Coronary/Structural Heart

Anthos Therapeutics Shares New Data from the Landmark AZALEA-TIMI 71 Study Demonstrating the Factor XI Inhibitor Abelacimab Significantly Reduced Bleeding in Patients Regardless of Age or Bleeding Risk

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–Data presented at the American College of Cardiology Annual Scientific Session show that the reduction of bleeding with abelacimab compared to rivaroxaban (Xarelto) was even greater in patients ≥75 years old compared to younger patients –Another analysis from AZALEA-TIMI 71 shows abelacimab, as compared to rivaroxaban (Xarelto), was associated with a greater absolute benefit in patients who are at higher risk for bleeding CAMBRIDGE, Mass., March 29, 2025 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a transformative, clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiovascular metabolic diseases, is presenting two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. These data will be presented today during the moderated poster sessions from 2:30-4:30pm CT. In the first analysis, the safety of abelacimab, a novel Factor XI inhibitor, was compared to rivaroxaban, a direct oral anticoagulant (DOAC), by patient age. Inhibition of Factor XI with abelacimab significantly reduced the relative risk of major or clinically relevant non-major (CRNM) bleeding compared with rivaroxaban regardless of age, with potential for greater absolute risk reduction (ARR) with older patients. The ARR in patients 75 years of age and older was 6.2% compared to 4.2% in patients less than 75 years. In addition, abelacimab consistently reduced bleeding risk in patients 75 years of age and older regardless of renal function, body mass index (BMI), and the use of concomitant antiplatelet therapy. “Patients with atrial fibrillation, particularly older patients, are frequently at a high risk of bleeding. There is a need for safer anticoagulants that can prevent thrombotic events while minimizing excess bleeding,” said Christian T. Ruff, MD, MPH, senior investigator of TIMI Group, director General Cardiology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School. “These data show that abelacimab significantly reduced the risk of major or CRNM bleeding, particularly among people over 75 who are vulnerable to such risks, and, if approved, could be a safer alternative for patients needing anticoagulation therapy.” In the second analysis, the safety of abelacimab was compared to rivaroxaban across a spectrum of bleeding risk, which was determined by using the direct oral anticoagulant (DOAC) score, a clinical tool leveraged to assess the risk of bleeding in patients who are prescribed DOACs. In patients with atrial fibrillation, abelacimab reduced rates of bleeding relative to rivaroxaban regardless of bleeding risk, with greater absolute safety benefit in those at higher bleeding risk. In the rivaroxaban arm, the rates of major or CRNM bleeding per 100 patient years increased stepwise across risk categories from 5.6% in the low risk category to 21.2% in the very high risk category. In contrast, the rates of bleeding in patients in the pooled abelacimab arm were 2.5% in the low-risk category to 7.1% in the very high-risk category. The ARR increased from 3.1% in the low risk category to 14.1% in the very high risk category (p-trend for ARR

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Catheter Precision to Participate in and Share Data at Upcoming Industry Conferences

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FORT MILL, S.C., March 26, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced their attendance at three upcoming conferences through April 2, 2025.

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Powerful Medical Receives FDA Breakthrough Device Designation for PMcardio STEMI AI ECG Model

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NEW YORK–(BUSINESS WIRE)–Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). This designation recognizes PMcardio as a breakthrough technology for the detection of ST-elevation myocardial infarction (STEMI) and STEMI […]

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Abbott Initiates New Intravascular Lithotripsy Clinical Trial to Improve Outcomes in Patients with Coronary Artery Disease

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Coronary Artery Disease (CAD) is the most common heart disease and most frequent cause of death in the U.S., with over 20 million adults affected by this condition Abbott’s investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound…

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Tenaya Therapeutics Publishes Preclinical Data Demonstrating TN-201 Enhances Cardiac Function and Survival in MYBPC3 Cardiomyopathy Models

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Robust Evidence of Disease Reversal in Severe Knock Out Mice Model Supports Tenaya’s Clinical Development Plan to Evaluate TN-201 as a Potential Treatment for Patients with MYBPC3-associated Hypertrophic Cardiomyopathy Robust Evidence of Disease Reversal in Severe Knock Out Mice Model Supports Tenaya’s Clinical Development Plan to Evaluate TN-201 as a Potential Treatment for Patients with MYBPC3-associated Hypertrophic Cardiomyopathy

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Anteris Reports One-Year Patient Outcomes for DurAVR® THV

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New class, biomimetic TAVR demonstrates sustained hemodynamic performance to one-yearMINNEAPOLIS and BRISBANE, Australia, March 21, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris® or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced one-year results for patients treated with its proprietary, balloon expandable, DurAVR® Transcatheter Heart Valve (THV) System. Rishi Puri, M.D. PhD presented the data at a late breaking clinical trial session at Sydney Valves on Friday 21 March 2025, 10:30am (AEST), titled: “Pioneering a New Class of Biomimetic TAVR with Sustained 1-Year Performance.” One-year Results Highlights: DurAVR® THV demonstrated a favorable hemodynamic profile sustained to one-year, with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.At one-year, clinical safety outcomes show positive results with no valve or cardiovascular related mortality and importantly no prosthesis-patient mismatch (PPM*) reported in these small annuli patients (aortic annulus area 395.80 + 37.26mm2).Current commercial devices have demonstrated rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression. Anteris Chief Medical Officer, Chris Meduri, M.D., commented: “The one-year data for DurAVR® THV continues to validate its groundbreaking hemodynamic performance, demonstrating sustained excellent effective orifice area (EOA) and low mean gradients. Most notably, this is the only transcatheter valve to show zero prosthesis-patient mismatch (PPM) in small annuli patients—an achievement that sets a new standard in TAVR. PPM is a well-established predictor of valve failure and disease progression, and eliminating it has profound implications for long-term patient outcomes. These results reinforce the transformative potential of DurAVR® as we move toward pivotal trials.” Sixty-five (65) patients have completed the primary endpoint measure at 30 days (previously reported as rolling cohorts at multiple medical conferences through 2023-2024). The DurAVR® THV System continues to demonstrate a consistent safety and efficacy profile, with high implant success across the clinical program. The one-year data builds on the existing body of clinical evidence and will be included in the planned Investigational Device Exemption (IDE) submission to the U.S. FDA to seek approval to conduct the DurAVR® THV randomized, global pivotal study. *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)2. 1. Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261. 2 Ferrara J, Theron A, Porto A, Morera P, Luporsi P, Jaussaud N, Gariboldi V, Collart F, Cuisset T, Deharo P. Prosthesis-Patient Mismatch in Small Aortic Annuli: Self-Expandable vs. Balloon-Expandable Transcatheter Aortic Valve Replacement. J Clin Med. 2022 Apr 1;11(7):1959. doi: 10.3390/jcm11071959. PMID: 35407567; PMCID: PMC8999619. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart 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® Transcatheter Heart Valve (THV), was designed in partnership 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. Forward-Looking Statements This announcement contains forward-looking statements, including the time for the presentation of the one-year data results and the inclusion of the one-year data in the IDE submission. 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, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release on the ASX by the Board of Directors. For more information:  Investor Relations Investor Relations (US)investor@anteristech.com mchatterjee@bplifescience.comDebbie Ormsby Malini 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@AnterisTechFacebookwww.facebook.com/anteristechLinkedInhttps://www.linkedin.com/company/anteristech

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Autonomix Medical, Inc. Granted U.S. Patent Covering Sensing Data Collection and Processing with Company’s Proprietary Catheter-Based Technology

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Continued progress with growing global patent portfolio to over 80 issued patents and 40 pending patent applications  Proprietary sensing and ablation technology has demonstrated potential to more precisely target and eliminate overactive nerves, improving response rates and enhancing patient outcomes across multiple indications THE WOODLANDS, TX, March 20, 2025 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. patent 12,217,863 (‘863 patent) titled, Medical Devices with Circuitry for Capturing and Processing Physiological Signals. The issued ‘863 patent gives Autonomix protection of proprietary technology used to collect and process sensing data for real-time physiological monitoring with broad application use that includes, e.g., heart mapping, arterial mapping, parenchymal monitoring, central nervous system monitoring and implant, robotic and wearable precision applications. “We are pleased to strengthen our patent protection for this potential groundbreaking technology. The continued positive data on its application, efficacy, and safety reinforce our confidence in its potential. We remain committed to advancing this innovation to address critical areas of unmet medical need. To date, our early clinical results have been highly encouraging for reducing pancreatic cancer pain. Beyond cancer pain, our technology holds promise for a broad range of conditions where nerve activity plays a key role, including hypertension within the cardiovascular space,” commented Brad Hauser, CEO of Autonomix. Autonomix’s first-in-class technology platform utilizes a catheter-based microchip sensing array antenna that may have the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. Once target nerves are identified, Autonomix uses its proprietary RF ablation technology to kill targeted nerves, enabling a precision guided sense, treat and verify approach to addressing a number of disease categories from chronic pain management to hypertension and cardiology. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. The Company expects to submit an IDE and commence U.S. clinical trials in 2025 to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the U.S. as a treatment for pancreatic cancer pain. For more information about the Company’s technology, please visit autonomix.com. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer, to submit and receive approval of an IDE, and to file a De Novo application. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLCJenene Thomas 908.824.0775 autonomix@jtcir.com

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CorVista Health to Present New Data on Non-Invasive Point of Care Test for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning at ACC.25

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BETHESDA, Md., March 20, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced the upcoming poster presentation of new data on its non-invasive point of care test for pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction (HFpEF) – using machine learning at the American College of Cardiology’s Annual Scientific Session (ACC.25), taking place March 29-31, 2025, in Chicago, IL. Details of the presentations are as follows: Title: Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-Invasive SignalsPresenter: Charles Bridges, M.D., Sc.D., EVP and Chief Scientific Officer of CorVista HealthFormat: PosterPresentation Number: 1166-41Date and Time: Sunday, March 30, 2025, at 12:00 p.m. ET – 1:00 p.m. ETLocation: South Hall CorVista Health will be exhibiting in the Future Hub Booth #FH8, where attendees can learn about the CorVista System. About CorVista System® The CorVista System is a point-of -care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or high pressure in the lungs—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com

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