Lindus Health and Sooma Medical announce pivotal device clinical trial for treatment of MDD

BOSTON, March 11, 2025 /PRNewswire/ -- Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials for life science pioneers, and Sooma Medical, a world-leading provider of effective brain stimulation treatments for psychiatric and neurological disorders, have announced their collaboration on a phase 3 clinical trial to evaluate the effectiveness of Sooma's transcranial direct current stimulation (tDCS) medical device in treating symptoms of major depressive disorder (MDD).

The study will examine the safety and efficacy of Sooma Medical's device, Sooma 2GEN, in improving MDD as a home-based treatment. The device, worn as a cap, uses tDCS therapy, a non-invasive technique using electrodes to deliver low-level electrical currents to the brain.

MDD is estimated to affect 8.3% of adults in the US, one of the most prevalent psychiatric disorders in the country. It is a leading cause of disability on a global scale, adversely affecting physical health, interpersonal relationships, and much more for those affected. tDCS devices offer an innovative solution for treating MDD for patients who haven't seen improvement with antidepressants and are safe and easy to use with no serious side effects, adverse interactions with other medications, or risk of developing dependency.

Lindus Health and Sooma Medical's clinical trial will enroll approximately 200 participants across the US. Lindus Health will leverage their virtual site capabilities including in-house medical monitoring as well as their digital advertising capabilities for patient recruitment. Lindus' proprietary eClinical platform, Citrus™, will be utilized for patient pre-screening activities, virtual study visits with clinicians and research coordinators, submission of patient-reported outcomes, and general study oversight.

"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 MDD is incredible, and we can't wait to hit the ground running."

"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 US data that will demonstrate Sooma 2GEN's capabilities in improving the quality of life in depression patients."

Sooma 2GEN has received clearance to treat MDD in several countries across Europe, however no device using tDCS therapy has received market entry approval in the US to date for any indication. Positive results from this study will further validate the safety and efficacy of Sooma Medical's device and support efforts to obtain clinical validation of their tDCS therapy for MDD in the US.

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.

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.
Learn more: soomamedical.com.

Lindus Health Media Contact:
Jodi Perkins
Amendola for Lindus Health
[email protected] 

SOURCE Lindus Health