Aura Oslapas says that being able to show her neurologist how her motor symptoms were fluctuating, using a mobile app she created, was the impetus for her to get a deep brain stimulation device. Now, StrivePD, the app she created based on her own first-hand experience with Parkinson's disease is FDA cleared to collect patient symptom data through measurements made by Apple Watch.

San Francisco, CA-based Rune Labs, which acquired the StrivePD software ecosystem in 2019, said the app enables precision clinical care and trial participation for Parkinson's patients who use an Apple Watch. Since the acquisition, Oslapas has worked with the company to evolve the StrivePD user experience, and also recently joined its patient advisory board.

For patients who also use Medtronic's Percept PC Deep Brain Stimulation device, FDA clearance for the StrivePD app is expected to enhance clinicians' ability to make brain-sensing data from these devices useful, as part of an existing partnership between Rune Labs and Medtronic. This clearance also sets the stage for leveraging StrivePD to reach a significant number of potential prodromal Parkinson's patients, the company noted.

"When people with Parkinson's are prescribed new medications, adjusting how much to take and when to take it until they find something that works can be a lengthy process. StrivePD helps people to track their symptoms and improvements, accelerating the time to an optimal medication schedule – and with today's clearance, more people will have access to this life-changing technology," Oslapas said. "StrivePD on Apple Watch is the long-awaited union of quantitative and qualitative data that encourages better care and communication between patients and clinicians, while also empowering people with Parkinson's who are striving to live better every day."

Previously, clinicians and researchers have made patient care decisions based on limited information. Having visibility into this data could accelerate drug development, using higher resolution metrics to inform trial design, endpoint selection, and patient stratification, as well as whether a treatment effect is detected, Rune Labs noted.

"As we have seen in oncology, the introduction of large quantities of real-world data has the power to transform drug development and fundamentally change disease prognosis. This clearance is a major step towards building a similar paradigm in neurology," said Brian Pepin, CEO and founder of Rune Labs. "With all of the data we will collect and the patients we will reach through this clearance, we will make sure the right participants enroll in trials, and help our pharma and medtech partners run more efficient trials with higher quality outcomes data, thereby enabling more therapies to come to market quickly to help those suffering from Parkinson's."

The StrivePD ecosystem draws data directly from Apple's Movement Disorder API, which provides a power-efficient approach to measuring and recording tremors and dyskinetic symptoms common in patients with Parkinson's disease. Rune Labs said users' personal information and privacy is protected and governed by the company's information security management system.