Mountain View, California-based Jan Medical has raised $7.5 million from Germany-based Brainlab to develop a connected diagnostic device that helps detect abnormal neurological conditions, like concussion and stroke. Jan Medical has raised at least $10.6 million in total to date.
The company will use the funds to complete various clinical trials and apply for its de novo FDA clearance and CE Mark registration.
Jan Medical CEO Paul Lovoi founded the company after his wife, named Jan, passed away following a subarachnoid hemorrhagic stroke.
“I knew a lot about stroke and the company was founded based on trying to find a better way to determine what was going on in the vasculature of the brain without cath labs and angiograms,” Lovoi told MobiHealthNews. “That was the genesis of the company.”
Although Lovoi started working on the company in 2003, he took a break and then came back to it full time in 2008.
Jan Medical’s system, called Nautilus BrainPulse 1100, includes a headset, data collector, battery, and touch screen computer. The headset has a sensor that detects heart rate, a sensor that detects ambient environment noise, and six accelerometers to measure the acceleration of the skull. This diagnostic test, which would be administered by a nurse who works in neuro critical care or emergency care, takes three minutes.
Lovoi said that while the offering includes a portable computer at the moment, he plans to eventually sync the headset to a tablet and store the data in the cloud.
Jan Medical has a number of trials underway, but the primary one is a concussion trial. The company plans to recruit 600 to 800 people who either play a sport with a high risk of concussion or a sport with low risk. The trial will then examine the effectiveness of using the Nautilus BrainPulse device for concussion diagnosis by comparing BrainPulse readings of those that play high-risk concussion sports to those that do not.
The first FDA clearance Lovoi aims to receive is for the Nautilus BrainPulse's ability to accurately and safely sense the brain's pulse. After that, Jan Medical aims to receive a clearance for specific claims relating to concussions followed by vascospasms and ischemic stroke.