Sooma Medical Announces Pivotal FDA IDE Clinical Trial for At-Home Brain Stimulation Device for Depression Treatment
HELSINKI, FINLAND, March 11, 2025 – Sooma Medical, a world-leading provider of effective brain stimulation treatments for psychiatric and neurological disorders, announces the approval of an Investigational Device Exemption (IDE) from the FDA. This approval enables Sooma to begin a pivotal study of its transcranial direct current stimulation (tDCS) medical device for depression treatment.
Sooma is leading the global fight against depression by offering a flexible and accessible treatment solution through its portable neuromodulation device. The device, worn as a cap, uses tDCS therapy, a non-invasive technique using a mild electrical current to stimulate the brain and alleviate depression symptoms without the need for pharmaceuticals. The company has previously received FDA Breakthrough Device Designation, a status reserved for novel therapies showing significant potential to improve the treatment of severe or life-threatening conditions, and is now seeking full FDA approval for the device.
Depression is a leading cause of disability on a global scale. It is estimated to affect 8.3% of adults in the US, one of the most prevalent psychiatric disorders in the country. Globally, an estimated 12 billion working days are lost every year to depression and anxiety at a cost of US$ 1 trillion per year in lost productivity.
Brain stimulation provides an effective solution for treating MDD, particularly for patients who haven’t responded to antidepressants. The treatment is safe and easy to use, without the serious or systemic side effects typically caused by antidepressants, and has no adverse medication interactions or risk of dependence. Sooma’s prescription-only therapies can be used as a standalone treatment or in combination with other treatment types. It is also one of the few brain stimulation therapies that patients can safely use at home.
The study will examine the efficacy of Sooma’s device, Sooma 2GEN, in improving major depressive disorder (MDD) as an at-home treatment. The clinical trial will enroll approximately 200 participants across the US. The clinical trial will be conducted in collaboration with Lindus Health which will leverage its virtual site capabilities, including in-house medical monitoring as well as its digital advertising capabilities for patient recruitment.
“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,” said Tuomas Neuvonen, co-founder and CEO at Sooma. “We offer an effective and accessible approach to treating MDD, ensuring everyone with depression receives the right treatment that suits their individual needs. We’re excited to partner with Lindus Health to generate the U.S. data that will demonstrate Sooma 2GEN’s capabilities in improving the quality of life in depression patients.”
“As the principal investigator, I’m honored to lead this pivotal trial evaluating the effectiveness of the Sooma 2GEN device. The study represents a significant step forward in providing a safe, non-invasive, and accessible treatment option for patients with major depressive disorder, especially those who haven’t found relief with traditional medications. By leveraging innovative virtual trial capabilities in collaboration with Lindus Health, we’re not only aiming to validate this promising therapy but also employ new methodologies that allow trial participation regardless of geographic location,” said Principal Investigator Dr. Christopher Reist, Professor Emeritus, Psychiatry & Human Behavior, School of Medicine, UC Irvine.
“We know firsthand that any one particular therapy or class of medications doesn’t necessarily work for all patients,” said Michael Young, co-founder at Lindus Health. “The opportunity to work with Sooma on their efforts to potentially bring an entirely new type of treatment to the hands of patients with depression is incredible, and we can’t wait to hit the ground running.”
Sooma 2GEN has received clearance to treat MDD in 35 countries worldwide. Positive results from this study will further validate the safety and efficacy of Sooma’s device and support efforts to obtain clinical validation of its tDCS therapy for MDD in the US.
About Sooma Medical
Founded in 2013, Sooma Medical is a Finnish medical device company specializing in non-invasive brain stimulation devices for neurological and psychiatric disorders. Sooma works closely with leading medical experts to develop effective treatment solutions. Manufactured in Finland, Sooma’s devices adhere to strict ISO 13485 and MDSAP quality management standards. To date, more than 25,000 patients have found relief with these treatments. Sooma Depression Therapy is available in more than 35 countries worldwide. In September 2023, Sooma became the first tDCS device manufacturer to receive EU MDR certification for medical devices. In March 2023, Sooma received FDA Breakthrough Device Designation, reserved for novel therapies that show significant potential to provide a substantial improvement over existing options for severe or life-threatening conditions.
About Lindus Health
Lindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. This is achieved through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a world-class clinical operations team with its unique software platform, and access to over 30 million Electronic Health Records.
Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint by handling the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.
To date, Lindus Health has delivered full-service clinical trials across the US, UK and Europe to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.
Media contact:
Tuomas Neuvonen
Co-founder and CEO, Sooma
Saara Arteva
PR Director, Bamla Agency, communications partner for Sooma
+358 41 5492392
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