Late last week, the Food and Drug Administration gave its stamp of approval to the marketing of the world's first device designed to help diagnose ADHD--a disorder that plagues some 6.4 million children--by scanning a child's brain waves. 

And, get this: the company behind the breakthrough was not a major pharmaceutical company or biomedical manufacturing firm.

In fact, it was a 10-person start-up in Augusta, Georgia, called Neba Health, a company so under-the-radar that Google hasn't even indexed its website

The Backstory

According to Neba's president, Howard Merry, the company was founded in 2006, and has had the same exact team over the last seven years--a pretty amazing feat when you consider the turnover rate for most start-ups. The journey, however, was far from easy. 

"There were some days that I would come to work, and the task before us was so herculean," says Merry. "We were such a small group with limited resources that, to be frank about it, I would despair."

Merry won't say how much capital the company has raised, but says several "high net worth individuals" made angel investments to keep the company afloat. 

Nicknamed the NEBA (its full name is the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid), the device looks like a small cap that gets affixed to a child's head, not altogether unlike the electrodes put on your chest during a trip to the doctor's office. The cap then measures electrical activity in the front of the brain--particularly, the ratio of "fast waves" to "slow waves." 

According to Merry, a lot of research shows that there are implications for kids who have ADHD that can be observed directly in these brain waves.  "We're basically processing these brain waves for a particular biomarker," he says. 

Neba's clinical tests proved that a clinician could use NEBA to improve accuracy by about 44 percent--that's an increase from 61 percent to 88 percent.

The Long Road to the FDA

Neba's discussions with the FDA began in 2006. Then, the clinical trial began in 2007. Trials ran through 2008 to 2009, and the FDA submission was in 2010. Then, there were about two years of questions from the FDA. 

"The strategy was to meet with the FDA, get as clear guidance as we could, and do exactly what they told us they wanted," he says. "We went back to them so many times until they were sick of us. You don't get the benefit of the doubt that Merck would. You're unknown to the FDA. You can't just talk--you have to show."

Working with a third-party clinical testing group, Neba studied 275 children and adolescents ranging in age from 6 to 17 years old, all of whom exhibited signs of attention or behavioral concerns. As the FDA noted its own release this week, "the study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone."

Now that the company has been granted approval to sell the device, Merry says he's targeting clinicians and hospitals as potential customers. 

The business model is fairly straightforward--it costs around $300 for parents to get their kids tested. Since no insurance company currently accepts a NEBA scan, a parent would enter the clinical and billing information with Neba directly, and Neba would then send that information to the clinician. The technician then runs the report, and Neba charges the patient once the data is uploaded. The whole process takes about an hour.

The Skepticism

The device is not without some controversy. Late last week, ABC News published a highly skeptical news story about Neba Health, quoting several pyschiatric experts doubting the company's motives. 

"I don't know that this is going to help the situation at all," Rachel Klein, a professor of child and adolescent psychiatry at NYU Langone Medical Center told ABC. "I think it's going to make people spend money needlessly."

Merry said the article hurt--especially because he didn't have a chance to respond. But he also argues that the story was fundamentally misinformed. 

"While there are some upfront costs, NEBA is worth it because of the increase in accuracy it brings the clinician and the overall costs associated with misdiagnosis," Merry says. 

Merry and his team are focusing on the NEBA to help diagnose ADHD now, but there are other products in development--in particular, two geared towards diagnosing depression and dementia. 

Obviously, seven years is a long time, and Merry is thrilled to finally see results. But it was hardly an easy route to get there. 

"Of course, you have to have a profit motive, but at some point, that's not enough," he says. "You have to have another motive, something that's satisfying."

"It may sound like BS," he says, "But it's about helping the kids.