Reporting Matt Roush
ANN ARBOR — The personalized medicine developer Everest Genomics announced Monday that it has completed the acquisition of 100 percent of the shares of Mountain View, Calif.-based Angiologix Inc., developer of the AngioDefender device for assessing heart and vein disease at its earliest stages.
Terms of the transaction were not disclosed.
AngioDefender is a highly accurate and low-cost tool designed to allow physicians to assess endothelial function — a key indicator of blood vessel health. Clinical syndromes such as stable and unstable angina, acute myocardial infarction (heart attack), claudication, and stroke relate, in part, to a loss of endothelial control of vascular tone, thrombosis, and the composition of the vascular wall. Such a tool could aid in the diagnosis of early stage atherosclerosis and cardiovascular disease in asymptomatic patients.
The endothelium, a thin layer of cells that line the walls of every blood vessel, is essential to ensuring that blood flows properly throughout the body. Over time, the effects of high blood pressure, cholesterol, stress, alcohol, smoking and genetics can damage endothelial cells, preventing them from performing their vital functions. Eventually, this damage to the endothelial cells will result in accumulation of fatty deposits called plaque that can rupture or have their caps shear off, causing clots that lead to heart attacks. If endothelial dysfunction is detected early enough, interventions like risk factor modification and drug therapy may improve prognosis.
“The clinical evidence of an association between endothelial dysfunction and atherosclerosis and CVD is very strong,” said Prasad Sunkara, Everist CEO. “By providing an accurate assessment of endothelial function, AngioDefender may help physicians and patients to make treatment decisions aimed at reducing the risk of these serious conditions.”
Subject to securing the required regulatory approvals, Everist Genomics will commercialize AngioDefender globally, starting in Europe and India during the first quarter of 2012.
The current gold standard for assessing endothelial function uses ultrasound to perform a costly and complex assessment of flow mediated dilation of the brachial artery, the major blood vessel of the upper arm. This type of assessment has several major limitations, such as requiring the use of expensive ultrasound equipment, a specialized ultrasound probe and a highly trained technician. Due to these limitations, along with the time required to perform ultrasound based measurement of FMD, its use has been confined to research applications.
AngioDefender overcomes these limitations by using a patented noninvasive technology for assessing endothelial dysfunction that produces consistent results regardless of operator differences. AngioDefender assesses endothelial dysfunction by measuring changes in volume of a segment of the brachial artery in response to a temporary occlusion of the artery. The AngioDefender test is much easier to perform than brachial artery ultrasound — the entire test can be conducted and results reported in about 15 minutes by a physician or technician — and the device will achieve a cost-savings of more than 80 percent when compared with brachial artery ultrasound. Several multinational studies have shown AngioDefender to correlate with Brachial Artery Ultrasound in measuring FMD.
“Our AngioDefender device has the potential to be a major advance in diagnosing and treating early stage atherosclerosis and CVD,” said Prasad Sunkara, CEO of Everist Genomics. “AngioDefender has been successfully validated in several multinational studies demonstrating its accuracy and reliability in assessing endothelial function through measurement of FMD. This innovative diagnostic reflects Everist Genomics commitment to developing and commercializing high-value prognostic testing technologies that have the potential to create substantial improvements in clinical outcomes while also reducing healthcare costs,” he added.
Sunkara said that if the device resulted in only a 1 percent reduction in the number of people developing advanced CVD, the annual savings would be enough to recover the total cost of performing the test on 20 million Americans every year and would generate an additional $1.03 billion in annual cost savings to the healthcare system.
“The medical community has been struggling for years to find diagnostic and treatment solutions for cardiovascular disease that improve patient outcomes in a way that is fiscally sustainable,” Sunkara said. “By identifying the disease in its earliest stage, when it is most responsive to therapy and life-style modification, tests that assess endothelial function may provide the ability to finally achieve that balance.”
In addition to identifying patients with early stage cardiovascular disease, AngioDefender might prove useful to monitor disease progression and effectiveness of cardiovascular therapies, enabling personalized dosage and treatment regimens. The test would be applicable to any patient, regardless of age, gender, ethnicity or pre-existing conditions. The test reports 25 elements of the patient record and CVD test parameters for each patient to a computer or mobile computing device for use by physicians.
Everist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease.
More at www.everistgenomics.com.