Global Kinetics announces FDA clearance for Kinetigraph

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Global Kinetics Corporation, a leader in health technology for people with Parkinson’s, has announced 510(k) marketing clearance for its next generation wrist-worn Parkinson’s KinetiGraph (PKG) System from the US FDA.

The new PKG technology enables a shift to “anywhere, anytime” monitoring from the previous clinically focused system. Underpinning this shift are technology enhancements to enable 24hr/7days of the week/365 days of the year wear and data capture for people with Parkinson’s.

Global Kinetics President and CEO Timothy I Still said clearance of the new technology signals a major milestone for Global Kinetics, underpinning aggressive expansion into new product and service offers to meet the needs of the Parkinson’s community worldwide.

“The new PKG technology is a core platform for the company to reach scale in the US, European and Asia Pacific clinical care markets by overcoming previous distribution and data handling constraints.

“The Second Generation PKG platform also enables us to capitalise on our growing telehealth and clinical trial services businesses, and to build on our already substantial partnerships with global pharmaceutical and device leaders in Parkinson’s,” said Mr Still.

Developed and trialled in Melbourne, where Global Kinetics Founders Professor Mal Horne and Professor Rob Griffiths developed the original PKG, the Second Generation PKG has strong support from local Parkinson’s patients who have been first to trial the System.

Robert, 65, who has worn the PKG for the past 10 months, said it has greatly improved his treatment plan with his neurologist.

“The data is presented is a report, which allows us to understand exactly what is happening, how to manage it and to compare my disease progression over time.

“The PKG is also a great way to manage my medications and ensure I take them on time, which is so important as I suffer short-term memory loss due to my Parkinson’s,” he said.

The Second Generation PKG is smaller, more compact and includes a touch sensitive backlit screen with haptic and visual feedback, a water resistance enclosure and mobile charging and data handling capacity.

With the appearance of a new generation smart watch, the Second Generation PKG has been designed to deliver meaningful clinical data to assist doctors, empower individuals and service industry partners such as drug companies.

The new Second Generation PKG was unveiled at the World Parkinson’s Congress in Portland, Oregon, and will now be distributed to patients and physicians in 15 key US movement disorder clinics.

Mr Still said: “The next major milestone is to achieve CE mark in Europe ahead of distribution into European markets, estimated for late 2016.

“Global Kinetics continues to realise year-on-year growth, delivering on its strategic business objectives while remaining steadfast in our mission to make a meaningful difference for people with Parkinson’s. We recently celebrated delivery of our 11,000th PKG report – and look forward to a new era of impact with our Second Generation PKG system,” he added.