Competitive Advantage

HeartGen’s competitive advantage is that it offers the only diagnostic tests of its kind in the field of heart failure diagnosis, and the ability to perform these tests and make these approaches available to treating physicians. HeartGen’s MSA-based approach in heart failure has undergone initial validation in three clinical Proof-of-Concept studies published in the leading cardiovascular journal Circulation and published under Dr. Josh Hare’s name in the current edition of the leading textbook on heart disease, Braunwald’s Heart Disease, validating its accuracy in determining both the 5 year prognosis of heart failure patients and the presence of myocarditis.

HeartGen tests will be offered as laboratory developed tests (LDTs) in conjunction with the University of Miami School of Medicine at a newly established CLIA laboratory at University of Miami. LDTs are not subject to FDA regulation, so the HeartGen tests can be offered to the public without regulation or pre-market review by the FDA. The tests will analyze the expression profile of the heart tissue or, when validated, blood sample of the heart failure patients from around the country, and then provide the treating physician with the quantitative gene expression profile scores needed to make improved treatment decisions for the patients, and improve patients’ lives and outcomes.

The management of patients with heart disease remains hampered by a lack of accurate biomarkers to assist doctors in assessing patient prognosis and in applying personalized medicine. Unfortunately, the current standard-of-care in cardiology is unable to distinguish accurately between the approximately 80% of patients with an excellent long-term prognosis from the approximately 20% of patients who will develop, within 5 years, a sudden circulatory collapse and require cardiac transplantation, or those who are at risk for sudden (arrhythmic) cardiac death. Similarly, the current standard-of-care in cardiology lacks reliable and easy tools to accurately distinguish those heart failure patients with the specific and treatable disease of myocarditis (inflammation of the heart muscle) from those who do not have myocarditis. These inabilities to accurately diagnose and therefore accurately treat heart failure patients can lead to unnecessary death and disability, can dramatically drive up the economic healthcare costs of the disease, and of course takes an enormous emotional toll on the patients and their families.