Closely-held VoxNeuro, a software-as-a-medical-device brain (SaMD) health company, is collaborating with Boston University to launch two studies that will evaluate the company’s cognitive health assessment platform in an outpatient setting to assess diagnostic accuracy.
The studies will focus on patients suffering from mild-traumatic brain injury (mTBI)/concussion and Alzheimer’s disease, respectively.
On a combined basis, mTBI/concussion and Alzheimer’s disease affect more than 10 million Americans annually. Inefficiencies of current behavior-based screening methodologies result in considerable excess cost and time to patients, clinicians and the healthcare system.
VoxNeuro’s cognitive health software is expected to provide additive diagnostic information to improve clinical management beyond traditional testing methods, representing a significant step forward for brain health with better identification and management strategies.
The studies will be led by John Connolly, Ph.D., VoxNeuro’s CSO, and Kyle Ruiter, Ph.D., VoxNeuro’s VP for clinical and scientific affairs. Co-investigators are Andrew Budson, M.D., professor of neurology at Boston University School of Medicine and associate director of Boston University’s Alzheimer’s Disease Research Center, and Katherine Turk, M.D., assistant professor of neurology at Boston University School of Medicine and co-leader of the Outreach, Recruitment and Engagement Core at the Boston University Alzheimer’s Disease Research Center.
“We are excited to test the hypothesis that by combining EEG brainwaves and cognitive testing, clinicians may be able to diagnose correctly who is suffering from Alzheimer’s disease or a brain injury in a manner that may not require a research laboratory to interpret the data,” Dr. Budson said in a statement.
Dr. Ruiter said that through the collaboration with Boston University, “we anticipate rich insights into VoxNeuro’s unique and proprietary data sets that will help drive the development of our second-generation product. Together, we are going to continue to push the boundaries of brain health through innovation.”
VoxNeuro also anticipates that this work may support new regulatory filings with the FDA and Health Canada.
VoxNeuro breakthrough SaMD technology uses validated brain biomarkers. The company’s EEG-based reports deliver a comprehensive understanding of how a brain is functioning through the objective measurement of a patient’s attention and concentration, information processing, and working memory.
