Rhythm

Acoramidis Demonstrates Real-World Benefit Versus Tafamidis in ATTR-CM, Reducing Risk of Clinical Worsening

– In the first peer-reviewed, real-world, contemporary, comparative effectiveness study of TTR stabilizers in ATTR-CM using U.S. claims data, acoramidis was associated with a statistically and clinically significant 34% reduction in a composite of clinical worsening events (diuretic intensification, heart failure hospitalization, and mortality) versus tafamidis (p=0.046), supporting improved clinical stability of acoramidis over tafamidis – Acoramidis was also associated with a significant 43% reduction in risk of diuretic intensification versus tafamidis (p=0.021); diuretic intensification is an early marker of worsening heart failure and worse clinical outcomes – Separation in clinical outcomes emerged within weeks of treatment initiation and increased over time, reinforcing a consistent early treatment effect and durable clinical stabilization – Findings underscore acoramidis’s differentiated profile, with potential to inform frontline treatment decisions and support switching individuals to acoramidis – An additional, independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data is expected to be released at an upcoming 2026 medical meeting PALO ALTO, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced results published in Cardiology and Therapy from the first peer-reviewed, contemporary real-world comparative effectiveness retrospective study of transthyretin (TTR) stabilizers in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating that acoramidis was associated with significantly lower risk of early clinical worsening compared to tafamidis. This represents the first peer-reviewed, real-world evidence differentiating clinical outcomes between approved TTR stabilizers, reinforcing acoramidis’s differentiated clinical profile in present-day practice. “These findings further position acoramidis as a differentiated TTR stabilizer in contemporary clinical practice,” said Richard Wright, M.D., M.A.C.C. of the Pacific Heart Institute, U.S. “The significant reduction in diuretic intensification, an early indicator of worsening heart failure, points to improved disease control and clinical stability. The progressive nature of ATTR-CM is evident in all Phase 3 trials and is seen again here. This demonstrates the need for clinicians to proactively mitigate disease progression, and these data have the potential to meaningfully inform treatment selection in newly diagnosed patients and in patients currently on other treatments.” In this analysis of newly treated individuals living with ATTR-CM, acoramidis showed early, consistent, and clinically meaningful advantages compared to tafamidis across key measures of disease progression during a mean follow-up of 4.6 months. The key findings from the study comparing acoramidis benefit versus tafamidis in individuals with ATTR-CM: 34% statistically and clinically significant reduction in risk of composite clinical worsening (HR 0.66; p=0.046), including diuretic intensification, heart failure hospitalization, and all-cause mortality43% reduction in risk of diuretic intensification (HR 0.57; p=0.021), an established early marker of worsening heart failure and predictor of hospitalization and mortality; diuretic intensification was rigorously defined as initiation or dose-equivalent escalation of oral loop diuretics, parenteral loop diuretics use, or addition of a thiazide-type diuretic48% reduction in initiation or dose-equivalent escalation of oral loop diuretics (HR=0.52; p=0.014)Rapid benefit, with separation of Kaplan-Meier curves observed within weeks of treatment initiation and increasing over timeFewer individuals with acoramidis initiated alternative ATTR-CM therapy as compared to those treated with tafamidis (4.6% vs 7.7%, respectively), consistent with findings of improved clinical stability with acoramidisBackground heart failure therapies in this study were well balanced across arms and reflect contemporary practice: 43-44% SGLT2i, 36-39% MRAMultiple falsification analyses testing for residual bias were nonsignificant The study leveraged a retrospective, longitudinal, new-user, active-comparator design using U.S. claims data and incorporated a unique dataset linking Komodo Healthcare Map U.S. claims with Claritas hub and specialty pharmacy data. After weighting, the analysis included 170 individuals with acoramidis and 448 individuals with tafamidis newly initiating treatment between Dec 2024-April 2025 and followed through July 2025, with a mean follow-up of approximately 4.6 months. Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR. Additional data on the real-world benefit of acoramidis versus tafamidis in individuals living with ATTR-CM is planned for fall medical meetings and scientific publications, including an independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data, expected to be released at an upcoming 2026 medical meeting. As with all real-world evidence studies, these findings should be interpreted in the context of inherent limitations of administrative claims data, including limited capture of cardiac biomarkers and other clinical measures of disease severity. Follow-up was limited given the recent approval of acoramidis, and longer-term data are needed to further add to these findings. About Attruby® (acoramidis)INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATIONAdverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BridgeBioBridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok. BridgeBio Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the real-world data regarding acoramidis, including the potential for the findings to inform frontline treatment decisions and treatment selection for newly diagnosed patients and patients currently receiving other treatments, and to support switching individuals to acoramidis; and BridgeBio’s plans and expectations regarding the presentation and publication of additional real-world data regarding acoramidis, including an independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data expected to be released at an upcoming 2026 medical meeting. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the risk that results from retrospective, observational, real-world evidence studies, including studies based on administrative claims data, may be subject to confounding, selection bias, residual bias, incomplete or inaccurate data, limited follow-up or other limitations and may not be predictive of future clinical outcomes or treatment effects; that the observed associations and differences between acoramidis and tafamidis may not be replicated in additional analyses, independent studies or longer-term data or may not translate into improved long-term clinical outcomes; that the findings may not meaningfully inform treatment selection or support switching patients to acoramidis; that additional real-world studies, including the independent study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data, may yield results that differ from or do not confirm the findings described in this press release; that plans or timing for future medical meeting presentations or scientific publications may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact:Kaitlyn Reilly, Director, Communicationscontact@bridgebio.com   (650) 789-8220 BridgeBio Investor Contact:Kristen Kelleher, Director, Investor Relationsir@bridgebio.com

Rhythm AI’s STAR Apollo Mapping Technology Demonstrates 90% of Patients Experienced Freedom from Atrial Fibrillation (AF) at One-Year Following Redo Ablations for Persistent AF

Late-breaking study presented at HRX 2026 met primary feasibility endpoint in 100% of patients Majority of patients had minimal or no AF symptoms at 12 months STAR Apollo™ Mapping System identifies atrial fibrillation (AF) drivers based on the fundamental electrophysiological principles…

StimCardio’s NeuroPulse Study Reports Substantial Reduction in Recurrent Atrial Fibrillation Events Via Non-Invasive Wearable Neuromodulation Following Ablation

90% freedom from atrial arrhythmias at six months with neuromodulation vs. 80.8% with sham Randomized, double-blind, sham-controlled results presented as late-breaking clinical science at HRX Live 2026 and simultaneously published in peer-reviewed Heart Rhythm ATLANTA and LOS ANGELES,…

JACC: Clinical Electrophysiology Publishes 12-Month Outcomes from Field Medical’s First-in-Human Field PULSE Trial: 94.2% Per-Vein PVI Durability with Optimized Waveform

Late-breaking HRX data advance Field Medical’s “instantaneous ablation” workflow and expand the clinical evidence for high-voltage focal PFA with the FieldForce™ PFA System ATLANTA and CARLSBAD, Calif., Sept. 20, 2026 /PRNewswire/ — Field Medical, Inc., advancing high-voltage focal…

Adagio Medical Highlights First Patient Treated in IDE Study Evaluating Next-Generation vCLAS™ Ultra System for Ventricular Tachycardia at Banner – University Medical Center Phoenix

LAGUNA HILLS, Calif.–(BUSINESS WIRE)—- $ADGM #ARRHYTHMIA–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced highlights from the first patient enrolled in the Company’s study evaluating its next-generation vCLAS™ Ultra Ultra-Low Temperature Ablation (“ULTA”) Ventricular Ablation System. The study is designed to support a Premarket Approval (“PMA”) supplement to the Company’s PMA f

Thryv Therapeutics Announces JACC: Heart Failure Publication of Converging Human Genetic, Preclinical, and Clinical Evidence Supporting Phase 2a Development of Lead SGK1 Inhibitor THRV-1268 in Heart Failure

THRV-1268 Maintained a Near-Normal Ejection Fraction and Outperformed Empagliflozin Monotherapy in a Validated Model of Heart Failure; Phase 1 Studies Demonstrated Favorable Safety Profile and QTcF Shortening SAN FRANCISCO, Sept. 15, 2026 /PRNewswire/ — Thryv Therapeutics Inc. (“Thryv”),…

AliveCor Launches KardiaACCESS: A Medicare-Covered Program Built to Improve Blood Pressure, Diabetes, and Heart Health

Under the new CMS ACCESS Model, eligible Original Medicare beneficiaries can receive clinician-guided care and medical-grade connected tools to lower health risks at $0 out-of-pocket costMOUNTAIN VIEW, Calif., Sept. 15, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced KardiaACCESS, a 10-year initiative under the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions). Designed to go beyond passive monitoring, KardiaACCESS provides clinician-guided, outcome-aligned care to help people actively lower blood pressure, balance blood sugar, and manage their overall cardio-kidney-metabolic health. Managing chronic conditions often means brief doctor visits and trying to connect the dots alone. Regular monitoring is the key to identifying what is happening with your heart, and the KardiaACCESS program serves as the bridge to communicate with care teams both in and out of the doctor’s office. KardiaACCESS treats connected health systems together—addressing the links between blood pressure, diabetes, lipids, and kidney function to deliver real health improvements and keep people out of the hospital. According to the American Heart Association, more than 70% of U.S. adults aged 60 to 79 live with cardiovascular disease. Furthermore, the Centers for Disease Control and Prevention (CDC) reports that three in four U.S. adults have at least one chronic condition, with interconnected issues like high blood pressure and diabetes serving as the primary drivers of chronic kidney and heart disease. “We’ve been helping patients manage heart health conditions for over a decade,” said Priya Abani, CEO of AliveCor. “We know the center of chronic disease management often starts at the heart, and we are uniquely positioned to connect the dots across cardio-kidney-metabolic health. With KardiaACCESS, we provide active clinical guidance and medical-grade tools to help people manage their blood pressure, diabetes, lipids, and weight—empowering them to improve their real health numbers, reduce risks, and protect their hearts from home.” Program Details: 100% Covered ($0 Cost): Participating in the CMS ACCESS Model allows KardiaACCESS to offer complete program availability, dedicated clinical guidance, and health tools with $0 out-of-pocket cost. There are no co-pays, no deductibles, and no hidden fees for qualifying Original Medicare (Part B) beneficiaries.Clinician-Guided Outcome Care: Expert guidance delivered by Kardia Medical Group, working alongside your routine care to provide active clinical guidance, progress checks, and doctor-ready reports.Whole-Body Health Focus: Rather than treating symptoms in isolation, KardiaACCESS supports the complete Cardio-Kidney-Metabolic (CKM) system—helping lower systolic blood pressure, stabilize A1c, manage weight, and protect long-term kidney and heart function.Connected Support & Tools: Program members receive connected devices, lifestyle coaching, virtual care visits, and Kardia app membership to keep their care team connected between routine doctor appointments. KardiaACCESS is currently available to eligible Original Medicare (Part B) beneficiaries in 48 states, with expansion to Arkansas and South Carolina coming soon. Early Heart & Metabolic Support (eCKM Track): Diagnosed high blood pressure (hypertension) and/or high cholesterol, prediabetes, or overweight/obesity.Established Condition Management (CKM Track): Diagnosed Type 2 diabetes, chronic kidney disease (CKD), or established heart disease/cardiovascular conditions. As the pioneer of personal, medical-grade electrocardiogram (ECG) technology, AliveCor brings unmatched clinical scale and validation to the ACCESS model. To date, the company’s technology has supported more than 6.4 million patients globally and recorded over 400 million ECGs—a figure that continues to grow by more than one million recordings each week. Available in more than 40 countries, AliveCor’s solutions are backed by more than 250 peer-reviewed publications and are cleared to detect 39 distinct cardiac conditions, including life-threatening heart attacks and ischemia. To learn more about KardiaACCESS and to check coverage and eligibility visit https://kardia.com/access. KardiaACCESS is provided by Kardia Medical Group, a clinical partner of AliveCor, in participation with the Centers for Medicare & Medicaid Services (CMS) ACCESS Model. KardiaACCESS is an outcome-aligned care program covered under Medicare Part B for eligible beneficiaries. Centers for Medicare & Medicaid Services (CMS) and KardiaACCESS are trademarks or registered trademarks. All care services and clinical evaluations are rendered under Cardiac Health Medical Group. About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) devices, is transforming cardiology with its medical-grade AI solutions. The company was named to the inaugural TIME World’s Top Health Tech Companies 2025 list – recognition of its commitment to delivering innovative devices and services that empower patients and physicians with personalized, actionable heart data. With over 400 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L cleared to detect 39 cardiac conditions (with determination availability varying by geography), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook. Media ContactMorgan MathisDirector of Corporate Communications, AliveCorpress@alivecor.com

Abbott receives FDA approval for its TactiFlex™ Duo Ablation Catheter to treat people with abnormal heart rhythms

Abbott’s TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter to treat complex atrial fibrillation (AFib) cases Strong clinical evidence demonstrates the device’s high rates of safety and effectiveness…