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EvergreenHealth and nQ Medical Seek FDA Clearance for Revolutionary Parkinson's Disease Assessment


March 2023

Kirkland, Wash. – Following a successful clinical investigation at EvergreenHealth, a community-owned hospital in Kirkland, WA, nQ Medical and the EvergreenHealth Research Program are working together to earn FDA clearance for the nQ System, an easy-to-use software with the potential to forever change the way we manage Parkinson's Disease.

The nQ System uses artificial intelligence to measure how a person with Parkinson's disease types on their personal computer at home, gathering data on things like speed, latency, and accuracy, in order to enable the physician to build an objectively accurate picture of where the individual is in their disease progression and suggest any necessary adjustments in their treatment plan. Prior to the nQ System software, Parkinson's patients could only be assessed periodically during in-person appointments with a physician or through remote patient surveys.

nQ Medical was granted Breakthrough Designation by the FDA in 2018 and is awaiting final clearance to the U.S. market.

"This is an entirely novel way of assessing motor performance in patients with Parkinson's Disease using digital technology. With artificial intelligence helping us interpret data, we can get the most objective and accurate understanding of where a person is in their Parkinson's journey and how they are responding to their medication," said EvergreenHealth's Pinky Agarwal, MD, who was the principal investigator for the nQ System study.

"At EvergreenHealth, we conducted a first-of-its-kind pivotal study investigating the utility of a novel software as a medical device for the assessment of Parkinson's disease-related motor impairment based on keystroke data. This study illustrated that passively collected real-world data can effectively complement standardized onsite clinical assessments in a manner that is accurate, minimally burdensome to patients, and highly accessible," said Dr. Ijah Mondesire Crump, vice president of clinical affairs at nQ Medical.

EvergreenHealth enrolled more than 50 local Parkinson's patients for the study, which took place August 2021 to March 2022. To participate, enrollees simply had to download the nQ software onto their home computers and use the computer for an average of 15 minutes a day. EvergreenHealth staff helped enrollees every step of the way and conducted in-person checkups a minimum of four times throughout the study's duration with each patient.

"The software was easy to install on my home computer, and all I had to do was go about my business as usual. The research team was awesome to work with and easy to get ahold of, so they let me know if I was typing enough and I could reach them if I had any issues," said Eric Singsaas, an enrollee in the study. "It was an incredibly convenient and unintrusive way to monitor my Parkinson's."

The results of the nearly six-month study showed that the nQ System has the potential to fill the current need for an objective, remote assessment of motor performance for use in Parkinson's Disease treatment.

This means that with the evidence EvergreenHealth researchers have collected using the innovative technology from nQ Medical we are one step closer to significantly improving outcomes for Parkinson's Disease patients.

"Being able to give back by participating in this kind of study is a great honor," said Singsaas. "I'm just so glad to be a part of something that can help others, and I hope this technology can benefit many more Parkinson's patients like me."

Additionally, the evidence gathered by EvergreenHealth researchers showed nQ scientists that the nQ System could have applications in a number of neurodegenerative conditions including Alzheimer's disease.

"The study allowed us to gather additional data for experimental analysis purposes, including the evaluation of the device's sensitivity to drug concentration changes over time," said Teresa Arroyo-Gallego, chief data scientist at nQ Medical. "These data have allowed us to explore new areas of application for the nQ System device that open new paths for future developments."

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