January 25, 2016 — Jan Medical announced today that it has secured $7.5 million in Series C funding from Brainlab Inc. Funds will be used to complete ongoing clinical trials and filing of product de novo with the U.S. Food and Drug Administration (FDA) and CE Mark registration in the EU for BrainPulse, a new diagnostic tool designed to rapidly and reliably help detect abnormal neurological conditions including concussion and stroke.
The BrainPulse device captures a novel, non-invasive, physiological signal that utilizes the cardiac output to measure vasculature and brain tissue conditions. The BrainPulse data has the potential to significantly impact non-invasive neurodiagnostics and provide a clinically relevant ‘aid to diagnoses’ for a range of indications, including concussion and stroke.
The BrainPulse data has been shown to detect and longitudinally observe sports-related concussion in a clinical trial at Stanford University, reported in the Clinical Journal of Sport Medicine. In another early trial published by Neurocritical Care, the device detected vasospasm with clinically meaningful accuracy at the University of California San Francisco (UCSF). Additional clinical trials in concussion detection and vasospasm are ongoing.
In addition to the Series C funding, Brainlab will provide resources to assist in ongoing clinical research, regulatory filing and commercialization activities for Jan Medical, as well as expertise in research and development. Ken Bruener, vice president of marketing and business development, Brainlab, will become the Brainlab representative on the Jan Medical Board of Directors.