Implicity’s EVIDENCE-RM Study Demonstrates Marked Improvement in ICD Patient Outcomes Comprehensive analysis of real-world data shows significant clinical and medico-economic advantages of Implicity’s universal, alert-based remote monitoring platform. Cambridge, Mass., April 24, 2025 – IMPLICITY®, a leader in remote patient monitoring and cardiac data management solutions, today unveiled new findings from its EVIDENCE-RM study¹. Leveraging extensive data from the French National Health Data System (SNDS), the study demonstrated clear clinical and medico-economic benefits associated with Implicity’s universal monitoring system (UMS) compared to conventional, manufacturer-specific systems, including Abbott, Biotronik, Boston Scientific, and Medtronic. The study, recently published in Heart Rhythm, analyzed clinical outcomes and costs for over 69,000 patients with implantable cardioverter-defibrillators (ICDs) and defibrillators with cardiac resynchronization therapy (CRT-Ds). Patients remotely monitored using Implicity’s platform showed increased survival rates and a reduction in both the number and duration of all-cause and heart failure-related hospitalizations, resulting in substantial healthcare cost reductions. Key findings attributed to Implicity’s IM009² platform include: 26% reduction in mortality (HR, 0.74; 95% CI, 0.73–0.77; P=.001) 4% decrease in HF hospitalizations, total corrected healthcare costs, and mean duration of hospitalization 8% decrease in hospital-related costs, primarily driven by decreased costs in cardiovascular disease care Incremental Cost-Effectiveness Ratio (ICER) of approximately -$112 USD (-103€) per Day Alive and Out of Hospital (DAOH) based on the French Healthcare System “Managing patients with ICDs and CRTs presents considerable challenges, since they are at high risk of hospitalization due to arrhythmias and heart failure, » said Dr. Niraj Varma, Professor of Medicine and Director, Cardiac Pacing & Tachyarrhythmia Devices at the Cleveland Clinic. « The EVIDENCE-RM study clearly demonstrates that a universal monitoring solution operating alert-based remote monitoring can significantly reduce these risks, improving patient outcomes and substantially lowering healthcare costs. This is an important advancement in our ability to proactively manage patients with ICDs and CRTs.” « These findings mark a pivotal moment in remote cardiac care and prove Implicity’s effectiveness with unparalleled clinical results, » stated Implicity CEO Dr. Arnaud Rosier. « A 26% reduction in mortality and better use of healthcare resources highlight the impact of universal remote monitoring, driven by AI, over fragmented manufacturer-specific systems. Implicity is committed to driving innovation so that every cardiac patient receives proactive, efficient care.” About Implicity Implicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure. Implicity’s platform provides critical health information augmented by FDA-cleared AI³ algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes. With access to the Health Data Hub, one of the world’s largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 100,000 patients in over 200 medical facilities across the US and Europe. Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes References Varma et al., “Impact of a universal monitoring system (‘third party’) on outcomes of ICD patients: A nationwide study,” Heart Rhythm, 2024. IM009: 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. IM007: 2021. ILR ECG ANALYZER created by Implicity is intended to be used by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. ILR ECG ANALYZER supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the ILR ECG ANALYZER only supports ECG data from Medtronic ICMs. ILR ECG ANALYZER is intended to be electronically interfaced with other computer systems (remote monitoring platforms) that supply the ECG data to ILR ECG ANALYZER and receive the output of ILR ECG ANALYZER (analysis) for viewing by healthcare professionals. ILR ECG ANALYZER provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifacts. ILR ECG ANALYZER is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. ILR ECG ANALYZER interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. ILR ECG ANALYZER is interfaced with the compatible remote monitoring platform from which it receives compatible ICM data file input (Medtronic LNQ11 Medtronic REVEAL XT 9529 Medtronic REVEAL DX 9528) and to which it transmits the output. Read carefully all instructions

Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling medical teams to intervene and avoid hospitalization.  Cambridge, Mass., May 17, 2024 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new groundbreaking algorithm, SignalHF*, used in its remote monitoring solution.  Implicity was the first private company authorized to access the Health Data Hub, one of the largest databases of patients with heart diseases in the world. Based on the Health Data Hub complete medico-administrative database and comprehensive datasets from Implicity’s AI-based remote monitoring platform, the Implicity team trained and validated a machine learning algorithm that assesses the risk of future heart failure events, enabling physicians to intervene before a patient requires hospitalization.  “Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalizations each year. Preventing even a portion of these would be a game-changer in cardiac care,” said Dr. Arnaud Rosier, Implicity’s CEO and cardiologist.  “SignalHF is an innovative and effective tool that physicians can use to assess risk of hospitalization due to heart failure earlier, enabling interventions that can lead to better outcomes and reduce hospital admissions.”  SignalHF is unique in that the manufacturer-agnostic solution can be used to analyze data collected from a variety of Cardiac Implantable Electronic Devices (CIED), including implantable cardiac defibrillators (ICD), pacemakers (PM) and cardiac resynchronization therapy devices (CRT-P, CRT-D) from Biotronik, Boston Scientific and Medtronic. SignalHF is the first pacemaker compatible heart failure algorithm on the market. The algorithm can accurately identify trends indicating whether a patient’s condition is worsening. Care teams receive an automatic alert when the patient’s risk score crosses an established threshold, indicating an individual is at high risk of experiencing heart failure and being hospitalized in the near future.   “Comprehensive heart failure management includes treatment, prevention, and personalization. Implicity’s solution is part of this approach. Our alerts are generated in context with a patient’s medical profile to help personalize care management plans. Furthermore, 75% of the alerts preceding a patient hospitalization are sent at least 14 days in advance  – offering a two-week window to adjust medications or take proactive measures,” said Issam Ibnouhsein, Head of Data at Implicity. About ImplicityImplicity provides a remote monitoring and research platform used by Independent Diagnostic  Testing Facilities and cardiac electrophysiology centers to deliver better, high-quality care for their patients with Cardiac Implantable Electronic Devices. Implicity’s platform aggregates, normalizes, and standardizes data from any implantable cardiac device  across all manufacturers. Furthermore, Implicity carries out R&D on AI-based algorithms aiming  at improving patient care and serving the future of preventive medicine. www.implicity.com    *SignalHF is an FDA-cleared Class II medical device. See the instructions for use for more information.

Implicity Joins the AWS ISV Accelerate Program Cambridge, Mass., December 12, 2023 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has joined the Amazon Web Services (AWS) Independent Software Vendor (ISV) Accelerate Program, a co-sell program for AWS partners that provide software solutions that run on or integrate with AWS. The program helps AWS partners drive new business by directly connecting participating ISCs with the AWS Sales organization. “This is an important milestone that amplifies our reach and validates our mission to bring digital innovation to cardiology. By deepening our relationship with AWS, we can help even more clinicians improve cardiac care by delivering cutting-edge solutions that enable more efficient and effective remote monitoring,” said Jon Hunt, PhD., Implicity’s Chief Commercial Officer in North America. Implicity’s AI-powered* platform allows healthcare professionals to better manage the growing streams of patient information produced by cardiac implantable electronic devices (CIEDs), such as pacemakers and implanted defibrillators. The solutions can also interpret data and automatically alert care teams when intervention is required. The AWS ISV Accelerate Program provides Implicity with co-sell support that benefits to meet customer needs through collaboration with AWS field sellers globally. Co-selling provides better customer outcomes and assures mutual commitment from AWS and its partners. « Before Implicity, our team would have spent hours weeding through alerts and reports. This would have delayed the treatment of patients with clinically significant events or critical episodes. Additionally, their customer support and service have been second to none. They are truly dedicated to helping clinicians streamline their care and optimize their workflow. This system is life-changing, » said Dan Morris, Device Clinic Lead at the Heart Center of Nevada. AWS ISV Accelerate program members are held to the industry’s highest standards. To gain acceptance into the AWS ISV Accelerate Program, proof of customer excellence was required to validate the success users have experienced using the technology. Implicity also had to pass a rigorous technical and security review of its platform to ensure the quality and design of its solutions. The program gives Implicity-focused co-selling support and access to expanded sales enablement resources from AWS. It also provides technical enablement and business resources to enhance Implicity’s offerings and drive innovation. About Implicity Implicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure. Implicity’s platform provides critical health information augmented by FDA-cleared AI* algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes. With access to the Health Data Hub**, one of the world’s largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 94,000 patients in over 195 medical facilities across the US and Europe. *FDA cleared Class II medical device, and CE marked Class I (under MDD) medical device; see the instructions for use for more information.**Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes.