Startups, Devices & Diagnostics, Diagnostics

Concussion diagnostic device EyeBox receives FDA nod

New York-based startup Oculogica has created an objective, baseline-free diagnostic to detect whether someone's had a concussion.

The recent media attention around concussions have pushed the condition to the forefront of many discussions about safety in sports.

A long-standing problem in addressing the issue though, has been the lack of an objective test that accurately diagnose whether somebody has received a concussion.

New York-based startup Oculogica is trying to change that with its EyeBox device, the first non-invasive and baseline-free diagnostic tool for the detection of concussions.

The company received De Novo marketing approval of its product by the FDA following promising results from a multi-site clinical study of 282 patients who presented in the emergency room and concussion clinic with suspected traumatic brain injury.

EyeBox tracks a person’s eye movements while they watch roughly four-minutes of video and then uses a proprietary algorithm to determine whether they have received a concussion.

“Eye tracking has the potential, if is done properly, to be a noninvasive way to make an assessment about what’s going on inside the brain,” said Oculogica CEO Rosina Samadani in a phone interview.

With regulatory approval in the bag, Oculogica is commencing sales of its product starting with pilot programs at various clinics around the country. The small 6-person startup was founded in 2013 by Rosina’s sister, neurosurgeon Uzma Samadani, and has raised around $6 million.

Getting reimbursement still remains an early challenge, with payer organizations generally wary of novel technologies. But Samadani said the EyeBox is a cost effective and safer alternative to tests like CT scans and can also reduce costs downstream through better treatment and faster recovery from concussions.

The wide array of potential customers for the EyeBox include sports medicine physicians, university physicians and military doctors looking to diagnose brain injuries for soldiers. The lack of a necessary baseline test for the EyeBox is especially relevant for elite athletes who can potentially game tests in an effort to get back on the field.

Alan Shahtaji, a sports medicine physician at UC San Diego, said the standard test for a concussion still consists of an array of eye and balance tests. He added that an objective diagnostic would be especially useful in marginal cases where the extent of brain injury is initially difficult to determine.

“There’s no single objective diagnostic for concussion, there’s a set of diagnostic tools that we can use but they’re still largely subjective,” Shahtaji said in a phone interview. “We don’t really have anything that can determine whether someone has had a concussion like we do with an ACL injury.”

To be sure, a host of other companies including Bethesda, Maryland-based RightEye and Palo Alto, California-based SyncThink have emerged with VR-based devices that can track visual impairment as an indication of brain health.

Those products retail at lower prices than the EyeBox, but fall short in their ability to actually adjudicate whether someone has suffered from a concussion.

In fact, SyncThink, which works with sports teams like the Golden State Warriors, has previously been reprimanded by the FDA for promoting its device as a way to detect concussions.

“In concussion, the market is really muddy with people who have been developing the something more like a toy than a diagnostic,” Samadani said.

While Shahtaji said there needs to be a clinical assessment component to the use of any diagnostic tool, he sees the use of a device like the EyeBox as being especially vital in developing a normative data set that can be used to develop better treatment and recovery protocols for concussions.

Samadani agreed and said she hopes that that EyeBox will be integrated into regular checkups to help track patient’s brain health as part of their overall health.

Moving forward, Oculogica is hoping to increase the portability of its EyeBox diagnostic and expand the kind of indications that the device can be trained to detect.

The product has already received breakthrough device designation by the FDA to help expedite its use in diagnosing elevated intracranial pressure and plans to move into other neurological diseases from there.

Picture: Getty Images, Iaremenko

Shares1
Shares1