Brainstorming a Better Brain Device: UC Invention Headed to Clinical Trial

It might be a familiar scenario: after a conference, a group of doctors sit around brainstorming ideas to improve a clinical challenge. While often these solutions fizzle by the time clinicians return to their busy schedules, that's not the case with Sense Diagnostics. Developed by a team of specialists at University of Cincinnati’s (UC) College of Medicine, the non-invasive headgear device that uses radio waves to detect changes in the brain is drawing both attention and investment.

In 2008, Matthew Flaherty, MD, and Opeolu Adeoye, MD, both faculty members at the UC College of Medicine and physician researchers at the UC Gardner Neuroscience Institute, identified a clinical need to evaluate the brain activity for patients who are in the hospital, often sedated and sometimes on a ventilator. "This is a scenario I’ve seen as a neurologist, where we evaluate in an ICU, and we don’t know what’s going on with (patient) brains,” says Flaherty. "Maybe three or four days could pass with the patient in a sedated state, and during that time there could be neurological damage.”

With this challenge in mind, these UC physicians posed the question: "Is there a way other than sending people down for repeated CT scans to keep track of what’s going on in the brain?” This led to the idea of a non-invasive central nervous system sensor, using radio frequency waves similar to cell phone technology. Flaherty and Adeoye along with two other UC researchers—George ‘Chip’ Shaw, MD, PhD, and Joe Clark, PhD—applied for and received a small grant for exploring point-of-care devices for neurotechnologies (POC-CENT), through the NIH. "It allowed us to do some proof of principle testing—we chose intracerebral hemorrhage as the disease state—we create a model for it, and we felt there was a reasonable chance we could see blood in the head,” explains Flaherty.

Intracerebral hemorrhage (ICH) can be life-threatening. A type of stroke caused by bleeding within the brain tissue itself, it can deprive the brain of oxygen and blood supply. ICH makes up about 10 percent of stroke cases (about 70,000 a year in the United States) and may affect people with hypertension, head trauma or malformations in the arteries and veins in the brain or spine. Treatment focuses on stopping the bleeding, removing the blood clot and relieving the pressure on the brain.  

The device would monitor and provide real-time data of changes in the brain, including swelling and hemorrhage, so that doctors can deliver more precise treatment. The goal is to reduce deaths and long-term disabilities that result from hemorrhagic stroke or traumatic brain injury (TBI). In addition to TBI and hemorrhagic stroke, the technology may be developed to address other brain conditions, such as ischemic stroke, seizure and hydrocephalus (fluid on the brain), and modified to fit into care settings outside of the hospital.

To develop a prototype for the device, Flaherty and Adeoye enlisted the help of co-inventor Shaw, associate professor of emergency medicine, with a strong physics background.  

Shaw built the first device at UC "and he was probably the most important in the process early on,” says Flaherty. They also partnered with Ken Wagner, PhD, (then a research scientist at the VA), Joseph Korfhagen, PhD, then a graduate student, and Joe Clark, PhD, a professor in the Department of Neurology and Rehabilitation Medicine, to help coordinate animal model device testing. Korfhagen stayed on with Sense and is now the company’s director of research and development.

The next big step forward for the team was a grant from UC’s Technology Accelerator for Commercialization in 2013. 

"It provided us funds to continue our experiments, but just as importantly, it linked us to Dan Kincaid. He provided us with business advice and helped us—as physicians without much business training—to develop a game plan,” says Flaherty.

Kincaid, a lawyer and entrepreneur, had been investing with the Queen City Angels and consulting with startups for about four years when he met the Sense team. It turned out to be a fortuitous pairing: Kincaid’s goal was to work with and grow a company improving patients’ lives through technology and ultimately lowering treatment costs. "The more I got to understand the potential of the Sense technology, the more enthused I became,” says Kincaid. "When they asked me to come on board as CEO, I jumped at the chance. As an entrepreneur, you don’t often have the opportunity to work with a technology as promising as Sense’s, and it’s even more rare to have one that comes surrounded by a group of people with as much character, passion and intelligence as this team has. It was an incredibly easy call for me to jump in.”

In the fall of 2014, the team received an Ohio Third Frontier grant and soon thereafter a Phase I Small Business Innovation Research (SBIR) award from the National Science Foundation (NSF), which led them to a Phase II, NSF-SBIR award in 2016.

The device has been refined along the way since that first model as well, from one pair of antenna to a multiple antenna array, and the Sense team has a functioning prototype and has been approved to begin its first in human clinical trial in patients with ICH at UC Medical Center.  

"ICH is a complex disease, so we want to see what the signal looks and how we can correlate it against the CT scans in the same patients. That will help us refine an algorithm to interpret the data in a meaningful way,” says Flaherty

Current practice is repeated CT scans done 12 to 24 hours after an ICH, so some patients may have multiple scans over the course of their hospitalization which can become cumbersome and costly for patient and care teams. This device could monitor patients almost continuously and would be portable enough to stay with the patient. 

"We are continuously refining. We will refine again after this study, each time working to improve the headset design,” says Flaherty.

Most recently, Sense announced a successful new round of investment funding of $1.3 million going toward the phase I clinical trial operating expenses and continued product refinement. Flaherty says the next pivotal trial will be one that leads to approval of the devices and will likely require additional fundraising. 

Kincaid says he is encouraged by the level of interest and support Sense has received has received. "It’s a testament to what we’re building that seasoned investors, like Queen City Angels and Accelerant, and organizations with a track record of excellence, like the NSF and the Cleveland Clinic Foundation, are supporting our vision with financing, advice and making important connections for us. 

"As the CEO of a startup medical device company, I could not have asked for a better team than these folks. It’s accelerated our development in a major way.”