Sway nabs $750K for FDA-cleared balance assessment app

Original Article

Published by Jonah Comstock at Mobi Health News - June 21, 2013 - 07:53 am

A new mobile health startup has emerged from stealth mode with a first round of funding, FDA 510(k) clearance, and an app launch, not to mention a partnership. Tulsa, Oklahoma-based Sway Medical, formerly Capacity Sports, raised $750,000 from individual angel investors and the OKAngel Sidecar Fund, a fund financed by the state of Oklahoma to promote entrepreneurship. The iOS app, called Sway Balance, is cleared by the FDA for prescription use and uses the mobile device's accelerometer to perform a balance assessment on the user.

Balance assessments have a number of possible use cases: assessing an elderly person's fall risk, tracking recovery from an injury, or detecting instability from a medication change. Thanks to a partnership, the company's first use case is screening for concussions.

"Using individualized movements to evaluate stability, the Sway Balance software can detect instability from a head injury," the company's press release states. "Athletes simply hold a mobile device against their chest and perform clinical balance movements. A balance score quickly evaluates total stability on a 100 point scale, with 100 being well balanced. An athlete’s data is then displayed on the mobile device to evaluate progress and trends over time, providing improved quality of care for athletes. Athletes and their families will also be able download the app to review results, track trends, and self-administer prescribed Sway Balance tests."

The app is available for a free download in the App Store, but because of the prescription clearance, most features of the app will only be available to medical professionals with a login issued by the company. That membership is not yet available for purchase, but the company plans to offer it starting next month for $199 for an annual subscription. The device is available on iPhones, iPod touches and iPads and only cleared for Apple devices.

To address concussions, Sway announced a partnership with ImPACT Applications, a software company that developed a concussion-evaluation software in the early 1990s. Sway's initial offering will combine cognitive testing from ImPACT with balance evaluation from Sway, to provide a robust platform for tracking the effects of a head injury.

A number of companies, including Cambridge, Massachusetts-based MC10 and Seattle-based X2 Biosystems, are working on wearable sensors that aim to measure the impact of head injuries in near-realtime. And many startups have focused on balance sensing in another use case: fall detection (and, hopefully, prevention) among the elderly. As for Sway Balance, the company says it's just starting with concussion management. The product is cleared for evaluating postural sway in connection with nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue.

"Future versions of the Sway Balance app will assist in monitoring patient outcomes in physical therapy, orthopedic and primary care physician practices, senior living facilities, and worksite medical clinics settings," says the press release. The company also lists "monitoring the impact of prescribed medications" as a possible future use case.