The Latest Cardiac and Vascular News
WASHINGTON, Jan. 13, 2026 /PRNewswire/ — A novel approach to removing excess fluid through the skin and a new strategy to prevent right ventricular failure after LVAD implantation are among the highlights of the January issue of the Journal of Cardiac Failure (JCF). Together, these…
BEAVERTON, Ore., Jan. 12, 2026 /PRNewswire/ — YorLabs, Inc., a medical technology company pioneering next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC), today announced the successful completion of the first clinical procedure…
Aims to Build on Positive 2025 Interim TN-201 Results in First Half of 2026 with Longer-Term Follow-Up Data for Cohorts 1 and 2 from MyPEAK™-1 Trial of Adults with MYBPC3-Associated HCM Expects to Report One-Year Cohort 1 Data and Early Cohort 2 Data from RIDGE™-1 Study of TN-401 for PKP2-Associated ARVC in First Half of 2026 Plans to Pursue Alignment on Regulatory Pathways for Lead Gene Therapy Programs in 2026 Raised $60 Million in 4Q25 to Support Runway Through mid-2027 SOUTH SAN FRANCISCO, Calif., Jan. 09, 2026 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today provided an update on its clinical development programs and outlined its strategic priorities for 2026. “2025 was a momentous year for Tenaya as we demonstrated early evidence of safety and potentially disease-modifying activity for our gene therapy programs for MYBPC3-associated hypertrophic cardiomyopathy and PKP2-associated arrhythmogenic cardiomyopathy—devastating inherited heart conditions with limited treatment options,” said Faraz Ali, Chief Executive Officer of Tenaya. “These encouraging results offer real hope to patients and families in need of transformative therapies. On the strength of these data, we successfully raised additional capital to advance both programs through key clinical milestones in 2026, including more mature data readouts from both programs. We remain steadfast in our mission to deliver potentially curative therapies for those living with serious genetic heart diseases.” Program Updates and Anticipated 2026 Milestones: TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In the first half of 2026, Tenaya expects to share interim data for Cohort 2 patients dosed with 6E13 vg/kg of TN-201, as well as updates from Cohort 1 patients who received 3E13 vg/kg doses of TN-201 in the MyPEAK-1 Phase 1b/2 clinical trial for the potential treatment of HCM due to MYBPC3 mutations.In the second half of 2026, one-year Cohort 2 data and two-year Cohort 1 data from MyPEAK-1 are anticipated.Tenaya plans to pursue regulatory alignment on TN-201 pivotal studies over the course of 2026 with an update to be released in the second half of the year.In November 2025, Tenaya presented promising data from the MyPEAK-1 trial. The interim data reported included safety, biopsy and leading indicators of efficacy results for the three patients enrolled in Cohort 1 with follow-up ranging from Week 52-78, as well as initial safety data and biopsy and efficacy results for Cohort 2 patients as of the July 2025 data cut off. Key findings included: TN-201 was generally well tolerated at both dose levels. No dose-limiting toxicities were observed, and all patients have successfully tapered off immunosuppressive medicine.MyBP-C protein levels increased over time, with a substantial increase in protein levels observed commensurate with higher dose in Cohort 2.Multiple parameters associated with risk of complications and/or survival improved among a majority of patients with greater than 26 weeks of follow-up.These data were presented at the 2025 American Heart Association Annual Scientific Sessions and simultaneously published in Cardiovascular Research. To date, seven patients have been enrolled in the MyPEAK-1 trial. Following implementation of modest protocol amendments in alignment with U.S. Food and Drug Administration (FDA) input, Tenaya expects to resume enrollment in the 6E13 vg/kg dose expansion cohort to generate additional safety and efficacy data in 2026 TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) In the first quarter of 2026, the DSMB for the RIDGE-1 Phase 1b/2 clinical trial of TN-401 gene therapy for the potential treatment of adults with ARVC caused by mutations in the plakophilin-2 gene, (PKP2) is expected to convene. The DSMB will review all available safety data for the three patients dosed at 3E13 vg/kg (Cohort 1) and three patients dosed at 6E13 vg/kg (Cohort 2,) dose levels. Following DSMB review, Tenaya plans to continue to enroll patients in RIDGE-1 at one or both dose levels.Tenaya expects to present one-year data for Cohort 1 and initial Cohort 2 data in the first half of 2026. Additional Cohort 2 data is anticipated in the second half of 2026.Tenaya plans to pursue regulatory alignment on TN-401 pivotal studies in the second half of 2026 and to share an update by year-end, as available.In December 2025, Tenaya presented positive initial Cohort 1 data in the ongoing RIDGE-1 clinical trial. The data reported included safety, biopsy and arrhythmia results from Cohort 1 as of the October 2025 data cut off, with follow-up ranging from 20-40 weeks post-dose. Key findings included: TN-401 was well tolerated at the 3E13 vg/kg dose, and no dose-limiting toxicities were observed. Adverse events (AEs) were generally mild, asymptomatic and manageable and deemed unrelated to TN-401 treatment.Biopsies demonstrated robust transduction and expression in all patients within first eight weeks.Clinically meaningful improvements in electrical instability were observed in the first two patients with greater than six months follow-up after TN-401 dosing.Enrollment and dosing of Cohort 2 is complete with no new serious AEs related to TN-401 reported in the cohort to date. In July 2025, the RIDGE-1 trial DSMB reviewed all available data and endorsed dose escalation to the 6E13 vg/kg level and expanding enrollment of Cohort 1, per protocol. Cash Position and Updated Guidance Tenaya ended the third quarter of 2025 with $56.3 million in cash, cash equivalents and investments in marketable securities. With the additional proceeds of $60 million from the December 2025 public offering (prior to deducting underwriting discounts and commissions and offering expenses), the company expects that such resources will be sufficient to fund planned operations through mid-2027. About TN-201 Gene Therapy and the MyPEAK-1 Phase 1b/2 Clinical TrialTN-201 is an adeno-associated virus serotype 9 (AAV9)-based gene therapy designed address the underlying cause of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM) by delivering a working MYBPC3 gene to heart muscle cells via a single intravenous infusion and thereby increasing insufficient MyBP-C protein levels with the aim of halting or even reversing disease after a single dose. The U.S. Food and Drug Administration has granted TN-201 Fast Track, Orphan Drug and Rare Pediatric Drug Designations. TN-201 has also received orphan medicinal product designation from the European Commission. The ongoing MyPEAK-1 Phase 1b/2 clinical trial (Clinicaltrials.gov ID: NCT05836259) is a multi-center, open-label, dose-escalating (3E13 vg/kg and 6E13 vg/kg) study of symptomatic adults (up to 24) who have been diagnosed with MYBPC3-associated HCM. MyPEAK-1 is designed to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201 gene replacement therapy. MyPEAK-1 has tested doses of 3E13 vg/kg and 6E13 vg/kg in two cohorts of three patients each. In July 2025, Tenaya reported that the trial’s independent Data Safety Monitoring Board (DSMB) concluded that TN-201 had an acceptable safety profile to allow enrollment of expansion cohorts at either the 3E13 vg/kg (Cohort 1) or 6E13 vg/kg (Cohort 2) dose levels. To learn more about gene therapy for HCM and participation in the MyPEAK-1 study, please visit HCMStudies.com. About TN-401 Gene Therapy and the RIDGE-1 Phase 1b/2 Clinical TrialTN-401 is an investigational AAV9-based gene therapy being developed for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC, also known as arrhythmogenic cardiomyopathy or ACM) due to mutations in the Plakophilin-2 (PKP2) gene. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record and demonstrated ability to target heart muscle cells. TN-401 has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration. Tenaya’s development of TN-401 is supported in part by a grant from the California Institute of Regenerative Medicines (CIRM). The RIDGE-1 Phase 1b/2 clinical trial of TN-401 in patients with PKP2-associated ARVC is a multi-center, open-label, dose escalation study being conducted in the U.S. and UK. RIDGE-1 is intended to assess the safety, tolerability and preliminary clinical efficacy of a one-time intravenous infusion of TN-401. RIDGE-1 will seek to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC, have an ICD and are at increased risk for arrhythmias as determined by premature ventricular count (PVC) during screening. In July 2025, Tenaya announced that the RIDGE-1 trial’s independent Data Safety Monitoring Board (DSMB) endorsed dose escalation per protocol following a review of available data from three patients dosed at 3E13 vg/kg (Cohort 1). Enrollment in the 6E13 vg/kg dose cohort is complete and additional enrollment in the RIDGE-1 will be considered following a review of all available safety data by the trial’s DSMB. To learn more about gene therapy for ARVC and the RIDGE-1 clinical trial, please visit ARVCstudies.com or ClinicalTrials.gov (NCT06228924). About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com. Forward Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “aims,” “expects,” “plans,” “potentially,” “anticipated,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the planned timing to report additional data from MyPEAK-1 and RIDGE-1 and pursue regulatory alignment for the TN-201 and TN-401 programs; the sufficiency of Tenaya’s cash runway to support operations through mid-2027; the clinical, therapeutic and commercial potential of, and expectations regarding the safety and efficacy of TN-201 and TN-401; Tenaya’s expectations regarding enrollment in MyPEAK-1; expectations regarding the upcoming DSMB review of RIDGE-1 safety data and plans to continue to enroll patients in one or both dose cohorts; statements regarding the continued development of TN-201 and TN-201 and TN-401 clinical outcomes, which may materially change as more patient data become available; and statements made by Tenaya’s Chief Executive Officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of MyPEAK-1 and RIDGE-1 data at the referenced time; the timing and progress of MyPEAK-1 and RIDGE-1; the potential failure of TN-201 and/or TN-401 to demonstrate safety and/or efficacy in clinical testing; the potential for any MyPEAK-1 or RIDGE-1 clinical trial results to differ from preclinical, interim, preliminary or expected results; the potential for the U.S. Food and Drug Administration and/or other regulatory agencies to conclude at any time that TN-201 and/or TN-401 may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials, including MyPEAK-1 and RIDGE-1; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in Tenaya’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025, and other documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Tenaya ContactsMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com InvestorsAnne-Marie FieldsPrecision AQ annemarie.fields@precisionaq.com MediaWendy RyanTen Bridge Communicationswendy@tenbridgecommunications.com
— EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 — — Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY — — First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome — — Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) — NAARDEN, the Netherlands and MIAMI, Jan. 09, 2026 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2026. NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. “2025 was an important year for NewAmsterdam, as we continued to further the regulatory process for obicetrapib and the fixed-dose combo. In partnership with Menarini, the company is preparing for a potential commercial launch in Europe, contingent upon an EMA approval decision that is expected in 2H26. In PREVAIL, we are encouraged by the rate of overall MACE events (blinded) in this cardiovascular outcomes trial (“CVOT”), which suggest that the initial 12 month rate is tracking in line with the overall rate observed in the Phase 3 BROADWAY trial,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are also excited to announce the RUBENS trial enrolled its first few patients in December and could allow for additional label enhancements, if approved, for patients with Type 2 Diabetes and/or Metabolic Syndrome that are not at their LDL-C risk-based goals. We expect topline results from the trial by the end of 2026.” “As we look to 2026, we remain committed to advancing our broader clinical development strategy, which includes three Phase 3 trials, PREVAIL, REMBRANDT, and RUBENS. In addition and based on the positive data from our Alzheimer’s disease (“AD’”) biomarker analysis from the BROADWAY trial, we are planning to start our first dedicated Alzheimer’s trial in 2026. This study could further demonstrate the potential of obicetrapib to modify key biomarkers and clinical pathology of AD. Lastly, we continue to make progress towards building out a portfolio of obicetrapib based combinations, conducting studies that could guide the development of proprietary fixed-dosed combinations in the future,” continued Dr. Davidson. Key 2025 Achievements: In June and July 2025, NewAmsterdam announced positive data from the prespecified AD biomarker analysis in the BROADWAY clinical trial and presented at the 2025 Alzheimer’s Association International Conference (“AAIC”). The pre-specified analysis was conducted to assess the effect of obicetrapib on plasma biomarkers of AD in both the full analysis set and in patients carrying the apolipoprotein E4 (“ApoE4”) gene, based on phenotypic analysis. NewAmsterdam observed statistically significant reductions in p-tau217, a key biomarker of AD pathology, in both the full analysis set (p
BIRMINGHAM, Ala. — January 8, 2025 — Rampart, a Birmingham, Alabama–based medical device company redefining interventional radiation safety, today announced the launch of the SECURE Clinical Program, Studies Evaluating Clinical Utility of Radiation mitigation Equipment, a first-of-its-kind, multi-specialty clinical initiative designed to further advance the scientific evidence for next-generation radiation […]
Agreement expands Cardio Diagnostics’ global footprint and supports improved detection and management of coronary heart disease in India. CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), a leader in epigenetics and AI-driven Precision Cardiovascular Medicine, Aimil Ltd., a company at the forefront of the instrumentation industry in India since 1932, introducing innovative, best-in-class […]
SS Innovations Develops New Instruments to Advance Robotic Surgery in Large, Underserved Patient Segments, including Pediatric and Cardiac Markets
MINNEAPOLIS, Jan. 06, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, confirmed today that Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using its Barostim device replaced the Category III codes as of Jan. 1, 2026. In the U.S. healthcare system, Category I CPT codes signify established procedures, supporting adoption, coverage, and reimbursement nationwide. The new CPT codes for use with Barostim procedures are available in the reimbursement guide here, and on CVRx’s website. U.S. hospitals and physicians performing Barostim procedures should update their billing systems and start using these new codes for all procedures performed on or after Jan. 1, 2026. “We believe the new Category I CPT codes will enable more predictable and consistent reimbursement for Barostim patients and healthcare professionals,” said Kevin Hykes, President and Chief Executive Officer of CVRx, “and validate the important role of Barostim therapy in the heart failure treatment continuum.” About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding the anticipated effect the new codes will have on Barostim’s adoption are forward-looking statements. These statements speak only as of the date of this press release and are based on our current expectations and projections about the future and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause actual results to differ from our expectations, including the actual impact the new codes have on reimbursement and patient access. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
European decision on approval is expected by Q1 2027If approved, etripamil nasal spray is expected to offer patients a safe and effective self-administered treatment option for PSVT outside of the healthcare setting MONTREAL and CHARLOTTE, N.C., Jan. 06, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) seeking the approval of etripamil nasal spray, developed to be the first rapid, reliable option in the treatment of paroxysmal supraventricular tachycardia (PSVT) outside of the healthcare setting. Etripamil, which has the conditionally approved brand name TACHYMIST™ in Europe, is an investigational, novel calcium channel blocker delivered via a nasal spray by the patient for the potential treatment of PSVT and other cardiac arrhythmias. A decision on approval is expected by the first quarter of 2027. “Following guidance from the EMA, this MAA incorporates the global clinical data package that supported the U.S. Food and Drug Administration approval of etripamil for the treatment of PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “TACHYMIST could become the first approved patient self-administered therapy representing a meaningful step forward in patient care for the approximately two million people suffering from PSVT in Europe.” About the Pivotal RAPID Phase 3 TrialThe MAA submission is supported by efficacy, safety, and tolerability results from a robust clinical trial program based on data from more than 1,800 participants and more than 2,000 episodes of PSVT. This includes the successful Phase 3 RAPID trial, a global, randomized, double-blind comparison of etripamil vs. placebo, published in The Lancet in 2023. In clinical studies, participants using etripamil were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered etripamil (N=99) converting from PSVT to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR=2.62; p
Fourth major national payer releases positive comprehensive coverage for AI-powered Heartflow Plaque AnalysisMOUNTAIN VIEW, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced Heartflow Plaque Analysis is now covered by Aetna across all lines of business, including Commercial, Medicare Advantage, and Aetna Better Health Medicaid plans. Aetna is the fourth major national commercial insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines issued by radiology benefit manager EviCore, following similar decisions by Humana, Cigna, and UnitedHealthcare. Heartflow Plaque Analysis is covered for the majority of insured lives across the United States. This coverage milestone follows the American Medical Association’s recent implementation of the new Category I Current Procedural Terminology (CPT®) payment code 75577 for Heartflow Plaque Analysis, effective January 1, 2026, which established 0.85 relative value units (RVUs) and a combined total of 4.00 RVUs for physicians performing the service. “Aetna’s decision to cover Heartflow Plaque Analysis nationwide is a pivotal step in expanding access to our AI-driven plaque quantification and characterization technology,” said John Farquhar, President and CEO of Heartflow. “With four major commercial payers and Medicare now recognizing the innovation and value of our platform, more clinicians can gain earlier, clearer insights into coronary plaque. More patients will benefit from early detection and precise quantification of plaque with Heartflow Plaque Analysis, leading to more personalized treatment strategies and improved prognostic assessment, helping set a new benchmark for cardiovascular care.” The updated coverage became effective on December 23, 2025 for Aetna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-69% stenosis) identified on coronary CTA. The policy expands access for patients to AI-driven plaque analysis, supporting earlier diagnosis, personalized risk stratification, and more precise management of CAD. The new CPT code was issued in response to increased utilization of AI-powered plaque quantification and characterization technology like Heartflow Plaque Analysis and strong clinical evidence supporting its value. Together, broader national payer coverage and Category I reimbursement position the Heartflow platform as the highest-value pathway in cardiac CT, expanding access and supporting practical adoption in clinical practice. Heartflow’s continued advancement of Heartflow Plaque Analysis builds on the real-world evidence demonstrated in the landmark DECIDE Registry data, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions. The DECIDE registry showed that more than 50% of patients had their medical management changed when Heartflow Plaque Analysis with Heartflow Plaque Staging* was added compared to their management based on CCTA alone.1 A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025 provided the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume measurement as a predictor of future heart attacks or cardiovascular death.2 Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to the gold standard, IVUS, using blinded core lab adjudication.3 About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 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 ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide.4 Key benefits include: Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been 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 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, SOC 2 Type 2, 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 DECIDE Registry. Rinehart, et al., presented at SCCT 2025.2 Fairbairn et al., presented at AHA 2025.3 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.4 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol.*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.
