Author: Ken Dropiewski

Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma

– TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery. – Approval builds on a trusted solution in neurovascular embolization for over 25 years. IRVINE,…

DeLorean AI Releases New Cardiovascular AI White Paper Showing Predictive AI Can Prevent Heart Failure and Cut Costs by Up to $350,000 Per Patient

Clinically validated platform delivers predictive precision, empowering clinicians with real-time visibility to reduce preventable complications and improve patient outcomes PALM BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) — DeLorean AI has announced the release of a new white paper demonstrating that its Cardio AI platform can accurately identify patients at risk of progressing to heart failure before symptoms appear, giving providers a clinically validated tool to intervene earlier and improve outcomes. The analysis, drawn from 12 million patient records, shows DeLorean AI’s models achieve 87% sensitivity in predicting progression toward heart failure, offering payers and providers measurable outcomes that reduce avoidable care costs by as much as $250,000–$350,000 per patient annually. “Value-based care is under enormous pressure right now, as we’ve seen with Optum renegotiating many of its contracts,” said Dr. Severence MacLaughlin, CEO and Founder of DeLorean AI. “If payers, providers, and even agencies like CMS and HHS had predictive visibility into patient deterioration before it happens, these payment structures wouldn’t break down. Predictive AI is the missing infrastructure that allows value-based care to actually work.” Cardiovascular disease continues to drive the highest medical expenditures in the United States, costing $417.9 billion annually and contributing to more than 941,000 deaths each year. Heart failure alone can exceed $350,000 per patient in the year of diagnosis, despite being a condition with a predictable and preventable trajectory when proactive care is implemented. DeLorean AI’s models analyze longitudinal EHR and claim data to deliver predictive precision that gives clinicians a clearer view of patient trajectories now and in the future. Findings from the white paper include: Accurate identification of early deterioration from hypertension or ischemic heart disease toward heart failure with 87% sensitivityPredictive insight into whether a patient’s condition will improve, worsen, or remain stable with 85–87% accuracyPrediction of acute heart failure hospitalization up to 90 days in advance, supporting timely interventionProvide Next Best Actions (NBAs) for licensed professionals to avert adverse events of patients predicted to have a cardiac event, keeping patients out of the hospital and decreasing costs These clinically validated performance metrics equal or surpass those seen in peer-reviewed cardiovascular machine-learning studies, while leveraging a significantly larger dataset. “Predictive and Interventive AI for prevention is now possible at scale,” said Dr. MacLaughlin. “By giving clinicians the power to see risk earlier and in the future, two weeks, four weeks and 8 weeks, we’re enabling hospitals to stay ahead of deterioration and provide care that’s more precise, proactive, and personalized.” Cardio AI integrates with any EHR and keeps providers at the center of care. The platform: Flags patients who may be progressing toward cardiac complicationsIdentifies deviations from ACC/AHA guideline-recommended therapiesSurfaces patient-specific next-best actions rooted in evidence-based medicineSupports primary care physicians and cardiologists with intuitive, accessible intelligence The white paper shows that predictive, preventative care delivers significant value for health systems, insurers, and patients. Managing individuals in pre-event stages such as hypertension (I-10) or chronic ischemic heart disease (I-25) reduces cardiac claims by $60,000–$70,000 per patient annually, while preventing heart failure altogether generates $250,000–$350,000 in savings per patient. With more than three million Americans at elevated risk, predictive intervention represents a pathway to billions in avoidable healthcare spending nationwide. “Technology should amplify human expertise, not replace it,” said Dr. MacLaughlin. “Our platform gives clinicians the clarity and confidence to intervene earlier, reduce preventable complications, and drive better outcomes across entire populations.” DeLorean AI’s approach centers on transparency, clinical validation, and ethical AI. The platform is built for real hospitals, real providers, and real patients, offering precision without overpromising and innovation grounded in medical science. About DeLorean AI: DeLorean AI is a Palm Beach-based healthtech company pioneering predictive artificial intelligence for chronic and acute disease detection. Founded by Dr. Severence MacLaughlin, DeLorean AI develops clinically validated tools that empower healthcare providers to identify at-risk patients earlier, recommend optimal interventions, and dramatically improve outcomes. The company’s platform focuses on key disease areas including cardiovascular disease, chronic kidney disease, end stage renal disease, cardiovascular disease diabetes, COPD, and depression. With seven patents in process and a proprietary model trained on over 80 million patient records, DeLorean AI delivers real-time risk stratification, suggested clinical actions, and future-state predictions, reducing costs and extending lives. As it expands from B2B partnerships to direct-to-patient engagement, DeLorean AI is redefining what’s possible in proactive, data-driven healthcare. Media Contact:Carolina Arguellesinquiries@deloreanai.com Disclaimer: This content is provided by sponsor. The statements, views, and opinions expressed in this content are solely those of the content provider and do not necessarily reflect the views of this media platform or its publisher. We do not endorse, verify, or guarantee the accuracy, completeness, or reliability of any information presented. This content is for informational purposes only and should not be considered financial, investment, or business advice. All business and investment activities involve risks, including the potential loss of capital. Readers are strongly encouraged to perform their own due diligence and consult with a qualified advisor before making any financial decisions. Neither the media platform nor the publisher shall be held responsible for any inaccuracies, misrepresentations, or financial losses resulting from the use or reliance on the information in this press release. Speculate only with funds you can afford to lose. In the event of any legal claims or concerns regarding this article, we accept no liability or responsibility . Globenewswire does not endorse any content on this page. Legal Disclaimer: This media platform provides the content of this article on an “as-is” basis, without warranties or representations of any kind, express or implied. We assume no responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained herein. Any complaints, copyright issues, or inquiries regarding this article should be directed to the content provider listed above. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/93800c5e-3507-41b9-806e-22d6de8c1b24

Rona Therapeutics Unveils the Global First Bi-valent PCSK9-LPA siRNA into Clinical Development for Cardiovascular Risk Reduction

SHANGHAI and SANTA BARBARA, Calif., Dec. 17, 2025 /PRNewswire/ — Rona Therapeutics, a global leader in next-generation RNAi medicines, today announced the submission of RN5681 to the Australian Human Research Ethics Committee (HREC), advancing the company’s first bi-valent siRNA into…

Cytokinetics Announces NMPA Approval of MYQORZO® (aficamten) in China for Patients with Obstructive Hypertrophic Cardiomyopathy

Approval Triggers Milestone Payment of $7.5 Million from Sanofi; Cytokinetics Eligible to Receive Additional Milestone Payments and Royalties on Net Sales in Greater China SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM), to improve exercise capacity and symptoms. Under the terms of its license and collaboration agreement with Cytokinetics, Sanofi has exclusive rights to develop and commercialize MYQORZO for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. The approval of MYQORZO in oHCM in China triggers a $7.5 million milestone payment from Sanofi to Cytokinetics. Cytokinetics remains eligible to receive up to $142.5 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of MYQORZO in Greater China. MYQORZO is only approved for use in China. Aficamten is currently under regulatory review in the U.S, where the FDA is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. On December 12, 2025 the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending marketing authorization in the European Union (EU) for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. About MYQORZO® (aficamten) MYQORZO® (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties.1 MYQORZO was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM. In preclinical models, MYQORZO reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for MYQORZO is assessing its potential as a treatment that improves exercise capacity as measured by peak oxygen uptake (pVO2) and relieves symptoms in patients with HCM. MYQORZO was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients symptomatic obstructive hypertrophic cardiomyopathy (HCM). MYQORZO received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the U.S. Food & Drug Administration (FDA) and for the treatment of symptomatic obstructive HCM from the National Medical Products Administration (NMPA) in China. Aficamten is also currently under clinical investigation in ACACIA-HCM, a Phase 3 trial in patients with non-obstructive HCM and CEDAR-HCM, in a pediatric population with oHCM. Aficamten has not been deemed safe or effective for use in either of these patient populations. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. HCM is the most common monogenic inherited cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an estimated 400,000-800,000 additional patients who remain undiagnosed in the U.S.2,3,4 Two-thirds of patients with HCM have obstructive HCM (oHCM), where the thickening of the cardiac muscle leads to left ventricular outflow tract (LVOT) obstruction, while one-third have non-obstructive HCM (nHCM), where blood flow isn’t impacted, but the heart muscle is still thickened. People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.5 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.6 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company building on its over 25-years of pioneering scientific innovation in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction with intention to create a muscle biology franchise business focused on medicines designed to optimize muscle performance for patients with cardiac and other diseases of muscle dysfunction. MYQORZO® (aficamten), the company’s cardiac myosin inhibitor, is approved for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) in China, and under regulatory review in the U.S. The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization in the European Union for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction, ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. About the Sanofi and Cytokinetics Collaboration In 2024, Sanofi acquired exclusive rights to develop and commercialize MYQORZO® (aficamten) from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Previously, CORXEL acquired the rights to develop and commercialize MYQORZO in Greater China from Cytokinetics in accordance with Cytokinetics’ global registration programs. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by any date, if ever, or our earning or receiving any milestone payments or specific quantum of royalties from commercialization of MYQORZO in Greater China. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, the commercialization activities of Sanofi, the actions of regulatory activities, and the results of our on-going clinical trials. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in China. References: Chuang C, Collibee S, Ashcraft L, et al. Discovery of Aficamten (CK-274), a Next-Generation Cardiac Myosin Inhibitor for the Treatment of Hypertrophic Cardiomyopathy. J Med Chem. 2021;64(19):14142–14152. https://doi.org/10.1021/acs.jmedchem.1c01290CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 DOI: 10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575Symphony Health 2016-2021 Patient Claims Data DoF;Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. Am J Cardiol. 2016; 15;117(10):1651-1654.Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21 Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

Thermedical Announces First Patient Treated in Pivotal Clinical Study Evaluating SERF Ablation for Life-Threatening Ventricular Tachycardia

MIT-alumni-founded Thermedical advances novel deep-tissue ablation technology to address critical unmet needs in severe ventricular tachycardia WESTON, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of advanced thermal-ablation technologies, today announced that the first patient has been treated in a pivotal clinical study evaluating its Saline Enhanced Radiofrequency (SERF) Ablation System with the Durablate® […]

Improve Effectiveness of Cardiac Assessments in Early Phase Trials with Early Precision QT and AI-powered Data Quality Checks, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn about the advantages of leveraging EPQT and AI-powered data quality in early phase QT assessment. The featured speakers will share considerations for determining whether early phase QT data may support regulatory waiver of a stand-alone QT study. Attendees will…

Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop® System

A new multi-direction DWI sequence, the latest Swoop® system software, and the first advancement in Hyperfine’s Optive AI™ software, delivers clearer, higher-quality images for stroke diagnosis, enhancing the value of the Swoop® system in acute neurological care. GUILFORD, Conn.–(BUSINESS WIRE)–Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined […]

CVCT 2025: Cleerly Late-Breaking Science Identifies Thresholds of High Plaque Burden in Non-Obstructive CAD that May Carry Greater Risk Than Obstructive Disease

DENVER–(BUSINESS WIRE)–Cleerly, a leader in AI-based cardiovascular imaging, presented new, late-breaking science from the international CONFIRM2 Registry at the Global CVCT Scientific Program 2025 in Washington, DC. “These findings fundamentally change how we should assess cardiac risk in patients by addressing the historically overlooked risk of non-obstructive coronary artery disease,” said Andrew […]