Latest news with #HRS
Cision Canada
13-05-2025
- Business
- Cision Canada
Thryv Therapeutics to Share Recent Clinical Results and Participate in Upcoming Healthcare Investor Conferences
MONTREAL, May 13, 2025 /CNW/ - Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced its participation in two upcoming prominent investor conferences in New York City. The company will share recent clinical results in Long QT Syndrome presented at the 2025 Heart Rhythm Society Annual Meeting and recent developments for its pre-clinical and clinical programs for both heart failure and atrial fibrillation. Clinical Results Presented at HRS 2025 On April 27, 2025, Thryv presented new clinical data from Part 2 of the Wave I study at the Heart Rhythm Society (HRS) Annual Meeting. The study enrolled adult patients with genetically confirmed Long QT Syndrome Type 2 or Type 3 who received oral doses of LQT-1213 at either 7 mg TID or 16 mg TID for 2⅓ days (seven total doses). LQT-1213 appeared to be generally well-tolerated across both dose groups. Clinically meaningful and statistically significant reductions in QTcF interval were observed in the high dose cohort. Key regulatory endpoints for Long QT Syndrome – such as QTcF area under the curve (AUC) and maximal peak-to-trough effects – demonstrated mean reductions of up to 11 milliseconds (p=0.028) for QTcF AUC. In a subsequent analysis of peak-to-trough changes, the 53 milliseconds (p<0.0001) reduction in QTc is consistent with publications of other drugs studied but not approved for this indication. These results provide important clinical proof-of-concept that LQT-1213 – part of Thryv's series of highly selective SGK1 inhibitors – may offer a disease-modifying approach and lay the foundation for continued clinical development of SGK1 Inhibitors for Long QT Syndrome. Upcoming Investor Conferences RBC Capital Markets Global Healthcare Conference 2025 Dates: May 20–21, 2025 Fireside Chat: Wednesday, May 21, 2025, at 9:30 am EST (Track IV – 2 nd Floor) Location: InterContinental New York Barclay, New York, NY Thryv Therapeutics will participate in a fireside chat and host one-on-one meetings with investors about its future program plans and Series B financing throughout the conference. Jefferies Global Healthcare Conference 2025 Dates: June 3–5, 2025 Location: New York Marriott Marquis, New York, NY Thryv Therapeutics will participate in one-on-one investor meetings. To request a meeting at either conference, please contact: [email protected] Study Highlights Wave I is a multi-part, first-in-human proof-of-concept clinical study designed to evaluate the safety, pharmacokinetics (PK), and efficacy of LQT-1213 in patients with both acquired and congenital forms of Long QT Syndrome. Part 1 results were presented at the American College of Cardiology's Annual Scientific Session in March 2024. Read the full poster here. Part 2 is a single-blind, placebo run-in, multiple-dose safety study in participants with cLQTS Type 2 or 3. Results were presented at the Heart Rhythm Society Annual Meeting in April 2025. Read the full abstract here. More about the Wave I study (Parts 1 and 2) can be found at: About Thyrv's SGK1 Inhibitors Thryv Therapeutics is advancing a series of potent and selective SGK1 (serum and glucocorticoid-regulated kinase 1) inhibitors that target the underlying causes of electrical and structural remodelling which leads to cardiac conditions such as Long QT Syndrome, heart failure, and atrial fibrillation. In heart tissue, SGK1 has been shown to adversely affect ion channel function and surface expression. Its activation is implicated in prolongation of the QT interval, contributing to both congenital and acquired forms of LQTS and adverse outcomes in cardiometabolic diseases such as heart failure and atrial fibrillation. Inhibition of SGK1 may address the root cause of electrical dysfunction and offer a disease-modifying therapy by targeting both electrical and structural remodeling of cardiomyocytes. About Long QT Syndrome (LQTS) Long QT Syndrome (LQTS) is a disorder of the heart's electrical system that delays ventricular repolarization, prolonging the QT interval on an ECG. This can lead to torsade de pointes — a potentially fatal arrhythmia — and sudden cardiac death. LQTS can be congenital, caused by mutations in cardiac ion channel genes (commonly LQT1, LQT2, or LQT3), or acquired, resulting from medications or medical conditions. Congenital LQTS is a rare orphan disease, affecting approximately 1 in 2,000 people worldwide. About Thryv Therapeutics Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv is pioneering a precision medicine approach to treat Long QT Syndrome, heart failure and atrial fibrillation with potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK1). For more information, please visit
Yahoo
05-05-2025
- Business
- Yahoo
New Clinical Study Data Showcase Long-Term, Sustained Benefits of Abbott's Volt™ PFA System for Patients with AFib
Long-term data from the Volt CE Mark Study show strong results out to 12 months in patients receiving pulsed field ablation (PFA) therapy with the Volt™ PFA System The 12-month results of the Volt CE Mark Study confirm the long-term safety and efficacy of the Volt PFA System The data were presented at the 2025 Heart Rhythm Society (HRS) annual meeting ABBOTT PARK, Ill., April 26, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) has announced new data from its Volt CE Mark Study that show strong safety and efficacy out to 12 months for patients receiving pulsed field ablation (PFA) therapy with the Volt™ PFA System for the treatment of atrial fibrillation (AFib). The data also highlights the excellent safety profile of the Volt PFA System alongside the system's ability to achieve results with fewer therapy applications (just 4.7 applications per vein on average) than on-market competitive PFA systems. PFA therapy works differently from traditional cardiac ablation approaches by delivering high energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms. Abbott designed its Volt CE Mark Study to assess the impact of the Volt PFA System in two different patient groups – people battling paroxysmal atrial fibrillation (PAF) - episodes that come and go - as well as persistent AFib (PersAF) - episodes that last longer than seven days. The 12-month data from the Volt CE Mark Study were presented at the 2025 Heart Rhythm Society (HRS) annual meeting held in San Diego (April 24-27, 2025) and simultaneously published in Heart Rhythm, the official journal of the Heart Rhythm Society. Sustained Performance of the Volt PFA SystemData from the Volt CE Mark Study showed that after 12 months, Abbott's Volt PFA System delivered: Outstanding long-term performance. The Volt PFA System demonstrated sustained performance in both safety and effectiveness out to 12 months for patients with PAF and PersAF. Freedom from arrhythmia. 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia after 12 months – one of the lowest rates of reoccurrence in PAF patients in a long-term PFA study to date. Quality of life (QoL) benefits. After 12 months, the Volt CE Mark Study showed a significant QoL benefit for patients, with QoL assessment scores improving from 64.1 to 88.1. Excellent safety profile. After 12 months, just 2.7% of Volt patients had experienced a primary safety endpoint event with zero patients suffering from hemolysis (destruction of red blood cells), coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury – all potential challenges of PFA therapy. "The long-term 12-month results from the Volt CE Mark Study paint a picture of a PFA system that performs exceptionally well in two different groups of patients – each with unique therapy needs and clinical approaches," said Prof. Gian-Battista Chierchia, director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels in Belgium. "These long-term data provide us a strong picture of how the Volt PFA System will perform in clinical settings as we leverage PFA therapy for our patients." To date, clinical experience following CE Mark has further confirmed that the Volt PFA System can support treating patients battling either PAF or PersAF, allowing the system to help as many patients as possible. The Volt PFA System also provides a single-catheter PFA approach, improves workflow and provides procedural flexibility by allowing for light sedation or general anesthesia. A new sub-analysis from the VOLT-AF IDE Study presented at HRS 2025 showed no significant difference in safety or acute effectiveness outcomes in cases performed under conscious or deep sedation when compared to procedures performed with general anesthesia. "Our goal from the beginning with the Volt PFA System was to design a PFA system that would provide outstanding results in patients battling a range of atrial arrhythmias, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. About the Volt CE Mark StudyAbbott's Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study designed to demonstrate the safety and effectiveness of the Volt PFA System for the treatment of symptomatic, recurrent, drug-refractory PAF and PersAF. The study enrolled 150 patients at 11 sites across Europe and included a feasibility sub-study in which additional imaging assessments were collected to confirm the acute safety of the Volt PFA System. About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube. View original content: SOURCE Abbott
Ottawa Citizen
25-04-2025
- Health
- Ottawa Citizen
Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe® PF System
Article content VANCOUVER, British Columbia — Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA. Article content Article content Article content Key results included: Article content 'These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.' Article content With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter. Article content 'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions.' Article content The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication. Article content 'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.' Article content Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter. Article content About Kardium Article content We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation. Article content Article content CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements. Article content Article content Article content Article content Article content
National Post
25-04-2025
- Health
- National Post
Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe® PF System
Article content VANCOUVER, British Columbia — Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA. Article content Article content Key results included: Article content 'These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.' Article content With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter. Article content 'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions.' Article content The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication. 'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.' Article content Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter. Article content About Kardium Article content We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation. Article content Article content CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements. Article content Article content Article content Article content Article content
Business Wire
25-04-2025
- Business
- Business Wire
Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe ® PF System
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA. Key results included: 0% device-related primary safety events 78% 12-month primary effectiveness 100% acute procedural success 25-minute average time to isolate all pulmonary veins 1.2 PFA applications per vein on average "These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.' With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter. 'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions." The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication. 'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.' About the Globe PF System Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter. About Kardium We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation. CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements.
