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Anthos Therapeutics Announces ~84% of Eligible Patients Have Transitioned to Abelacimab in the AZALEA-TIMI 71 Extension Study of Atrial Fibrillation Patients at a Moderate-to-High Risk of Stroke

Rhythm by Comments are Disabled

75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study. When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment. “The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr. Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women’s Hospital, Senior Investigator of the TIMI Study Group, an Associate Member of the Broad Institute of MIT and Harvard, and an Associate Professor of Medicine at Harvard Medical School. The initial results of the AZALEA-TIMI 71 study1 of patients with atrial fibrillation at moderate-to-high risk of stroke were presented at the American Heart Association 2023 scientific congress during a late-breaking session. For the primary endpoint, abelacimab 150 mg dosed once-monthly, demonstrated a highly significant 67% reduction in major or clinically relevant non-major bleeding.1 In addition, there was a substantial 74% reduction in major bleeding alone and a 93% reduction in gastrointestinal (GI) bleeding, all favoring abelacimab over rivaroxaban, a standard-of-care anticoagulant.1 “We are very pleased that the open-label extension of the AZALEA-TIMI 71 study has completed its transition phase and that the vast majority of eligible patients voluntarily opted to receive abelacimab 150 mg once-monthly moving forward,” said Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. “Too many patients with diagnosed atrial fibrillation are not receiving an anticoagulant today or are taking an inappropriate dose, due to the risk or fear of bleeding, the possibility for drug-drug interactions, dosing complications due to age or renal status or just because they forget to take their daily medication. If approved, it is our hope that abelacimab will provide patients with the protection they need against blood clots, but with a placebo-like bleeding profile.” Atrial fibrillation, or AF, is the most common type of irregular heart rhythm. The most severe complication of AF is stroke,2 which can be prevented by taking an anticoagulant, or “blood thinner.” The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 However, data from multiple patient registries and claims-based data analyses highlight that approximately 40% to 60% of patients with atrial fibrillation are either not on an anticoagulant or are receiving a sub-therapeutic dose and are thereby not benefiting from the protection that anticoagulants provide. This underuse of anticoagulants has been cited as one of the greatest public health issues facing cardiovascular patients.4 About Abelacimab Abelacimab is a highly selective, fully human monoclonal antibody that binds to FXI and locks it in the inactive state, preventing the formation of activated FXI (FXIa). As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status. Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.5 Abelacimab is the only Factor XI inhibitor being studied for both conditions. In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.1 In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the AZALEA-TIMI 71 Phase 2 Study The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily. With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:1 Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P

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RapidAI Wins 2024 MedTech Breakthrough Award For “Best Care Coordination Platform”

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LOS ANGELES, June 06, 2024 (GLOBE NEWSWIRE) — MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies, and products in the global digital health and medical technology market, today announced that RapidAI, the global leader in developing Artificial Intelligence (AI) and clinical workflow solutions to combat life-threatening neurovascular, cardiac, and vascular diseases, has been selected as the winner of the “Best Care Coordination Platform” award in the 8th annual MedTech Breakthrough Awards program. The 2024 MedTech Breakthrough Award recognizes the breakthrough innovation of the RapidAI Clinical Platform, a proven solution that provides clinicians from thousands of hospitals in over 100 countries with deep clinical context to make faster and more informed treatment decisions while also enhancing their confidence in diagnosis. By opening up the care pathway through the power of AI and enhanced connectivity, RapidAI transforms the quality of care delivered to patients by facilitating faster, more informed decision-making. “RapidAI’s Clinical Platform moves the needle by pairing together the most clinically validated deep AI algorithms with workflow efficiencies that take the friction out of the healthcare system, making it our ‘Best Care Coordination Platform’ for 2024,” said Steve Johansson, managing director of MedTech Breakthrough. “The workflow efficiencies and connectivity that RapidAI enables ensures that every patient, no matter where they go for care, has access to the most trusted technology and clinical specialists – all while delivering measurable financial and operational impact.” According to the World Stroke Organization (WSO), over 100 million people in the world have experienced a stroke, of which over half will die as a result. On top of this, the WSO estimates 143 million healthy years of life are lost for those who do survive. For stroke patients alone, RapidAI’s technology has been shown to reduce both length-of-stay and non-fatal complications, increase mechanical thrombectomy procedure volume, reduce the number of costly futile transfers, and give radiologists and hospital staff valuable time back through its cutting-edge AI and workflow solution. “We are honored that the RapidAI Clinical Platform has been recognized by MedTech Breakthrough for the care orchestration and workflow efficiencies that it enables,” said Karim Karti, CEO of RapidAI. “By enhancing cross-department collaboration and team communication, the RapidAI Clinical Platform benefits care teams by fostering prompt collaboration and mitigating wasted time and resources. Our commitment to delivering clinical, financial, and operational excellence in advanced artificial intelligence distinguishes our platform from other healthcare AI imaging solutions in neurology, cardiology, and beyond. ” The mission of the MedTech Breakthrough Awards is to honor excellence and recognize innovation, hard work, and success in a range of health and medical technology categories, including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices, Medical Data & Privacy, and many more. This year’s program attracted thousands of nominations from over 18 different countries throughout the world. About MedTech BreakthroughPart of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com.  Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose. About RapidAIRapidAI is the global leader in AI imaging analysis and clinical decision support, leading the next evolution in patient workflow technology and clinical decision-making. The company has helped set a new standard for stroke care with its presence in over 2,200 hospitals across more than 100 countries. Its clinically deep AI technology has played a pivotal role in over 25 clinical trials worldwide, 350 publications, and 11 NEJM articles, and was instrumental in changing the guidelines for stroke care. Today, the company continues to transform the clinical landscape by enhancing operational efficiency for improved patient outcomes in stroke care and beyond. This includes empowering healthcare professionals to make confident decisions, driving better operational performance, and providing tangible financial ROI – all while ensuring that every patient, regardless of their entry point into the healthcare system, has access to world-class technology and clinical expertise.

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ECHO IQ TECHNOLOGY CHAMPIONED IN INDEPENDENT SCIENTIFIC REVIEW

Coronary/Structural Heart by Comments are Disabled

Echo IQ’s EchoSolv-AS decision-support software for cardiology delivers significant potential benefits to hospital networks according to independent scientific presentation at prestigious New York Valves scientific conference.
NEW YORK, June 6, 2024 /PRNewswire/ — At the Structural Heart Summit New York Valves earlier today, Dr. Pedro Covas (Baylor Scott & White, The Heart Hospital Plano TX) delivered the scientific presentation: AI-Powered Cardiac Ultrasound Improves Identification of High-Risk Aortic Stenosis (Echo IQ).
Dr. Covas highlighted the unmet need for an AI system for aortic stenosis – a form of heart valve disease characterised by high rates of mortality when untreated. He revealed that the condition is underdiagnosed and undertreated worldwide, partly due to the complexity in the diagnosis of severe aortic stenosis (including low-flow states), and that there is a need for assistance to improve rates of diagnosis. As backed up by the research presented by Dr. Covas, Echo IQ uses artificial intelligence to aide in identifying a high-risk phenotype of aortic stenosis, to ultimately help with timely diagnosis and treatment.
LEARN HOW ECHO IQ USES AI TO SUPPORT ENHANCED DISEASE DETECTION:
The independent research presented by Dr. Covas considered whether artificial intelligence could improve accuracy and reproducibility of diagnosis of severe aortic stenosis in a real-world hospital setting. To test this, Echo IQ’s technology (EchoSolv) was applied to the echocardiographic report data of one of Baylor Scott & White’s leading academic heart hospitals over a 7-month period with a subset of the assessments adjudicated via comprehensive image review by expert cardiographers.
The findings showed EchoSolv to be successful in identifying more patients at risk of aortic stenosis than human-only diagnosis. Specifically,

EchoSolv accurately identified 15% more patients with severe aortic stenosis than human-only diagnosis
Where initial underdiagnosis occurred, patients were found to have a “low flow” state of disease in 30% of cases (subsequently identified by EchoSolv)

The research concluded that:

Echo IQ’s technology can automatically identify aortic stenosis patients at-risk using only echocardiographic measurement data.
Echo IQ’s technology has the potential to improve diagnostic rates of severe aortic stenosis, particularly in low flow states.
There are important implications for less specialized cardiology centers, where echocardiographers are likely to benefit the most from automated diagnosis of severe AS.

Echo IQ Chief Medical Advisor, Professor David Playford said: “This kind of independent research demonstrates exactly how Echo IQ’s artificial intelligence can help healthcare professionals identify patients with severe cases of aortic stenosis as well as those with significant risk of disease. Diagnosing aortic stenosis accurately, and in a timely fashion, is extremely complex and the findings shared by Dr. Covas show clearly how Echo IQ’s artificial intelligence can help improve clinical performance.”
About Echo IQ
Echo IQ uses artificial intelligence for decision support in structural heart disease. The company’s first fully AI-enabled solution has been submitted for final FDA clearance. The company is headquartered in Sydney, Australia and is publicly listed on the Australian Securities Exchange (ASX:EIQ). Don Fowler is President, Echo IQ USA, and is based in Austin, TX.
SOURCE Echo IQ Limited

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ACSD Granted Significant Telemedicine Patent

Rhythm by Comments are Disabled

IRVINE, Calif., June 5, 2024 /PRNewswire/ — ACS Diagnostics, Inc. of Irvine CA, with executive offices in Chattanooga TN, has been granted U.S Patent No. 11,980,452. The patent relates to ACSD’s Cardiac Monitoring CORE technology, specifically ambulatory ECG. The patented CORE device provides for multiple telemedicine related tests , including ECG/EKG, Holter, Event, and Mobile Cardiac Telemetry. The Core monitor integrates a cell phone module to alleviate the necessity for a companion phone for patient transmissions.
This is the fifth CORE technology patent, and relates to a single cardiac monitoring device offering to perform more than one of the above mentioned test modalities. The Core monitor is the only telemedicine device that is patented to offer the worldwide cardiology community all these tests within a one device. With this patent, the days of a provider needing to purchase a different monitor for each test are over.
This technology, and all related test modalities, are being successfully used by thousands of US customers, transmitting ECG patient data 24/7 to our California based IDTF laboratory. The ACSD IDTF laboratory is completely staffed with cardiac technicians to monitor patients and alert physicians to significant cardiac events.
A number of companies provide products for this market, including GE Healthcare, Medtronic, BioTelemetry / Philips, Boston Scientific, Samsung, Hill-Rom, IRhythm Technologies, Johnson & Johnson, OSI/Spacelabs, and a host of smaller players.
ACSD respects intellectual property rights and has a growing portfolio of patents, which are listed at www.ACSD4u.com/patents. ACSD firmly believes in innovation through research and development, and it will vigorously enforce its intellectual property rights.
SOURCE ACS Diagnsotics

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First-in-Human Data for Sensome Clot-Sensing Guidewire Used in Ischemic Stroke Treatment Demonstrate Ability to Automate Clot Characterization With No Safety Issues

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PARIS–(BUSINESS WIRE)–Sensome, the pioneer of microsensing technology for instant intra-operative tissue analysis, today announced positive results from its first-in-human CLOT OUT clinical trial evaluating the safety and performance of its Clotild® Smart Guidewire System used during mechanical thrombectomy treating ischemic stroke. The results showed that the technology met all primary […]

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Prevencio Selected for Prestigious MedTech Innovator 2024 Accelerator Cohort

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KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., a leader in AI-powered blood tests for cardiovascular diagnostics, has been selected to join the 2024 Accelerator Cohort of MedTech Innovator, the world’s largest accelerator for medical technology companies. This honor places Prevencio among the top 5% of 1,300 applicants, reflecting the company’s innovative approach to […]

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AliveCor’s AI-backed ECG Offerings Featured in New Film Series on Innovative Technologies Presented by the Consumer Technology Association

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The Human Component series, produced by BBC StoryWorks Commercial Productions, is now available to stream 
MOUNTAIN VIEW, Calif., June 5, 2024 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced its participation in The Human Component, a new online branded series developed for the Consumer Technology Association (CTA) and produced by BBC StoryWorks Commercial Productions, the commercial content division of BBC Studios.
The series showcases innovative technologies that are supporting healthier communities, stronger societies and a more resilient planet. Through compelling, human-led films, The Human Component celebrates global efforts to maximize the full potential of technology.
“We are incredibly proud to take part in The Human Component alongside innovators who are just as committed to introducing game-changing ideas to improve lives as we are,” said Priya Abani, CEO of AliveCor. “The series beautifully depicts the real-life impacts of technologies like our AI-backed ECG solutions and services, and how they are helping transform society for the better.”
AliveCor’s film shares the story of Dr. Cleveland Francis, a cardiologist and musician who was diagnosed with a heart condition after collapsing at home. After his episode, Dr. Francis used one of AliveCor’s FDA-cleared Kardia™ devices to take a real-time, clinical-grade ECG that he shared with his doctor, leading to a definitive diagnosis. Capable of remotely identifying six of the most common arrhythmias in just 30 seconds, Kardia personal ECGs place the power of advanced AI technology directly into users’ hands. They also offer healthcare providers a way to capture patients’ elusive arrhythmias, contributing to earlier diagnoses and improving clinical decision-making.
This is the second series that BBC StoryWorks has created for CTA, a trade association that brings together companies that improve lives through technology. By highlighting how innovators across industries are advancing groundbreaking new technologies, The Human Component explores how we can solve some of the most pressing challenges facing the world today.
To learn more, watch AliveCor’s full film at alivecor.com/cleveland-cardiology-ai.
About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.
SOURCE AliveCor, Inc.

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First Commercial Use of Baylis Medical Technologies’ PowerWire® Pro for In-Stent Restenosis

Peripheral/Endo by Comments are Disabled

MISSISSAUGA, ON, June 5, 2024 /PRNewswire/ – Baylis Medical Technologies today announced the completion of its first clinical use of the PowerWire® Pro Radiofrequency (RF) Guidewire to safely cross a chronically occluded peripheral stent.

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Photograph of Dr. Iafrati and his team holding up a PowerWire® Pro box after their successful case. (CNW Group/Baylis Medical Technologies Inc.)

The procedure was performed in April 2024, by Mark Iafrati, MD, Professor of Vascular Surgery in Nashville, TN. The patient was suffering from a chronically occluded stent that extended from the inferior vena cava (IVC) down to the left common iliac vein. Previous attempts to cross the occlusion with mechanical tools were unsuccessful, likely owing to the dense fibrotic nature of the occlusion. The patient was brought back and Dr. Iafrati performed the procedure with the PowerWire Pro RF Guidewire, which utilizes RF energy to vaporize a channel through occlusions, allowing for successful crossing and subsequent revascularization of the iliocaval stent. 

“This marks a significant advancement in the treatment of patients with in-stent restenosis”, commented Dr. Iafrati. “I was able to easily cross the occluded stents with the PowerWire Pro RF Guidewire when my standard tools had failed.”
This spring, the FDA cleared Baylis Medical Technologies’ PowerWire Pro RF Guidewire, a device designed to cross occluded peripheral vessels, including those with stents, using radiofrequency technology.Frank Baylis, Executive Chairman of Baylis Medical Technologies, expressed enthusiasm about the PowerWire® Pro RF Guidewire’s potential impact, stating, “This innovation aims to simplify the often challenging and time-consuming process of crossing chronic occlusions in revascularization procedures, ensuring uninterrupted patient treatment.”
About Baylis Medical Technologies Inc.
Baylis Medical Technologies seeks to improve the lives of patients through the conception and commercialization of state-of-the-art medical devices. The company proudly carries forward Gloria Baylis’ legacy to enhance access to care through its divisions of Endovascular and Design and Manufacturing Services. Baylis Medical Technologies’ clinical solutions are utilized by healthcare professionals worldwide to improve patient outcomes for individuals with cardiovascular and other medical conditions. Learn more about our innovative products and ongoing mission at www.baylismedtech.com.For any inquiries, please contact [email protected] or call 1-888-505-4885

PRM-00910 J-1 V-1 © Baylis Medical Technologies Inc., 2024. PowerWire is a trademark and/or registered trademark of Baylis Medical Technologies Inc. in the United States and other countries. Baylis Medical Technologies Inc. reserves the right to change specifications or to incorporate design changes without notice and without incurring any obligation relating to equipment previously manufactured or delivered. Patents Pending and/or issued. CAUTION: Federal Law (USA) restricts the sale of these devices to or by the order of a physician. Before use, consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.

SOURCE Baylis Medical Technologies Inc.

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Nanox Launches Artificial Intelligence Functionality in Second Opinions Platform

Radiology by Comments are Disabled

Nanox integrates FDA-cleared population health AI solutions into its Second Opinions service New AI capabilities available to patients who submit chest and abdominal CT scans for second opinions Offering the power of Artificial Intelligence to their second opinion CT report to promote early detection of chronic conditions PETACH TIKVA, Israel, June 05, 2024 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., has launched an artificial intelligence (AI) functionality in the Second Opinions online medical consultation service. Second Opinions is a platform provided by USARAD Holdings INC, a subsidiary of Nano-X Imaging Ltd., that provides teleradiology services. The platform connects patients with radiologists and other subspecialty physicians for additional consultation on their medical diagnoses. Second Opinions has integrated three of Nanox.AI’s FDA 510(k)-cleared AI solutions, enabling patients to conveniently get second opinions from experts in various medical and surgical subspecialties including radiology, neurology, oncology and orthopedic surgery. The integration of Nanox.AI’s tools is intended to promote the early detection of chronic conditions on chest and abdominal CT scans: AI Cardiac solution (HealthCCSng) detects coronary artery calcium, an early sign of coronary artery diseaseAI Bone solution (HealthOST) assesses bone mineral density, and highlights vertebral spine compression fractures which can indicate risk of osteoporosisAI Liver solution (HealthFLD) measures liver density, which can indicate fatty liver disease These AI-driven insights are reviewed and approved by Second Opinions physicians and incorporated into reports for patients who submit eligible chest and abdominal CT scans. “We are excited to bring AI-powered, early detection through the Second Opinions platform to patients seeking peace of mind concerning their health and diagnoses,” said Erez Meltzer, Nanox Chief Executive Officer. “The integration of Nanox.AI’s solutions into the Second Opinions service will help empower radiologists and other healthcare providers by providing them with advanced AI tools that aim to improve patient outcomes. We will continue exploring opportunities to leverage our AI technology to promote accessible early diagnosis and preventative management.” Learn more about Second Opinions and its new AI capabilities at Artificial Intelligence (AI) Service – Second Opinions. About USARADUSARAD is a U.S.-based teleradiology company with a network of radiologists, certified by the American Board of Radiology. USARAD provides imaging interpretation and database services to radiology practices, hospitals, medical clinics, diagnostic imaging centers, urgent care facilities and multi-specialty physician groups in the U.S and additional countries, improving service levels, streamlining practice economics and enhancing physician efficiency. About Nanox.AINanox AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI technology, Nanox AI helps clinicians extract valuable and actionable clinical insights from routine medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit https://www.nanox.vision/ai. About NanoxNanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox’s vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox’s products and services create a worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision. Contacts Media Contact:Ben ShannonICR WestwickeNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Westwickemike.cavanaugh@westwicke.com

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Eko Health Raises $41 Million to Scale AI-Driven Heart and Lung Disease Detection

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Supporting more than 500,000 U.S. healthcare professionals, Eko combines FDA-cleared algorithms with digital medical devices to enhance the early detection of cardiac and pulmonary diseases during physical exams.SAN FRANCISCO, June 5, 2024 /PRNewswire/ — Eko Health, a pioneer in applying artificial intelligence for early detection of heart and lung diseases, today announced it has raised $41 million in Series D financing. With participation by ARTIS Ventures, Highland Capital Partners, NTTVC, and Questa Capital, the funding round will be used to expand U.S. and global access to the company’s early disease detection platform.

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Supporting more than 500,000 U.S. healthcare professionals, Eko combines FDA-cleared algorithms with digital medical devices to enhance the early detection of cardiac and pulmonary diseases during physical exams.

The funding builds on recent commercial and clinical milestones, including U.S. FDA clearances for its structural heart murmur and low ejection fraction (Low EF) detection algorithms. Eko’s murmur detection algorithm was clinically validated in a Massachusetts General Hospital study and found to double identification rates of structural heart murmurs versus conventional practice in primary care. The low EF detection algorithm, developed with Mayo Clinic, was shown in an Imperial College London study to significantly enhance the identification of heart failure with reduced ejection fraction in GP clinics. By enhancing detection capabilities, Eko’s platform significantly reduces diagnostic bottlenecks, leading to earlier interventions and improved patient outcomes.

“Eko harnesses AI to unlock universal access to expert-level cardiac and pulmonary disease detection for patients everywhere,” said Connor Landgraf, CEO and co-founder of Eko Health. “Just as Ring transformed doorbells into home security systems, Eko has reinvented the world’s most ubiquitous medical tool into a powerful early disease detection platform, creating the world’s largest install base of professional AI-enabled cardiology devices.”
Cardiovascular and pulmonary diseases are among the leading causes of death worldwide, underscoring the critical need for early detection. Millions of patients remain unaware of their risk factors, often due to limited access to effective detection tools. Eko is addressing this gap by introducing sophisticated detection capabilities into any physical exam — from primary care exams at NCH Healthcare System in the U.S. to maternal-fetal health exams in Nigeria.”Eko has spent the past decade building an unparalleled dataset of digital heart and lung sounds, which it leverages to develop clinical AI for the physical world,” said Vas Bailey, PhD, Chair of the Board at Eko Health and Partner at ARTIS Ventures. “Like countless others, I lost a parent much too early to undetected heart disease. I am deeply inspired by the team’s dedication to saving lives by equipping hundreds of thousands—and soon millions—of clinicians worldwide with our groundbreaking early detection platform.”Eko will use the new capital to deepen its presence in the U.S. and accelerate its expansion into key international markets, supported by new strategic investments from Double Point Ventures in the U.S., Singapore-based global investor EDBI (the corporate investment arm of the Singapore Economic Development Board), and LG Technology Ventures, backed by the LG Group of South Korea. With the new funding and regulatory clearances, Eko is poised to rapidly expand access to its AI-enabled cardiac and pulmonary disease detection platform, empowering millions of healthcare professionals to improve patient outcomes in the coming years.About Eko HealthEko Health is a leading digital health company advancing how healthcare professionals detect and monitor heart and lung disease with its portfolio of digital stethoscopes, patient and provider software, and AI-powered analysis. Its FDA-cleared platform, used by over 500,000 healthcare professionals worldwide, allows them to detect earlier and with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. Eko Health is headquartered in Emeryville, California, with over $165 million in funding from ARTIS Ventures, DigiTx Partners, Double Point Ventures, EDBI, Highland Capital Partners, LG Technology Ventures, Mayo Clinic, Morningside Technology Ventures Limited, NTTVC, Questa Capital, and others.Media Contact:Sam Moore[email protected]SOURCE Eko Health

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