Brava Diagnostics has an exclusive, worldwide license to a high-sensitivity point-of-care platform for the acute care market. The Company is seeking financing to fund diagnostic product development for rapid multiplex tests for emergency medicine and critical care.
Our first point-of-care product will be a high-sensitivity troponin test for diagnosis of heart attack. New guidelines from the American College of Cardiology (ACC) are driving the shift to high-sensitivity troponin assays. Core lab tests suffer from turnaround time of more than an hour, when minutes count to initiate therapy to preserve heart muscle. Current point-of-care tests do not meet the sensitivity and precision requirements of the new ACC guidelines.
Evanescent planar waveguide technology is the core technology that enables precise measurements at very low concentrations. MBio Diagnostics developed the platform over ten years and has commercialized products outside of human health. Brava will build on these accomplishments by adapting the instrument for the healthcare market, developing in vitro diagnostic assays and executing clinical trials.
The executive team is comprised of accomplished veterans of the diagnostics industry, with deep experience ranging from start-up to multi-national companies.
High Cost, High Incidence Diseases
Our initial products will address cardiovascular disease and sepsis.
Among the most prevalent of life-threatening diseases are heart attack and heart failure. According to the 2014 National Hospital Ambulatory Medical Care Survey, U.S. emergency departments ordered or ran 7.6 million cardiac enzyme tests to assess chest pain and 3.6 million BNP tests to diagnose heart failure. The worldwide market for cardiac markers was approximately $1.7 billion in 2018 and is projected to reach $2.4 billion by 2025. Our initial cardiac marker assays will address the unmet need for rapid, accurate tests to manage these high-cost conditions.
Sepsis costs the U.S. health system $24 billion annually and is the most expensive condition to manage. There are approximately 5.3 million patients to screen in the U.S. alone. Brava tests are under development to differentiate bacterial from viral infections and to assess disease status.
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