An Ohio company whose product could save lives in a variety of ways is nearing FDA approval and gaining steam. Sense Neuro Diagnostics, based in Cincinnati, is developing a non-invasive way to monitor for brain-bleed injuries. It created three different devices using the same technology — one for use in the ICU to monitor patients susceptible to a brain bleed, one used in emergency settings, and one developed in conjunction with the U.S. Department of Defense that would be used on the battlefield.
“We’ve developed technology that detects, measures, and monitors neurological disorders in the brain,” CEO Geoff Klass said. “We were started by four individuals out of the University of Cincinnati who all dealt in the stroke and traumatic brain injury space. They were frustrated by the inability to objectively detect and monitor patients suffering from a stroke or traumatic brain injury, which is all a very subjective process where they look into a patient’s eyes and have them move and speak to try to assess their situation. So, they set out to develop technology to immediately assess these patients.”
The phrase “brain bleed” may not be a household term, but there are more than 67,000 cases in the U.S. each year. Sense Neuro’s products can detect multiple brain injury and bleeding scenarios, as well as monitor for worsening conditions. That means that instead of health care workers constantly monitoring patients through relatively subjective tests, they can see the status of conditions instantly. And for those who have just suffered a brain injury, the time to detect the problem could be critical.
“We like to say, ‘Time is brain.’ Someone who has suffered a traumatic brain injury or stroke needs to get immediate treatment,” Klass said. “But what happens today, all too often, is that a patient is picked up by an ambulance and taken to a hospital that is ill-prepared to treat the condition they’re suffering from. It takes, on average, five hours to get that patient from that hospital to the proper hospital for their kind of treatment. That five-hour delay has very significant effects, and can result in permanent disability or even death for that patient.”
Founded in 2014, Sense Neuro has had a long path toward commercial availability. Since TechOhio first covered the company in 2021, it has completed its first clinical trial, has been working through FDA safety standards, and has developed three different algorithms — one that detects blood in the brain, one that detects an expanding bleed, and one that determines stroke by subtype. Now, it’s working through final FDA clinical trials, which will begin shortly and take about nine months. With completion of that program, the startup will be able to commercialize the product.
“The most important thing and our big focus right now is on the clinical trial we’re about to start,” Klass said. “That trial is going to be what gives us our first FDA clearance. That moves the company from startup mode to a commercial company that’s actually generating revenue. That’s our primary focus, and we’re all excited about getting that going. We’re also really excited about our relationship with the Department of Defense. That moves us to a whole new level.”
Klass isn’t the only one excited about Sense Neuro. The company has gathered a variety of funding along the way, raising more than $10 million in total, including a recent $250,000 from Cincinnati’s St. Elizabeth Healthcare. For years, Cincinnati-based Queen City Angels has been a leading investor and advisor to Sense Neuro. And Klass said State of Ohio programs, such as the Ohio Third Frontier, and other resources have been instrumental in getting them to this point.
“The Third Frontier was part of our early investment round that got us off the ground, and we’ve had angel investment from Queen City Angels and their members individually,” he said. “Cincinnati has been great. I can’t say enough about Queen City Angels and the effort that they’ve made to help us out. They haven’t just invested in us, they take a really active role in the company and have worked with us constantly to help. Working with the University of Cincinnati is also very important to us — that’s where our technology originally came from and they’ve gotten actively involved in our clinical trials.”
But funding isn’t the only important thing for Sense Neuro. The company needs to have a solid medical footing for their device, and they have that as well, attracting interest, investment, and partnership from Ohio’s world-renowned medical community and beyond.
“We have many opportunities that we’re working through, and we’ve been getting some institutional funding as well,” Klass said. “The Cleveland Clinic was an early investor, and we’ve also gotten investment from the Mayo Clinic Ventures and are part of their accelerator program, which we’re really proud of. We’ve also gotten investment from St. Elizabeth Healthcare here locally. That investment from the health care community is really important to us, because it really adds to the credibility of what we’re trying to do.”