European Union and Australian Concussion Protocols May Now Include "Sway System" As Objective Test

Sway Medical, LLC a US mobile medical device company is announcing the European Union's CE Mark & Australian TGA approval for medical device use. End Quote

(1888PressRelease) September 13, 2016 - Tulsa, OK - Sway Medical, LLC is announcing the immediate availability for their Apple iOS mobile device App platform "Sway" into the EU countries. Frank Wolfe, Sway's COO stated " Sway Medical is very excited at the opportunity to expand its reach to athletes in the European Union." "The concussion industry has heavily relied on subjective testing to determine an athlete's concussion injury." "Sway provides immediate measurement on Balance, Motion Reaction Time and Concussion Symptom documentation, grading and tracking" according to Wolfe. "Sway removes geography from the equation as it immediately pushes the test results data from the mobile app to a secure cloud server, allowing off site consultations. The US Olympic Ski & Snowboard Team have used Sway for over 3 years as their team participates all across the world. to make the test data available immediately to other included medical professionals." Many NCAA Division 1-3 Athletic programs and professional sport teams have been using Sway their athletic trainers and physician may measuring during a game to objectively support a suspicious or concussion evaluation from the sidelines of the game. Team physicians, who may or may not, be onsite may be immediately consulted to assist as they have immediate access to the data via their mobile device or Sway Portal. The Sway Portal may be logged into from any computer's browser where advanced reports and outcome analytics may be performed or referenced.

Tulsa Neurosurgeon, NFL UNC and Director of the University of Oklahoma Concussion Center Eric Sherburn, MD, FACS points out "Sway is a real advancement towards unbiased objectivity in rapidly evaluating the concussed athlete during a game as it may be easier to remove a youth athlete from a game, the professional and high level athletes can present different challenges towards concussion examination and proper removal from a game." "Advanced sport is evolving towards improved concussion management protocols and policies where it's still about ensuring the athlete is safe to continue to play if a suspicious injury is suspected." "Sway is the first FDA cleared medical device that can acutely assist physicians and Athletic Trainers to rapidly and objectively measure an athlete's status compared to their baseline, as the test takes 1.5 minutes to perform. Dr. Sherburn also states "The greater risk is not the first initial concussion itself as much as the risk of the athlete receiving a second blow to the head while their brains is still injured from the first concussion injury." "Second Impact Syndrome has a very high complication rate, including possible death so it's important we get it right and include objective measurement to support the medical decision being made." "No medical professional wants to be wrong but the subjective protocols are still very highly variable such as BESS and SCAT." "Sway is an example of logical and validated improvement upon what has been considered standard where technology is assisting medical advancement in concussion management, even from an iPhone you may carry in your pocket."

The youth sports market should benefit substantially as medical professionals are not always available at every youth game and practice. This leaves acute decision making up to the coaches and parents, who may or may not have any medical education or knowledge on concussions. The Sway System was labeled by the FDA and CE Mark to allow trained coaches to be able to administer a non-invasive 1.5-minute test and immediately contact their referring doctor or trainer who can see the data immediately and assist with the acute medical decision needing to be made. This is not equipping coaches to play doctor as they do not want that liability nor do they have the medical training for such usually but Sway provides a communication pathway for doctors to assist them in improved decision making until the athlete can be further evaluated. Sway measures concussion metrics objectively to provide the medical professional with enhanced, objective information to improve decision making. A concussion examination is always advised by a qualified medical professional and quantifying with Sway measurements improve that process. Concussion Diagnosis and Return to play post injury recovery testing is now affordable, timely and mobile thanks to mobile medical device technologies such as Sway.

Sway may be purchased online by medical professionals from Sway's website www.swaymedical.com. The mobile App is a free download from the Apple App store but login credentials are issued to a private system upon system purchase. There is an annual per patient or athlete profile fee that ranges from 3-4.50 USD, depending on the volume of profiles purchased. Multiple system user adds are also an annual fee and may be purchased for 50.00 USD each.

Press Contact:
Mary McMahon
Sway Medical, LLC
1840 East 15th Street Tulsa, Oklahoma 74114
(612) 888-7929
http://www.swaymedical.com/

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