Cincinnati-based med startup creates device for brain injuries, seeks FDA approval

CINCINNATI (WXIX) - A Cincinnati-based medical startup is seeking the U.S. Food and Drug Administration’s approval for a device that can spot brain bleeds and injuries in seconds.

The device is designed to detect and monitor even the smallest brain bleeds at the point of care, such as an ambulance, emergency department or in the military.

“It really is important which hospital the patient either goes to or is taken to, because if you’ve got a big hemorrhage in your brain, you’re going to need a neurosurgeon,” George Shaw, M.D., said. “Not every hospital has neurosurgery, so really, getting that person to the right hospital is critical, and then deciding how fast they get imaging, which is what this is intended for, is critical as well, because time is brain.”

NeuroHawk, designed by Sense Neuro, is unlike current diagnostic methods that rely on CT or MRI imaging because it provides real-time assessment at the patient’s side.

“I’m by training an ER doc. It’s busy. I don’t have 30 minutes or an hour to get an answer to a critical question, such as, ‘Do I think this patient has blood in their head or not?’” Shaw explained. “That is a time-critical, life and death, potentially, decision. I want to make it as quick as I can. We can answer that question and help them decide when that person gets imaging within 40 seconds.”

The device is being backed by the U.S. Department of Defense and UC Health.

It can be worn as a headset that passes radio frequency through the brain, scanning and analyzing how signals are affected by changes in brain tissue.

“It’s actually using about the same frequency as my cell phone, which we found through experimentation and analysis, is the best frequency to detect blood that is where it shouldn’t be,” Shaw said. “Those signals go to get processed, filtered, etc, and then they go to a computer algorithm which we created, which then says blood yes or no, and the way that works is normal brain to that signal. If there’s no blood, looks one way, has one signature, and then brain with blood in it, because of what I just said, you’ve got this collection of material that has a very different dielectric constant. Looks another way.”

Now the device is seeking medical approval from the FDA.

The submission of Neurohawk to the FDA comes after nearly 16 years of intense

research and development.

“We’ve executed well over that period of time, and it just takes time. A big chunk of that is, this is a very this is a de novo device, which means there’s no similar device out there like this. So the FDA rightfully demands that there are more hoops for us to jump through, which is fine,” Shaw said.

“This is life-saving technology,” he added. “Getting the patient acutely diagnosed with and getting the patient to the right specialist in hospital is crucial, and this will save time in that procedure, and it really does come back to you’ve got an injured brain, the longer it’s not treated correctly, the worse the patient can do, and the more brain cells you lose.”

Sense Neuro Diagnostics hopes for regulatory clearance from the FDA by March.,

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