Latest news with #HARTCADhs
Business Wire
10-06-2025
- Business
- Business Wire
Prevencio Awarded U.S., European and Japanese Patents for HART CADhs, Its AI-Driven Blood Test for Coronary Artery Disease
KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular disease, today announced that it has been granted patents for its HART CADhs® test in the United States—marking the second U.S. patent for this novel test—as well as the European Union and Japan. These patents protect Prevencio's proprietary methods and algorithms for detecting obstructive coronary artery disease (CAD) using a multi-protein, AI-driven blood test platform. The newly issued patents strengthen Prevencio's intellectual property portfolio and support its long-term strategy to expand HART CADhs adoption globally. HART CADhs is the only blood test that combines multiple cardiac proteins with machine learning to deliver a highly accurate, non-invasive diagnosis of obstructive CAD. 'Securing patent protection in the U.S., Europe, and Japan marks a major step forward in advancing our innovation and market leadership,' said Rhonda Rhyne, Chief Executive Officer of Prevencio. 'These patents reinforce the uniqueness of our HART CADhs test and underscore our commitment to improving cardiovascular diagnostics worldwide.' Prevencio is redefining the future of cardiovascular diagnostics. With two marketed, AI-driven blood tests—HART CADhs and HART CVE—and bolstered by international patent protection, compelling clinical data, reimbursement, and recent FDA Breakthrough Device Designation, Prevencio uniquely delivers a convergence of innovation, validation, and commercial readiness. 'Cardiovascular disease is a global problem. International patent protection will help Prevencio to deliver scalable solutions that meet urgent diagnostic needs in the U.S. as well as global markets,' said James L. Januzzi, MD, a practicing cardiologist at MGH, Professor of Medicine at Harvard Medical School, Chief Scientific Officer at the Baim Institute for Clinical Research and Principal Investigator for the HART test development and validation. Cardiovascular disease remains the leading cause of death worldwide and accounts for more than $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed to improve accessibility, accuracy, and patient outcomes while reducing costs through earlier, more accessible, and accurate blood diagnostics. Both HART CADhs and HART CVE, a second AI-driven, multi-protein blood test that assesses a patient's one-year risk of heart attack, stroke, or cardiovascular death, are currently available to healthcare providers and for research use. About Prevencio, Inc. Prevencio is transforming cardiovascular care through AI-driven blood tests that deliver earlier, accurate, and more accessible diagnostics. The company's HART platform powers the development of proprietary tests for cardiovascular disease, including HART CADhs® for detecting obstructive coronary artery disease and HART CVE® for assessing one-year risk of heart attack, stroke, or cardiovascular death. For more information, visit Forward-Looking Statement: Except for historical and factual information contained herein, this press release contains forward-looking statements, the accuracy of which is subject to various uncertainties of early stage companies. The company does not undertake to update disclosures contained in this press release.
Yahoo
13-05-2025
- Health
- Yahoo
Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
KIRKLAND, Wash., May 13, 2025--(BUSINESS WIRE)--Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD)—a condition responsible for significant morbidity and mortality. The designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs. HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs delivers actionable insight through a simple, non-invasive blood draw, bridging critical diagnostic gaps in current cardiovascular care. "The FDA's Breakthrough Device Designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive coronary artery disease," said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. "We are committed to expanding the use of HART CADhs from outpatient settings into emergency care environments to ensure that patients receive earlier, more accurate, and potentially life-saving diagnoses." HART CADhs is currently available as a Lab Developed Test (LDT) with a 2 to 10-day turnaround, making it ideal for evaluating stable, non-urgent patients. The Breakthrough Device Designation enables close collaboration with the FDA and an expedited review process, supporting Prevencio's goal to advance the test into a rapid, FDA-cleared in vitro diagnostic (IVD) with a one-hour result time—ideal for evaluating chest pain patients in emergency rooms. HART CADhs was developed using Prevencio's proprietary HART platform in collaboration with researchers at Massachusetts General Hospital (MGH). In clinical research, the test demonstrated high accuracy (0.86 AUC) in detecting obstructive CAD, significantly outperforming standard-of-care tests such as stress echocardiography and nuclear imaging, which yielded only 0.52 AUC. "With nearly half of U.S. counties lacking access to a cardiologist and long wait times in urban centers, a simple, accurate blood test to diagnose obstructive CAD offers tremendous potential to improve access to early diagnosis and intervention," said James L. Januzzi, MD, a practicing cardiologist at MGH, Professor of Medicine at Harvard Medical School, Chief Scientific Officer at the Baim Institute for Clinical Research and Principal Investigator for the HART test development and validation. "Our studies show HART CADhs is informative in a broad range of patient types including those with acute symptoms as well as those not diagnosed with a heart attack yet may have dangerous arterial obstruction. This suggests usefulness in both acute and outpatient settings." Cardiovascular disease remains the leading cause of death in the United States and worldwide. According to the American Heart Association, cardiovascular disease and stroke account for over $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed to improve patient outcomes and reduce costs through earlier, more accurate, and more accessible diagnostics. In addition to HART CADhs, Prevencio also offers HART CVE®, a second AI-driven, multi-protein blood test that assesses a patient's one-year risk of heart attack, stroke, or cardiovascular death. Both tests are currently available to healthcare providers. About Prevencio HART Tests: Powered by AI, Prevencio is revolutionizing cardiac diagnostics with AI-driven blood tests for cardiovascular disease and custom diagnostics for diagnostic, medical device and pharmaceutical companies. Using this novel approach, the company has developed seven blood tests that significantly improve diagnosis and risk assessment for a variety of heart and blood vessel-related complications. HART test results have been peer-reviewed published 35 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress; American College of Cardiology Scientific Sessions; American Heart Association Scientific Sessions; American Diabetes Association Scientific Sessions; and Transcatheter Cardiovascular Therapeutics Sessions) and in top-tier journals—(Journal of American College of Cardiology; American Journal of Cardiology; Clinical Cardiology; Biomarkers in Medicine; Journal of American Heart Association; and European Journal of Preventive Cardiology). About Prevencio, Inc. Prevencio's vision is to revolutionize cardiac diagnostics with AI-driven blood tests—thereby improving care with highly accessible, accurate and cost-effective diagnosis and earlier treatment. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic risk scores and coronary artery calcium. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc. Forward-Looking (Safe Harbor) Statement: Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The company does not undertake to update disclosures contained in this press release. View source version on Contacts Christiaan Boer, cboer@ 206-557-4309
Business Wire
13-05-2025
- Health
- Business Wire
Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD) —a condition responsible for significant morbidity and mortality. The designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs. HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs delivers actionable insight through a simple, non-invasive blood draw, bridging critical diagnostic gaps in current cardiovascular care. 'The FDA's Breakthrough Device Designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive coronary artery disease,' said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. 'We are committed to expanding the use of HART CADhs from outpatient settings into emergency care environments to ensure that patients receive earlier, more accurate, and potentially life-saving diagnoses.' HART CADhs is currently available as a Lab Developed Test (LDT) with a 2 to 10-day turnaround, making it ideal for evaluating stable, non-urgent patients. The Breakthrough Device Designation enables close collaboration with the FDA and an expedited review process, supporting Prevencio's goal to advance the test into a rapid, FDA-cleared in vitro diagnostic (IVD) with a one-hour result time —ideal for evaluating chest pain patients in emergency rooms. HART CADhs was developed using Prevencio's proprietary HART platform in collaboration with researchers at Massachusetts General Hospital (MGH). In clinical research, the test demonstrated high accuracy (0.86 AUC) in detecting obstructive CAD, significantly outperforming standard-of-care tests such as stress echocardiography and nuclear imaging, which yielded only 0.52 AUC. 'With nearly half of U.S. counties lacking access to a cardiologist and long wait times in urban centers, a simple, accurate blood test to diagnose obstructive CAD offers tremendous potential to improve access to early diagnosis and intervention,' said James L. Januzzi, MD, a practicing cardiologist at MGH, Professor of Medicine at Harvard Medical School, Chief Scientific Officer at the Baim Institute for Clinical Research and Principal Investigator for the HART test development and validation. 'Our studies show HART CADhs is informative in a broad range of patient types including those with acute symptoms as well as those not diagnosed with a heart attack yet may have dangerous arterial obstruction. This suggests usefulness in both acute and outpatient settings.' Cardiovascular disease remains the leading cause of death in the United States and worldwide. According to the American Heart Association, cardiovascular disease and stroke account for over $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed to improve patient outcomes and reduce costs through earlier, more accurate, and more accessible diagnostics. In addition to HART CADhs, Prevencio also offers HART CVE®, a second AI-driven, multi-protein blood test that assesses a patient's one-year risk of heart attack, stroke, or cardiovascular death. Both tests are currently available to healthcare providers. About Prevencio HART Tests: Powered by AI, Prevencio is revolutionizing cardiac diagnostics with AI-driven blood tests for cardiovascular disease and custom diagnostics for diagnostic, medical device and pharmaceutical companies. Using this novel approach, the company has developed seven blood tests that significantly improve diagnosis and risk assessment for a variety of heart and blood vessel-related complications. HART test results have been peer-reviewed published 35 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress; American College of Cardiology Scientific Sessions; American Heart Association Scientific Sessions; American Diabetes Association Scientific Sessions; and Transcatheter Cardiovascular Therapeutics Sessions) and in top-tier journals—(Journal of American College of Cardiology; American Journal of Cardiology; Clinical Cardiology; Biomarkers in Medicine; Journal of American Heart Association; and European Journal of Preventive Cardiology). About Prevencio, Inc. Prevencio's vision is to revolutionize cardiac diagnostics with AI-driven blood tests—thereby improving care with highly accessible, accurate and cost-effective diagnosis and earlier treatment. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic risk scores and coronary artery calcium. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc. Forward-Looking (Safe Harbor) Statement: Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The company does not undertake to update disclosures contained in this press release.
