Lindus Health and Sooma Medical are joining forces for a Phase 3 clinical trial to evaluate the effectiveness of Sooma 2GEN, a device that employs transcranial direct current stimulation (tDCS) therapy.
This collaboration aims to explore new treatment possibilities for major depressive disorder (MDD), a condition impacting millions of people worldwide.
Sooma Medical is a Finnish company specialising in brain stimulation treatments for psychiatric and neurological conditions. It received approval for an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for the Sooma 2GEN device.
Designed for home use, the Sooma 2GEN device delivers low-level electrical currents to the brain through a cap-like mechanism. Its clinical trial will focus on assessing both the safety and therapeutic potential of this treatment in alleviating symptoms associated with MDD.
According to the US National Institute of Mental Health (NIMH), MDD affects approximately 8.3% of adults across the US, contributing significantly to global disability rates. While antidepressants are commonly used treatments, they do not always provide relief to all patients.
tDCS devices are expected to offer an alternative with fewer risks of severe side effects and dependency compared to traditional medications.
Sooma Medical co-founder and CEO Tuomas Neuvonen said: “Until now, early-stage treatment options have been limited for patients who don’t respond to medication or lack access to therapy. Those who have tried several antidepressants without success are considered ‘treatment-resistant’, which affects their prognosis and hope for improvement.
“We offer an effective and accessible approach to treating MDD, ensuring everyone with depression receives the right treatment that suits their individual needs.”
The clinical trial of Sooma 2GEN is set to enrol about 200 participants across various locations in the US.
Lindus Health plans to leverage its virtual site capabilities to streamline patient recruitment and monitoring processes. Its Citrus eClinical platform will be employed to facilitate key elements of the trial, including pre-screening, virtual consultations, and outcome reporting.
While Sooma 2GEN has already obtained approval for MDD treatment in several European countries, no tDCS device has yet been approved for market entry in the US for any condition. Successful trial results could be pivotal in obtaining clinical validation and regulatory approval for Sooma Medical’s device in the US.
Lindus Health co-founder Michael Young said: “We know firsthand that any one particular therapy or class of medications doesn’t necessarily work for all patients.
“The opportunity to work with Sooma on their efforts to potentially bring an entirely new type of treatment to the hands of patients with MDD is incredible, and we can’t wait to hit the ground running.”
In January 2025, Lindus Health secured $55m in Series B funding led by Balderton Capital. This capital injection is intended to enhance AI technology and improve the Citrus platform, aiding in study design optimisation, data monitoring automation, and expansion of clinical operations and product development teams.
