Syntropic Medical completes Phase IIa LUX study of HAVEN™, an investigational, non-invasive light-based approach for depression
Early clinical evaluation in Brazil supports safety and tolerability in adults with mild-to-moderate major depressive disorder; next steps focus on controlled trials and scalable delivery.
In January 2026, Syntropic Medical completed LUX, its first phase IIa clinical trial (NCT06922812) evaluating HAVEN™, a non-invasive brain stimulation device that uses intermittent light stimulation (ILS) as an investigational approach to treat depressive symptoms.
Depression is one of the world’s leading causes of disability and affects an estimated 280 million people globally.1 In the United States, an estimated 21.0 million adults experienced at least one major depressive episode in 2021, and only around 61% received any treatment that year.2
Even with treatment, outcomes are often limited. Treatment-resistant depression is commonly described as affecting around 30% of people receiving antidepressant treatment, and many patients cycle through multiple options over months or years.3 Patients consistently emphasise tolerability: in a discrete-choice experiment, the strongest driver of patient preference was minimising adverse reactions.4
This unmet need is compounded by a slow pace of true mechanism innovation. Most antidepressants still primarily target monoamine neurotransmitters (serotonin, noradrenaline, dopamine), a framework that has dominated for decades.5 Until relatively recently, the first new medication for major depression in decades was esketamine (2019).6 Traditional antidepressants can also take weeks to reach full effect – often up to 8 weeks – leaving a difficult early window for patients and clinicians.7
A renewed wave of innovation is now focused on neuroplasticity – the brain’s capacity to adapt and rewire. Psychedelic-assisted therapies are part of this momentum: in February 2026, COMPASS Pathways reported that COMP360 psilocybin achieved the primary endpoint in a second Phase 3 trial in treatment-resistant depression, with rapid onset from the day following administration.8
However, psychedelic-assisted therapy can be intensive and will not be right for everyone. In COMP360 studies, dosing visits are typically 6–8 hours with dedicated psychological support, and surveys suggest many mental health service users remain uncertain or unwilling to try psilocybin even if a doctor recommends it.9,10
HAVEN™ is designed to pursue the same overarching goal – engaging neuroplasticity – without a psychoactive drug or psychedelic experience but is designed for comfortable home use. In healthy volunteers, 60 Hz flickering light has been shown to induce widespread neural entrainment, synchrony, and plasticity and was well tolerated, supporting the biological rationale for ILS-based neuromodulation.11
The LUX trial targeted patients with mild to moderate depression who did not respond to conventional treatments, and the results confirmed ingoing hypotheses on its safety and tolerability when delivered in a hospital setting.
The clinical trial was conducted at the Institute of Psychiatry, University Hospital of São Paulo, in collaboration with Prof. André Brunoni and Prof. Kallene Vidal, both leading researchers in the field of Non-Invasive Neuromodulation in Psychiatry.
HAVEN™, Syntropic’s novel medical device, delivers non-invasive, 60 Hz intermittent light stimulation (ILS) designed to promote neuroplasticity and relieve symptoms of depression.
This successful completion of LUX marks an important development milestone and supports the company’s next clinical steps toward broader evaluation in controlled studies.
“To go from an idea to a solution used in patients within 18 months is truly inspirational and massively rewarding, particularly given the time for medtech companies working on class II-III devices is typically in the range of years, not months, to reach the same stage. What sets HAVEN apart is the speed of its effect, acting far faster than traditional antidepressants, which often require 6–8 weeks to take hold. This rapid onset addresses one of psychiatry’s most critical unmet needs: the initial treatment window, when anxiety, agitation, restlessness, and suicidal ideation can paradoxically worsen before any improvement occurs”.
Jack O’Keeffe, CTO at Syntropic Medical
Syntropic Medical will use the learnings from LUX to refine treatment protocols, optimise the user experience, and design larger, controlled clinical studies aimed at validating efficacy, durability, and real-world usability.
A second, larger study is already ongoing in the United States, evaluating HAVEN™ in the home setting led by Prof. Leigh Charvet from the NYU Langone Medical Center, one of the USA’s leading practitioners in telemedicine in mental illness.
The Clinical Trial in depth:
The completed open-label clinical trial (NCT06922812) was designed to evaluate the safety and tolerability of intermittent light stimulation (ILS) in adults with mild to moderate depression.
It involved 28 participants, aged between 18 and 65, each diagnosed with major depressive disorder and maintaining a stable antidepressant regimen for at least six weeks. Over the course of two weeks, each participant underwent ten stimulation sessions in the clinic: one per weekday, each lasting 30 minutes. These sessions were followed by clinical follow-up visits to assess safety, and efficacy was measured through changes in HDRS-17 scores and other validated scales assessing depression and anxiety symptoms.
“It’s remarkable how something so simple can have such a profound impact on depression”, said Prof. André Brunoni. “During the clinical trial, patients are highly motivated; most of them asked to keep the device and continue the stimulation at home”.
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 technologies intended to enhance the brain’s neuroplasticity, with the aim of improving outcomes in psychiatric disorders and cognition. Syntropic’s mission is to advance mental health care through innovative, scalable technologies that target underlying mechanisms of neuropsychiatric disorders such as depression.
Regulatory note: HAVEN™ is an investigational device. It has been evaluated in an early clinical study and is not yet approved for marketing in any jurisdiction.
About Researchers Prof. Andre Brunoni and Prof. Kallene Vidal
Prof. Brunoni is Psychiatrist, Neuroscientist and Professor of Psychiatry at UT Southwestern Medical Center, Dallas, Texas, where he also serves as chief of the Division of Interventional Psychiatry and holds the Sherry Gold Knopf Crasilneck Distinguished Chair in Psychiatry. He is a leading researcher in the field of Non-Invasive Neuromodulation in Psychiatry, recognised as one of the most cited and influential researchers in the world in 2019, 2020 and 2021 by Web of Science / Clarivate Analytics, with an extensive publication record including 432 peer-reviewed articles (Google Scholar H-index: 98, with over 50,966 citations), with several featured in top-tier journals including NEJM, JAMA Psychiatry, and Lancet Psychiatry. His research focuses on developing innovative therapeutic strategies using transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS), and other neuromodulation techniques for treating major depressive disorder, bipolar disorder, OCD, schizophrenia, and post-COVID cognitive symptoms
Prof. Vidal is an Assistant Professor in the Department of Psychiatry at UT Southwestern Medical Centerin Dallas, Texas, where her research focuses on neuromodulation treatment strategies for neuropsychiatric disorders and visual system assessments guided by the concept of the “eye as a window to the brain”. Vidal previously served as a psychiatrist and researcher at the Interdisciplinary Neuromodulation Service of the Institute of Psychiatry, University of São Paulo (IPq-HCFMUSP), where her work integrated non-invasive brain stimulation and retinal biomarkers to study depression, Alzheimer’s, cognitive effects of COVID-19, glaucoma, and macular degeneration.
About the 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
info@syntropicmedical.com
Syntropic Medical GmbH
Plöcking 1
3400 Klosterneuburg
www.syntropicmedical.com
www.linkedin.com/company/syntropicmedical
References
1. World Health Organization (WHO). Mental disorders – fact sheet (includes estimate of 280 million people living with depression in 2019). Updated 30 Sept 2025. https://www.who.int/news-room/fact-sheets/detail/mental-disorders
2. National Institute of Mental Health (NIMH). Major Depression (NSDUH 2021 data; treatment uptake). Last updated July 2023. https://www.nimh.nih.gov/health/statistics/major-depression
3. McIntyre RS, et al. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC10503923/
4. Xie P, et al. Preferences of patients with depression for medication management: a discrete choice experiment. 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12440862/
5. Hillhouse TM, Porter JH. A brief history of the development of antidepressant drugs. 2015. https://pmc.ncbi.nlm.nih.gov/articles/PMC4428540/
6. Yale Medicine. How ketamine drug helps with depression (notes FDA approval of esketamine in 2019 as first new medication for major depression in decades). https://www.yalemedicine.org/news/ketamine-depression
7. NHS. Antidepressants (time to effect; can take up to 8 weeks to work fully). https://www.nhs.uk/medicines/antidepressants/
8. Compass Pathways. Press release: Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression. 17 Feb 2026. https://ir.compasspathways.com/News–Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx
9. ClinicalTrials.gov document for COMP360 program (NCT05312151) informed consent form (notes dosing visit typically 6–8 hours). https://cdn.clinicaltrials.gov/large-docs/51/NCT05312151/ICF_006.pdf
10. Corrigan K, et al. Psychedelic perceptions: mental health service user attitudes to psilocybin therapy. 2021. https://pmc.ncbi.nlm.nih.gov/articles/PMC8205319/
11. Alamalhoda MA, et al. Exploring neural entrainment and synchrony in response to repeated 60 Hz flickering white light in healthy volunteers. PLOS ONE. 2025. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0332310