EVIDENCE-RM: A revealing study on the medical-economic impact of remote cardiac monitoring In a health expenditure framework, the question of the relative cost-effectiveness ratio of new medical technologies is essential. The EVIDENCE-RM retrospective study, conducted by Implicity, provided concrete elements on the medical-economic impact of remote monitoring for patients with implantable cardiac defibrillators (ICDs). A comparison between remote monitoring systems The aim of the study was to compare healthcare costs between Implicity’s universal remote monitoring platform, independent of the ICD manufacturer, and conventional solutions offered by the manufacturers.  Data from patients monitored via the Implicity platform in 2019 was cross-referenced with the French National Health Data System (SNDS) database, the analysis highlighted significant differences between care costs for patients monitored with the Implicity platform versus manufacturer’s solutions. Significant savings The study demonstrates that patients monitored on the IMPLICITY IM009¹ universal remote monitoring platform showed² : A 4% reduction in overall healthcare costs A 17.8% decrease in hospital costs, mainly due to the reduction in cardiovascular care expenditure A 7.9% increase in outpatient care costs, illustrating more proactive management Furthermore, Implicity’s universal platform demonstrated a negative incremental cost-effectiveness ratio of -€103 per day of life outside of hospital, indicating patients are spending more time outside of hospital while generating cost savings. A beneficial preventive approach These results indicate the Implicity platform facilitates better anticipation of complications and more effective preventive management, thereby reducing hospitalizations and associated costs. The adoption of universal and independent solutions could therefore constitute an interesting way to optimize health expenditure while improving the quality of care. ¹IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a solely means of diagnosis. It is offered to healthcare providers/professionals on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Class I, according to Medical Device Directive 93/42/EEC. See the instructions for use for more information. Covered under the conditions defined in Article L. 162-52 of the French Social Security Code.²E. Marijon. Cost impact of the use of a universal cardiac implantable electronic devices remote monitoring solution: results of the EVIDENCE RM study. Poster presentation :  European Society of Cardiology 2024; London. Implicity is a unique platform that aggregates and processes data from cardiac implantable electronic devices (CIEDs) and weight scales. This integration particularly benefits many heart failure patients who rely on CIEDs. By centralizing all relevant data on one platform, Implicity streamlines the management of a patient’s clinical situation, enhancing efficiency and clarity for healthcare providers. This consolidation allows patients to receive personalized support tailored to their specific needs, directly contributing to an improved quality of life from the comfort and safety of their homes. Through the Implicity Heart Failure platform, physicians are equipped with a dynamic solution, enabling proactive management of patient health progression. This approach not only facilitates the avoidance of hospital admissions but also addresses the need to control healthcare expenses efficiently. *Not currently available in the United States

Implicity revolutionizes remote cardiac monitoring: the EVIDENCE-RM study reveals unparalleled results Technological innovation in healthcare continues to demonstrate its positive impact on patient care. Implicity, an agnostic remote cardiac monitoring platform, conducted a large-scale retrospective study, EVIDENCE-RM¹, to assess the benefits of its platform in real-life conditions for managing CIED patients.  A robust study based on real world dataImplicity used patient data from the French National Health Data System (SNDS) and its own database to conduct the study. The study sample included 38,687 patients with implantable cardiac defibrillators (ICDs) and data was analyzed to assess the clinical and medico-economic impact of Implicity’s remote monitoring platform compared to the standard of care using manufacturer’s web portals. Study results: clinically proven effectivenessThe study demonstrated the significant benefits of the IMPLICITY IM009² remote cardiac monitoring solution compared to the standard of care using manufacturer’s web portals: a 26% reduction in the all-cause mortality rate a 2% reduction in all cause hospital admissions a 4% reduction in the length of all cause hospitalization stays A major step forward for patients and the healthcare systemThe study results confirmed Implicity’s contribution to improving the quality of patient care and management of patients with ICDs. By reducing all cause mortality and hospitalizations, the platform contributes to better patient care and lowers costs for the healthcare system. Major recognition from the French National Authority for HealthThe impact of the EVIDENCE-RM study results was recognized by the French National Authority for Health (HAS) to issue a favorable opinion on the registration of Implicity as a brand name for remote cardiac monitoring of CIED patients. The HAS decision was based on the superiority of the Implicity platform to improve the quality of patient care and lower healthcare system costs for CIED patients. Following the independent validation by HAS, Implicity has taken a decisive step towards wider adoption of its platform by healthcare systems for the benefit of patients and healthcare providers. ¹N. Varma et al., “Impact of a universal monitoring system (‘third party’) on outcomes of ICD patients: A nationwide study,” Heart Rhythm, 2024.²IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a solely means of diagnosis. It is offered to healthcare providers/professionals on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Class I, according to Medical Device Directive 93/42/EEC. See the instructions for use for more information. Covered under the conditions defined in Article L. 162-52 of the French Social Security Code.

Understanding Alert vs. Non-Alert Based Platforms in Remote Monitoring for CIEDs The type of monitoring platform used when remotely monitoring patients with cardiac implantable electronic devices (CIEDs) can significantly affect patient care. Non-alert-based platforms regularly collect and transmit data from patients’ devices, which clinicians can review during scheduled check-ups. However, without real-time alerts, this setup requires frequent manual review, which delays identifying critical health events, especially between routine appointments. Non-alert-based platforms may work well for stable patients, but timely intervention can be crucial for those with higher risk factors—and that’s where alert-based platforms excel. Alert-based platforms, such as Implicity, provide a more responsive and proactive approach to patient monitoring by automatically flagging significant changes in patient conditions in real time. These alerts are immediately sent to healthcare providers, allowing for prompt assessment and action on issues like arrhythmias or device malfunctions. This system prioritizes critical events and ensures clinicians are notified about them without needing to sift through routine data manually. Ultimately, alert-based monitoring offers a higher level of care, enabling clinics to respond faster, reduce emergency hospitalizations, and provide patients with the peace of mind that their health is continuously and actively monitored. Alert-based monitoring platforms like Implicity enhance patient care by enabling quicker detection and response to critical health events, helping to prevent emergency hospitalizations, and reassuring patients that their health is actively monitored.