Posted: 2014-09-11 in Press Releases
Global Kinetics Corporation Secures FDA Clearance to Sell Parkinson’s KinetiGraph™ System in USA.
… Parkinson’s KinetiGraph™ (PKG™) system to be available in key US market
…World leading Parkinson’s disease monitoring technology to be made available in US clinics within weeks...
Melbourne, Australia 11 September 2014: Australian technology company Global Kinetics Corporation has achieved a key milestone, securing important US regulatory clearance to market their world leading Parkinson’s disease mobile health technology in the high value American market.
Announcing the Food and Drug Administration determination, GKC Managing Director Mr Andrew Maxwell said the company was now moving swiftly to ensure the Parkinson’s KinetiGraph™ (PKG™) technology is available to over one million people living with Parkinson’s in the USA.
The Parkinson’s KinetiGraph™ or PKG™ wrist worn medical device allows neurologists to remotely monitor the disabling movement symptoms of Parkinson’s disease. Treating neurologists are able to use the information generated by the PKG™ system to aid in the management of movement disorder symptoms which may lead to greater independence, better quality of life, and lower health care costs.
Mr Maxwell commented: “Securing FDA clearance s an important step for our company. Our Parkinson’s KinetiGraph™ system is a world leading mobile health technology. It is now available in the United States to remotely monitor the key disabling movement symptoms of Parkinson’s disease.
“We are working closely with leading US neurologists and have already made excellent progress recruiting key reference sites to make the PKG™ technology available in the USA.”
“To date we have made this life changing technology accessible to more than 50,000 people living with Parkinson’s disease across Europe, Australia and Asia. The US market is the next frontier. We look forward to making the PKG™ device available to the one million Americans who are affected by the debilitating movement disorder.”
FDA clearance for the PKG™ technology follows regulatory approval in Europe and Australia.
Mr Maxwell added: “ We are looking forward to working with neurologists, patient advocacy groups and industry players in the US who have an interest in improving the lives of people with Parkinson’s.
The technology has been developed by Australian neurologists at the Melbourne based Florey Institute of Neuroscience and Mental Health and is now being rolled out by Global Kinetics Corporation.
Global Kinetics Corporation expects that PD patients in 30 nations worldwide will have access to PKG™ technology within 18 months.
For more information on the Parkinson’s KinetiGraph™ medical device please go to www.globalkineticscorporation.com.au
For further Information contact Emma Power at Monsoon Communications Australia on +61 419 149 525.
About Global Kinetics Corporation
Global Kinetics Corporation (GKC) is a privately held technology company headquartered in Australia focused on globally commercialising its innovative movement disorder technology, specifically for the management of Parkinson’s Disease. The company’s lead product is the Parkinson’s KinetiGraph™ (PKG™) medical device, a first in class medical technology assisting neurologists to better manage the key disabling movement symptoms of Parkinson’s.
The PKG™ wrist worn medical device automatically records motion data to assist doctors in their management of symptoms. This objective movement data recorded over 6 days, is downloaded within minutes and assists doctors to analyse movement disorder symptoms and symptom changes over time. Parkinson’s disease is a progressive disorder of the brain’s frontal lobe, which controls impulsive and non-impulsive movement. An estimated 6 million people around the world are affected. The main motor (or movement) related symptoms of Parkinson’s disease are bradykinesia, rigidity, tremors and postural instability. Other non-movement symptoms may be experienced such as speech and swallowing difficulties, cognitive impairment or behavioural change and sleep disturbance.