The FDA Breakthrough Devices Program is designed to speed the development of medical devices with potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions by speeding up their development, assessment and review.
"With more than 5 million patients in the U.S. each year evaluated for mild TBI in hospital emergency departments, there is an enormous need for better tools to objectively diagnose and manage this condition," said Donna Edmonds, president and CEO of BrainBox. "The breakthrough designation underscores the potential of BrainBox TBI to change clinical practice in concussion management and will accelerate our development program."
The product is composed of a multiplex, fluorescence immunoassay using a panel of in-vitro diagnostic serum measurements, including the biomarkers Glial Fibrillary Acidic Protein (GFAP), Neuron Specific Enolase (NSE), Neurogranin (NRGN) and others, and a quantitative interpretation of test results derived from these measurements in conjunction with computerized neurological assessments. The BRAINBox test, for use in point-of-care or clinical laboratory settings, provides physicians with a single score incorporating the data from all the test components and additional data useful for guiding treatment. The test is designed for patients 18 years or older who are treated by a hospital emergency department or urgent care center.
Separately, the company announced the initiation of its clinical study, named HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma), which is designed to support U.S. and international regulatory filings for marketing approval. The study, which is expected to take 18-20 months, includes serial assessments collected across 20 sites in the U.S., U.K. and Australia. Building upon the data and history of HeadSMART, its first mild traumatic brain injury study that produced several publications, it will enroll patients in hospital emergency rooms and urgent care center settings. The clinical trial is collecting extensive cognitive and neuropsychological test data critical to the assessment of each patient's cognitive state in addition to the biologic response measured by biomarkers that are released upon injury.
The Study Principal Investigator, W. Frank Peacock, M.D., FACEP, FACC, FESC, Professor, Vice Chair for Research, Henry J Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, said, "BRAINBox Solutions represents the promise of a potential game-changer for both clinicians and their patients. The ability to identify and objectively measure the spectrum of TBI has the potential to revolutionize the care of the more than 1 million Americans each year who suffer from this frequently catastrophic event."