franck Digne, Interventional Cardiologists at Centre Cardiologique du Nord (CCN) in Saint-Denis, France. This prospective pilot clinical study enrolled twenty patients undergoing PCI for coronary artery disease. Key findings from the study include: 100% clinical success and 95% technical success: All 20 patients met the study’s clinical success criteria of minimal residual stenosis post PCI. In all but one procedure the physician was able to complete the procedure entirely robotically without conversion to manual.No device-related adverse events: Clean safety profile with no intra-procedural vascular complications, major adverse events, or device related adverse events through 30-day follow-upNo physician radiation exposure: Operating physicians performed the procedures entirely protected from fluoroscopy radiation, supporting the system’s potential to reduce occupational risk in interventional cardiology.Performance across lesion complexity: The study included A/B1, B2, and C-type lesions, representing three levels of procedural complexity, including in complex coronary disease in tortuous distal vasculature. Dr. Nejjari discussed these findings during the November 1, 2026 scientific session “Innovations in Robotics for Transcatheter Heart Interventions” that took place at TCT. A manuscript documenting these findings has been submitted for publication and is under review. “These initial findings mark an important milestone in the advance of robotic technology in interventional cardiology,” said Dr. Nejjari. “The results are very encouraging, particularly the clinical success and safety observed across the patient cohort including in complex PCI. We are excited for the potential of this robotic innovation to improve care for patients and benefit physician safety and workflow. Robocath, a subsidiary of Stereotaxis, is a technology leader in pioneering advanced robotic innovations for interventional cardiology and neurointerventions. Robocath’s next-generation system builds on the clinical and technological experience of the first-generation R-One system, now used in centers worldwide. It adds advanced capabilities such as multi-device handling of up to five interventional devices simultaneously to support increasingly complex interventional procedures. “These first-in-human results support our confidence in our innovation strategy and reflect our commitment to advancing differentiated robotic technologies across endovascular interventions,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to building on these initial findings, progressing Robocath’s technology towards regulatory submissions, and delivering this promising technology to interventional physicians and patients suffering from coronary disease and stroke.” 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 Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam Announces Positive Heart Attack Pilot Study Results at TCT 2026: Patient-Recorded 3D ECG Shown to be as Accurate as Standard 12-Lead ECG
TIME Best Inventions 2026
TIME Best Inventions 2026
Nanox.AI’s Investigational AVC Solution Demonstrated 98.3% Sensitivity and 96.6% Specificity in Evaluable CT Scans.Findings Highlight the Potential of AI to Identify Previously Unreported Aortic Valve Calcification Using Existing Routine CT Scans.Findings published in the peer-reviewed journal JACC: Advances. PETACH TIKVA, Israel, Nov. 2, 2026 (GLOBE NEWSWIRE) — Nanox Imaging Ltd. (“Nanox” or the “Company”, NASDAQ: NNOX), a leader in innovative medical imaging technology, today announced that updated clinical data on Nanox AI Ltd’s (“Nanox.AI”) aortic valve calcification (AVC) AI solution was presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, taking place October 31 to November 3, 2026, in San Diego, California. Nanox.AI’s HealthAVC solution is intended to serve as a non-invasive, post-processing software application that detects and quantifies calcified plaques in the aortic valve. The software analyzes non-gated, non-contrast chest computed tomography (CT) images acquired during routine clinical care and provides a numeric aortic valve calcium score, a sex-based categorization, and a visual indication of the result. The HealthAVC device is being developed for the use by clinicians to assist in the detection and quantification of aortic valve calcification, supporting early identification of patients who may benefit from cardiovascular evaluation, ongoing monitoring, and potential consideration for TAVR. The solution is under development and is not yet cleared for clinical use or commercially available. “The low reporting rate may reflect the fact that most CT scans were performed for unrelated indications, alongside challenges in assessing aortic valve calcification and the lack of clearly defined clinical pathways for incidental findings,” said Ofir Koren, MD, FACC, FESC, Assistant Professor of Cardiology, Director, Cardiovascular Innovation Program of Cedars-Sinai Medical Center, consultant to Nanox.AI and lead author of the study. “AI-based clinical decision support could help address these challenges by providing consistent detection and quantitative assessment, potentially improving the recognition and reporting of AVC in routine practice. At the same time, we need to establish clearer, evidence-based recommendations for further evaluation and follow-up, particularly for patients with high calcium burden or findings suggestive of severe aortic stenosis.” The data was also published in the Journal of the American College of Cardiology (JACC). The TCT abstract, “AI-Detected Aortic Valve Calcification on Routine Chest CT Reveals a Large Hidden Population at Risk for Severe Aortic Stenosis,” was presented by Ofir Koren on Sunday, November 1, 2026. The study analyzed non-contrast chest CT from 440 evaluable adults aged 50 and older and compared AI findings with routine radiology reports. Key findings highlight an opportunity for AI-assisted detection A substantial documentation gap: 145 of 172 manually confirmed AVC-positive scans (84.3%) did not explicitly mention AVC in the original radiology report. This is a reporting measure, not a radiologists’ diagnostic-error rate.Detection of undocumented AVC: HealthAVC V1.0 identified 142 of these 145 cases (97.9%). Across all 440 evaluable scans, sensitivity was 98.3% (169/172) and specificity was 96.6% (259/268).Important workflow limitation: 56 of 496 submitted scans (11.3%) were non-evaluable. Counting manually positive rejected scans as missed yielded end-to-end sensitivity of 89.9% (169/188).Broader clinical context: Expert manual scoring identified two cases meeting sex-specific severe AVC thresholds. Among 86 AI-positive patients with clinically obtained echocardiography within ±365 days, 10 had mild-or-greater aortic stenosis. These selected data do not establish clinical benefit or a need for intervention. Nanox.AI’s HealthAVC solution will be highlighted at the RSNA 2026 Annual Meeting on the Innovation Theater; Tuesday, December 1 | 11:00am Schedule a meeting with Nanox at RSNA 2026| Booth #1759: https://www.nanox.vision/rsna2026 About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC X, a multi-source digital tomosynthesis system designed to make advanced 3D imaging accessible in more clinical settings; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provides access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. The Nanox.ARC X was selected as one of TIME’s Best Inventions of 2026. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit https://www.nanox.vision. About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit www.nanox.vision/ai. Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xii) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xiii) potential litigation associated with our transactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com
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TIME Best Inventions 2026
First plaque tool with prospective outcomes data. Faster, sustained LDL-C control: approximately 50% of patients reached goal by 90 days vs. approximately 35% with CCTA alone. GAMEFILM data highlight high prevalence of heart disease in retired NFL players, underscoring need for advanced plaque assessment SAN FRANCISCO, Nov. 02, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced prospective clinical outcomes from the DECIDE registry will be presented at the American Heart Association (AHA) Scientific Sessions 2026. In an evaluation of more than 6,000 well-matched patients, Heartflow Plaque Analysis with Plaque Staging demonstrated a 34% reduction in major cardiovascular disease (CVD) events and half the rate of myocardial infarction (MI) at one year compared to coronary computed tomography angiography (CCTA) alone. The significant reduction in major CVD events stemmed from meaningful shifts in patient care. By quantifying total plaque volume and staging disease severity, the platform equipped clinicians to optimize drug regimens earlier, driving a 41% early increase in patients achieving low-density lipoprotein cholesterol (LDL-C) goal, as compared to CCTA alone. “The DECIDE registry answers the core questions in preventive cardiology: Does AI-powered coronary plaque analysis guide medical therapy? Does it empower patients to achieve target lipid goals? And ultimately, does it reduce major CVD events?” said Leslee Shaw, Ph.D., Director of the Blavatnik Family Research Institute at the Icahn School of Medicine at Mount Sinai, New York, and co-lead investigator of the DECIDE Registry. “The one-year findings demonstrate that Heartflow Plaque Analysis provides clinicians with the objective data needed to optimize preventive care earlier and with greater precision, while significantly reducing major CVD events and heart attacks compared to CCTA alone. By directly linking this non-invasive approach to targeted lipid lowering, it helps bridge diagnostic imaging with meaningful risk reduction in everyday practice.” DECIDE Registry: Transforming Plaque Quantification into Preventive OutcomesModerated Digital 21, Nov. 9, 11:06 a.m. CT Key DECIDE findings regarding use of Heartflow Plaque Analysis: 34% fewer major CVD events (cardiovascular death, MI, revascularization or stroke) vs. CCTA alone and half the rate of MI over the first year.Management changed in >50% of patients by 90 days.50% reached target LDL-C (50% stenosis), 33% had severe or extensive plaque burden, and 29% had functionally significant ischemia.Retired linemen exhibited much higher plaque volumes for their age than non-linemen (63.3rd vs. 31.9th percentile).88% of players not currently on lipid-lowering therapy expressed willingness to initiate treatment following review of their AI plaque analysis results with a physician. “Many former players are surprised to learn that even after years of elite training and staying active, coronary artery disease can be quietly building in their arteries, and it remains their greatest long-term health threat,” said Yiannis Chatzizisis, M.D., Ph.D., Professor of Cardiology and Chief of the Cardiovascular Division at the University of Miami Miller School of Medicine, and GAMEFILM investigator. “When these former NFL players could see the precise volume and type of plaque in their own arteries with Heartflow Plaque Analysis, nearly 9 in 10 of those not on cholesterol-lowering therapy said they were ready to begin treatment. GAMEFILM is helping us understand the burden of disease in former professional athletes and giving them personalized insights to act on their heart health while there’s still time to make a difference with medication and lifestyle changes.” Building on its success enrolling retired players from the NFL, National Basketball Association (NBA) and National Hockey League (NHL), the GAMEFILM registry has now expanded to include former players from Major League Baseball (MLB), as well as professional staff from these leagues and U.S. college sports teams. This expansion broadens Heartflow’s initiative to evaluate hidden cardiovascular risk and support proactive, long-term disease management of former professional athletes across major sports. “Achieving faster, durable lipid control is a vital goal, and seeing that translate into a 34% reduction in one-year major CVD events in the DECIDE data is extraordinary,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “From the more than 6,000-patient DECIDE registry to our GAMEFILM registry, the data being presented at AHA prove that Heartflow Plaque Analysis goes beyond detecting disease to altering patient trajectories and connecting non-invasive precision to proactive, life-saving prevention.” Experience Heartflow Plaque Analysis with Plaque Staging at AHA 2026 AHA 2026 attendees are invited to visit Heartflow at exhibit booth #711 for live demonstrations of Heartflow Plaque Analysis and Heartflow FFRCT Analysis. See the full schedule of other Heartflow programs, including an expert theater, simulation zone, and more at event.heartflow.com/aha2026. 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.2 Heartflow Plaque Staging builds on this foundation, categorizing plaque burden into clinical risk stages to guide actionable risk stratification.3,4 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.5 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.3,6,7,8 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 ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com ________________________________1 Venkataramani AS, Gandhavadi M, Jena AB. Association between playing American football… JAMA. 2018;319:800–806. https://doi.org/10.1001/jama.2018.01402 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.3 Rinehart, et al. JACC Imaging. 2025.4 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)5 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–e454.6 Narula, et al. EHJ CVI 2024.7 Danad, et al. JAMA Cardiol 2017.8 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).
Dr. Megha Prasad and fellow physicians at NewYork-Presbyterian and Columbia complete first clinical cases with Conavi’s next-generation FDA-cleared hybrid IVUS–OCT imaging systemCompany introduces OCTIV™, powered by Novasight™, as the system’s commercial nameOCTIV combines IVUS and OCT in one catheter, with enhancements focused on image quality, deliverability and ease of useFirst commercial placement and completed clinical cases advance Conavi’s U.S. rollout ahead of TCT 2026 TORONTO, Nov. 02, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced the completion of the first U.S. placement and clinical cases with OCTIV™, powered by Novasight™, its FDA-cleared hybrid intravascular imaging system, at NewYork-Presbyterian/Columbia University Irving Medical Center. Interventional cardiologist Dr. Megha Prasad performed the first cases, marking a milestone in Conavi’s U.S. commercial rollout. “The first placement and clinical cases with OCTIV move our next-generation system from FDA clearance into clinical use in the United States,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “OCTIV brings the complementary information from IVUS and OCT into one catheter, with design enhancements focused on image quality, deliverability and ease of use.” OCTIV combines intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) in a single imaging catheter, providing simultaneous, co-registered views of coronary arteries to support assessment of coronary artery disease and guide percutaneous coronary intervention (“PCI”). The placement and first cases mark a milestone in Conavi’s targeted U.S. commercial rollout following FDA 510(k) clearance. “Having IVUS and OCT available in a single catheter gives us complementary information about the vessel during a coronary intervention,” said Dr. Megha Prasad, an interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. “In our first week with the OCTIV hybrid IVUS-OCT system, the device helped us identify a range of issues, from in-stent restenosis to dissections and plaque ruptures, findings that helped inform our treatment plans. In ostial and multivessel cases, we were able to switch between hybrid and IVUS-only runs, which gave us the full picture while conserving contrast. Paired with physiology, it also helped us assess vessels in patients with microvascular disease.” Hybrid Imaging and Key Differentiating FeaturesOCTIV brings together the following capabilities to support image-guided coronary interventions: Hybrid IVUS–OCT imaging: Simultaneous, co-registered images from a single catheter and pullback combine the imaging depth of IVUS with the high-resolution detail of OCT, allowing physicians to assess complementary features of the same vessel segment.Image quality: The platform includes enhancements designed to improve image quality, supporting visualization of vessel structures and detailed assessment of lesions and stent deployment.Catheter deliverability: An updated catheter design is intended to improve deliverability through coronary anatomy and facilitate access to the areas physicians need to assess.Ease of use: The patient interface module (“PIM”), which connects the catheter to the system, is positioned outside the sterile field. This configuration and a streamlined catheter connection workflow are designed to simplify setup and use in the catheterization laboratory.Contrast mitigation: Access to IVUS imaging without a contrast flush allows physicians to use IVUS for selected imaging steps and OCT where additional high-resolution detail is needed, supporting a tailored approach to contrast use. NewYork-Presbyterian/Columbia University Irving Medical Center is the first U.S. site in the targeted rollout of OCTIV. Conavi is focused on supporting clinical use at the hospital and advancing placement of the system at additional U.S. institutions. The first clinical cases were completed ahead of Conavi’s participation in Transcatheter Cardiovascular Therapeutics (“TCT”) 2026. The Company’s conference participation includes a podium presentation by Dr. Prasad featuring hybrid IVUS–OCT imaging, preclinical research and physician education sessions. The Company also introduced OCTIV as the commercial name for its next-generation system. The name brings together references to OCT and IVUS and is inspired by the musical term “octave”, reflecting two complementary imaging modalities working in harmony. OCTIV is powered by Conavi’s Novasight technology. About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/. (Note: Dr. Prasad discloses consulting payments from Conavi) Forward-Looking StatementsThis press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the anticipated clinical benefits and performance of OCTIV, continued clinical use, placements at additional U.S. institutions, participation in TCT 2026, the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory 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. ContactMark Quick, Chief Financial Officer | 416-483-0100Christina Cameron, Investor Relations | 416-483-0100 ext. 121 | IR@conavi.comSusan Thomas, Media | 619-540-9195
