Global Kinetics Corp., an Australian device developer with an FDA-cleared wearable designed to make objective assessments of Parkinson’s disease patients’ movement, has received more than $6 million (AUS $7.75 million) from the Australian government’s Biomedical Translation Fund. The funding is aimed at commercializing the device in the U.S. and other markets, according to the Global Kinetics’s website citing The Australian Financial Review.
The wearable, styled as a smartwatch, generates a score for bradykinesia — a slowness of movement associated with Parkinson’s disease, dyskinesia — involuntary muscle movements, and tremor. The smartwatch is worn for seven days before it is returned to the clinician who uses it to downloaded data to get a snapshot of a patient’s condition.
Global Kinetics COO Michelle Goldsmith told The Australian Financial Review that the company is in the process of developing a new model that could be worn all the time, be charged by the user at home, and give clinicians a continual feed of data on their symptoms to support more personalized treatment plans.
Since Global Kinetics received FDA clearance for the Parkinson’s KinetiGraph two years ago, the company’s U.S. rollout has focused on influential clinics as it pushes for reimbursement of the wearable. To date, 30 U.S. clinics use the company’s device as part of their routine clinical care, said Global Kinetics CEO John Schellhorn in response to emailed questions.
Schellhorn noted that the company is continuing to take part in studies to validate the wearable in clinical settings. Global Kinetics is also taking part in a 400 person clinical study as part of the Parkinson’s Foundation’s Outcomes Project to optimize the treatment of Parkinson’s disease. The company’s target users are neurologists.
He added that the strength of KinetiGraph is its passive collection of data from patients.
“Other systems on market and many of the new apps we see are task-based – that means they make the patient stop several times in the day and do something like tap a screen or touch their fingers together,” Schellhorn said. “This provides an incomplete picture and stimulates different parts of the brain. We are continuous and don’t require patients to do anything extra – that’s why doctors use us and patient compliance is so high – above 95 percent.”
A recent study of the KinetiGraph by the University of Melbourne found that data collected from patients could help inform clinical decisions for Parkinson’s disease patients such as adjusting their medication dosage, according to findings from the study published in the journal, Nature.
Of the 103 participants who took part, motor scores were assessed to be outside of the target in 78 percent of the cases. Changes in oral therapy were recommended for 74 percent and advanced therapy was recommended for 12 percent. Of the 77 who completed the study, 48 percent achieved their target but that figure also included 22 percent who achieved their target at the outset.
https://medcitynews.com/2018/04/fda-cleared-wearable-parkinsons-disease-patients-gets-6m-funding-boost/
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