|Nautilus BrainPulse 1100--Courtesy of Jan Medical|
Munich-based radiotherapy company, Brainlab, has invested a $7.5 million Series C financing into Mountain View, CA-based startup Jan Medical. The cash infusion is earmarked for the completion of ongoing clinical trials and submission of its neurological diagnostic software, Nautilus BrainPulse, to regulators.
Brainlab is looking to gain access to expertise adjacent to its own business, which is focused on radiosurgery and radiotherapeutic software for the brain. The private company has about 1,300 employees with 19 global offices, with its U.S. headquarters in Chicago.
It has nearly $330 million in annual revenue, with most of that coming from its cranial navigation software product, Brainlab's founder and CEO Stefan Vilsmeier told The Chicago Sun Times last June.
"With growing public awareness and concern about concussions, Brainlab is excited to invest in a partner that will provide medical professionals and athletic trainers with the tools to help accurately diagnose concussions," Brainlab CFO Joseph Doyle said in a statement about the investment. "This is an important and innovative product that allows us to expand our expertise in neurological diagnostic tools."
Jan Medical's BrainPulse portable device is designed to noninvasively monitor cardiac output to measure vasculature and related brain conditions. It could aid in the diagnoses of conditions such as concussion or stoke. In a clinical trial at Stanford University in 84 student football players, BrainPulse detected 10 out of 13 confirmed concussions for a sensitivity of 77% and 87% specificity--with 79 out of 91 recordings not finding concussion.
Jan Medical started a 700-patient trial earlier this month with final data due in a year. It's a prospective non-randomized trial of athletes age 10 to 25 with two cohorts, one of high-risk concussion patients and the other of low-risk concussion patients.
The startup plans to seek de novo approval with the FDA and CE mark registration in the EU for BrainPulse.
|How BrainPulse works--Courtesy of Jan Medical|
"This Series C funding further validates the potential of the BrainPulse device, as we accelerate our regulatory clearances and prepare for market launch," said Jan Medical President and CEO Paul Lovoi.
The system uses a headset with a photoplethysmogram sensor that detects heart rate and timing, a sound pressure level sensor for detecting ambient environment noise and 6 accelerometers to monitor acceleration. It incorporates a touchscreen computer for the user interface and data storage. BrainPulse requires only 45 heartbeats, which takes only about three minutes, to conduct its analysis.
- here is the announcement