Stardots advances HARMONI with second study site at Karolinska Institutet

Uppsala, Sweden, 2026-09-14. Stardots AB has completed the second Site Initiation Visit for HARMONI, with Professor Helena Kopp Kallner and the Karolinska Institutet team at Danderyd Hospital. Following the earlier site initiation in Uppsala, the milestone advances preparations for study delivery across both centres.

The need for better information in care

Premenstrual dysphoric disorder (PMDD) can disrupt working life, relationships and everyday activities through severe emotional and physical symptoms that recur around the menstrual cycle. For affected women, understanding this pattern and finding appropriate support can be an important part of managing its impact.

Assessment relies on the woman’s account of her symptoms and their timing, supported by prospective symptom tracking across menstrual cycles. This information is essential. Objective physiological measurements could, if validated, add another source of information to help clinicians understand hormone sensitivity and differences between patients.

HARMONI will investigate whether Psilmi®, Stardots’ investigational neuro-ocular measurement platform, can identify physiological patterns associated with hormone sensitivity, PMDD and ADHD. Approximately 250 participants are planned across the two sites in total, including participants with PMDD, ADHD, both conditions, and healthy controls.

The exploratory study combines eye-movement and pupil-response measurements with hormonal, molecular and clinical information, and EEG in a subset of participants. Professor Helena Kopp Kallner is the coordinating investigator, and Professor Inger Sundström Poromaa leads the Uppsala site.

Building a product around a clinical need

For Stardots, the commercial opportunity lies in developing measurement tools that help healthcare providers and treatment developers answer practical questions. Potential applications include characterising participants in clinical trials and, with further validation, supporting clinical assessment. Better information about biological differences could help researchers investigate patient groups and develop more targeted approaches.

The second site is a concrete step in building the evidence and practical experience needed for future adoption. Working across two centres creates an opportunity to learn how Psilmi fits into clinical research workflows beyond a single site. HARMONI will help evaluate the biological signals underlying these potential applications; uses such as treatment-response monitoring would require additional studies.

“The need is tangible: women living with PMDD can face recurring symptoms that disrupt work and relationships. We want to give clinicians additional information to help them understand what each woman is experiencing. Building a product that earns a place in care means demonstrating that it is useful and practical to use. That is also the foundation of a sustainable business. HARMONI’s second site initiation is a concrete step in building that foundation,” says Daniel Petrini, CEO of Stardots.

Psilmi remains an investigational platform for research and evaluation. It is not currently cleared as a medical device or intended to provide an independent clinical diagnosis. Clinical utility and future commercial applications remain to be demonstrated.

About HARMONI

HARMONI stands for Hormone-Associated Responses and Multi-Omics in Neuropsychiatric Investigation. The study is conducted in collaboration between Stardots, Karolinska Institutet and Uppsala University, with clinical study activities at Danderyd Hospital and Uppsala University Hospital.

About Stardots

Stardots is a Swedish medical technology company developing objective digital biomarkers and computational tools for neurology, psychiatry and precision medicine. Psilmi combines controlled stimuli, eye tracking and pupillometry to investigate physiological responses associated with nervous-system regulation.

Media contact
Daniel Petrini, CEO, Stardots AB
daniel.petrini@stardots.se  |  +46 707 827001  |  www.stardots.se