IMPLICITY Raises $23M to Broaden Use of Its Cardiac Remote Monitoring Platform Series A funding round will accelerate international expansion and fuel AI-based medical algorithm development. Cambridge, Mass., April 27th, 2022 – IMPLICITY®, a leader in remote patient monitoring and cardiac data management solutions, today announced it has raised $23 million in Series A funding led by new investors: Crédit Mutuel Innovation and Bpifrance. Additional investors for the round include BNP Paribas Development and previous seed investors: Serena, XAnge and Karista. This new funding comes just months after IMPLICITY received FDA clearance for a novel AI algorithm that analyzes ECG episodes from Implantable Loop Recorders (ILRs). “This financing round marks a new and exciting chapter for IMPLICITY. With clinical staff everywhere wrestling with an increasing volume of data coming from the growing number of connected devices, the need for a universal remote platform is now widely recognized as paramount. Coverage of remote care sparked by Covid-19 set the scene. In order to democratize remote cardiac care, our mission is to provide healthcare professionals with the best technology available to scale and monitor all cardiac patients,” said Dr. Arnaud Rosier, CEO and founder of IMPLICITY. The new funding will help speed the international rollout of IMPLICITY’s AI-based technology and cardiac data management solutions — enabling healthcare professionals around the world with a more holistic approach to caring for cardiac patients. Proceeds will be used to: Increase the company’s market presence in the US and support expansion into new markets Develop additional medical device software to strengthen the technological leadership of the company “We are very pleased to support the commercial expansion of IMPLICITY’s cutting-edge platform that enables cardiologists to provide more effective patient care by streamlining data across major remote cardiac monitoring devices,” said Delphine Cardi, Investment Director at Crédit Mutuel Innovation. “The company is already on a strong growth path in the U.S. and Europe, and we look forward to building on that momentum as they continue to develop next-generation offerings that move toward the prevention of heart disease.” “We are extremely impressed by IMPLICITY’s current international market success. We believe the company has the potential to become a world-class leader in cardiac remote monitoring. This investment will help accelerate adoption across all regions in 2022 and beyond, particularly in the U.S. This is a very large market opportunity that cannot be overstated,” said Chahra Louafi, Director of the Autonomous Patient Fund at Bpifrance. About IMPLICITY®IMPLICITY® is a software company that provides a universal cardiac remote monitoring and research platform to clinics and service companies, helping them provide the best remote care to cardiac patients. As a digital Medtech, IMPLICITY® develops AI and knowledge based algorithms to reduce healthcare professionals’ workload and allows them to potentially predict patient health status. The IMPLICITY® platform aggregates, normalizes and standardizes data from all implantable cardiac electronic device across all major manufacturers. In addition to having an FDA cleared solution and multiple CE markings, IMPLICITY® has been the first private company authorized to access the Health Data Hub*, one of the world’s largest patient databases     , supporting the development of its AI solutions to improve care for patients with chronic heart failure conditions. IMPLICITY® covers more than 60,000 patients in 100 medical facilities across the United States and Europe. * Health Data Hub is a health data platform put in place by the French government to combine existing health patient databases and facilitate their usage for research and development purposes. About Crédit Mutuel Innovation Crédit Mutuel Innovation is the venture capital subsidiary of Crédit Mutuel Equity (€3.5 billion of capital under management), part of Crédit Mutuel Alliance Fédérale. It invests tickets between €1m and €20m in innovative companies in the digital, life sciences and deeptech sectors. Crédit Mutuel Innovation enables entrepreneurs to develop their growth potential by connecting them to companies in the ecosystems it belongs. Because it takes more than five years to create a world leader, Crédit Mutuel Innovation invests (and often reinvests) its own capital on a long-term basis and builds long-term relationships with the entrepreneurs it supports. About Bpifrance and FPA Bpifrance‘s equity investments are made by Bpifrance Investissement. Bpifrance finances companies—at each stage of their development—​​with loans, guarantees and equity. Bpifrance supports them in their innovation projects and internationally. Bpifrance now also ensures their export activity through a wide range of products. Advice, university, networking and acceleration programs for startups, SMEs and ETIs are also part of the offer offered to entrepreneurs. Thanks to Bpifrance and its 50 regional locations, entrepreneurs benefit from a close, unique and efficient interlocutor to support them in facing their challenges. Bpifrance’s Autonomous Patient Fund, launched in early 2018, targets startups which develop innovations that allow: Optimization of health costs—Better care by helping to strengthen the relationship between a health professional and his patient (telemedicine, remote monitoring, digital therapies), An improvement in the quality and efficiency of care, Improvements in the care pathway, in particular for chronic diseases (diabetes, cancers, mental health, etc.), by helping to prevent diseases and their complications, by facilitating the diagnosis of the disease and by monitoring its evolution over time real, in particular thanks to artificial intelligence, « deep/machine learning.”

Cardiac Remote Monitoring Research: A Clear Opportunity for Transforming Patient Care Cardiac health issues typically require frequent monitoring, regular interventions, and quick decision-making when symptoms arise, which can place significant burdens on patients.  Accessing the most appropriate care for the situation can be a major challenge for these individuals, especially those facing transportation issues, family and work obligations, or other financial stressors that influence their care choices. Fortunately, new technologies are making it much easier for cardiac patients and their providers to make timely, informed decisions and when, how, and where to seek care. Cardiac remote monitoring (CRM) tools, including connected implantable devices, external monitors, and smartphone apps, can empower patients and caregivers to monitor ongoing health, identify emerging risks, and address issues before they turn into bigger problems. With nearly half of all U.S. adults at risk of developing some form of heart disease and an estimated 6-12 million people worldwide suffering with atrial fibrillation (a common heart arrhythmia that can lead to blood clots in the heart and increase the risk of stroke and heart failure), there is a clear and pressing need to deploy robust, patient-friendly CRM tools on a much broader scale. To do so, the healthcare community must continue to engage in innovative research and develop a better understanding of how these technologies impact patient self-care, utilization of resources, and long-term health outcomes. Harnessing the growing interest in Cardiac Remote Monitoring Even before the COVID-19 pandemic, remote patient monitoring (RPM) was a hot topic for healthcare providers searching for more efficient, less intrusive ways to stay connected with patients.  Using a combination of internet-enabled devices, smartphone apps, and audio or video chats, providers were already staying connected with more than 29 million patients at the start of the pandemic. The public health crisis has only intensified interest in tech-enabled care at home.  In addition to successfully using RPM strategies to avoid hospitalizations from the virus, providers and patients are both eager to use remote care for chronic disease management without the need to meet face-to-face. As of April 2021, close to a quarter of practices surveyed by the Medical Group Management Association (MGMA) stated that they were already offering RPM to their patients.  This tracks with predictions that the remote care market will be worth a staggering $1.7 billion by 2027, representing a 128 percent increase from current levels. Building the case for wider use of remote monitoring technologies Cardiac remote monitoring is likely to represent a major segment of that dynamic marketplace.  With such strong interest and so many individuals potentially eligible for cardiac monitoring, it’s no wonder that researchers have been actively exploring the impact of CRM on patient experiences, healthcare spending, and clinical outcomes. Many recent studies agree that CRM is a safe and viable alternative to traditional care strategies, highlighting the potential for CRM to actively reduce costs, avoid hospitalizations, and engage patients in their own care. For example, the landmark ECOST study found that remote monitoring of individuals with implantable cardioverter defibrillators (ICDs) resulted in fewer major adverse events than the standard of care.  Remote monitoring also helped reduce the number of shocks delivered, including a 52 percent reduction in inappropriate shocks.  Not only did patients have a better experience with remote monitoring, but the batteries in their devices lasted longer due to less usage. Moreover, the study proved that remote monitoring decreased costs for payers. A separate study also found improved patient adherence to care with CRM. Individuals participating in remote monitoring were notably more likely to stay adherent to regular checks and scheduled follow-ups compared to people undergoing conventional care. Lastly, CRM can help to control health system spending by reducing avoidable utilization.  In a recent European multi-center trial, researchers found a 79 percent reduction in planned in office evaluations – and no increase in unplanned clinic visits – among patients who only used home monitoring to manage their conditions.  Providers also saved time with these patients. CRM slashed the length of follow-up visits in half for remote-only patients. These and other ongoing studies show that CRM is a promising way to safely and effectively improve patient experiences, but aslo avoid unnecessary costs without negatively impacting clinical outcomes. Translating knowledge into action with an innovative CRM platform As a clinician-founded and outcomes-driven member of the CRM community, Implicity is excited to see the evidence building in favor of remote care for cardiac patients.  We strongly believe that data-driven remote care is transformative for patients and their clinicians, offering the chance to get ahead of developing concerns and promoting the delivery of preventive actions. Because we are so passionate about showcasing the power of remote care for cardiac conditions, we want to do our part to support innovation and evidence-based medicine.  That’s why we are launching our first Cardiac Remote Monitoring Contest to accelerate research into this critical topic. We are offering our platform to researchers who need to collect, analyze, and report on the raw data gathered from cardiac implants. Our tools can help examine outcome data, investigate processes, analyze economic impacts, gather insight on patient experiences, and more. As interest in remote cardiac monitoring continues to increase, this is a pivotal moment for technology developers, researchers, and clinicians.  We must work together to generate successful, high-quality research that can inform proactive, effective decision-making for clinicians, healthcare executives, and patients. To meet our independent panel of judges and to apply for the contest, please click here. Arnaud Rosier, CEO of IMPLICITY®.

IMPLICITY® to Showcase New Artificial Intelligence-based Innovations in Remote Cardiac Monitoring at HRS 2022 A key highlight will include a Rhythm Theater presentation focused on the constraints and challenges of remote cardiac monitoring (RCM), as well as the impact of AI in managing ILR dataflows and transforming RCM into an opportunity for clinical research. Cambridge, Mass., April 19th, 2022  – IMPLICITY®, a global leader in remote patient monitoring and cardiac data management solutions, is showcasing its portfolio of remote cardiac monitoring solutions at the upcoming Heart Rhythm 2022 (HRS 2022) in San Francisco, California, hosted by the Heart Rhythm Society, between April 29th and May 1st, 2022.  A key highlight will be a Rhythm Theater presentation titled, “Management of CIEDs with New Remote Monitoring Features: From Standard of Care to Artificial Intelligence,” on Friday, April 29, 2022, at 2:15 pm PST in the Innovation Expo, Booth 2155.  “Using CIEDs for remote monitoring (RM) is now considered the standard of care, but they add a significant burden for clinicians because they have a high false-positive rate. Our panel session will explore how novel technologies such as AI can significantly reduce this workload and help streamline clinic workflows,” said Dr. Arnaud Rosier, Ph.D., electrophysiologist, and CEO and co-founder of IMPLICITY®. Key opinion leaders on the panel include:  Niraj Varma, MB, ChB, FACC, Professor of Medicine and Consultant Electrophysiologist at the Cleveland Clinic, who pioneered the use of remote monitoring technology for implantable devices. Varma will chair the session and discuss how artificial intelligence (AI) is transforming the management of implantable loop recorder (ILR) data. Suneet Mittal, MD, FACC, FHRS, Director of the Electrophysiology Laboratory, and Associate Chief of Cardiology at The Valley Hospital in Ridgewood, New Jersey. He will share insights on remote monitoring as a standard of care, exploring various constraints and challenges.  As part of the session, Dr. Rosier will also explain how remote patient monitoring (RPM) can support opportunities for clinical research. IMPLICITY® recently launched a unique competition offering investigators a chance to gain free access to IMPLICITY®’s platform to support their studies with support from IMPLICITY®’s team of data scientists and engineers.  IMPLICITY® announced FDA clearance for its AI-powered ILR ECG Analyzer for Implantable Loop Recorders in December 2021. The company’s full suite of innovative solutions will be on display at the HRS 2022 event at booth #1641.  About IMPLICITY®IMPLICITY® is a digital MedTech that provides a universal remote cardiac monitoring and research platform to medical centers and service companies, helping them provide the best remote care to cardiac patients. IMPLICITY® develops AI and knowledge based algorithms to reduce healthcare professionals workload and allow to potentially predict patient health status. The IMPLICITY® platform aggregates, normalizes and standardizes data from all implantable cardiac electronic device across all major manufacturers. In addition to having an FDA cleared solution and multiple CE markings, IMPLICITY® has been the first private company authorized to access the Health Data Hub*, one of the world largest patient database, supporting the development of its AI solutions to improve care for patients with chronic heart failure condition. IMPLICITY® covers more than 60,000 patients in 100 medical facilities across the United States and Europe. For more information, visit: https://patients-info.implicity.com   * Health Data Hub is a health data platform put in place by the French government to combine existing health patient databases and facilitate their usage for research and development purposes

AI Drives Adoption for Remote Patient Monitoring By drastically reducing false positives, artificial intelligence tools make remote monitoring a more practical option for cardiologists and electrophysiologists  Remote patient monitoring (RPM) tools have been around – and performing at a high level – for years. In 2015, the Heart Rhythm Society (HRS) published a Consensus Statement that bestowed remote monitoring with a Class 1A recommendation, the society’s strongest possible endorsement.   And yet, adoption of these care-enhancing solutions has been relatively slow. By 2020, only one-in-five hospitals and health clinics had already adopted remote monitoring tools.   Part of this delay is due, no doubt, to simple inertia; it’s always difficult for any industry (especially one as large and complex as healthcare) to adopt new ways of doing things. Proper integration with electronic health record (EHR) systems has been another sticking point. And RPM has also been held up by antiquated healthcare reimbursement models.   One additional factor that has created a major snag in RPM adoption is the sheer volume of data produced by remote monitoring devices, such as implantable loop recorders (ILRs).  As providers look to adopt remote monitoring at scale, they must leverage artificial intelligence (AI) tools to help them manage these new streams of patient information.   False Positives in Remote Patient Monitoring  A major problem associated with the deluge of data from RPM tools is the persistent presence of false positives. This problem is particularly acute for patients with ILRs. The devices need to be sensitive enough that they detect virtually all possible instances of a given problem – for instance, the presence of an arrhythmia. However, this sensitivity can capture a large number of events that are considered arrhythmias, that in fact, are not arrhythmias. These false positives aren’t mere annoyances, they burden clinicians with extra work, and effectively reduce the number of patients that any given clinic can support through RPM tools.  Reducing RPM False Positives with Artificial Intelligence  As healthcare providers look to scale up their use of remote monitoring, AI tools will become a crucial support solution. By running data from RPM systems through appropriate AI algorithms, clinicians can drastically reduce the number of false alarms, thus improving patient care and reducing the burden on clinical staff.   In December of 2021, Implicity announced FDA clearance for a novel AI algorithm that analyzes ECG data from Implantable Loop Recorders (ILRs). The tool, called ILR ECG Analyzer*, is an AI-based medical algorithm specifically designed to flag and remove false positives. ILR ECG Analyzer applies AI to the heart rhythm data collected from specified Medtronic LINQ models, improving the accuracy of irregular heartbeat detection and prioritizing “true” events that warrant further action.  According to a recent study published in the European Heart Journal, Implicity’s AI tool can reduce the number of ILR incidents that need review by one-third. During the study, the algorithm reduced the false positivity rate by 80 percent, while maintaining 99 percent sensitivity. Of more than 2,800 episodes processed by ILR ECG Analyzer, more than 1,200 were reclassified as normal rhythm. In a clinical setting, each of these reclassified incidents would translate to a reduction in the level of resources required to provide appropriate care.  A Path Toward an Actionable Care Model As patients and providers have adopted RPM solutions during the COVID pandemic, both groups have seen the benefits and embraced the technology. It is highly likely that adoption will continue to accelerate as people increasingly come to rely on these solutions.  In the past, patients with implantable monitors have often been seen in-person for periodic visits. However, providers are far more likely to catch a problem through the continuous use of remote monitoring. Even if a patient is not experiencing symptoms, RPM solutions can detect a condition, and clinics can bring the patient in for earlier care. In the future, we are likely to see the rise of an “actionable care” model, with reimbursement models to match. That is, patients will receive care when they need it, based on actionable alerts.   This represents a huge improvement over the way care has traditionally been delivered. And AI tools, like Implicity’s ILR ECG Analyzer will be critical to making it happen.  * FDA cleared Class II medical device and CE marked Class I (under MDD) medical device, see the instructions for use for more information.

Implicity Hosts US Research Competition for Free Access to Advanced AI-powered Cardiac Remote Monitoring Platform Clinical and academic researchers can apply for one of three spots for free access to cardiac remote monitoring and ILR ECG Analyzer to support CRM research  Cambridge, Mass., March 10th, 2022 – Implicity, a leader in AI-powered remote patient monitoring and cardiac data management solutions, today announced an invitation for US-based researchers who are looking to conduct a study in the field of Cardiac Rhythm Management to apply for free access to Implicity’s cardiac remote monitoring software, including the ILR ECG Analyzer* & Advanced Research Tool. This is an opportunity for investigators to use highly-intelligent cardiac remote care & research solutions to support their studies for a minimum of one year, with support from Implicity’s team of data scientists and engineers.  “Research is at the heart of what we do at Implicity. Our solution is already the official remote monitoring platform of one of the largest research consortiums in Europe, our goal now is to support academic medical centers, physicians, and researchers in the US as we look to improve the treatment and diagnosis of cardiovascular diseases. We are excited to host this unique research competition, provide study support through our device-agnostic platform, and learn of the findings from these studies,” said Dr. Arnaud Rosier, CEO, and founder of Implicity.  Cardiac remote monitoring has already been shown to reduce the number of unnecessary emergency department visits and improve the time to diagnose clinical events. As the adoption of RM continues to grow, more studies will be needed to measure the ongoing impact of emerging technologies and new applications. From managing patient data content forms to organizing cross-device data, the Implicity platform is an effective tool that researchers can use to drive more efficient operations while also enabling scale. Implicity’s research competition is open to physicians, medical interns, physician groups, academic facilities, PhDs, PhD students or other allied health professionals based in the United States, leading studies that involve remote monitoring data from cardiac implantable electronic devices (CIEDs), ILR ECG analysis, or other areas related to cardiac remote monitoring.  The deadline to apply is Tuesday May 10th, 2022. A panel of industry judges will make decisions shortly thereafter – the panel includes Prof. Jagmeet Singh (Boston, MA), Prof. Niraj Varma (Cleveland, OH/London, ENG) and Dr. Suneet Mittal (Paramus, NJ/New York City, NY).  Winners receive free access to Implicity’s AI-powered Cardiac Remote Monitoring platform and features, including the ILR ECG Analyzer and the Advanced Research Tool module, for a minimum of 12 months.  For application instructions and proposal requirements, visit: https://patients-info.implicity.com/landing-page/research_contest/ or reach out directly to Implicity at researchcontest@patients-info.implicity.com  About Implicity Implicity provides an AI-powered remote monitoring and research platform used by Independent Diagnostic Testing Facilities and cardiac electrophysiology centers worldwide to deliver advanced high-quality care for their patients with connected CIEDs. On this platform, Implicity 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. Implicity is the first private company authorized to access the Health Data Hub**, one of largest databases of patients with heart diseases in the world, supporting the development of its ground-breaking AI solutions. Implicity covers 70,000 patients in over 100 medical facilities across Europe and the United States. * 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 put in place by the French government to combine existing health patient databases and facilitate their usage for research and development purposes.

September is the #AFib Awareness Month What is Atrial Fibrillation? Atrial fibrillation (AF) is the most frequent cardiac arrhythmia. AF is a significant burden to healthcare professionals and society, with an increased risk of stroke and embolism. Its incidence varies with age, from 1.7% for the youngest to 23.4% for the oldest. Moreover, AF also impacts patients’ mortality, increasing with age. The use of a cardiac implantable electronic device (CIED) is familiar, and its relationship to AF has been widely described in the literature. It has been demonstrated that patients implanted with a dual-chamber pacemaker experienced AF in 75% of the cases, and 69% of the patients had AF detected by the pacemaker despite being asymptomatic. Insertable cardiac monitors (ICMs) are a solution to record a  patient’s electrocardiogram for up to several years. ICMs automatically record abnormal rhythmic episodes, such as bradycardias, tachycardias, and AF. CIEDs transmit the abnormal events by remote monitoring to the manufacturer, then transfer them to the physician. This amount of information can impact the workflow of the healthcare providers in charge of analyzing them. The main limitation is the number of false positive diagnoses classified as an AF event when it was just an artifact or noise. Remote monitoring (RM) is recommended to reduce the number of in-office follow-ups for patients with pacemakers who have difficulties attending in-office visits. RM is also utilized to detect the progression of clinical AF, monitor the atrial high-rate episodes and subclinical AF burden, and see changes in underlying clinical conditions. Implicity is committed to improving efficient and early AF detection via RM to improve patient care. Implicity’s latest science shows the performance of a novel algorithm to reduce by 79% the false positive rate of Medtronic ICM devices (HRS 2021). Moreover, Implicity developed a new AI-based algorithm allowing the reduction of false positive AF detection by 72% (ESC 2021). Implicity is involved in developing new AI solutions that save healthcare professionals time and ease the workload in patient follow-up. Jean-Luc Bonnet, Ph.D., Head of Clinical Affairs, Implicity