Stardots aims to optimize deep brain stimulation treatment for Parkinson’s patients in new clinical study

Uppsala, Sweden – July 23, 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 company has conducted a site initiation visit to the clinical trial partner Darthmouth Hitchcock Medical Center (DHMC), for the upcoming trial of ANLIVA® DBS in patients with Parkinson’s disease. Patient inclusion in the trial is set to begin during the second half of 2025.

Stardots develops medical device software (SaMD) to optimize diagnostics and treatment of neurological and psychiatric disorders using objective measurements. ANLIVA® DBS is a SaMD device that aims to improve deep brain stimulation (DBS) treatments by using patient-tailored data to optimize treatment settings. Current methods to calibrate DBS treatment in Parkinson’s disease patients consist of time-consuming manual tests, leaving room for transformative improvements.

“Deep brain stimulation has revolutionized care for people with advanced Parkinson’s, but tuning the optimal settings still rely too much on trial-and-error in repeated clinical visits. ANLIVA DBS offers a clear potential for treatment improvement. By harnessing continuous patient-specific data and smarter algorithms, we may calibrate stimulations more precisely, more quickly, and ultimately keep symptoms under better control. The upcoming study provides a first step to turn that promise into everyday clinical reality,” comments Anas Hannoun, MD Clinical Assistant Professor of Neurology, Movement Disorders at Geisel School of Medicine at Dartmouth.

The clinical trial will investigate ANLIVA® DBS in idiopathic Parkinson’s disease patients who are currently being treated with, or are scheduled to receive, deep brain stimulation treatment. In total, 30 patients will receive treatment with ANLIVA® DBS over 12 months. Based on the trial’s outcome, the company aims to apply for a 501(k) FDA market approval in the US.

“We are very excited to take the next step in the clinical evaluation of ANLIVA DBS and at the same time deepen our collaboration with Darthmouth Hitchcock Medical Center. Deep brain stimulation treatment for Parkinson’s disease is well-integrated into clinical practice, both in the U.S. and globally, and the improvement thereof stands to create a positive impact on a great number of patients’ lives. We look forward to communicating the study initiation shortly,” says Daniel Petrini, CEO of Stardots.

About ANLIVA® DBS 

ANLIVA® DBS is a medical device software that predicts optimal deep brain stimulation (DBS) settings for individual patients, enhancing treatment effectiveness. Using digital twin technology, the software analyzes the patient’s neurological imaging data to determine optimal settings. This advancement replaces traditional manual adjustments, which burdens both patients and healthcare resources with time-consuming calibration sessions.

Healthcare providers simply upload patient imaging data to receive ANLIVA® DBS’s recommended settings. The software’s computational algorithms are drawn from extensive mathematical modeling research conducted at Uppsala University. FDA clearance through a 510(k) submission is anticipated in the first half of 2026.

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.