Charleston startup passes FDA muster with tech that can pinpoint concussions

A startup that grew out of research at the Medical University of South Carolina and The Citadel has hit the market and closed on a new round of funding.

Blinktbi Inc.’s EyeStat device, now being sold to schools and athletic programs, puffs food-grade carbon dioxide into a subject’s eye, triggering the blink reflex. Then, high-speed cameras within the device capture thousands of images and gauge how long it took for the person to blink. 

The upstart raised nearly $5 million in 2017, its first year. Those early funds were used in part to finance ongoing research at The Citadel to prove the device can be used to detect concussions and other maladies.

Ryan Fiorini, Blinktbi’s chief operations officer, said the EyeStat prototype weighed 100 pounds, and it utilized a gaming computer to process the images.

The next job was to cut it down to size. 

“It didn’t fit in the back of my full-size SUV,” said Fiorini, who has a doctorate immunology and microbiology from MUSC. “We rolled that into the engineer’s office and said, ‘We need this to be four-and-a-half pounds.’” 

They were able to pull it off. 

The company cleared a formidable hurdle at the end of 2019, when the U.S. Food and Drug Administration gave Blinktbi permission to market its device, after a rigorous review process that took months to complete. One study published in 2013 found the FDA’s process to get medical devices to market from the idea phase typically takes between three and seven years.

Now free to begin selling EyeStat, Fiorini said the company is leasing the technology to lessen the blow of the device’s full cost of about $10,000.

The latest round of funding, for about $6 million, will help offset the costs of manufacturing the medical devices, to make that option possible.

Fiorini said organizations can rent EyeStat for around $200 per month. 

One day, the company hopes insurance will cover the use of the technology. 

The University of Pittsburgh Schools of the Health Sciences estimated the number sports-related concussions every year falls between 1.7 million and 3 million. About 300,000 are football injuries. Half go unreported.

Concussions happen when a blow to the head causes the brain to bounce around in the skull, leading to a chemical response, according to the Centers for Disease Control and Prevention. Those chemical changes make the brain more sensitive to stress until it heals.

The CDC found in one study that children and teens account for 65 percent of all concussions.

Fiorini’s own son suffered a concussion when he fell off a dock as a toddler. 

“What we would come to find out is that there was no way to test him,” Fiorini said in a TEDx talk in Charleston last year.

Studies of how the blink reflex can indicate diseases like Parkinson’s and schizophrenia date back to the 1950s. But no tool has been developed in the intervening decades to use the response to help with diagnosis.

Dr. Nancey Tsai, a neurosurgeon at MUSC, came up with the idea for a portable machine that could measure the blink reflex in 2011. 

From there, the Zucker Institute for Applied Neuroscienceswhich is embedded within MUSC, helped to license the technology. Mark Semler, CEO of the institute and now an adviser to Blinktbi, said the startup is the second in the institute’s portfolio to pass FDA clearance.

“The market is huge, because there’s no good option out there,” Semler said. “The blink can’t be cheated.”

Right now, Fiorini said the company has fewer than 10 employees working out of its office on Rutledge Avenue. Among its advisers are heavy-hitters in the world of sports, including Danny Morrison, the former president of the Carolina Panthers, Steve Smith, a longtime wide receiver in the NFL, and Harvey Schiller, former executive director of the United States Olympic Committee and former president of the International Baseball Federation.

Looking forward, Blinktbi is researching whether its technology could help to detect Alzheimer’s disease and multiple sclerosis.

Fiorini said he can see EyeStat in the hands of police for field tests, giving officers an immediate, objective measure of sobriety — though each new application for the device would require a new round of FDA approvals.