SHANGHAI, Sept. 12, 2025 /PRNewswire/ — Pulnovo Medical, a globally recognized leader in medical devices for pulmonary hypertension (PH) and heart failure (HF), is proud to announce that its PADN catheter and generator has received two Investigational Device Exemption (IDE) approvals—HDE…
Coronary/Structural Heart
AI-Enabled Eko Health Stethoscope TRICORDER Trial Marks Historic Leap in Early Heart Disease Detection
Landmark TRICORDER study finds major gains in detection of heart failure, atrial fibrillation, and valvular disease with Eko Health’s AI-enabled stethoscopes in routine exams. SAN FRANCISCO, Sept. 11, 2025 /PRNewswire/ — Eko Health, a leader in AI-powered cardiac and pulmonary disease…
European Society of Cardiology (ESC) Congress 2025 Late Breaking Results Confirm Caristo FAI-Score™ Technology’s Superior and Complementary Predictive Value for Cardiac Death Beyond hsCRP
FAI-Score has stronger predictive value than hsCRP for 10-year cardiac death, even among those with zero calcium score and no visible coronary plaque In patients with low hsCRP, high FAI-Score predicts 7-fold higher risk of cardiac death OXFORD, England, Sept. 11, 2025 /PRNewswire/ –…
JenaValve Announced ESC Guidelines Recognize TAVI as Class IIb Recommendation for Aortic Regurgitation
IRVINE, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that the newly published guidelines from the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) include transcatheter aortic valve implantation (TAVI) as a treatment option for patients with severe, symptomatic aortic regurgitation (AR) when ineligible for surgery. This decision marks the first formal recommendation for TAVI in AR guidelines.
Catheter Precision Announces Tender Win and First Purchase Order in Croatia
FORT MILL, S.C., Sept. 10, 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 today announced that it has received the first purchase order from a hospital in Croatia after winning a competitive tender bid.
Orchestra BioMed Presents New AVIM Therapy Clinical Data at HRX Demonstrating Substantial and Sustained Blood Pressure Reductions that are Reproducible Upon Reactivation Following Washout
Results from long-term follow up of patients treated with atrioventricular interval modulation (“AVIM”) therapy show blood pressure-lowering effects are sustained for years after activation, reversible with no observed rebound hypertension upon deactivation of treatment, and reproducible upon reactivation following a washout periodSimultaneous peer-reviewed publication of AVIM therapy mechanistic and clinical results Orchestra BioMed and Medtronic (NYSE: MDT) have a strategic collaboration to develop and commercialize AVIM therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, an estimated global population of over 750,000 patients annuallyAVIM therapy has FDA Breakthrough Device Designation for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk, an estimated U.S. population of over 7.7 million patients NEW HOPE, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced new data from its AVIM therapy program, presented at the HRX Live 2025 Meeting, in Atlanta, GA, demonstrating that the blood pressure-lowering effects of AVIM therapy may be sustained for years after activation, are reversible with no evidence of rebound hypertension or blood pressure exceeding initial baseline values, and can be restored upon reactivation. These data further support AVIM therapy’s potential role as a controllable, programmable, and durable device-based therapy for uncontrolled hypertension. Avi Fischer, MD, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed presented an overview of mechanistic and clinical data supporting the potential role of AVIM therapy for the treatment of uncontrolled hypertension during the Innovation Summit at HRX Live 2025, as part of the session titled “Pacing and Implanted Device Therapy.” His presentation coincided with the simultaneous peer-reviewed publication of these results in Heart Rhythm O₂, titled, “Atrioventricular Interval Modulation (AVIM) for Management of Hypertension.” Dr. Fischer stated, “These results add to the growing body of promising data supporting AVIM therapy’s potential role as a novel and programmable treatment option for patients whose hypertension remains uncontrolled despite existing medical regimens. The sustainability, reversibility and reproducibility of effect demonstrated in these results provides additional confidence in the efficacy and safety profile of AVIM therapy currently under investigation in the BACKBEAT global pivotal study. Importantly, these data highlight the potential for AVIM therapy to halt the progression of hypertensive heart disease, which could have significant clinical benefit to millions of patients globally.” Key Findings: Sustainable blood pressure reduction during chronic treatment with AVIM therapy: A group of patients (n=16) who originally participated in the MODERATO II trial and underwent long-term follow-up for an average of 3.6 years had sustained 24-hour ambulatory systolic blood pressure (“aSBP”) reductions of 8.9 mmHg (p
Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 26-29
WASHINGTON, Sept. 4, 2025 /PRNewswire/ — The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 26-29, at the at the Minneapolis Convention Center in Minneapolis, MN….
Idorsia to collaborate with two leading academic medical centers to launch IMPACT-HTN – a US initiative to transform care for patients with difficult-to-control hypertension
Multi-phase program to standardize treatment, generate real-world evidence and explore AI-powered tools to improve outcomes for hypertension patients Allschwil, Switzerland & Radnor, Philadelphia – September 5, 2025Idorsia Ltd (SIX: IDIA) announces a first-of-its-kind initiative with the Stanford Hypertension Center and Duke Heart Center to launch IMPACT-HTN, a new three-phase program to transform and modernize the management of difficult-to-control hypertension. Patients requiring multiple medications for difficult-to-control hypertension face increasing challenges with care coordination, evaluation of underlying causes, and worsening outcomes. The initiative, led by Dr. Vivek Bhalla of the Stanford University School of Medicine and Dr. Sreekanth Vemulapalli of Duke University School of Medicine, is expected to generate real-world evidence, standardize clinical decision-making and deliver scalable tools that leverage AI technology to help identify patients with difficult-to-control hypertension who may benefit from innovative therapies that utilize new pathways, including Idorsia’s once-daily TRYVIO™ (aprocitentan), the first systemic hypertension treatment to target a new pathway in over 30 years. Sreekanth Vemulapalli, MD, Associate Professor of Medicine, Duke Heart Center, commented:“With novel therapies emerging to improve hypertension control, we are thrilled to work with our esteemed colleagues at Stanford and other hypertension centers to standardize the evaluation, management and access to innovative therapies for our patients with difficult-to-control hypertension. We’ll be collaborating with companies to develop high-touch AI tools aimed at supporting the care of our patients to meet people where they are. This is a cross-institutional collaboration which we hope to expand to improve the outcomes of our patients.” Despite progress in improving patient outcomes, hypertension remains a major global health issue, affecting an estimated 50% of adults in the U.S. Patients whose blood pressure that remains above target despite the use of appropriate therapy face significantly higher risks of cardiovascular events, including heart attack, stroke and kidney failure, and are nearly twice as likely to experience premature mortality compared to those with controlled blood pressure. Difficult-to-control hypertension is defined as above-goal elevated blood pressure in a patient despite the concurrent use of multiple antihypertensive drug classes. Vivek Bhalla, MD, Associate Professor of Medicine/Nephrology, Founding Director of the Stanford Hypertension Center, commented: “The IMPACT-HTN program challenges the boundaries of the standard care model for hypertension treatment by building a platform to fundamentally shift how we approach difficult-to-control hypertension. I’m proud to collaborate with Idorsia and Dr. Vemulapalli as well as Dr. Kenneth Mahaffey, the Founding Director of the Stanford Center for Clinical Research for this initiative. By developing and publishing best practices, analyzing real-world data and harnessing emerging technologies, we’re working to deliver impactful solutions that can transform hypertension care and improve lives.”The multi-phased IMPACT-HTN program is expected to deliver actionable tools, data and insights to improve care for those with difficult-to-control hypertension, including: A digital care algorithm to standardize how difficult-to-control hypertension is assessed and managed. Through interactive tools such as patient-facing algorithms, AI chatbots and a program portal, this initiative aims to transform protocols to improve patient care.A personalized hypertension risk score that will build on existing risk scores for prevention to better identify difficult-to-control hypertension patients at risk for negative cardiovascular outcomes so appropriate treatment protocols can be implemented sooner. A prospective early patient experience initiative that will enroll patients from hypertension specialty centers to better understand the treatment obstacles for patients with difficult-to-control hypertension and how newer treatments, like Idorsia’s TRYVIO, are impacting the treatment paradigm. Srishti Gupta, MD, CEO of Idorsia, commented: “We are proud to have pioneered the first treatment tackling a new pathway in hypertension in over three decades and as a leader in this area, we understand that our commitment to improving patient outcomes goes beyond the medicine. We are proud to collaborate with two of the world’s leading research institutions, on this exciting new program and believe IMPACT-HTN will help reimagine the pathways of care for hypertension patients who need additional options.” TRYVIO, a dual endothelin receptor antagonist (ERA) is now available to prescribe. It is indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. 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, but many patients remain undiagnosed and undertreated. Important Safety InformationTRYVIO may cause serious side effects, including:TRYVIO can cause major birth defects if used by pregnant patients and has a BOXED Warning for embryo-fetal toxicity. People who can become pregnant must not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO.People who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO, each month during treatment with TRYVIO, and 1 month after stopping TRYVIO.People who can become pregnant should use acceptable birth control before starting treatment with TRYVIO, during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body. If you are a person who can become pregnant, your healthcare provider will talk to you about pregnancy testing recommendations and the need to use acceptable birth control, the benefits and risks of TRYVIO, and the need to report suspected pregnancy right away to your healthcare provider. What is TRYVIO?TRYVIO is a prescription medicine used to treat high blood pressure (hypertension) in adults who are taking other high blood pressure medicines and whose blood pressure is not well controlled.Do not take TRYVIO if you are pregnant or currently trying to become pregnant.allergic to aprocitentan or any of the ingredients in TRYVIO. Before taking TRYVIO, tell your healthcare provider about all of your medical conditions, including if you: have liver problemshave heart failurehave anemiahave kidney problems or get dialysisare pregnant or plan to become pregnant during treatment with TRYVIO. TRYVIO can cause serious birth defects.are breastfeeding or plan to breastfeed. It is not known if TRYVIO passes into your breastmilk. Do not breastfeed if you take TRYVIO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.TRYVIO may cause other serious side effects, including: Liver problems. TRYVIO may cause liver problems. Your healthcare provider should do blood tests to check your liver before starting treatment and as needed during treatment with TRYVIO. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with TRYVIO: nausea or vomiting yellowing of your skin or whites of your eyes pain in the upper right stomach dark urine tiredness fever loss of appetite itching Fluid retention. Fluid retention and swelling are common during treatment with TRYVIO and can be serious. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider may treat you with other medicines (diuretics) if you develop fluid retention or swelling.Low red blood cell levels (anemia). Anemia is common during treatment with TRYVIO and can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with TRYVIO.Decreased sperm count. TRYVIO may cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you. Your healthcare provider may stop treatment with TRYVIO if you develop certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of TRYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan 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. Aprocitentan is approved as JERAYGO® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve 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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Novo Nordisk to present new semaglutide data on ‘food noise’, body composition and cardiovascular benefits, as well as pipeline data at the EASD diabetes congress
The INFORM real-world evidence study shows impact of semaglutide on reducing ‘food noise’, and the STEP UP clinical trial highlights semaglutide’s effect on control of eating and body composition after losing weightNext-generation obesity treatment cagrilintide demonstrates promise as standalone therapy (REDEFINE 1); data also being presented on amycretinThe first head-to-head real-world study, REACH shows superiority of Ozempic® versus dulaglutide on cardiovascular events such as heart attack and stroke Bagsværd, Denmark, 5 September 2025 – Novo Nordisk today announced the presentation of 35 abstracts from across its diabetes and obesity portfolio at the upcoming European Association for the Study of Diabetes (EASD) congress 2025 from 15 to 19 September in Vienna, Austria. The presentations include clinical and real-world data reinforcing semaglutide’s broad health benefits, widest approved indications, and its well-established weight loss effect. Novo Nordisk will also present data on new obesity pipeline therapies, including CagriSema, cagrilintide and amycretin. On 17 September, Novo Nordisk will also host an R&D investor event to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. “With the broadest approved indications in both obesity and type 2 diabetes, semaglutide is today making a real difference in helping people lose weight while also protecting them from cardiovascular events such as heart attacks,” said Martin Holst Lange, chief scientific officer and executive vice president, Research & Development at Novo Nordisk. “We are now leading the way in developing next-generation treatments – such as combining cagrilintide with semaglutide or using it as a monotherapy – to better meet the needs of people living with diabetes and obesity, and we are excited to present these data at EASD.” Summary of presentationsAccepted data at the 61st annual meeting of the EASD include the following poster and oral presentations. Accepted abstracts include preliminary data that may be subject to change in the final published manuscripts. Dates and times of the presentations can be found on the EASD website. EASD scientific symposia SOUL Trial: Effects of oral semaglutide on cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk – Wednesday 17 September; 08:30 – 09:30 CEST EASD poster and oral sessionsWegovy® (once-weekly semaglutide 2.4 mg) Impact on food noise after initiating semaglutide treatment: results from a US survey (INFORM). Short oral presentation (45-SO) – Tuesday 16 September; 12:00 – 13:00 CESTImpact of once-weekly semaglutide on cardiovascular events in adults with overweight or obesity in a real-world Danish population. Oral presentation (148-OR) – 18 September; 11:30 – 11:45 CEST Once-weekly semaglutide 7.2 mg Effect of semaglutide 7.2 mg on anthropometric measures of obesity: the STEP UP trial Oral presentation (145-OR) – Thursday 18 September; 10:45 – 11:00 CESTControl of eating with semaglutide 7.2 mg in adults with obesity: the STEP UP trial. Oral presentation (146-OR) – Thursday 18 September; 11:00 – 11:15 CESTEffect of semaglutide on body composition and proximal muscle strength: the STEP UP trial. Oral presentation (147-OR) – Thursday 18 September: 11:15 – 11:20 CEST Ozempic® (once-weekly semaglutide 1.0 mg) Comparative effectiveness of once-weekly semaglutide vs dulaglutide on cardiovascular outcomes in US Medicare beneficiaries with type 2 diabetes and atherosclerotic cardiovascular disease. Late breaking presentation (LBA-19) – Thursday 18 September; 10:45 – 11:00 CEST Rybelsus® (once-daily oral semaglutide) Oral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (2-OR) – Tuesday 16 September; 10:15 – 10:30 CESTEffects of oral semaglutide on hospitalisation rates in people with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease: SOUL trial results. Oral presentation (127-OR) – Wednesday 17 September; 14:30 – 14:45 CEST Semaglutide for MASH Impact of semaglutide on liver-related responses in people with metabolic dysfunction-associated steatohepatitis with/without type 2 diabetes: post hoc analysis of the ESSENCE trial. Short oral presentation (555-SO) – Tuesday 16 September; 13:15 – 14:15 CEST CagriSema REDEFINE 2: a randomised trial of combined semaglutide 2.4 mg and cagrilintide 2.4 mg for the treatment of adults with BMI ≥27kg/m2 and type 2 diabetes. Oral presentation (73-OR) – Wednesday 17 September; 09:45 – 10:00 CESTCagriSema improves glycaemic outcomes across weight loss categories in adults with BMI ≥27 kg/m2 and type 2 diabetes in the blinded continuous glucose monitoring subgroup in REDEFINE 2. Oral presentation (13-OP) – Wednesday 17 September; 14:30 – 14:45 CESTREDEFINE1: a randomised study of combined semaglutide 2.4 mg and cagrilintide 2.4 mg for the treatment of overweight or obesity in adults. Oral presentation (190-OR) – Thursday 18 September; 16:15 – 16:30 CEST Cagrilintide Efficacy and safety of cagrilintide 2.4 mg in adults with overweight/obesity: data from REDEFINE 1. Short oral presentation (43-SO) – Tuesday 16 September; 12:00 – 13:00 CEST Amycretin Amycretin, a novel, unimolecular glucagon-like peptide-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Oral presentation (63-OR) – Tuesday 16 September; 15:15 – 15:30 CESTPharmacokinetics, safety and tolerability of amycretin in people with renal impairment. Oral presentation (15-OR) – Wednesday 17 September; 15:00 – 15:15 CESTThe effect of amycretin, a unimolecular glucagon-like peptide-1 and amylin receptor agonist, on body weight and metabolic dysfunction in mice and rats. Oral presentation (188-OR) – Thursday 18 September; 15:45 – 16:00 CEST About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that mimics the effects of the naturally occurring hormone GLP-1, which regulates weight and blood sugar. It has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease, and other related cardiometabolic diseases1-5. Semaglutide has a well-established safety and tolerability profile supported by over 33 million patient-years of exposure since its launch in 20186. Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comMax Ung+45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin+45 3079 1471cftu@novonordisk.comAlex Bruce +45 34 44 26 13axeu@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com _______________________References1. Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024;391:109-121.2. Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375:1834-1844.3. McGuire DK, Marx N, Mulvagh SL, et al. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. 2025.4. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389:2221-2232.5. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6:275-286.6. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]). Novo Nordisk A/S, Bagsværd, Denmark.
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Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~ ~Subgroups – including Black or African American adults, older adults, women, and participants with comorbid obesity – face heightened risk of poor cardiovascular outcomes and represent high unmet need~ ~Lorundrostat demonstrated significant and clinically meaningful blood pressure reductions across all participant subgroups, with a favorable safety and tolerability profile~ RADNOR, Pa., Sept. 05, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage 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 announced new subgroup analyses from the Phase 3 Launch-HTN trial, evaluating the blood pressure–lowering efficacy and safety of lorundrostat in difficult-to-treat and high-risk patient populations with high unmet medical need. The results were presented at the American Heart Association (AHA) Hypertension Scientific Sessions in Baltimore, MD, September 4-7, 2025. “In our Phase 3 Launch-HTN trial we were intentional about recruiting a diverse patient population, including those at high-risk. These participants continue to face uncontrolled hypertension despite treatment with existing therapies,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Lorundrostat demonstrated a clinically meaningful blood pressure reduction across the full study population, including these difficult-to-treat groups. Importantly, the safety and tolerability profile was consistent with our topline results, reinforcing the potential of lorundrostat as a transformative therapeutic for patients living with uncontrolled or resistant hypertension.” Launch-HTN is the largest global Phase 3 trial to date in uncontrolled or resistant hypertension, enrolling a diverse group of participants with high cardiovascular risk, including Black/African American (29%), adults aged ≥65 years (41%), women (47%), participants with obesity (63%), and those requiring three or more background antihypertensive medications (60%). Across all of these subgroups, lorundrostat 50 mg demonstrated consistent, statistically significant, and clinically meaningful reductions in blood pressure compared with placebo. “Hypertension remains the leading modifiable risk factor for cardiovascular disease. These findings from the Launch-HTN study highlight the potential of lorundrostat to address a critical unmet medical need and improve blood pressure control in high-risk patient cohorts, including: Black and African American patients, patients 65 yrs or older, females, patients with comorbid obesity and patients on 3 or more anti-hypertensives,” said Dr. Manish Saxena, MBBS, Hypertension Specialist and Clinical Co-Director at William Harvey Heart Centre, Barts Health NHS Trust and QMUL. “With consistent blood pressure lowering effect across diverse, high-risk subgroups, lorundrostat could help improve outcomes for patients and reduce the burden of hypertension on the healthcare system.” Table. Subgroup Analysis of AOSBP Change for Lorundrostat 50 mg vs Placebo at Week 6 LSM Reduction in AOSBP, mmHg CharacteristicLorundrostat 50 mg(n=808)Placebo(n=270)LSM Difference (90%CI), Lorundrostat vs PlaceboAge ≥75 y-18.2-6.6-11.6 (-17.4, -5.8); p=0.001165-74 y-16.7-9.8-6.9 (-11.4, -2.4); p=0.0109