PR: Stardots receives approval from the Swedish Medical Products Agency for Psilmi clinical investigation in ADHD and hormone sensitivity

Uppsala, Sweden, 2026-08-04 Stardots AB today announces that the Swedish Medical Products Agency, Läkemedelsverket, has approved the company’s clinical investigation application for Psilmi, Stardots’ investigational neuro-ocular measurement platform. The study will be conducted in collaboration with Karolinska Institutet and Uppsala University and will investigate biomarkers of hormone sensitivity in women with ADHD, premenstrual dysphoric disorder, PMDD, and comorbid ADHD and PMDD.

The study, titled “Biomarkers for hormone sensitivity in women with premenstrual dysphoric disorder and attention deficit hyperactivity disorder”, is an exploratory, prospective, observational cohort study designed to integrate eye-tracking, EEG, hormonal, molecular, and clinical data. Approximately 250 women are planned for inclusion across five groups, including women with PMDD, women with ADHD, women with comorbid ADHD and PMDD, and healthy controls.

Psilmi is a non-invasive Software-as-a-Medical-Device concept that uses controlled visual and cognitive stimuli together with eye tracking and pupillometry to extract interpretable biomarkers across domains such as arousal regulation, cognitive control, sensorimotor function, social processing, and valence response. In the upcoming study, Psilmi will be used to investigate whether hormone sensitivity can be detected through objective physiological signals, including eye movement patterns, pupil dynamics, EEG differences, and biological markers.

“This is an important milestone for Stardots and for Psilmi,” said Daniel Petrini, CEO of Stardots AB. “Psychiatry has long lacked objective, reproducible, physiologically grounded measurement tools. With Psilmi, our ambition is to build a measurement layer that can support clinicians and researchers across several psychiatric and neurodevelopmental conditions. The approval from Läkemedelsverket moves us one step closer to validating that vision in a highly relevant and underserved area of women’s mental health.”

The clinical investigation will be conducted at Karolinska Institutet/Danderyd Hospital and Uppsala University/Akademiska Hospital, with Professor Helena Kopp Kallner as coordinating investigator and Professor Inger Sundström Poromaa as principal investigator at Uppsala University. The study is expected to run through 2027, subject to final ethical approval from the Swedish Ethical Review Authority.

Beyond this specific study, Stardots sees Psilmi as a scalable measurement infrastructure for objective psychiatry, with potential applications in ADHD, autism, depression, anxiety, women’s mental health, treatment monitoring, patient stratification, and clinical development programs.

In parallel with our clinical validation work, we are seeing increasing interest from industry partners in how objective neuro-ocular biomarkers could support CNS drug development, neuromodulation, patient stratification, and treatment monitoring.

The study remains subject to final approval by the Swedish Ethical Review Authority before initiation.

Regulatory Note: Psilmi™ is currently available for research use only. Regulatory submissions and FDA 510(k) clearance followed by CE marking are planned for 2027.

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 is a Swedish company developing Psilmi®, a stimulus-driven neuro-ocular measurement platform designed to make psychiatric assessment more objective, reproducible, and physiologically grounded. Psilmi combines controlled visual and cognitive stimuli, eye tracking, pupillometry, and biomarker extraction to support research and future clinical decision support across psychiatric and neurodevelopmental conditions.

For further information, visit www.stardots.se