Coronary/Structural Heart

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

Tissue Dynamics and Galmed Unveil Unknown Metabolic Pathway for Cardiac Fibrosis and Heart Failure which Supports the Development of Aramchol for Cardiac Fibrosis

– Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using a human cardiac organoid model, revealing disease biology that is not accessible through conventional animal models. – In inflammatory human cardiac organoids, the combination of…

New analysis of Idorsia’s aprocitentan demonstrates significant and sustained reduction in albuminuria in patients with uncontrolled / resistant hypertension

The findings demonstrate that aprocitentan may help reduce the risk of kidney disease progression, cardiovascular events, and mortality in patients with resistant hypertension. Allschwil, Switzerland – June 01, 2026Idorsia Ltd (SIX: IDIA) announces new analyses from the Phase 3 PRECISION study demonstrating that aprocitentan, Idorsia’s dual endothelin receptor antagonist, significantly reduces albuminuria and improves albuminuria risk categories in patients with resistant hypertension. The data were presented by Prof. Markus Schlaich at the 35th Congress of the European Society of Hypertension (ESH). The oral presentation, entitled “Effect of the Dual Endothelin Receptor Antagonist Aprocitentan on Albuminuria”, underscores the role of endothelin pathway inhibition not only in blood pressure control, but also in addressing kidney-related risk in this high-risk population, further supporting the evidence presented in Hypertension titled “Aprocitentan in Patients with Chronic Kidney Disease and Resistant Hypertension”. Addressing a critical unmet need in resistant hypertensionHypertension remains the leading modifiable risk factor for cardiovascular disease and premature death, with patients whose blood pressure is difficult to control facing even higher risks of stroke, myocardial infarction, heart failure, and kidney disease. In resistant hypertension in particular, chronic kidney disease and type 2 diabetes are common and contribute to poor long-term outcomes. Albuminuria, measured as urine albumin-creatinine ratio (UACR), is a well-established biomarker of kidney damage and is strongly associated with increased cardiovascular morbidity and mortality, and more rapid progression towards kidney failure. Albuminuria is more commonly observed in conditions such as Type 2 diabetes and hypertension, as well as older age. Changing to a lower risk category, as a result of lowering albuminuria is therefore an important therapeutic objective beyond blood pressure lowering. Potential to improve long-term renal and cardiovascular outcomesBy lowering albuminuria and shifting patients to lower risk categories, aprocitentan may help reduce the risk of kidney disease progression and cardiovascular risk in patients with difficult-to-control hypertension. Prof. Markus Schlaich, MD, FAHA, FESC, ISHF, The University of Western Australia, Perth, and lead investigator in the PRECISION study commented:“These data represent a major step forward in the management of difficult-to-control hypertension. By targeting the endothelin pathway, aprocitentan not only delivers robust and sustained blood pressure reductions, but also drives clinically meaningful improvements in albuminuria – an established marker of kidney and cardiovascular risk. The ability to lower albuminuria risk category in nearly half of these high-risk patients underscores the potential of aprocitentan to change the treatment paradigm and deliver tangible long-term benefits for patients who remain inadequately controlled on current therapies, particularly those in whom treatment decisions are complicated by the risk of hyperkalemia.” New PRECISION analysis: meaningful reductions in albuminuriaThe new analysis evaluated the effect of aprocitentan in 730 patients with confirmed resistant hypertension receiving at least three antihypertensive agents, including a diuretic.Key findings include: Rapid and substantial reductions in UACR: In patients with baseline microalbuminuria (UACR 30–300mg/g) and macroalbuminuria (UACR >300mg/g), aprocitentan significantly reduced UACR at Week 4 compared with minimal changes on placebo. Sustained long-term effects: By Week 36, treatment with aprocitentan 25 mg reduced mean UACR: From 77.5 mg/g to 34 mg/g in patients with microalbuminuriaFrom 860.2 mg/g to 286.7 mg/g in patients with macroalbuminuria Early improvement/normalization in albuminuria risk category: As early as Week 4: Up to 45% of patients with microalbuminuria achieved normal albumin levels with aprocitentanUp to 39% of patients with macroalbuminuria improved to a lower risk category At Week 36, approximately 46% of patients with baseline micro- or macroalbuminuria achieved a lower albuminuria risk category Stable eGFR in both microalbuminuria and macroalbuminuria eGFR did not decline but remained stable, confirming the renal protective effect of aprocitentan Preservation of normal kidney status: More than 92% of patients with normal albumin levels at baseline remained within the normal range during treatment. Targeting endothelin: a novel and clinically meaningful mechanismIdorsia’s Chief Scientific Officer & Head of Research, Martine Clozel, also spoke at the event with a presentation entitled “From dream to reality: improving lives though endothelin-related innovations”. Aprocitentan, Idorsia’s dual endothelin receptor antagonist approved as TRYVIO™ in the US and as JERAYGO™ in Europe, is the first therapy of its kind to target the endothelin pathway in systemic hypertension. Endothelin is a key driver of vasoconstriction, inflammation, fibrosis, and organ damage, and is often upregulated in patients with resistant hypertension and kidney disease. The findings from this analysis reinforce the central role of endothelin in both the development and consequences of hypertension, including the potential to reduce kidney damage progression and long-term cardiovascular risk. Unlike therapies targeting the renin–angiotensin–aldosterone system (RAAS) pathway, which may be associated with electrolyte disturbances such as hyperkalemia, endothelin receptor antagonism with aprocitentan has not demonstrated an increased risk of hyperkalemia. Building on proven blood pressure efficacyThe albuminuria data complement previously reported results from PRECISION, where aprocitentan demonstrated: Rapid, double-digit reductions in systolic blood pressureSustained efficacy over 48 weeksConsistent effects across office and ambulatory measurementsConsistent blood pressure reductions across key patient subpopulations, including those with high-risk comorbidities Importantly, the treatment effect was maintained in patients with common and clinically relevant comorbidities, including type 2 diabetes, obesity (including severe obesity), chronic kidney disease, and congestive heart failure, as well as across demographic subgroups such as older patients and those with higher cardiovascular risk profiles. Aprocitentan has also shown a manageable safety profile, with mild and transient edema as the most commonly observed treatment-related effect and no significant drug–drug interactions – an important consideration in patients with complex regimens. Importantly, no signal for hyperkalemia or hyponatremia was observed, supporting its use in patients with resistant and difficult-to-control hypertension, including those with chronic kidney disease, even with an eGFR (estimated glomerular filtration rate) as low as 15ml/min/1.73m2, diabetes, or heart failure, without additional electrolyte monitoring burden. About aprocitentanAprocitentan is approved as TRYVIO® in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. TRYVIO is now included in the American College of Cardiology’s (ACC) and the American Heart Association’s (AHA) new comprehensive clinical practice guidelines for the management of high blood pressure. Aprocitentan is approved as JERAYGO® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union, the UK, and Switzerland, and a marketing authorization application is under review in Canada. Notes to the editor About Prof. Markus Schlaich, MDMarkus Schlaich is a nephrologist and a European Society of Hypertension (ESH) accredited hypertension specialist. He is a Fellow of the American Heart Association (FAHA), the European Society of Cardiology (FESC), and the International Society of Hypertension (ISHF). He served as an Executive Committee of the ISH from 2018-2020 and is currently on the Management Board of the global ISH May Measurement Month campaign. Markus is President of Hypertension Australia and a Trustee of the Foundation for High Blood Pressure Research. Markus has a strong background in clinical research with a focus on the pathophysiology of hypertension, involvement of the kidneys, and hypertension mediated organ damage. He has a specific interest in treatment modalities targeting the sympathetic nervous system and other relevant pathways such as the endothelin system to improve BP control and thereby outcomes for patients with difficult-to-control hypertension. For his work he received the Björn Folkow Award from the European Society of Hypertension (ESH) and the Arthur C. Corcoran Award from the AHA Hypertension Council, both in 2021. He has authored more than 450 articles in peer-reviewed journals and serves on the Editorial Board of Hypertension and Journal of Hypertension. Prof. Schlaich serves as a consultant to Idorsia. Key literature Danaietash P et al. Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan. J Clin Hypertension 2022 Jul;24(7):804-813.Schlaich MP, et al. A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension. The Lancet, 2022; Dec 3;400(10367):1927-1937.Rossignol P, et al. Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension. Hypertension. Online ahead of print, December 2025, doi.org/10.1161/HYPERTENSIONAHA.125.25563Iglarz M, et al. At the heart of tissue: endothelin system and end-organ damage. Clin Sci 2010; 119:453-63.Clozel M. Aprocitentan and the endothelin system in resistant hypertension. Can J Physiol Pharmacol 2022; 100:573-83. About IdorsiaThe purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients. To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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Mineralys Therapeutics Presents New Data from the Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Hypertension and Chronic Kidney Disease at European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)

– Post hoc analysis from pivotal Launch-HTN trial shows statistically significant and clinically meaningful reductions in blood pressure in participants with chronic kidney disease – – In participants with chronic kidney disease and baseline albuminuria, lorundrostat significantly reduced urine albumin-to-creatinine ratio – – Lorundrostat demonstrated a favorable safety profile in participants with and without chronic kidney disease over 12 weeks – RADNOR, Pa., May 30, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today presented new clinical data for lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland. “Despite the availability of current therapies, up to 75 percent of patients with chronic kidney disease still have uncontrolled or resistant blood pressure, contributing to a high risk of cardiovascular events and kidney disease progression,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “These results, together with our Explore-CKD trial findings, demonstrate lorundrostat’s potential to address the compounded burden of hypertension and CKD, underscoring its promise as an important potential treatment option for this difficult-to-treat population with high unmet need.” The analysis evaluated the efficacy and safety of once-daily lorundrostat 50 mg by CKD status among 800 participants with uncontrolled or resistant hypertension enrolled in the randomized, double-blind, placebo-controlled Phase 3 Launch-HTN trial. Among participants with CKD (n=192), 71% were receiving three or more anti-hypertensive medications at baseline, compared with 56% of those without CKD. In addition, 31% of participants with CKD had systolic blood pressure (SBP) ≥160 mmHg at baseline, versus 17% of participants without CKD. Lorundrostat demonstrated significant reductions in SBP that were comparable between CKD and non-CKD participants. At week 12, placebo-adjusted SBP reductions were 9.6 mmHg in participants with CKD (p=0.0022) and 12.2 mmHg in those without CKD (p

HeartFocus Launches HeartFocus Link, Bringing AI-Guided Cardiac Ultrasound Education and Guidance to Any Cart-Based System

BORDEAUX, France–(BUSINESS WIRE)–HeartFocus, AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, has announced its expansion to any cart-based system with the launch of HeartFocus Link. Available now for medical schools, residency, and ultrasound training programs, HeartFocus Link addresses one of the most persistent barriers in cardiac ultrasound education and adoption: the challenge of helping healthcare professionals build confidence and competency using the

CorWave Achieves Major Regulatory Milestone with ISO 13485 Certification Across its Entire Operations

CLICHY, France–(BUSINESS WIRE)–CorWave, a clinical-stage medical company pioneering innovative cardiac assist devices, announces that its Quality Management System has been certified by an independent notified body in accordance with the international ISO 13485 standard. The certification covers the design, development, manufacturing, distribution, and servicing of implantable Left Ventricular Assist Devices (LVADs). This certification marks a foundational regulatory milestone on the path to

FDA Grants Coredio Breakthrough Designation for AI Platform Bringing Advanced Heart Failure Assessment Beyond the Hospital

SANTA CLARA, Calif.–(BUSINESS WIRE)–Coredio, a digital health company developing the first software-as-a-medical-device (SaMD) platform dedicated to heart failure (HF) hemodynamic assessment, today announced that the U.S. Food and Drug Administration has granted its Cardiac Performance Simulation Engine (CPSE™) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheter