RICHMOND, Va., Dec. 8, 2020 /PRNewswire/ — BRAINBox Solutions today announced the initial closing on a $23 million Series A financing to support the clinical development of the company’s BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate.
“The BRAINBox TBI test has enormous potential to significantly improve patient care as an aid to objectively diagnosing and managing the treatment of concussion patients,” said Marc Goldberg, BioVentures Investors Co-Founder and Managing Partner. “The company has made great progress, particularly in this challenging COVID-19 environment, in advancing the development of the BRAINBox TBI testing system, including laying the groundwork for the pivotal, HeadSMART II clinical trial and securing ‘Breakthrough Designation’ from the FDA.” He noted there are more than five million patients evaluated in emergency rooms annually for mild TBI as well as additional patients in urgent care settings.
Bob Sledd, a BRAINBox Director and immediate past chairman of the board of Owens & Minor, added, “With this funding, the company is well positioned to take the key future steps necessary for a FDA regulatory filing for product approval and commercialization.”
BRAINBox TBI is the first test designed to assist in both the diagnosis and prognosis of concussion. The multi-marker and multi-modality test, which can be used in either point of care or clinical laboratory settings, includes a panel of blood biomarkers as well as advanced digital neurocognitive testing in partnership with BrainCheck, Inc. Using proprietary AI algorithms, BRAINBox TBI combines the results of the test components and patient reported outcomes to generate a single, objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury-related symptoms up to three months post-event.
FDA granted BRAINBox TBI Breakthrough Device designation in June 2019. The program is designed to accelerate the development, assessment and review of products with potential to provide more effective diagnosis or treatment of life–threatening or irreversibly debilitating conditions.
“With funding from the Series A we are well positioned to conduct the HeadSMART II study, and pending its successful completion, file for U.S. FDA approval,” said Donna Edmonds, BRAINBox’s CEO. “Support from this investor group is a strong vote of confidence in our strategy and our vision for changing the paradigm and setting the Standard of Care for Diagnosis and Prognosis with BRAINBox TBI.” She added that the HeadSMART II trial is expected to begin enrolling patients in the very near future.
Along with the financing, the company announced two key appointments to its Board of Directors and Scientific Advisory Board. Joining the Board of Directors is Scott Gazelle, MD, PhD, FACR, Professor of Radiology at Harvard Medical School and Vice Chair of the MGH Department of Radiology. Damon Kuehl, MD, FACP, Vice Chair of Emergency Medicine, Associate Professor of Emergency Medicine at Virginia Tech’s Carillon School of Medicine, and Director of the School’s Emergency Medicine Residency Program has been appointed to the company’s Scientific Advisory Board and its Sports Advisory Board.
“We are fortunate these two opinion leaders have agreed to help guide our efforts to develop BRAINBox TBI, which has great potential to become the gold standard in concussion diagnosis and prognosis,” said Ms. Edmonds. “Dr. Gazelle is a physician-scientist and academic entrepreneur who has been involved in the development, commercialization and assessment of new medical technologies for more than 25 years. Dr. Kuehl brings extensive clinical expertise in TBI, along with commitments to improving diagnosis and treatment, and youth sports.”
About BRAINBox Solutions
BRAINBox Solutions is developing the first AI–enabled, multi–modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion. The company seeks to establish a clinical best–practice standard for the diagnosis and prognosis of concussion. The product incorporates a panel of proprietary, patented blood biomarkers that can be read in a few moments on a point–of–care instrument or using standard laboratory systems, as well as neurocognitive testing, to provide a single–system score that measures the severity of the injury and guide treatment. The company is led by key physician and scientific thought leaders in the field and an experienced, clinically focused management team.
For more information, contact:
Donna Edmonds, CEO