Vienna, Austria, July 23, 2025
Syntropic Medical completes first patient stimulation in depression clinical trial
- On May 5, 2025, Syntropic Medical reached a major development milestone by successfully completing its first patient stimulation (First Patient First Visit) in it’s phase IIa depression clinical trial.
- The LUX clinical trial targets patients with moderate to severe depression who do not respond to conventional treatments.
- HAVEN, Syntropic’s novel medical device, delivers non-invasive, 60 Hz intermittent light stimulation (ILS) to promote juvenile neuroplasticity and relieve symptoms of depression.
On May 5, 2025, Syntropic Medical completed the first full stimulation cycle in its clinical trial of a novel non-invasive brain stimualtion therapy for depression. The patient underwent ten sessions of brain stimulation with HAVEN, the company’s light-based neurostimulation device. This milestone marks the beginning of a new therapeutic pathway for patients who do not respond to conventional treatments.
“Watching the first patient complete the stimulation using our prototype was deeply meaningful. It’s the moment our work left the engineering lab and entered the lives of real people,” said Maria Teresa Ferretti, Clinical Operations and Partnerships Manager at Syntropic Medical. “We’re not just testing a device. We’re taking the first real step toward a breakthrough in mental health care, using a treatment with an entirely new mechanism of action.”
Depression is the most prevalent mood disorder globally, with over 20 million adults affected in the U.S. in 2019 alone. While antidepressants remain the standard of care, they are far from universally effective. Nearly 70% of patients fail to achieve remission, and many struggle with significant side effects. These limitations underline the urgent need for safer, more tolerable alternatives.
Syntropic Medical is addressing this gap with a non-invasive therapy based on 60 Hz intermittent light stimulation (ILS). This technique, shown in preclinical studies with healthy individuals to be safe and to promote juvenile neuroplasticity, targets the brain’s ability to adapt and rewire: a key element in depression recovery.
The Clinical Trial
The ongoing open-label clinical trial (NCT06922812) is designed to evaluate the safety and tolerability of intermittent light stimulation (ILS) in adults with moderate to severe depression.
It involves 30 participants, aged between 18 and 59, each diagnosed with a major depressive episode and maintaining a stable antidepressant regimen for at least six weeks. Over the course of two weeks, each participant undergoes ten stimulation sessions: one per weekday, each lasting 30 minutes. These sessions are followed by clinical follow-up visits and efficacy is measured through changes in HDRS-17 scores and other validated scales assessing depression and anxiety symptoms.
The clinical trial is conducted at the Institute of Psychiatry, University Hospital of São Paulo, in collaboration with Prof. André Brunoni and Dr. Kallene Vidal, both leading researchers in the field of Non-Invasive Neuromodulation in Psychiatry.
About Syntropic
Syntropic is an Austria-based clinical stage medical device company spun out of the Institute of Science and Technology Austria (ISTA) by Mark Caffrey, Jack O’Keeffe, Dr. Alessandro Venturino, and Prof. Sandra Siegert. The company is developing new technologies that enhance the brain’s neuroplasticity, allowing for the treatment of psychiatric disorders and the improvement of cognition. Syntropic’s mission is to advance mental health care through the development of innovative technologies that target underlying causes of neuropsychiatric disorders such as depression.
About Researchers Prof. Andre Brunoni and Dr. Kallene Vidal
Prof. Andre Brunoni, MD, PhD
Associate Professor at University of São Paulo Medical School, Head of the Interdisciplinary Neuromodulation Service and Co-Director of the ECT Service of the HC-FMUSP Institute of Psychiatry.
Prof. Brunoni is a leading researcher in the field of Non-Invasive Neuromodulation in Psychiatry. He was recognised as one of the most cited and influential researchers in the world in 2019, 2020 and 2021 by Web of Science / Clarivate Analytics (more than 15 400 citations). His research involves the use of non-invasive brain stimulation techniques, such as transcranial direct current stimulation, transcranial magnetic stimulation and “deep” transcranial magnetic stimulation in the treatment of mental disorders, such as mood disorders, obsessive-compulsive disorder and schizophrenia.
Dr. Kallene Vidal, MD, PhD
Associate Researcher at the Interdisciplinary Neuromodulation Service of the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo Medical School (IPq-HC FMUSP).
Dr. Vidal currently conducts research at the Interdisciplinary Neuromodulation Service of the Institute of Psychiatry, University of São Paulo (IPq HCFMUSP), where she applies non-invasive brain stimulation and retinal biomarkers to investigate depression, Alzheimer’s disease, cognitive effects of COVID-19, glaucoma, and macular degeneration.
About University of São Paulo Medical School, Department of Psychiatry
The Department of Psychiatry at the University of São Paulo (FMUSP) is a premier center for psychiatric research, education and clinical care across Latin America. Its Institute of Psychiatry (IPq–HCFMUSP) hosts Brazil’s largest Interdisciplinary Neuromodulation Service, internationally recognized for advancing non-invasive brain stimulation such as transcranial magnetic stimulation and direct current stimulation.
In 2023, the department also launched the National Center for Research and Innovation in Mental Health to develop cutting-edge interventions. With robust clinical trials, state-of-the-art facilities and strong global partnerships, the department stands at the forefront of neuromodulation innovation in mental health.
For more information, please contact:
Mark Caffrey
CEO of Syntropic Medical
Syntropic Medical GmbH
Plöcking 1
3400 Klosterneuburg
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