ASSURE Wearable Cardioverter Defibrillator
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KMTS, Biobeat Partner to Expand Diagnostic Insight in Cardiac Recovery
ZACKS· 2026-01-14 17:06
Company Collaboration - Kestra Medical Technologies, Ltd. (KMTS) announced a collaboration with Biobeat Technologies, Ltd. to enhance patient monitoring and diagnosis for users of the ASSURE Wearable Cardioverter Defibrillator (WCD) during cardiac recovery, including a $5 million investment in Biobeat's Series B financing [2][10] - The partnership aims to improve clinical decision-making by providing enhanced blood pressure visibility during critical recovery phases, supporting remote at-home care [3][5] Technology Integration - The collaboration will integrate Biobeat's FDA-cleared cuffless blood pressure monitoring technology into the ASSURE WCD platform, enhancing its clinical relevance and supporting better care for patients with complex heart conditions [5][8] - Biobeat's device is the only FDA-cleared patch-based wearable that provides continuous blood pressure measurements over 24 hours, which will be added to the ASSURE system for comprehensive data insights [8][9] Market Position and Financials - Following the announcement, KMTS shares declined by 5.9%, although the stock has increased by 42.8% over the past six months, outperforming the industry and the S&P 500 [4] - KMTS currently has a market capitalization of $1.37 billion, and the collaboration is expected to strengthen its competitive position in the cardiac recovery management market [5][10] Industry Prospects - The wearable medical devices market is projected to reach $67.65 billion by 2026, with a CAGR of 25.1% through 2035, driven by the demand for remote patient monitoring and home healthcare solutions [11] - The collaboration aligns with the growing trend towards digital healthcare and remote monitoring, which is increasingly important in the context of patient recovery [10][11] Financial Strategy - Kestra is expanding its sales team and has recently raised approximately $138 million through an equity offering of 6,000,000 common shares at $23.00 per share, which will support its growth initiatives [12]
Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra's ASSURE Device
Globenewswire· 2025-11-10 14:52
Core Insights - Kestra Medical Technologies announced positive primary results from the ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS), confirming the safety and effectiveness of the ASSURE WCD in clinical practice [1][2][3] Study Overview - ACE-PAS is the largest prospective real-world study of wearable defibrillators, enrolling 21,612 patients across the U.S. from November 2021 to July 2025 [6] - The study provides contemporary data on the risk of life-threatening ventricular tachycardia and fibrillation in patients with reduced cardiac function [2] Effectiveness and Safety - The primary effectiveness endpoint was achieved with a 100% successful conversion rate for ventricular tachycardia and fibrillation events, exceeding the prespecified performance goal [5] - The study met its primary safety endpoint, reporting an inappropriate-shock rate of 0.0065 per patient-month, confirming a strong safety profile [5] - 94% of patients experienced no false positive shock alarms, enhancing user confidence [5] Patient Protection and Compliance - 2.6% of patients experienced at least one life-threatening VT/VF event within a few months, underscoring the importance of the ASSURE WCD for vulnerable populations [5] - The device detected high-rate atrial fibrillation in 4.2% of patients, with 35% previously undiagnosed, and severe bradycardia/asystole in 0.3%, allowing for timely intervention [5] - Patients wore the device for a median of over 23 hours per day, with one-third continuing use beyond 90 days, indicating high compliance in real-world settings [5] Implications for Clinical Practice - The results of ACE-PAS may inform future updates to clinical practice regarding the identification and protection of patients at early risk of sudden cardiac death [3] - The study emphasizes the critical role of wearable device monitoring and therapy in managing sudden cardiac arrest risk [3]
Kestra Medical Technologies to Present Late-Breaking ACE-PAS Trial Results at AHA 2025, Showcasing Next-Generation Wearable Defibrillator System
Globenewswire· 2025-11-04 13:00
Core Insights - Kestra Medical Technologies, Ltd. is participating in the American Heart Association (AHA) Scientific Sessions 2025, highlighting its commitment to advancing cardiac care through innovative technology [1] - The company will present primary results from the ACE-PAS Trial, which evaluates a next-generation wearable cardioverter defibrillator system, emphasizing its significance in real-world clinical applications [2][3] Company Overview - Kestra Medical Technologies focuses on wearable medical devices and digital healthcare, aiming to improve patient outcomes in cardiovascular disease through connected monitoring and therapeutic interventions [6] Study Details - The ACE-PAS Trial is the largest prospective study of its kind, enrolling over 20,000 patients in the U.S. to assess the effectiveness and safety of the wearable cardioverter defibrillator [3] - Key endpoints of the study include overall shock conversion success, inappropriate shock rate, first shock conversion success, median daily wear time, and false alarm rate [3] Industry Impact - The selection of the ACE-PAS study for a late-breaking presentation at AHA underscores the growing recognition of wearable defibrillator therapy and its role in enhancing clinical insights for cardiac recovery [4] - Kestra's innovations are positioned to redefine the integration of wearable monitoring and therapy within connected care and digital health, aiming to optimize patient protection and recovery [4] Event Participation - At the AHA conference, Kestra will also host live demonstrations and discussions, showcasing its leadership in data-driven solutions for cardiac recovery [5]
Kestra Showcases Cardiac Recovery System Platform at HFSA 2025, Redefining Sudden Cardiac Arrest Risk Management
Globenewswire· 2025-09-25 12:00
Core Insights - Kestra Medical Technologies, Ltd. is debuting its Cardiac Recovery System (CRS) platform at the 2025 Heart Failure Society of America Annual Scientific Meeting, highlighting its commitment to advancing care for heart failure patients [1][4]. Company Overview - Kestra Medical Technologies is a commercial-stage wearable medical device and digital healthcare company focused on improving patient outcomes in cardiovascular disease through intuitive, intelligent, and connected monitoring and therapeutic intervention technologies [5]. Product Features - The CRS platform includes the ASSURE Wearable Cardioverter Defibrillator, which aims to close the gap in sudden cardiac death protection by providing actionable insights during the early phase of heart failure recovery [2]. - Attendees at the conference can engage with the CRS platform through immersive experiences and hands-on demonstrations, showcasing its ability to empower clinicians and enhance patient-provider connections [3]. Industry Engagement - Kestra will also participate in the Devices in Heart Failure Meeting, allowing attendees to see the ASSURE system and understand its integration into clinical workflows to support guideline-directed medical therapy [4].