CorVista Health to Present New Data on the Use of Machine Learning as a Non-Invasive Point-of-Care Rule-out Test for Heart Failure at ACC 2024

  • New data support the feasibility of machine learned algorithms to detect elevated left ventricular end-diastolic pressure (LVEDP)
  • Data collected using the CorVista System®, the world’s first non-invasive point-of-care solution approved for evaluating the presence of coronary artery disease and pulmonary hypertension

Bethesda, MD—April 7, 2024—CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis, will present new data exploring the potential of a Non-Invasive Point-of-Care Rule-out Test for Heart Failure using Machine Learning at the American College of Cardiology 73rd Annual Scientific Session and Exposition in Atlanta, GA on April 7.

The CorVista System is the world’s first non-invasive point-of-care solution for evaluating the presence of coronary artery disease and pulmonary hypertension. The developmental model to be presented, intended to assess left ventricular end-diastolic pressure (LVEDP), exhibits the potential to serve as an effective rule-out test, with a sensitivity of 92% (≥25 mmHg) and 86% (≥20 mmHg) and specificity of 68% (TTE group), with a negative predictive value of 99.5% (≥25 mmHg) and 99.1% (≥20 mmHg), at a disease prevalence of 4%.

Timely identification of left ventricular dysfunction plays a pivotal role in effective heart failure management, however, measuring elevated LVEDP currently relies on invasive left heart catheterization. While echocardiographic indices can be used to indicate potential diastolic dysfunction, they pose challenges in data collection and interpretation, creating a need for a non- invasive, point-of-care method to identify patients with elevated LVEDP.

“This data exemplifies CorVista Health’s commitment to advancing novel machine learned diagnostic solutions to identify patients with CAD (coronary artery disease), PH (pulmonary hypertension) (both now FDA-cleared) and elevated LVEDP at point of care.” Both PH and elevated LVEDP, particularly when due to Heart Failure with Preserved Ejection Fraction (HFpEF), are vastly underrecognized and underdiagnosed often delaying life-saving treatments” said Charles Bridges, M.D. Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “We believe the CorVista System can uniquely and effectively address these important unmet needs for people living with cardiovascular disease, especially in rural and underserved populations.”

Lead Author Abstract Title Presentation Details
Navid Nemati Development of a Non-Invasive Point-Of-Care Rule-Out Test for Heart Failure using Machine Learning Session 1462 - Innovation, Digital Health, and Technology 14
April 7, 2024 - 3:15pm EST Location: Hall B4-5
(Georgia World Congress Center)

About CorVista® System

CorVista System is an Rx only, non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a symptomatic patient's cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting, or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista System with CAD and PH Add-Ons has been cleared by FDA to market within the US. CorVista System is developed and manufactured by Analytics For Life, Inc. and licensed to CorVista Health, Inc.

About CorVista Health

CorVista Health, Inc. is applying machine learning to deliver novel cardiac disease detection algorithms using the proprietary CorVista System platform to transform cardiovascular care and the patient experience. CorVista Health is dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low-

resource settings where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

 

Toronto, ON and Bethesda, MD, April 5, 2024 — Analytics for Life, Inc. and CorVista Health Inc. announced the FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module. The CorVista® System is the first FDA-cleared, machine learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP), an indicator of pulmonary hypertension (PH).

 

Pulmonary hypertension is a progressive disorder that affects the blood vessels in the lungs, causing the heart to work harder to deliver blood to the area. PH affects approximately 1% of the global population, and over half of patients with heart failure may be affected – the vast majority of whom (80%) live in areas with limited access to advanced  cardiovascular medical and surgical care. Despite advances in diagnostic technologies, PH is still often difficult to diagnose due to overlapping symptoms with other heart and lung conditions. Limited early detection and existing treatment options have contributed to increasing mortality rates for people living with PH, highlighting the need for continued diagnostic innovation. The CorVista System with PH Add-On responds to this need, positioned to enable earlier diagnosis and better patient experiences in the detection and treatment of PH.

 

The non-invasive CorVista System was recently cleared for use in evaluating the presence of significant coronary artery disease. In 2022 the FDA designated the CorVista System with PH Add-On as a Breakthrough Device for its potential to improve the diagnosis of PH. The breakthrough designation followed FDA’s review of a pilot performance study which demonstrated a reasonable expectation for the device to provide more effective diagnosis of PH in the standard of care.  Results of the extensive clinical validation study supporting the market application (IDENTIFY PH) showed algorithm performance in identifying patients with elevated mPAP with sensitivity of 82% and specificity of 92% with a negative predictive value (NPV) of >99%. Introduction of the PH indication to the CorVista System will allow healthcare providers the ability to test symptomatic patients for multiple significant cardiovascular conditions in a single non-invasive procedure at the initial point-of-care. Having now successfully received market clearance, the CorVista System with PH Add-On joins a small cohort of under 100 breakthrough-designated devices to enter the US market.

 

"As we continue to expand the CorVista System, we are proud to deliver meaningful advancements in diagnostics that support the earlier-stage detection of serious conditions, such as  PH and CAD," said Ian Shadforth, Vice President and General Manager at CorVista Health. "Through CorVista, we are seeing how the power of machine learning can revolutionize care pathways, enabling earlier-stage detection and diagnosis, and ultimately empowering clinicians to deliver improved care and long-term outcomes."

 

"Through the CorVista System, we have harnessed the potential of machine learning to develop our cutting-edge detection algorithms and deliver precise and reliable diagnostic tools,” said Jonathan Woodward, Chief Technology Officer and General Manager at Analytics for Life. “The Pulmonary Hypertension Add-On underscores our unwavering dedication to advancing novel solutions that make a tangible difference in patients' lives.”

 

"I can't emphasize the importance of early diagnosis enough,” said Vallerie V McLaughlin, M.D. Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director Pulmonary Hypertension at the University of Michigan Ann Arbor and CorVista Health Medical Advisory Board member. “This technology has the potential to really improve the time from symptoms to diagnosis."

 

Analytics For Life will continue to partner with CorVista Health to commercialize the CorVista System within the US. For more information regarding the CorVista System, please visit: www.CorVista.com 

 

About Pulmonary Hypertension

Pulmonary hypertension is challenging to diagnose, affecting an estimated 1% of the world population and up to 10% of people greater than 65 years of age as well as 50% of patients with heart failure. The vast majority of those persons with this disorder (80%) live in areas with limited access to appropriate medical and surgical care. Pulmonary arterial hypertension is an aggressive disease resulting in right ventricular pressure/volume overload, right ventricular failure, and, in many cases, early death.

 

About CorVista® System

CorVista System is an Rx only, non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a symptomatic patient's cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting, or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista System with CAD and PH Add-Ons has been cleared by FDA to market within the US. CorVista System is developed and manufactured by Analytics For Life, Inc. and licensed to CorVista Health, Inc.

 

About Analytics For Life

Analytics 4 Life stands at the forefront of digital health, dedicated to propelling next-generation technologies that revolutionize point-of-care diagnostics . Headquartered in Toronto, Canada, Analytics For Life specializes in pioneering non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System®. The innovative CorVista System offers a non-invasive, point-of-care solution enabling physicians to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise.  Spearheading its introduction in the United States is our exclusive commercial partner, CorVista Health.

 

For more information on Analytics For Life and the CorVista System, please visit: www.analytics4life.com

 

About CorVista Health

CorVista Health, Inc. is applying machine learning to deliver novel cardiac disease detection algorithms using the proprietary CorVista System platform to transform cardiovascular care and the patient experience. CorVista Health is dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low-resource settings where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

Bethesda, MD., January 23, 2024CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis announces expansion of their Medical Advisory Board with the appointment of Dr. Anjali Tiku Owens.

Anjali Tiku Owens, MD, is an Associate Professor of Medicine in the Division of Cardiology, Section of Heart Failure and Transplantation at the Perelman School of Medicine of the University of Pennsylvania. She is the founding Director of the Penn Familial Cardiomyopathy Program, Director of the Hypertrophic Cardiomyopathy clinic and was appointed the Medical Director of the Penn Center for Inherited Cardiovascular Disease in 2015. She has a special interest in novel therapies for genetic cardiomyopathy.

"As we near commercialization of our first indication of the CorVista System for Coronary Artery Disease (CAD), it is essential we continue to bring cardiovascular experts onboard our Medical Advisory Board. We are thrilled to welcome Dr. Anjali Tiku Owens to our esteemed board," said Don Crawford, President and CEO of CorVista Health. "Dr. Tiku Owens' wealth of experience and expertise in cardiology, particularly in genetic cardiomyopathy and novel therapies, will be invaluable as we work to revolutionize cardiovascular care."

Dr. Tiku Owens joins a distinguished group of medical professionals on the CorVista Health Medical Advisory Board, contributing to the company's mission to improve the availability and accessibility of cardiovascular disease diagnosis. The announcement follows the recent FDA clearance of the CorVista System with CAD Add-On.

"I am honored to join CorVista Health's Medical Advisory Board and contribute to the advancement of cardiovascular care.” Said Dr. Anjali Tiku Owens, MD, Associate Professor of Medicine, University of Pennsylvania. “The CorVista System holds immense promise in transforming how we diagnose and treat cardiovascular diseases. I look forward to collaborating with CorVista and the Medical Advisory Board to make a meaningful impact on patient outcomes."

About CorVista® Health
CorVista Health, Inc. is applying machine learning to deliver novel cardiac disease detection algorithms to enhance the CorVista System platform over time, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com. CorVista Health is dedicated to addressing the FDA’s call to action for leveraging health technologies to advance health equity, as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline in life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has the potential to enable more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista® System with CAD add-on has been cleared to market as a 510(k) device. Additional CorVista System Add-Ons for Pulmonary Hypertension and LV Filling Pressure are currently investigational devices limited by federal law (or United States) law to investigational use and are not available for commercial distribution. CorVista System is developed and manufactured by Analytics 4 Life, Inc., and licensed exclusively to CorVista Health, Inc.

 

Contact:
Chris Bing Ernst
[email protected]
415.710.9445

Washington DC—November 12, 2023CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the presentation of Machine Learning to Detect Pulmonary Hypertension data at AHA.

“We are pleased to present this important data at this year’s AHA meeting.” said Don Crawford, President and CEO of CorVista Health. “Pulmonary hypertension is a challenging condition to diagnose, especially early in the disease progression. This presentation follows the FDA’s Breakthrough Designation for the CorVista System Add-On to detect pulmonary hypertension and the recent FDA clearance of the coronary artery disease platform.”

Pulmonary hypertension (PH), a life-threatening condition with significant morbidity and mortality, affects an estimated 1% of the world population. It is present in 10% of people over age 65 and 50% of patients with heart failure. Further, the subgroup of pulmonary arterial hypertension (PAH) is frequently diagnosed years after symptom onset, at a point when the pathophysiologic changes have become irreversible.

Existing diagnostics for PH are insufficient; for instance, the sensitivity and specificity of Transthoracic Echocardiography (TTE) varies over a wide range. Moreover, TTE requires specialized equipment and technical support that is often unavailable. Herein we present the results of a machine-learned model addressing the need for an improved point-of-care test for PH in newly symptomatic subjects.

The presentation demonstrates the ability to develop a point of care method to detect PH, based on cardiac orthogonal voltage gradient (OVG) signals and photoplethysmographic (PPG) signals. A machine learned (ML) algorithm was developed to discriminate subjects with no evidence of diastolic dysfunction nor PH on TTE vs. those with mPAP≥25 mmHg from right heart catheterization.

The AUC of the algorithm was 0.93, the sensitivity 87%, and the specificity 83%. Further, the performance is preserved in all subgroups, including pre-capillary PH. This supervised machine-learned model therefore provides strong preliminary evidence that an algorithm can be developed to assess the likelihood of PH in patients with new onset symptoms of cardiovascular disease.

“This important data demonstrates the feasibility to detect pulmonary hypertension, as well as enabling potentially earlier diagnosis in the progression of the disease.” said Charles Bridges, M.D. Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “We believe the CorVista System® can make a tremendous impact to patients suffering from pulmonary hypertension, especially in rural and underserved populations.”

About CorVista® Health
CorVista Health, Inc. is applying machine learning to deliver novel cardiac detection algorithms to enhance the CorVista System platform over time, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com. CorVista Health is dedicated to addressing the FDA’s call to action for leveraging health technologies to advance health equity, as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline in life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has the potential to enable more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low- resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

About CorVista® System
The CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista® System with CAD add-on has been cleared to market as a 510(k) device. Additional CorVista System Add-Ons for Pulmonary Hypertension and LV Filling Pressure are currently investigational devices limited by federal law (or United States) law to investigational use and are not available for commercial distribution. CorVista System is developed and manufactured by Analytics 4 Life, Inc., and licensed exclusively to CorVista Health, Inc.

 

1. Janda S, et al. Diagnostic accuracy of echocardiography for pulmonary hypertension: a systematic review and metanalysis. Heart 2011; 97-612-22.

Washington DC—September 21, 2023CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce that it has been honored with the Editor’s Choice designation as the Top MedTech Startup for 2023 by MedTech Outlook.

This award follows the announcement last week of the FDA clearance of the CorVista System to detect the presence of coronary artery disease. As the company ramps up for commercialization, CorVista Health was recognized and awarded the designation by the editors of MedTech Outlook amongst the other top ten startups.

“This honor is a testament to the impact and transformation the CorVista System will make to aid clinicians diagnosing cardiovascular conditions,” said Don Crawford, President, and CEO of CorVista Health. “From all of us at CorVista Health we too believe our novel solution will aid physicians’ diagnosis of their patients at the point of care providing important and rapid insights into their patient's condition.”

The CorVista System is indicated to analyze sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, and fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient’s signs, symptoms, and clinical history as an aid in diagnosis.

“We are glad to feature CorVista Health as the Editor’s Choice and one of the Top 10 MedTech Startups - 2023,” said Alex D’Souza, Managing Editor of MedTech Outlook. “This recognition is a testament to CorVista’s prowess in leveraging AI to advance cardiac disease detection. The revolutionary CorVista System enables physicians to easily evaluate cardiovascular status at point-of- care; aiming to improve both time to diagnosis and the patient experience.”

About CorVista® Health
CorVista Health, Inc. is applying machine learning to develop novel cardiac detection algorithms to enhance the CorVista System platform over time, with the aim of transforming cardiovascular care and the patient experience. CorVista Health is dedicated to addressing the FDA’s call to action for leveraging health technologies to advance health equity, as presented by FDA Commissioner Dr. Robert Califf. Particularly, the decline in life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has the potential to enable more equitable care by providing access to immediately actionable, high- quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

About CorVista® System
The CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista® System with CAD add-on has been cleared to market as a 510(k) device. Additional CorVista System Add-ons for Pulmonary Hypertension and LV Filling Pressure are currently investigational devices limited by federal law (or United States) law to investigational use and are not available for commercial distribution

Contact:
Chris Bing Ernst
CorVista Health
[email protected]
415.710.9445

Washington DC—September 12, 2023CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the FDA clearance of the CorVista System® with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.

The CorVista® System is a non-invasive medical device system comprised of hardware and software components that are designed to work together to allow a physician to evaluate the patient at point-of-care for cardiac disease using a static machine-learned detection algorithm. The CAD Add-On is the first of the company’s anticipated suite of cardiac detection algorithms to receive market clearance.

“From all of us at CorVista Health, we are thrilled to announce we have obtained FDA clearance of the CorVista System,” said Don Crawford, President and CEO of CorVista Health. “Our point-of-care, non- invasive solution rules out significant CAD with a negative predictive value (NPV) of 99%. Furthermore, it requires no fasting, radiation, or significant capital investment. The ability to obtain a result within minutes will be a game changer in aiding physicians to detect the potential presence of cardiac disease.”

The CorVista System is indicated to analyze sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient’s signs, symptoms, and clinical history as an aid in diagnosis.

The clearance was based on an extensive blinded clinical validation dataset (N=1,816), collected through the IDENTIFY study, showing performance in identifying significant CAD with sensitivity of 88% and specificity of 51%. These results are comparable to the rule out performance of coronary computed tomography angiography (CCTA)1. Additionally, this performance is maintained in the currently underserved female population. This milestone follows the announcement of receiving FDA
Breakthrough Designation for the company’s second disease specific Add-On module in development focused on pulmonary hypertension.

“We believe CorVista Health has the ability to transform the way cardiovascular disease is diagnosed, particularly in underserved low-resource settings where there is the greatest need,” said Charles Bridges, M.D., ScD., Executive Vice President, Chief Scientific Officer of CorVista Health. “CorVista Health’s innovative solution has the potential to make a tremendous impact to our healthcare system and enable more equitable care.”

1. Knuuti, Ballo, et al; (2018) The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability, European Heart Journal, Volume 39, Issue 35, 14 September 2018, Pages 3322–3330, https://doi.org/10.1093/eurheartj/ehy267

About CorVista® Health
CorVista Health, Inc. is applying machine learning to develop novel cardiac detection algorithms to enhance the CorVista System platform over time, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com. CorVista Health is dedicated to addressing the FDA’s call to action for leveraging health technologies to advance health equity, as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline in life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has the potential to enable more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low- resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista® System with CAD add-on has been cleared to market as a 510(k) device. Additional CorVista System Add-ons for Pulmonary Hypertension and LV Filling Pressure are currently investigational devices limited by federal law (or United States) law to investigational use and are not available for commercial distribution.

Washington DC—August 9, 2023CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the election of Dr. Tim Attebery to its Board of Directors.

As the company approaches commercialization, CorVista Health recognizes the importance of enhancing its Board of Directors with specialized expertise in the field of cardiovascular care. Dr. Attebery’s significant contributions in reshaping the model of cardiovascular care delivery in the USA through his innovative leadership at organizations such as the American College of Cardiology and Cardiovascular Associates of America make him a highly valued addition to the board.

“Our shareholders, along with the leadership team of CorVista Health, are thrilled to have Tim join our Board of Directors.” said Don Crawford, President, and CEO of CorVista Health. “His insights and expertise will enrich our board, and I am confident that his vast experience in healthcare and leadership will be instrumental in driving our future growth and development.”

As a member of our board, Dr. Attebery will provide further guidance and governance, drawing from his deep understanding of the cardiovascular healthcare space. His involvement will additionally support CorVista Health as it enters the next phase of growth following FDA Breakthrough Designation for their pulmonary hypertension focused device.

“I believe CorVista Health can transform the way cardiovascular disease is diagnosed, particularly in underserved geographies and populations with the greatest need,” said Dr. Attebery. “Advancements in healthcare are essential to help improve the diagnosis of cardiovascular patients especially in rural areas, and CorVista’s innovative solution has the potential to make a tremendous impact to our healthcare system.”

About CorVista® Health
CorVista Health, Inc. is applying machine learning to develop a novel cardiac diagnostic platform, CorVista® System, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com CorVista Health is dedicated to addressing the FDA’s call to action for leveraging health technologies to advance health equity, as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline in life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has the potential to enable more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.

About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. CorVista System is an investigational device limited by federal law to investigational use. CorVista System is not available for commercial distribution.

IDENTIFY PH presented at ATS

Washington DC—May 21, 2023CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, announces the presentation of a machine-learned algorithm to IDENTIFY PH at the American Thoracic Society (ATS)

(ML) phase space electro-mechanical pulse wave analysis to identify pulmonary hypertension (PH) patients with new onset symptoms at the point-of-care. This presentation follows the recent achievement of the Breakthrough Designation from the FDA for the CorVista System to aid in the diagnosis of pulmonary hypertension.

This IDENTIFY PH study is a prospective, multi-center study designed to recruit patients for the training and validation of machine-learned algorithms based on the CorVista System’s novel approach to measure and analyze the patient’s electrical and hemodynamic signals at the point of care. The measurements are used to identify PH patients with new onset symptoms. The study enrolled consecutive patients across US- based healthcare centers who presented symptoms suggestive of PH. These patients underwent signal data acquisition and were enrolled with transthoracic echocardiography (TTE), or right heart catheterization (RHC) data. The primary objective of the study was to demonstrate a ML algorithm’s predictive capability for PH diagnosis, with diagnostic accuracy measured using the area under the curve of the receiver operating characteristic (AU-ROC).

“After our recent Breakthrough Designation for pulmonary hypertension, we are now pleased to present this proof-of-concept research based on the IDENTIFY PH Study.”

said Don Crawford, President and CEO of CorVista Health. “The data presented today demonstrates the potential of being able to aid identification of PH patients who present with new onset symptoms.”

Signals were collected using a proprietary signal capture device recording synchronous orthogonal voltage gradients and photoplethysmographic waveforms from resting patients for 3.5 minutes. Also collected were patient metadata (e.g., birthdate, height, weight) and the results of the patient TTE, or RHC.

“We are pleased to present this multidisciplinary work, which provides strong evidence that an algorithm with high performance can be developed to assess the likelihood of PH in patients with new onset symptoms of cardiovascular disease at the point-of-care.” said Charles Bridges, M.D., Sc.D., Presenter and Chief Scientific Officer of CorVista Health. “This advancement, when integrated into a point-of-care test, holds great promise for early PH detection within the clinical pathway.”

Detailed results are available in the attached abstract from the ATS 2023 program; A Supervised Machine-learned Algorithm to IDENTIFY PH in Patients With New Onset Symptoms.

The CorVista System is an investigational device Limited by Federal (or United States) law to investigational use.

###

About CorVista® Health
CorVista Health, Inc. is applying machine learning using real world test data to develop a novel cardiac diagnostic platform, CorVista® System, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com

CorVista Health is focused on FDA’s recent call to action to better leverage health technologies to advance health equity as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline of life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has potential to enable more equitable care by providing access to immediately actionable, high quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In doing so, the CorVista System is uniquely poised to advance the quality of care in rural and low- resource settings.

About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis will be available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions.

Contacts
CorVista Health, Inc.
Chris Bing Ernst
(415) 710-9445
[email protected]

IDENTIFY Study Results Published in PLOS ONE

Washington DC—November 17, 2022—CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces the publishing of the IDENTIFY Study in PLOS ONE, the multicenter validation of a machine learned (ML) phase space electro-mechanical pulse wave analysis to predict elevated left ventricular end diastolic pressure (LVEDP) at the point-of-care. This publication follows the recent achievement of the Breakthrough Designation from the FDA for the CorVista System to aid in the diagnosis of pulmonary hypertension.

This IDENTIFY study prospectively validated a machine-learned approach based on the CorVista System’s novel approach to measure and analyze the patient’s electrical and hemodynamic signals at the point of care. The measurements are used for the prediction of LVEDP, a key indicator of heart failure. Consecutive outpatients across 15 US-based healthcare centers with symptoms suggestive of coronary artery disease were enrolled at the time of elective cardiac catheterization and underwent signal data acquisition immediately prior to angiography to pair with the LVEDP measurement. The primary objective was to validate a ML algorithm for prediction of elevated LVEDP using area under the curve (AUC) of the receiver operating characteristic as the measure of diagnostic accuracy.

“After our recent Breakthrough Designation for pulmonary hypertension, we are now pleased to publish the IDENTIFY Study and share the positive data in predicting elevated LVEDP.” said Don Crawford, President and CEO of CorVista Health. “The IDENTIFY study published in PLOS ONE demonstrates the potential of being able to aid in the diagnosis of elevated LVEDP, a key indicator Heart Failure with Preserved Ejection Fraction (HFpEF), and cardiac conditions including other types of heart failure at the point of care.”

The study cohort consisted of 684 subjects stratified into three LVEDP categories, ≤12 mmHg (N=258), LVEDP 13-24 mmHg (N=347), and LVEDP >25 mmHg (N=79). Testing of the ML predictor demonstrated an AUC of 0.81 (95% CI 0.76-0.86) for the prediction of an elevated LVEDP with a sensitivity of 82% and specificity of 68%, respectively.

“It has been a truly exhilarating process to be involved in this rigorous and multidisciplinary work to bring forward this novel digital device” said Rola Khedraki, M.D., Division of Advanced Heart Failure and Transplant Cardiology, Scripps Clinic. “Our study demonstrated the feasibility of using a machine learned algorithm leveraging electromechanical signals to identify patients with elevated LVEDP with a high level of accuracy. We believe that the translatability of this novel technology into various clinical settings to identify patients with undifferentiated dyspnea at the point of care has the potential to be hugely valuable and impactful.”

The study concluded a machine learned algorithm utilizing electromechanical pulse wave features was able to predict an elevated LVEDP among symptomatic patients who had a precise measurement of LVEDP. These data suggest a potential role for the novel CorVista System to predict of an elevated LVEDP at the point-of-care.

The CorVista System is an investigational device Limited by Federal (or United States) law to investigational use.

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About CorVista® Health
CorVista Health, Inc. is applying machine learning using real world test data to develop a novel cardiac diagnostic platform, CorVista® System, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com

CorVista Health is focused on FDA’s recent call to action to better leverage health technologies to advance health equity as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline of life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has potential to enable more equitable care by providing access to immediately actionable, high quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In doing so, the CorVista System is uniquely poised to advance the quality of care in rural and low-resource settings.

About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions.

Contacts
CorVista Health, Inc.
Chris Bing Ernst
(415) 710-9445
[email protected]

Washington DC—October 25, 2022—CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic solution for patients with suspected pulmonary hypertension.

The FDA’s Breakthrough Devices Program is a voluntary program available to therapeutic devices that establish they have the potential to provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions. Breakthrough designation provides several important benefits, including prioritized review of future regulatory submissions and greater opportunity to interact with FDA experts throughout the review process.

“We’re very pleased for the opportunity to continue to work closely with the FDA to fulfill our mission to improve the diagnosis and treatment of cardiovascular diseases and importantly our solution for pulmonary hypertension for which the Breakthrough Designation was awarded.” said President and CEO Don Crawford. “While the CorVista System is not yet FDA cleared, we are hopeful that Breakthrough Device Designation will help expedite patient access to the CorVista System as a non-invasive point of care diagnostic solution.”

The CorVista System offers two important improvements to the current standard of care for diagnosing pulmonary hypertension – expansion of the population for use of a non-invasive, point-of-care test and potential for significant reduction in time to diagnosis and treatments thereby allowing improved patient outcomes. The CorVista System Breakthrough Device Designation was supported by prospective clinical studies which allow for a highly accurate labeling of subjects with and without the disease of interest, and the application of novel machine learning techniques which have provided clear evidence the system is likely to improve the current standard of care.

“Unfortunately, there have not been any meaningful advancements to facilitate the early diagnosis of pulmonary hypertension in decades,” said Vallerie V McLaughlin, M.D. Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director Pulmonary Hypertension at the University of Michigan Ann Arbor and CorVista Health Medical Advisory Board member. “I am hopeful the non-invasive CorVista System will enable clinicians to diagnose patients suffering from pulmonary hypertension at an earlier stage, ultimately improving patient care and outcomes.”

Importantly, a critical impediment to correctly diagnosing PH patients results from their frequent presentation with symptoms similar to other common cardiovascular disease states such as, coronary artery disease and heart failure, further increasing the complexity of its recognition and ultimately diagnosis. The CorVista System with its novel PH Add-On is intended to indicate the likelihood of elevated mean pulmonary arterial pressure at point-of-care so that by identifying patients with PH earlier in the clinical pathway, patient care can be better triaged, and treatment outcomes can be maximized by patient type and need.

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About Pulmonary Hypertension
Pulmonary hypertension is challenging to diagnose, affecting an estimated 1% of the world population and up to 10% of people greater than 65 years of age as well as 50% of patients with heart failure. The vast majority of those persons with this disorder (80%) live in areas with limited access to appropriate medical and surgical care. Pulmonary arterial hypertension is an aggressive disease resulting in right ventricular pressure/volume overload, right ventricular failure, and, in many cases, early death.

About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions.

The PH Add-On is just one of the CorVista System algorithms under development. The CorVista System (which includes easily portable hardware and software) is designed as a platform device to be complimented over time with other AI/ML cardiovascular disease detection algorithms or “Add-ons” for indicating the likelihood of CAD, elevated Left-Ventricular Filling Pressure and other disease indicators. The CorVista System (and its Add-Ons) is an investigational device limited by federal law to investigational use. CorVista System is not currently available for commercial distribution.

CorVista Health is focused on FDA’s recent call to action to better leverage health technologies to advance health equity as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline of life expectancy in rural and disadvantaged urban areas has been cited as key evidence of disparate health outcomes. CorVista System has potential to enable more equitable care by providing access to immediately actionable, high quality cardiovascular status results in lowresource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In doing so, the CorVista System is uniquely poised to advance the quality of care in rural and disadvantaged urban settings.

About CorVista® Health
CorVista Health, Inc. is applying machine learning using real world test data to develop a novel cardiac diagnostic platform, CorVista® System, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com

Contacts
CorVista Health, Inc.
Chris Bing Ernst
(415) 710-9445
[email protected]

CorVista provides actionable cardiac diagnostics at the point of care by applying advanced machine learning for more rapid and accurate diagnosis of cardiac disease.
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