PM – Stardots submits patent application for its PSI platform following clinical results on autism and ADHD

Uppsala, Sweden – June 11, 2025 – Stardots AB – a leading developer of software medical devices to simplify and improve the diagnosis and treatment of neurological and psychiatric conditions – today announces that the company has submitted a patent application for its PSI platform following positive clinical results from a pilot study carried out at Uppsala University. The patent aims to protect the PSI platform and the use of digital biomarkers for improvement of diagnosis and treatment in neurological conditions such as autism and ADHD.

Stardots is developing medical device software (SaMD) to optimize diagnostics and treatment of neurological and psychiatric conditions, using advanced mathematical modeling of sensor data. The PSI platform aims to offer a more timely and accurate diagnosis, and individualized care, of autism, ADHD, anxiety, and depression.

A recent pilot study conducted together with a research team at Uppsala University, evaluating the methods and algorithms, has shown promising results. One of the study’s objectives was to identify characteristic oscillations in the pupillary network following light stimuli by analyzing pupil changes with eye-tracking technology. A total of 178 adults participated in the study including neurotypical controls, and people with prior diagnosis of autism, ADHD, anxiety or depression. All participants were high-functioning, which makes prediction harder.

The results showed distinct differences in pupillary regulation and revealed clusters of biomarkers correlating with different diagnoses, making it plausible to separate the diagnoses with a high mean accuracy autism 90%, ADHD 83%, anxiety 81%, and depression 88%. The results indicate that eye-tracking measurements provide a good basis for objective biomarkers.

“These results show strong correlations in clusters of biomarkers in several psychiatric conditions, indicating this is a promising set of objective measurements that could complement the diagnostic manuals used today. In cases where subjective assessments are insufficient to establish a diagnosis, these easy-to-use eye-tracking tests can offer additional methods to support the decision basis. We are not aiming to replace the clinicians, we are aiming to help them,” says Pär Nyström, associate professor in psychology at Uppsala University.

Following the results from the pilot study, Stardots has submitted a provisional patent application for the PSI platform at the American Patent Office (UPSTO), covering pupil regulation detection and correspondence with psychiatric conditions.

“The study demonstrates that eye-tracking measurements are a good source of objective biomarkers that can broaden the basis for assessment criteria in neuropsychiatric investigations. With a broad intellectual property protection, we can continue to develop the PSI platform aiming to make it beneficial in clinical use and drug development,” says Daniel Petrini, CEO of Stardots.

About PSI

PSI is a platform aimed at early diagnosis of autism, ADHD, depression and anxiety, especially in children. Research at Uppsala University has identified biomarkers linked to biological processes and root causes of these diagnoses, which can increase the chances of a correct and early diagnosis. This would reduce lead times in healthcare and additionally facilitate targeted and individualized interventions. Stardots is now implementing these biomarkers in an application to make the testing easy to use in clinical practice. The development and clinical trials are taking place in collaboration with Uppsala University. FDA clearance through a 510(k) submission is anticipated in late 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 conditions 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.