While those at high risk for stroke are alert for signs in the process, they are not able to be vigilant while asleep, which means that thousands of people are subject to wake-up strokes that are often only discovered hours later. Zeit Medical's brain-monitoring device could raise the alarm and help people get to the hospital quickly enough to prevent strokes and possibly save lives.
In the past, stroke victims were not able to be helped. A medication that works was developed in the 1990s. Later, a surgical procedure was created. Both must be administered within the first few hours after the stroke occurs.
Urs Naber and Orestis Vardoulis founded Zeit (time) to reduce the time between a 911 call about a stroke victim and receiving the necessary therapy. The company is part the Y Combinators Summer 2021 cohort.
Naber said that it used to be impossible to do anything. But suddenly, it didn't matter how fast you get to the hospital. Your brain begins to die as soon as a stroke strikes. Therefore, time is of the utmost importance. Millions have been spent to reduce the time from 911 call to transport and from the hospital door until treatment. But no one has addressed the hours before the 911 call, so we recognized that this is where innovation is needed.
Only if the stroke was detected early enough that the patient and others can be sent to the hospital. This is not the only situation that needs to be addressed.
Operating nurses and surgeons monitor patients closely and can identify signs of stroke by monitoring the EEG.
People are trained to see certain patterns with their eyes. Vardoulis said that they learned from top neurologists how they process the data visually and built a tool to automatically detect them. Because they helped to define the signals that were important, it was a huge help in our ability to speed up the process of deciding which features are important.
The team designed a headband that is soft and wearable, with an embedded EEG to monitor brain signals. The data is transmitted to a smartphone app to be analyzed by a machine-learning model that was trained on the patterns. If anything is found, an alarm is sent out to the user and the caregivers. You can also set it to call 911 automatically.
Vardoulis stated that the vast majority of data we have analysed comes from the OR. Here, it is immediately possible to verify the ground truth. We found an algorithm that accurately captures the onset events in the OR, with zero false positives.
They believe this should translate well to the home where there are fewer complicated variables. They are working with high-risk individuals who have had one stroke to test this. The months following a stroke (or related event) can be dangerous, as second events are more common.
We have a current research kit, which was shipped to people involved in our studies. It includes the headband as well as a phone. Vardoulis said that users are using it every night. We are preparing for a pathway that will allow us commercialization at some point in 2023. We are working with the FDA to determine the clinical evidence required to make this happen.
They have been awarded the Breakthrough Device designation, which, like BrainQ stroke rehabilitation company, puts them in a position to quickly move forward with certification and testing.
Naber said that although we are going to start in the US and see a global need, we will also be expanding internationally. Many people might need to visit the hospital more often because of the high prevalence of aging in certain countries.
For now, the plan is to continue gathering data and partners until they are able to set up large-scale studies. This will almost certainly be necessary to transfer the device from direct to consumer to reimbursable. Insurance covers the cost of the device. They are primarily focused on strokes at the moment, but the method can be modified to monitor for other neurological conditions.
Vardoulis stated that they hope to see a future in which everyone at risk for stroke is issued this device. This is the missing piece of the stroke care continuum.
