Coronary/Structural Heart

Cardiawave Announces First Routine Treatments Performed with Valvosoft® Following CE Mark Approval and Accelerates Its Deployment

Cardiawave Announces First Routine Treatments Performed with Valvosoft® Following CE Mark Approval and Accelerates Its Deployment After demonstrating its safety and performance in more than 100 patients during clinical development, Valvosoft®, the first non-invasive ultrasound technology designed to treat severe symptomatic aortic stenosis, is now being used in routine clinical practice across several European centers.This innovation makes it possible to repair the valve rather than replace it in patients who cannot immediately undergo a valve replacement procedure. Levallois-Perret, France, June 15, 2026 – Cardiawave, a French medtech pioneer in non-invasive ultrasound therapies for the treatment of aortic stenosis, has reached a major milestone. Following the CE marking1 of Valvosoft® at the end of 2025, the Company today announces the first patients treated in routine clinical practice in Europe with Valvosoft®, marking the beginning of the deployment of this innovation across France, the Netherlands, and Germany. A Breakthrough Innovation: Repairing the Valve Rather Than Replacing It Valvosoft® is the first non-invasive medical device developed for the treatment of severe symptomatic aortic stenosis. The technology is intended for patients for whom immediate valve replacement (TAVR or SAVR) is not recommended, or who decline surgical intervention. “The rollout of Valvosoft® following CE mark approval represents a major milestone for Cardiawave and for patients suffering from severe symptomatic aortic stenosis. We can now offer a non-invasive treatment option to patients for whom immediate valve replacement is either not feasible or not desired. This achievement also marks Cardiawave’s transition into a new phase of growth, driven by the deployment of Valvosoft® across several European countries and our ambition to become a leading player in the non-invasive treatment of aortic stenosis,” said Carine Schorochoff, Chief Executive Officer of Cardiawave. Aortic stenosis is a degenerative disease caused by the progressive calcification of the aortic valve leaflets, leading to valve stiffening and reduced oxygenated blood flow to the body’s organs. The consequences include chest pain, shortness of breath, heart failure, and an increased risk of sudden cardiac death. The condition affects approximately 2% of people over the age of 65 and 12.4% of those over 75234. Without treatment, life expectancy drops to 2.3 years in patients with severe symptomatic aortic stenosis, with a significant risk of sudden death5. Valvosoft® offers a unique approach worldwide: restoring the mobility of the native valve without surgery or implantation. The technology uses high-intensity ultrasound pulses to fragment calcifications on the valve leaflets while preserving surrounding tissues. The result is a sustained improvement in valve opening and hemodynamic performance, without the need for general anesthesia. Twelve-month results from the Valvosoft® First-in-Human (FIM) Study and the Valvosoft® Pivotal Study, presented at EuroPCR 20256 (100 patients treated across 12 European centers), confirmed both the safety of the technology and its effectiveness in improving cardiac function and patients’ quality of life. “Severe symptomatic aortic stenosis remains a life-threatening condition with a poor prognosis if left untreated. Valvosoft® introduces a unique approach: restoring the mobility of the native valve without surgery or implantation. Clinical study results obtained in 100 patients confirm the feasibility, efficacy, and safety of this non-invasive therapy for patients who previously had no therapeutic option available,” said Professor Emmanuel Messas, Interventional Cardiologist at HEGP (AP-HP) and Clinical Investigator of the study. Deployment in Europe and Global Expansion Prospects CE mark approval paves the way for large-scale deployment of Valvosoft®. Since May 2026, several Valvosoft® systems have been placed into clinical use, with a progressive rollout across multiple hospital centers in France and throughout Europe. Distribution agreements are currently under discussion across Europe, the United Kingdom, the Middle East, and India. Cardiawave is initially targeting approximately 300,000 patients in Europe and the United States who are either ineligible for immediate aortic valve replacement (AVR) or unwilling to undergo such procedures. In the longer term, the technology could benefit several million patients suffering from moderate forms of the disease. The global addressable market for aortic stenosis exceeds €10 billion. Building on its European success, the Company is preparing its entry into the U.S. market through the submission of an Investigational Device Exemption (IDE) application. At the same time, Cardiawave is strengthening its manufacturing capabilities in collaboration with French industrial partners to meet growing demand. To support these ambitions, Cardiawave has launched a financing round that will accelerate Valvosoft® production, support ongoing clinical studies in Europe and the United States, and advance the development of additional therapeutic applications. For more information : https://vimeo.com/1172170018/f7bf449742?share=copy&fl=sv&fe=ci Press contact  : Florence PORTEJOIE / FP2COM + 33 (0)6 07 76 82 83 – fportejoie@fp2com.fr  About Cardiawave Founded in 2014 by Mickaël Tanter, Mathieu Pernot, Emmanuel Messas, Mathias Fink, and Benjamin Bertrand, Cardiawave develops innovative non-invasive ultrasound therapies for cardiovascular diseases. Valvosoft® is a CE-marked medical device in the European Union and currently remains an investigational device outside Europe, intended solely for clinical research purposes. The device is based on Cardiawave’s proprietary Non-Invasive Ultrasound Therapy (NIUT) technology, developed in collaboration with leading academic institutions, including the Langevin Institute, Inserm Physics for Medicine, and HEGP. The Company has built a strong intellectual property portfolio comprising 10 patent families. 1 https://cardiawave.com/valvosoft-the-first-non-invasive-treatment-for-severe-symptomatic-aortic-stenosis-ssas-from-cardiawave-receives-ce-marking/ 2 Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI:10.1093/eurheartj/ehy107) 3 Lindman B, et al. Calcific Aortic Stenosis. Nature Reviews Disease Primers 2, Article number: 16006. March 03, 2016. (DOI: 10.1038/nrdp.2016.6) 4 Osnabrugge R., et al. Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. Journal of American College of Cardiology, Volume 62, Issue 11, Pages 1013-1014. September 2013. (DOI: 10.1016/j.jacc.2013.05.015) 5 Malaisrie S, et al. Transcatheter Aortic Valve Implantation Decreases the Rate of Unoperated Aortic Stenosis. European Journal of Cardio-thoracic Surgery, Volume 40, Issue 1, Pages 43-48. July 2011. (DOI:10.1016/j.ejcts.2010.11.301) 6 https://cardiawave.com/wp-content/uploads/2025/05/Cardiawave-Announces-Positive-12-Month-Results-May-22nd-2025.pdf
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Tectonic Therapeutic Completes Enrollment in TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients

APEX 24-week Phase 2 trial is evaluating the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF)APEX Phase 2 trial enrolled 191 patients across 14 countries, with approximately 72% of patients in the enriched population of CpcPH with a pulmonary vascular resistance (PVR) >3 WU at baselineTX45 APEX Phase 2 topline results expected in early Q1 2027 WATERTOWN, Mass., June 10, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”), today announced the completion of enrollment for the APEX trial, a 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”). The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”) >3 Wood Units (“WU”) at baseline. “Reaching full enrollment in our APEX Phase 2 clinical trial represents a critical milestone for our TX45 clinical development program and brings us one step closer to potentially delivering a much-needed therapeutic option to patients suffering from PH-HFpEF,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “We are deeply grateful to the clinical investigators, study coordinators, and, most importantly, the patients and their families whose participation makes this vital research possible. The strong momentum we experienced during enrollment underscores the significant unmet medical need in PH-HFpEF, especially in patients with CpcPH. With the trial now fully enrolled, we look forward to the upcoming topline results for APEX, expected in early Q1 2027, which will help further characterize the therapeutic profile of our candidate and guide our strategy moving forward.” The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR >3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. In the APEX clinical trial, the mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR >3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Tectonic expects topline results from the APEX clinical trial in early Q1 2027. The APEX Phase 2 clinical trial is a global, randomized, double-blind, placebo-controlled, proof-of-concept trial designed to evaluate the safety and efficacy of two dose regimens of TX45 administered subcutaneously (“SC”) in patients with PH-HFpEF, enriched for patients with CpcPH. Patients were randomized to receive 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC every other week of TX45, or a placebo. Change from baseline in PVR in the PVR >3 WU population is the primary endpoint of the trial. ¹ Baseline characteristics are preliminary and subjective to change. About Group 2 Pulmonary Hypertension in HFpEFThe World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About TX45, a long-acting Fc-relaxin fusion proteinTX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About TectonicTectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit https://tectonictx.com/ and follow us on LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and expected results of current clinical trials of Tectonic’s product candidates, including the ongoing APEX Phase 2 clinical trials for its lead product candidate, TX45, in patients with PH-HFpEF. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed for the quarter ended March 31, 2026 and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts: Investors:Dan FerryLifeSci Advisors(617) 430-7576 Media:Kathryn MorrisThe Yates Network(914) 204-6412 CONTACT: daniel@lifesciadvisors.com, kathryn@theyatesnetwork.com

Huxley Medical Expands SANSA Diagnostic Platform with Point-of-Care Enrollment and Additional Cardiovascular Risk Marker

ATLANTA, June 10, 2026 /PRNewswire/ — Huxley Medical, a commercial-stage medical technology company expanding access to sleep apnea testing across health systems, cardiology, and primary care, today introduced two additions to its SANSA® platform: SANSA GO™, a point-of-care enrollment…

Medmovie Launches HxHeart.com, Bringing Its Trusted Cardiovascular Education Library to Any Browser — and Releases a New Video on the Hidden Risks of Coronary Artery Disease

The same clinician-approved animations from the Hx Heart app are now available online at HxHeart.com — free, instantly, with no download required. BERKELEY, Calif., June 9, 2026 /PRNewswire/ — Medmovie, Inc., creators of the Hx Heart app, announced that its cardiovascular education…

Anteris Advances Global PARADIGM Expansion with French Regulatory Clearance

MINNEAPOLIS and BRISBANE, Australia, June 08, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the “PARADIGM Trial”). This authorization marks a significant milestone in the Company’s clinical and regulatory strategy and enables patient recruitment to commence at leading centers in France. “Securing French regulatory clearance is an important step in the execution of the PARADIGM Trial,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. “France represents a strategically important market with highly experienced centers and investigators, reinforcing the quality and conduct of the study.” The Company continues to advance its global clinical strategy, with ongoing site activations and patient enrollment across the United States and Europe. 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 enroll 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. Forward-Looking Statements This announcement contains forward-looking statements, including statements regarding the expectation that patient recruitment will commence in France. 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. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, 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

FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF

SUNNYVALE, Calif., June 05, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use. FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials. “Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options,” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “FDA recognizes this need and the strengths in our completed CardiAMP HF clinical data to be the first of two trials to support Premarket Approval.” About CardiAMP Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Japan Pharmaceutical and Medical Device Agency has indicated that the clinical results from three completed clinical trials for the treatment of ischemic heart failure likely provide sufficient evidence of safety and efficacy to support a successful submission for approval. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use.  About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Upcoming Catalysts in 2026: CardiAMP HF Manuscript PublishedCardiAMP HF Japan PMDA Submission Q4 2026 Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to submission for and subsequent market clearance of the CardiAMP Cell Therapy. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

HeartSciences Launches MyoVista Insights™ Version 1.3 with AI-ECG Algorithm Marketplace and First FDA-Cleared Algorithm

Bunkerhill Health’s FDA-cleared ECG-EF algorithm for the detection of reduced ejection fraction becomes the first cleared AI-ECG algorithm available through MyoVista Insights, advancing HeartSciences’ SaaS-based, recurring-revenue marketplace strategySouthlake, TX, June 02, 2026 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today announced the commercial release of MyoVista Insights™ version 1.3, a major platform update that introduces the MyoVista Insights AI-ECG Algorithm Marketplace. The Marketplace enables third-party algorithm results to be integrated into the MyoVista Insights platform, beginning with an FDA-cleared AI-ECG model from Bunkerhill Health. The Bunkerhill ECG-EF model enables clinicians to detect reduced left ventricular ejection fraction (LVEF ≤40%) from a routine 12-lead ECG. The launch marks the first time a cleared AI-ECG algorithm is available through MyoVista Insights, making the ECG-EF algorithm accessible to healthcare facilities of every size, from large integrated health systems to community hospitals, critical access hospitals, and primary care practices across the United States. It also establishes the platform as a commercial pathway for AI-ECG developers seeking to reach clinical users through a recurring, SaaS-based revenue model, without the cost or complexity, of building their own end-to-end workflow and distribution infrastructure. HeartSciences is in active discussions to add further third-party owned and cleared algorithms and expects the marketplace to expand over the coming quarters. Andrew Simpson, Chief Executive Officer of HeartSciences, said, “The launch of our AI-ECG marketplace is a defining milestone for HeartSciences. We are now delivering a cleared AI-ECG algorithm into clinical workflows through MyoVista Insights, with a recurring, SaaS-based revenue model that we believe can create meaningful and scalable value for the Company. Bunkerhill’s ECG-EF algorithm is the first of what we expect to be many. We are in active discussions with additional algorithm developers who recognize that delivering algorithms into clinical practice, not simply developing them, is the critical step, and we believe MyoVista Insights is uniquely positioned to be that delivery platform for institutions of every size.” Detection of reduced LVEF from a routine ECG supports earlier identification and is expected to result in more effective referral of patients at risk of heart failure. Assessments performed with assistive AI-ECG algorithms are eligible for Medicare reimbursement under the Hospital Outpatient Prospective Payment System, assigned to Ambulatory Payment Classification (APC) 5734 at a national payment rate of approximately $136 per assessment for 2026. With AI-ECG forecast to become a multi-billion-dollar market, HeartSciences believes an established reimbursement pathway, combined with its recurring SaaS-based revenue model, positions the Company to capture meaningful and scalable revenue as adoption grows and additional algorithms are added to the platform. Nishith Khandwala, Co-founder and Chief Executive Officer of Bunkerhill Health, added, “We share HeartSciences’ commitment to making advanced cardiac AI more accessible in everyday clinical practice. This collaboration gives more health systems a pathway to adopt our FDA-cleared ECG-EF algorithm and to use routine ECG data to support earlier evaluation and more informed clinical decisions for patients at risk of heart failure.” MyoVista Insights is a cloud-native, next-generation ECG management system designed to be device-agnostic that delivers workflow efficiency and third-party, FDA-cleared AI results directly into clinical practice. Because it is cloud-based, cost-effective, and independent of any single manufacturer’s hardware, the platform gives institutions of every size a unified environment for deploying cleared AI-ECG algorithms within routine clinical workflows. MyoVista Insights holds Epic Toolbox designation for the ECG Management System category and supports integration with electronic health records through HL7v2 order and results workflows, single sign-on (SSO), and SMART on FHIR. About HeartSciences HeartSciences is a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”). The Company’s MyoVista Insights platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making. Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions. For more information, please visit: https://www.heartsciences.com. X: @HeartSciences About Bunkerhill Health Bunkerhill Health delivers generative AI for clinical reasoning and action. Its flagship platform, Carebricks, analyzes structured and unstructured patient data to understand each patient’s full history, apply AI-powered reasoning across all available context, and automate next steps. Carebricks helps health systems improve outcomes, increase efficiency, and close care gaps without adding to clinician workload. For more information, please visit https://www.bunkerhillhealth.com/. Safe Harbor Statement This announcement 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. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 24, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2025 filed with the SEC on September 11, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2025 filed with the SEC on December 15, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2026 filed with the SEC on March 16, 2026, and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Investor Relations: Integrous CommunicationsMark Komonoski, PartnerPhone: 877 255 8483Email: mkomonoski@integcom.us Media Contact: HeartSciencesGene GephartPhone: +1 682 244 2578 Ext. 2024Email: info@heartsciences.com