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.

New Study Shows Algorithm Highly Effective at Identifying Patterns and Classifying AF Episodes. Cambridge, Mass., October 24, 2023 – Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, today announced the results of a clinical study published in the Cardiovascular Digital Health Journal. The findings show Implicity’s proprietary algorithm significantly reduced the number of alerts related to transmissions by cardiac implantable electronic devices (CIEDs) in patients being remotely monitored for atrial fibrillation (AF) by filtering standard device notifications and automatically classifying episodes that meet the threshold for clinical relevance. “For a patient with AF who is already anticoagulated, a single AF episode isn’t as important as established patterns or occurrences associated with arrhythmia progression and patient outcomes. This study proved Implicity’s algorithm can reduce AF alert fatigue by effectively detecting trends, both positive and negative, and categorizing events that require intervention or adjustments in treatment,” said Jagmeet P. Singh MD MMSc DPhil The retrospective study analyzed real-life data from more than 4,000 recipients of Abbott, Biotronik, Boston Scientific, or Medtronic CIED who were being continuously monitored for AF. Implicity compared the incidence of standard CIED-transmitted alerts from device manufacturers with the incidence of events detected after filtering by Implicity’s algorithm. Results showed the algorithm broke down 67,883 AF burden-related alerts into 9,728 (14.3%) clinically relevant AF events, according to the European Society of Cardiology classification. Notably, the median number of alerts per patient year decreased by 57.9%. “Sending physicians only clinically relevant alerts, based on the detection of distinct presentations of AF, can reduce the time electrophysiologists spend reviewing notifications that don’t require action by several hours. This will increase the efficiency and quality of care of patients with AF, save time for the medical staff, and help promote the adoption of RPM – leading to more meaningful remote monitoring and ultimately better outcomes,” said Dr. Arnaud Rosier, electrophysiologist, CEO, and co-founder of Implicity. Continuous remote monitoring is critical for properly managing patients with AF. It allows providers to track patients’ heart rhythms for early intervention and treatment, reducing complications such as stroke and heart failure. Yet a previous study published in European Heart Journal showed that atrial arrhythmia episodes account to up to 51% of the events clinicians are expected to review, suggesting that tackling these alerts could significantly reduce the alert burden. Implicity’s algorithm works with any device that collects atrial burden trends data and can classify the following scenarios in line with ESC recommendations: Paroxysmal AF Persistent AF Increasing paroxysmal AF Back to sinus rhythm Back to paroxysmal AF 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. To learn more, visit www.implicity.com*CE marked class I medical device (MDD); 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.  

Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer Cambridge, Mass., September 27, 2023 – Implicity®, a leader in remote patient monitoring and cardiac data management solutions, announced that Jon Hunt, PhD., has joined the company as its new Chief Commercial Officer (CCO) in North America. In this role, Hunt will focus on business and sales strategies for the U.S. market to maximize growth, scale operations, and support technological innovations that help meet the growing demand for remote cardiac monitoring. Hunt brings nearly four decades of experience in the cardiovascular medical device industry. Most recently, Hunt served as Executive Vice President and Chief Business Officer at HeartBeam (NASDAQ: BEAT), a cardiac technology company that developed the first 3D vector ECG platform for heart attack detection. As a vital member of the senior leadership team, he played a critical role in taking the company public. Prior to HeartBeam, Hunt held multiple leadership positions at organizations such as the Medical Device Innovation Consortium (MDIC), Cryterion Medical, and Cameron Health. In addition, he served as President and CEO of Bardy Diagnostics,  whose novel ECG monitoring system achieved US and European approval under his leadership.  Hunt began his career with Cardiac Pacemakers (now Boston Scientific Corporation) as the Director of Clinical Programs. “Having an executive of Jon’s caliber and experience is key to achieving our goal of becoming the leader in remote cardiac monitoring in the US market.  Jon brings extensive experience in the CRM/EP market and a proven track record of scaling startup companies and building commercial teams. We look forward to his guidance and expertise as we continue to build on our successes and provide healthcare professionals nationwide with more effective solutions for managing heart disease,” said Dr. Arnaud Rosier, electrophysiologist, CEO, and founder of Implicity. Hunt joins Implicity as the company hits several critical business inflection points. Implicity recently submitted for US FDA clearance for a machine learning algorithm that can predict acute heart failure, the world’s leading cause of hospitalization. In May, Implicity revealed ground-breaking research demonstrating its AI-powered solutions significantly improve outcomes for patients with cardiac implantable devices. This as the U.S. market for remote patient monitoring has experienced significant growth. According to recent reports, the industry is expected to reach a value of more than $25 billion by 2028. “I could not be more excited to join the Implicity team at this important juncture,” said Hunt. “I’ve witnessed firsthand the healthcare ecosystem’s need for innovative solutions that can enable providers to monitor remote cardiac devices more effectively and analyze massive volumes of cardiac data more efficiently. The company and its AI-powered technology are poised to revolutionize cardiology care delivery and improve the lives of millions of people around the globe.” About Implicity Implicity is a digital MedTech software company that provides the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by Cardiac Electrophysiologist Arnaud Rosier, MD, Ph.D., the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants. 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. To learn more, visit www.implicity.com * 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.