BRAINBox Solutions today announced initial investments into the company’s Series B financing to support U.S. regulatory clearance and initial commercialization of its BRAINBox TBI concussion diagnostic/prognostic test in adults and completion of a clinical study in pediatric patients. Genoa Ventures is leading the financing, which includes other current and new investors.
“We have made significant clinical and pre-commercial progress in developing the BRAINBox TBI test,” said Donna Edmonds, BRAINBox Solutions’ CEO. “We are working with selected platform partners as we determine the fastest path to market for use in both point-of-care and emergency department settings.” She noted that in addition to the adult population, the company is developing BRAINBox TBI tests for pediatric patients, and, through a National Institutes of Health grant, for geriatric patients.
“The BRAINBox TBI test is the first to integrate physiologic and functional testing, an approach that is designed to maximize sensitivity and specificity, and provide objective criteria for the diagnosis and prognosis of acute traumatic encephalopathy, commonly known as concussion,” said W. Frank Peacock, MD FACEP, FACC, FESC, the study’s Principal Investigator and Professor, Vice Chair for Research, Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine.
The company’s key progress and achievements include:
HeadSMART II trial – The pivotal trial to support FDA clearance in adults has enrolled 2000 subjects, including subjects for the company’s Normative Data Base in support of the Neurocognitive Component of the Multi-Marker Multi-Modality Product. The company has presented its clinical data at several medical meetings over the past several months.
Pediatric Test – The company entered a funded collaboration with USA Hockey, to evaluate biomarkers in blood and saliva for concussion in elite girls and boys high school hockey players. The study aims to add to the information in the development of the company’s pediatric test by providing objective evidence of neurocognitive changes due to head impacts. The company’s pilot clinical trial in pediatric subjects is currently underway.
“In the current healthcare environment, where priorities include appropriate resource utilization, timely value-based care and patient satisfaction, both patients and clinicians strongly desire a quantitative approach that guides the next step in concussion management,” commented Chad Cannon MD, Chair & Clinical Service Chief, Professor, Department of Emergency Medicine at University of Kansas Medical Center and The University of Kansas Health System, and a Principal Investigator for the HeadSMART II trial.
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