In 2004, Mark Tommerdahl and his colleagues started to do a different kind of experiment.

“We’ve been doing nothing but animal experiments until that time and we started to do correlations between human sensory testing and very high resolution animal neurophysiological experiments and found, you know, correlation is very good,” Tommerdahl said.

Spinning out of experiments and research conducted at UNC-Chapel Hill, Cortical Metrics was founded by Tommerdahl. Fifteen years years later and still a professor at UNC-CH teaching biomedical engineering, Tommerdahl looks forward to bringing low-cost diagnostic brain health care to the public.

“That’s what we’re all about because of the rising cost of insurance and the rising cost of medical bills,” said Tommerdahl. “You know, why not come up with a low cost method.”

As a neuroscience analytical company, Cortical Metrics aims to develop objective assessments of brain performance based on decades of neuroscientific research and expertise in engineering.

Extensive researches

Cortical Metrics’ devices are currently used in researches all across the world at around 70 different institutional sites. The company had over 80 peer review publications that utilized these methods, and the number is still growing for different uses.

Usually these devices were used in studies of people with neurodevelopmental disorders that include Autism, ADHD, Tourette’s, obsessive compulsive disorder and other neurodegenerative disorders such as Parkinson’s, Alzheimer’s, aging-related dementia, multiple sclerosis and pharmacological insult.

“So that we knew that we could predict different aspects of brain function based on how you feel, based on how the sensory percept,” Tommerdahl explained. “So we started designing stimuli or ways to deliver stimuli to two fingers or to points of the skin. And because you can deliver stimuli to points of the skin, then basically side by side and the brain, those places in the brain interact in a very specific way. And those interactions are very influenced by different things going on in the brain.”

Turning experiment results into an actual product requires money. Cortical Metrics started off its first funding mechanism in a major funding mechanism for autism. Then it started to also work in traumatic brain injury and did studies about traumatic brain injury and sports concussion.

“The office of naval research became very interested in our work because we got some very good results out of our sports concussion studies,” Tommerdahl said. “And once that started, then we started miniature.”

“We basically, up until that point, all we had done is the world’s first portable tactile stimuli which weighed about 15 pounds, wasn’t like the brain gauge today,” Tommerdahl continued. “And so with office-enabled sort of sponsorship, we actually were able to miniaturize the product and make it a real product.”

Cortical Metrics adopted a completely non-diluted formula in terms of funding. The company had collaborative colleagues and customers around the world for 10 years who were paying for the devices.

“We’ve had a product since 2005 and people have been using this in the fields since 2006. And so from the very beginning, the science behind this and the science behind the methods has been what’s moving this forward,” Tommerdahl said. “And that’s because other researchers and other clinical researchers and other clinicians are using the device and using the methods out in the field. That doesn’t cost us anything. They actually pay us to work with us.”

Regulatory challenges

Getting something from the lab to a real product takes a long process. And it does take a lot of effort for Cortical to get to that point.

“And so you sort of matriculate over,” Tommerdahl said. “This has been a 15 year process that in the last couple of years that now we have a FDA-listed model.”

One of the biggest challenge Cortical ever faced, as Tommerdahl pointed out, was the regulatory agencies.

“When you’re dealing with an Institutional review board and basically there are uneducated people on IRB who say things like ‘oh well this is dangerous device’. You might, a child might swallow it, it looks like a computer mouse,” Tommerdahl said.

The list of trouble makers also extends to regulatory compliance people and conflict of interest people.

“So we don’t do human subjects testing at UNC anymore because of the conflicts-of-interest people. We turned down a $1 million funding for that reason that they couldn’t stay on schedule,” Tommerdahl elaborated.

Target customers and advertising

Cortical is still relatively new in the market of subscriptions. Currently, there are about 800 of Cortical’s brain gauges in the field. Despite counting people who bought lifetime systems, Cortical only has between 200 and 300 subscribers.

Speaking of its target market, Tommerdahl said it was consisted mainly of researchers, clinicians and anybody who works with patients with neurological insults. However, there’s also a wide variety of other different subscribers.

“Basically, we have a lot of customers that practice treating patients with some kind of neurological insult and that’s a wide range of things from pain to neurodegenerative processes to TBI that leads to Parkinson’s or dementia or whatever,” Tommerdahl said. “But, military world is our customer, civilians are customers and everybody in between.”

Customers of Cortical are also worldwide. According to Tommerdahl, around 50 percent of its customers are outside the United States.

In terms of advertising, Tommerdahl was usually invited to give talks to high level people in the field — people at different universities and people at medical conferences. He was also giving workshops and conferences to a wide variety of clinicians. Besides words of mouth, Cortical also had a blog that helped with the advertising.

“The blog helps. We have video cast and we have blog posts. We have different bloggers on their own independent websites who send stuffs to us. And you know, they advertise that,” Tommerdahl said.

Tommerdahl said that he was not afraid of data privacy since Cortical’s data were protected by the highest level of encryption.

“And even if they do crack it, they wouldn’t be able to understand it,” Tommerdahl added.

Without any existing competitor in the market, Tommerdahl said that he just wanted to keep up with the demand in the near future after a long and slow evolution.

“Demand is growing. We’re just keeping up with it,” Tommerdahl said.