PM – Stardots includes first subject in clinical trial of ANLIVA® in the U.S.

Uppsala, Sweden – Februari 6, 2025 – Stardots AB – a leading developer of software medical devices to simplify and improve the diagnosis and treatment of neurological and psychiatric disorders – today announces that the first subject has been included in a clinical trial of ANLIVA® Hand Movement and ANLIVA® Eye Movement. The trial, performed in collaboration with the Dartmouth Hitchcock Medical Center in New Hampshire, U.S., aims to evaluate the accuracy of Stardots’ medical devices in patients with Parkinson’s disease or essential tremor.

The current lack of readily available biomarkers for Parkinson’s disease complicates the diagnosis and treatment optimization, as caregivers today need to rely solely on subjective assessments. The ANLIVA® Hand Movement and ANLIVA® Eye Movement devices are at the forefront of digital health innovation, developed to offer precise measurement of motor and ocular symptoms associated with the disease.

Stardots and Dartmouth Hitchcock Medical Center is now performing an open, controlled, pivotal, and exploratory clinical trial to evaluate the performance of ANLIVA® Hand Movement and ANLIVA® Eye Movement. The devices are used to quantify and classify symptoms and disease states using sensor data from smartphones and eye-tracking cameras in subjects with Parkinson’s disease or essential tremors. The study will enroll approximately 60 subjects, and the results will be a pivotal part of an application for marketing approval of ANLIVA® Hand Movement in the U.S. under the 510 (k) regulatory pathway, which is slated to be submitted by mid-2025.

“The ANLIVA platform has the potential to provide digital biomarker data that can significantly enhance the understanding of Parkinson’s disease and other neurological disorders, optimize treatment plans, and ultimately improve the quality of life for patients. We are excited by the high interest from patients to participate in the ongoing clinical trial, which constitutes a key step toward a potential marketing approval of our first software medical device in the U.S.,” comments Daniel Petrini, CEO of Stardots.

“I am happy to work with Stardots towards launching and conducting this clinical trial. This is a promising step to achieve a much needed mathematical and objective physical biomarker that is both reliable and easy to collect. Such biomarkers are essentially helpful to our patients of Parkinson’s Disease,” said Dr Anas Hannoun, Clinical Assistant Professor of Neurology, Movement Disorders at Dartmouth Hitchcock Manchester Division.

The neurology clinic for Parkinson’s Disease and Movement Disorders of Dartmouth Hitchcock Medical Center has been designated as a “Center of Excellence” by The Parkinson’s Foundation. 

For further information, please contact:
Daniel Petrini, CEO
Tel: +46 70-782 70 01
E-mail: daniel.petrini@stardots.se

About Stardots AB

Stardots AB develops software-based diagnostic tools (Software as Medical Device) for neurological and psychiatric disorders such as Parkinson’s, autism, ADHD, dementia and Alzheimer’s. The company’s product platforms ANLIVA®, PSI® and QUEST® use advanced mathematical modeling of sensor data from smartphones, eye cameras and other sensors to enable faster and more reliable diagnosis and optimized treatment. Stardots’ first product, ANLIVA® Hand Movement for Parkinson’s disease, currently being evaluated in a clinical trial in collaboration with Dartmouth Hitchcock Medical Center in the U.S., has the potential to reach market approval by the end of 2025. Stardots, headquartered in Uppsala, Sweden, has the U.S. as its primary target market.

For further information, visit www.stardots.se.