This vital information can help identify at-risk patients earlier than other commercially available cardiovascular screening tools and will enable physicians to accelerate treatment decisions. The AngioDefender testing device is based on the Company’s patent-protected platform technology, AngioEF3000™, and is capable of detecting early endothelial cell damage even in asymptomatic patients whose blood pressure and cholesterol levels fall within normal ranges.
The Unmet Need
Cardiovascular disease (CVD) is the leading cause of death of men and women in the United States, accounting for more than one-third (34.3%) of all U.S. deaths. CVD also is one of the costliest diseases to treat and manage: a 2010 report by the American Heart Association (AHA) estimates the disease will cost the nation approximately $503 billion per year.
Research on CVD treatment shows that early medical intervention and lifestyle modification are essential to improving patient outcomes and cost efficiency. For example, the AHA estimates that if 20% to 25% of Americans currently diagnosed with high blood pressure (hypertension) reduced their systolic blood pressure by 12 to 13 points, it would result in about a 25% reduction in the risk of death from heart disease and generate greater than $75 billion in annual cost savings for healthcare payers and employers.
Despite advances in CVD diagnosis and treatment, however, the disease is frequently diagnosed too late for optimum medical intervention. Until recently, the medical community lacked the diagnostic tools for detecting blood vessel damage, a critical juncture when medical interventions are most effective. Multi-center clinical studies show that cardiovascular disease begins years before patients present with high blood pressure, elevated cholesterol levels or abnormal EKG readings. As illustrated below, CVD diagnosis using conventional testing methods is not typically accurate in patients with sub-clinical or early stage disease. Consequently, patients, physicians, insurance companies, Medicare, and employers all stand to benefit from new technology that can speed diagnosis and assessment of CVD.
Stages of Atherosclerosis
Atherosclerosis is a condition in which fatty material collects along the walls of arteries. This fatty material thickens, hardens (forms calcium deposits), and may eventually block the arteries.
The Medical Insight
A single layer of cells called the endothelium lines the walls of every blood vessel in the body. These endothelial cells are often referred to by cardiologists as “the governing intelligence” of vascular health. Healthy endothelial cells are essential to enabling blood to flow through the body without clotting and helping to keep arteries healthy and flexible. Over time, the effects of malnutrition, lack of exercise, stress, alcohol, smoking and genetics causes inflammation that damages endothelial cells, preventing them from performing their vital functions. Eventually, this damage to the endothelial cells will show up as high blood pressure, elevated cholesterol levels, and fatty deposits in the vessels (atherosclerosis). But by the time these symptoms begin to present, the vascular system may have undergone years of damage and cardiovascular disease will have taken root.
Scientists have demonstrated that endothelial cell damage is a key biomarker and the earliest detectable sign of cardiovascular disease. Multi-center clinical studies have demonstrated that patients within normal ranges for lipids or blood pressure but with moderate to severe endothelial cell dysfunction, are at high risk of developing atherosclerosis and CVD.
Limitations of Legacy Testing Techniques
Legacy testing methods that only measure blood pressure or cholesterol levels have significant limitations because they fail to assess endothelial cell health. Even assessment procedures that include metrics of endothelial cell health have presented substantial limitations. Brachial artery ultrasound, for instance, requires expensive equipment and probes, along with a highly skilled operator, and is and time-consuming to perform. Intracoronary studies of endothelial dysfunction are invasive with high risk of complications, involve anesthesia and catheter insertion, require an interventional cardiologist and are also costly to perform. Shortcomings of current testing methods point to a critical need for new medical technology that can assess endothelial cell function at lower costs and without undue stress on patients.
Accurately Identifying Patients at Risk for Cardiovascular Disease
Everist Genomics’ proprietary AngioDefender is a noninvasive device that measures endothelial cell function via sensor technology that monitors and analyzes patients’ pulse waves before and after an increase in blood flow. This technology addresses the limitations presented in legacy testing methods by enabling physicians to perform assessments that are:
Since the device provides important data to physicians for predicting, preventing, treating and monitoring cardiovascular disease, AngioDefender results can guide the decision to prescribe pharmacotherapy and lifestyle modification while continuously monitoring responses to such therapy for personalized treatment planning for individuals that are at risk of atherosclerosis or CVD.
The Cost Saving Opportunity for the Healthcare System
If screening patients with the AngioDefender resulted in just a 1% reduction in the number of people developing CVD, the savings realized by the healthcare system would be sufficient to: