Devices & Diagnostics

FDA-cleared iPhone app measures balance as a part of concussion screening on the sidelines

A concussion can manifest itself a variety of ways, from a headache to impaired memory to slurred speech. That’s why athletic trainers, nurses and physicians have a growing toolkit of assessment techniques for evaluating athletes who undergo a blow or jolt to the head. One piece that’s missing from that toolkit, according to Oklahoma entrepreneur […]

A concussion can manifest itself a variety of ways, from a headache to impaired memory to slurred speech. That’s why athletic trainers, nurses and physicians have a growing toolkit of assessment techniques for evaluating athletes who undergo a blow or jolt to the head.

One piece that’s missing from that toolkit, according to Oklahoma entrepreneur Chase Curtiss, is a way to evaluate balance that is less subjective than assessments like the Balance Error Scoring System and more affordable than force platforms.

Inspired by research he did as a graduate student in a neuropsychology lab at Wichita State University, Curtiss founded Sway Medical in 2011. In a matter of two years, the company has developed and received FDA clearance for an iPhone app that doctors, nurses, athletic trainers and physical therapists would use to evaluate an athlete’s balance after a potentially dangerous hit.

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Now the company has just secured two more key components in its path to commercialization: a strategic partner and a $750,000 Series A from angel investors and the OKAngel Sidecar Fund. Both of those things will help it launch the Sway Balance iOS mobile app for medical professionals this summer.

Here’s how the app works. A player holds the iPhone against his chest and performs a short series of balance movements. Using data collected from the iPhone’s motion detection technology, the app then delivers a balance score from one to 100. The idea is that athletes are screened at the beginning of the season using the app to establish a baseline score, like they would with other concussion assessment tools.Then they can then be tested again after an incident, to show if they have probably suffered a concussion and should receive medical attention.

The app underwent extensive clinical validation at Wichita State and a pilot study with a local school district, Curtiss said, and received its FDA clearance in September. Although other mobile concussion screening tests haven’t applied for clearance because they aren’t necessarily considered a medical tool, Curtiss said he saw broader medical applications for the app that warranted the investment in pursuing a nod from the FDA.

But for now, rather than establishing a large sales force of its own and trying to market the app independently, Curtiss said Sway’s strategy is to distribute through partners. Its first partner is ImPACT Applications Inc., which under an agreement will integrate the Sway’s app into its product offerings. ImPACT markets a computer-based concussion system that’s used by teams in MLB, NHL, NFL and WWE, plus thousands of high school, colleges and clinical centers. Curtiss said Sway is also working with a partner in the physical therapy space but has not publicly announced it yet.

And the company likely has numerous other potential partners as well. Detecting concussions has taken center stage for numerous mobile app, software and medical device developers over the past few years as new research has suggested that multiple traumatic brain injuries could increase risk of series long-term complications like depression, thoughts of suicide and chronic traumatic encephalopathy.

The app is meant to be just one piece of a thorough concussion assessment to guide medical treatment and monitoring of traumatic brain injuries.  Curtiss said it’s available for download in the app store now and will be opened up for subscriptions in about two weeks.

[Image credit: ImPACT Applications]