Prevencio, Inc.
The New-Age Cardiovascular Diagnosis

8 million ER visits for chest pain.

1.1 million in-patient invasive cardiac catheterizations in U.S. –procedure can cause heart attack, stroke or death

The above staggering figures bring out the vivid picture of how every one of three deaths in the U.S. occurs due to cardiovascular disease (CVD). Studies reveal that it’s CVD that kills more people in the country than all cancers combined. The traditional diagnostic methodologies like cardiac catheterizations, also known as angiograms, are expensive, yield inaccurate results, and can have serious side effects including heart attack and death. “About 60 percent of the coronary catheterizations are unnecessary,” expresses Rhonda F. Rhyne, a seasonal professional who has spent almost two decades in the executive management for biotechnology and medical technology companies. For most of her career, Rhonda devoted herself to fighting cardiovascular disease. She explains that although single protein tests, specifically troponin and BNP, have helped to refine prognosis and patient care, due to the multifactorial issues related to cardiac diseases, single protein tests are not highly accurate, leading to unmet clinical needs. Evidently, there is an impending need to improve CVD diagnosis with highly accurate tests based on advanced technologies, like Artificial Intelligence, that will surpass the accuracy of standard-of-care tests—precisely what Prevencio specializes in.

Prevencio employs Artificial Intelligence to interrogate well-characterized clinical data sets to produce novel, multi-protein, algorithmically-scored tests. Its novel, AI-driven HART blood tests utilize machine learning, multiple proteins, and proprietary algorithms to revolutionize the diagnosis and risk prediction of cardiovascular ailments. “We’re using state-of-the-art AI technology to offer a low-cost, more accurate, easily acceptable, and accessible means of diagnosing heart diseases and heart disease risk that lead to better outcomes,” remarks Rhonda, President, CEO, and Board Director, Prevencio. The AI-driven, multiple protein biomarker approach generates data with utmost precision that allows physicians to better identify heart disease and risk elements and stratify patients accordingly.

Prevencio’s HART blood tests improve the diagnostic and prognostic accuracy of CVDs by bringing the right treatment to the patient in an expeditious manner. The AI-based blood tests diagnose problems like obstructive coronary artery diagnosis (with HART CADhs test), one-year risk of heart attack/stroke/ cardiac death (with HART CVE), Kawasaki Disease diagnosis (with HART KD)), peripheral artery disease diagnosis (with HART PAD), and many more. Rhonda mentions that each test begins first with a physician assessing cardiac health, then, if necessary, drawing blood for analysis at the Prevencio lab. The company’s lab measures the protein levels in the blood, and then uploads those values to the cloud for algorithm processing and report generation. The report is then safely delivered to the physician’s portal to ensure safe access by doctors and patients alike. Essentially, these reports are maintained safely in the Microsoft Azure platform to ensure confidentiality and easy access.

Out of the plethora of tests developed and validated by the company, Precencio is principally focused on growing revenue centered on 3 lead tests-HART CVE, HART CADhs, and HART KD. The HART CVE is a cost-effective, low-risk, highly accurate multi-protein blood test that chiefly includes four proteins, namely NT-proBNP, Osteopontin, Kidney Injury Molecule-1, and Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) that precisely determine heart-related stress and alarm clinicians of any potential complications in the next year.

To that end, HART CVE can assess pre-drug/post-drug effects on composite cardiac health and even helps in Clinical Trial Enrichment by identifying high-risk vs. low-risk patients. With Massachusetts General Hospital’s Internal Validation and University of Hamburg Heart Center’s External Validation with accuracy scores equivalent of 79 percent and 86 percent, respectively, HART CVE is undoubtedly more accurate than the standard clinical risk scores, single and multiple protein tests, and coronary artery calcium scores. Moreover, the HART CADhs test can assist in evaluation of chest pain patients that are “indeterminant/gray zone”. These chest pain patients may have plaque/obstruction in the heart arteries and may not be suffering from a heart attack, but are at the imminent risk of having one. This has been identified as another clear unmet medical need and where the three protein-based HART CADhs play a pivotal role in diagnosing people with obstructive coronary artery disease diagnosis. Rounding off its stellar solutions is HART KD that essentially involves proteins NT proBNP, C-Reactive Protein (CRP), and Thyroxine Binding Globulin to accurately diagnose Kawasaki disease in children.

We’re using state-of-the-art AI technology to offer a low cost, more accurate, easily accessible means of diagnosing heart diseases that leads to better outcomes

With over 109 biomarker results, more than 250 clinical variables, and medical outcomes (up to 5 years) from almost 2501 patients, the company is building its own data bio-repository. In essence, Prevencio’s HART solution has clinical utility in multiple settings. It is well suited for wellness monitoring, complex care management, care for chronic disorders like obesity, diabetes, and CV patients as well as monitor patients without known heart disease but have the risk factors like smoking, family history, peripheral artery disease, and diabetes. Currently, the company is catering to physician offices, concierge practices, telemedicine, and clinical trials. They also have use in retail health pharmacy wellness monitoring, and emergency rooms. In conjunction with or replacing cardiac stress testing or Cardiac CT Angiograms (CCTA), the HART CVE and HART CADhs bring significant improvement in the overall diagnostic reliability.

Illustrating how the HART diagnoses stand a step higher when it comes to accuracy, Rhonda cites a recent instance about a patient who had received a high coronary artery calcium score. The patient was then sent for a Cardiac CT angiogram which showed the patient as having 80percent obstruction. The patient was sent to the cardiac cath lab for a stent to open the artery, but and the heart artery was shown to only have 30-40 percent obstruction and did not necessitate a stent to open the heart artery.
In parallel, for comparison, the doctor decided to do a HART CADhs test. HART CADhs showed a 40 percent obstruction. This is but one instance when Prevencio’s diagnostic solution would have been a boon for the patient by preventing anxiety, time, expense, and harmful radiation exposure from the coronary artery calcium test and further radiation and dye exposure (which can cause kidney injury) from Cardiac CT angiograms and cardiac catheterization procedure—the latter of which can cause a heart attack, stroke, kidney injury, or cardiac death.

Today, the robust diagnostic mechanism is also proving its mettle amidst the Covid19 uncertainties and helping in effective cardiac monitoring. With stringent norms compelling people to lock themselves inside, HART makes it easier for people to get diagnosed by bringing the easily assessable blood tests rather than having to schedule an appointment for cardiologist visits or imaging. The easily obtained and reproducible HART CVE blood tests can be used for monitoring cardiac adverse effects post-covid and for other causes.

Squaring impossible circles in cardiac care through its out-of-the-box HART tests, Prevencio is looking forward to expanding its sales and marketing to broadly distribute the availability of its unique solution. “As we move forward, we plan to put our test on a point-of-care with our protein-measuring platform partners,” concludes Rhonda. And judging by the roadmap Prevencio has planned, there is no doubt the company will reach new heights in the CVD diagnostics paradigm.