November 19, 2019

Prevencio Announces Highly Accurate, AI-driven Blood Test with High Sensitivity (hs) Cardiac Troponin for the Diagnosis of Heart Disease

HART CADhs test addresses up to 30% of Emergency Department (ED) chest pain patients
who cannot safely be ruled-in nor ruled-out for heart attack

KIRKLAND, WA — Prevencio, Inc. today announces data confirming the high accuracy of its AI-driven, multiple-protein HART CADhs test, a biomarker clinical/proteomic panel inclusive of high sensitivity cardiac troponin for the diagnosis of obstructive Coronary Artery Disease (CAD), also known as heart disease. Researchers highlighted that these important findings, presented November 18 at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, performed with high accuracy on two different patient groups from Massachusetts General Hospital (MGH) and The University Heart Center, Hamburg, Germany.

October 10, 2019

Bayer inks deals with eleven startups, including Prevencio, under Bayer’s G4A Digital Health Partnerships

Berlin, Germany

Eleven healthcare startup companies have inked deals for Bayer’s “G4A Digital Health Partnerships” to drive forward innovative digital health solutions for patients. Bayer provides financial funding and commercial partnerships.

 

Bayer will support these companies aiming for longer-term collaborations to drive forward the development of specific digital solutions to improve patients’ health in the fields of cardiovascular diseases, oncology, ophthalmology, pulmonology, radiology as well as digital therapeutics. The participating healthcare companies were selected by Bayer from over 750 applications out of 65 countries based on the strategic fit, development stage of the project, and the assessment of internal experts.

 

Prevencio was selected as an Advance Track partner and was the only cardiovascular company selected.  Under the terms of the Advance Track, commercial partnerships deals include initial project funding, followed by incremental milestone-based payments.

March 18, 2019

Prevencio Announces Two Validation Studies Confirming High Accuracy of Novel HART AI-driven Tests

Compelling Data for HART CVE Test for CardioVascular Events and HART CAD Test for Coronary Artery Disease

KIRKLAND, WA— Prevencio, Inc. today announces data confirming the high accuracy of its AI-driven, multiple-protein HART CVE Test for predicting CardioVascular Events and HART CAD Test for diagnosing Coronary Artery Disease. Researchers believe these important findings, presented March 17 at the 2019 American College of Cardiology (ACC) Scientific Sessions in New Orleans, demonstrate robustness and accuracy of these tests. The new data, from two additional hospitals, confirm results previously published from Massachusetts General Hospital and Dr. James Januzzi.

January 28, 2019

Prevencio Announces Two Additional Peer-reviewed Manuscripts for Novel HART Tests using AI-driven Approach

HART AS Test for Aortic Stenosis and HART AKI Test for Acute Kidney Injury Risk 

 

Add to Growing Evidence for HART Tests

 

KIRKLAND, WA— Prevencio, Inc., announces the publication of data for two more

tests, HART AS and HART AKI, in its expanding pipeline of multi-protein, AI-driven tests

for cardiovascular disease and related conditions.

November 12, 2018

New Prevencio Study Using AI Demonstrates Novel Blood Test Accurately Predicts Acute Kidney Injury (AKI) Risk

Prevencio’s multi-protein, AI-driven HART AKI test allows earlier interventions to prevent AKI

 

KIRKLAND, Wash.—November 12, 2018--Prevencio, Inc. today announces data demonstrating high accuracy for its multiple-protein HART AKI test. Researchers believe these important findings, presented November 10 at the 2018 American Heart Association (AHA) Scientific Sessions in Chicago, will lead to more accurate prediction of AKI risk. This could alter patient management and reduce the alarming incidence of AKI.

August 27, 2018

Prevencio Announces Data Demonstrating HART PAD Blood Test Accurately Diagnoses Peripheral Artery Disease in Diabetic Patients

Prevencio’s multi-protein, AI-driven biomarker test has potential to improve clinical outcomes

and reduce costs in the treatment of diabetic patients

KIRKLAND, Wash.--Aug. 27, 2018--Prevencio, Inc. today announces data demonstrating its

HART PAD test accurately diagnoses peripheral artery disease (PAD) in diabetes mellitus

(DM) patients, a patient population in which PAD prevalence has traditionally been difficult to

assess. Researchers believe these important findings, presented August 25 at the 2018

European Society of Cardiology (ESC) Congress in Munich, Germany, could lead to early

identification of PAD and improve patient clinical outcomes, as well as prevent patients

without PAD from undergoing unnecessary, expensive, and invasive tests.

July 25, 2018

Clinical Cardiology Publishes Study Demonstrating Simple Blood Test from Prevencio Accurately Detects Cardiovascular Disease

Multi-protein diagnostic test with 98 percent accuracy published in official journal of the American Society for Preventive Cardiology

KIRKLAND, Wash.— Prevencio, Inc., announces the publication of data that demonstrates a simple new blood test accurately diagnoses significant Peripheral Artery Disease (PAD), a circulatory problem in which plaque-narrowed arteries reduce blood flow to a patient’s limbs and kidneys. If left untreated, PAD can lead to clogged arteries and increase the risk of a major cardiac event or amputation. Researchers believe the data, published in Clinical Cardiology, could lead to the use of this test as a gatekeeper to imaging or invasive testing, thus reducing cost and exposures to potentially harmful intravenous contrast and/or ionizing radiation.

June 25, 2018

New Prevencio Study Using AI Determines Simple Blood Tests Accurately Diagnose Heart Disease and Predict Adverse Heart Events in Diabetic Patients

Performance of HART CAD and HART CVE multiprotein, AI-driven tests presented at 2018 American Diabetes Association Scientific Sessions 

 

KIRKLAND, Wash. — Prevencio, Inc. today announces data which indicates its HART CAD and HART CVE tests accurately diagnose Coronary Artery Disease (CAD) and risk for Major Adverse Cardiac Events (MACE) in Diabetic Mellitus (DM) patients. Researchers believe the data, presented on June 24 at the American Diabetes Association 2018 Scientific Sessions, can assist patients in getting guideline-recommended serial evaluations proven to enhance health outcomes.

March 07, 2018

New Prevencio Study Using AI Demonstrates Simple Blood Test Accurately Diagnoses Aortic Stenosis

Novel test with 98 percent accuracy to be presented at American College of Cardiology 2018 Scientific Sessions

 

KIRKLAND, Wash.— Prevencio, Inc., today announces its HART AS multi-protein,

artificial intelligence (AI)-driven test, which data indicates accurately diagnoses Aortic

Stenosis (AS)—a condition with a 50 percent death rate when left untreated.

AS is the most common valvular heart disease in the Western world, present in more

than 20 percent of older adults. The condition occurs when the heart's aortic valve

narrows, which frequently occurs with aging. This narrowing prevents the valve from

opening fully, which reduces or blocks blood flow from the heart into the aorta. Left

untreated, AS can lead to adverse cardiac events, including heart failure and death.

November 14, 2017

New Study Using Artificial Intelligence Shows Prevencio’s Simple Blood Test Accurately Detects Presence of Peripheral Artery Disease

Novel multi-protein test data with 98% accuracy presented at American Heart Association 2017 Scientific Sessions

 

KIRKLAND, Wash.— Prevencio, Inc., today announces data that demonstrates a simple new blood test accurately diagnoses significant Peripheral Artery Disease (PAD), a circulatory problem in which plaque-narrowed arteries reduce blood flow to a patient’s limbs and kidneys. If left untreated, PAD can lead to clogged arteries and increase the risk of a major cardiac event or amputation. Researchers believe the data, presented at American Heart Association 2017 Scientific Sessions, could lead to the use of this test as a gatekeeper to imaging or invasive testing, thus reducing cost and exposures to intravenous contrast and/or ionizing radiation.

April 26, 2017

New Blood Test Predicts Major Cardiac Events Better Than Clinical Evaluation of Other Common Risk Factors

KIRKLAND, Wash. Prevencio, Inc. today announced the publication of data which demonstrates that a simple, new blood test is more accurate than evaluating commonly-used risk factors in determining whether a person will have a heart attack, stroke or major cardiac event. Researchers believe the data, published in the American Journal of Cardiology (AJC), could revolutionize how doctors identify patients—not only higher-risk patients who need aggressive treatment, but also lower-risk patients who could avoid expensive and invasive procedures.

March 17, 2017

New Study Shows Prevencio’s Simple Blood Test Determines Risk of Heart Attack, Stroke, or Cardiovascular Death

KIRKLAND, Wash.—Prevencio, Inc. today announces the presentation of data which demonstrates that a simple blood test is more accurate than commonly-used risk factors in determining whether a person will have a heart attack or major cardiac event.  Researchers believe the data, presented at American College of Cardiology (ACC) Scientific Sessions, could lead to improved risk classification of patients, thereby allowing more aggressive therapy in higher-risk patients and avoiding expensive or invasive treatment in lower-risk patients.

In the study, Massachusetts General Hospital and Prevencio researchers developed and validated a multi-protein blood test, HART CVE, to predict a patient’s one-year risk of having a heart attack, stroke, or cardiovascular death. Principal Investigator James L. Januzzi, MD, is a practicing cardiologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School...

February 27, 2017

Prevencio, Inc. data published in Journal of the American College of Cardiology (JACC) shows new blood test predicts significant heart disease 90 percent of the time, also predicts risk of future heart attack

KIRKLAND, Wash.—Prevencio, Inc. today announces the publication of data that

demonstrates that a simple blood test is substantially more accurate in diagnosis of

heart disease than standard diagnostic methods, delivering results in only two hours.

Researchers believe the data, published in Journal of the American College of

Cardiology (JACC), could lead to improved diagnosis of obstructive coronary artery

disease (CAD), lower disease and death rates, and lower healthcare costs.

In the study, Prevencio researchers and Massachusetts General Hospital developed a

clinical and multi-protein blood test, HARTTm CAD, to diagnose a patient’s likelihood of

having clinically significant obstruction of the coronary arteries which could require

invasive intervention to possibly prevent a heart attack or death. Lead author and

Principal Investigator James L. Januzzi, MD, is a practicing cardiologist at

Massachusetts General Hospital and Professor of Medicine at Harvard Medical School...

September 07, 2016

Prevencio Researchers Identify Clinical and Multi-Protein Test Panel to Diagnose Obstructive Coronary Artery Disease

Data Presented as Late-Breaking Science at 2016 European Society of Cardiology Congress

 

KIRKLAND, WA—September 7, 2016—Prevencio, Inc., a pioneer in multi-protein diagnostic and prognostic tests for cardiovascular disease and related adverse events, today announces the presentation of Late-Breaking Science at the European Society of Cardiology (ESC) Congress, the world’s largest and most influential cardiology meeting. Prevencio researchers teamed to develop a clinical and multi-protein panel to diagnose obstructive coronary artery disease. The data was presented by Principal Investigator, James L. Januzzi, MD, a practicing cardiologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. 

 

Researchers assayed and analyzed blood proteins and clinical variables from the Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA Study).  For this study, 927 subjects with coronary angiography were included, and considered for the presence or absence of >70% obstruction in at least one major coronary artery. The data demonstrated high accuracy for the score to predict the presence of significant coronary obstruction.  The score had an area under the receiver operating characteristic curve (AUC) of 0.87, and had 90% positive predictive value (PPV) for a one cut-off score. In an alternative five score model, a score of 5 (very high risk) produced a PPV of 93% and a score of 1 (very low risk) produced a negative predictive value (NPV) of 91%.

 

When the new test score, referred to as HARTTM CAD, was compared with available data for the renowned Framingham Risk Score (FRS), the HART CAD produced consistent and superior performance for predicting presence of coronary artery disease (AUC of 0.87 for HART CAD versus 0.52 for FRS). Similarly, when HART CAD was compared with available data for exercise and nuclear stress tests, which are standards of care in the evaluation of coronary artery disease, the HART CAD was substantially more accurate for predicting coronary artery disease (AUC of 0.87 for HART CAD versus 0.52 for stress testing).

 

 “We were pleased to identify a diagnostic score of clinical variables and proteins with excellent accuracy for the diagnosis and exclusion of patients with underlying significant coronary artery disease,” said Januzzi.  “It is impressive the panel performed well across multiple groups including those without prior known coronary artery disease, those presenting without acute myocardial infarct, and notably in women, who represent a diagnostic challenge.”

 

Consistent with its ability to predict presence of significant CAD, the HART CAD panel also predicted risk of future myocardial infarction (also known as MI or heart attack) and, in subjects with an elevated score, there was a shorter time to MI as compared to subjects with a lower score.

 

The panel’s clinical parameters included sex and history of percutaneous coronary intervention, as well as four proteins (adiponectin, apolipoprotein C-1 [Apo C-1], kidney injury molecule-1 [KIM-1], and midkine).  “Taken together, the proteins in our score represent a unique pathophysiologic mix of abnormal glucose and fatty acid metabolism (adiponectin), hyperlipidemia (Apo C-1), renal dysfunction/injury (KIM-1) and vascular injury and plaque infiltration (midkine), and explains why the ‘orthogonal’ information provided by these proteins added independent value to the clinical variables. We look forward to testing the HART CAD score in patients with different pre-test probabilities and hopefully bringing a new, non-invasive test to the millions of patients who need improved diagnosis for coronary artery disease,” said Januzzi.

 

Interest in coronary artery disease is driven largely by the fact that the disease is a major public health concern. It is a leading cause of death in the U.S., affecting nearly 20 percent of people ages 65 and older.  Current coronary artery disease testing modalities, including stress testing and cardiac computed tomography (CT) have limitations, including variable accuracy, limitations in obese and female patients, and need for ionizing radiation with adjunctive imaging for stress testing, as well as ionizing radiation, limited availability, and high costs for cardiac CT.  Moreover, up to 50% of patients are needlessly referred for invasive coronary catheterization, subjecting them to additional ionizing radiation and complications including death. As such, a non-invasive, low-cost, and safe test would be valuable and potentially result in reduction of morbidity, mortality, and healthcare costs.

 

“It is rewarding to work with dedicated researchers to identify a panel that may safely and noninvasively help cardiac patients while also reducing healthcare expenditures,” said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. “We look forward to our next steps of platform partnering, finalizing the testing kit, and conducting our FDA pivotal trial. We are also very thankful for the support of our investors.”

 

About Prevencio:

Prevencio, is a pioneer in multi-protein diagnostic and prognostic tests for cardiovascular disease and related adverse events. The Company's proprietary HART™ CAD Test is a first-in-class product. The worldwide market potential for the HART™ Test is ~ $2 billion in recurring annual revenue. For additional information, the Company's website is www.PrevencioMed.com.  Prevencio—Preventing the Preventable.™

 

Prevencio Media Contact: Rhonda Rhyne, rrhyne@prevenciomed.com, (858) 204-4116

 

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, size, potential, growth and penetration rates, the accuracy of which is necessarily subject to uncertainties and risks including the Company’s sole dependence on HART technology and various uncertainties characteristic of development stage companies. The Company does not undertake to update the disclosures contained in this press release.

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