Lindus Health and Sooma Medical have announced a collaboration to conduct a Phase 3 clinical trial evaluating a novel brain stimulation device for treating major depressive disorder (MDD). The study will assess the safety and efficacy of Sooma's transcranial direct current stimulation (tDCS) medical device, Sooma 2GEN, as a home-based treatment option for patients suffering from depression.
The device, which is worn as a cap, employs tDCS therapy—a non-invasive technique that uses electrodes to deliver low-level electrical currents to specific regions of the brain. This approach represents a potential breakthrough for patients who haven't responded adequately to conventional antidepressant medications.
Addressing a Significant Unmet Need
Major depressive disorder affects an estimated 8.3% of adults in the United States, making it one of the most prevalent psychiatric disorders in the country. It ranks as a leading cause of disability globally, with profound negative impacts on physical health, interpersonal relationships, and overall quality of life.
"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," explained Tuomas Neuvonen, co-founder and CEO at Sooma Medical.
The tDCS approach offers several potential advantages over pharmacological interventions, including the absence of serious side effects, no adverse interactions with other medications, and no risk of developing dependency—critical considerations for a condition that often requires long-term management.
Trial Design and Implementation
The clinical trial will enroll approximately 200 participants across the United States. Lindus Health, self-described as an "anti-CRO" focused on conducting faster and more reliable clinical trials, will leverage its virtual site capabilities and in-house medical monitoring expertise to facilitate the study.
Patient recruitment will utilize Lindus Health's digital advertising capabilities, while the company's proprietary eClinical platform, Citrus™, will support patient pre-screening, virtual study visits with clinicians and research coordinators, submission of patient-reported outcomes, and general study oversight.
Michael Young, co-founder at Lindus Health, emphasized the importance of exploring alternative treatment modalities: "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."
Regulatory Status and Future Implications
While Sooma 2GEN has already received clearance to treat MDD in several European countries, no device using tDCS therapy has yet received market entry approval in the United States for any indication. Positive results from this Phase 3 trial would 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 market.
The FDA has already recognized the potential of this approach by granting Sooma Breakthrough Device Designation in March 2023—a status reserved for novel therapies that show significant potential to provide substantial improvement over existing options for severe or life-threatening conditions.
"We offer an effective and accessible approach to treating MDD, ensuring everyone with depression receives the right treatment that suits their individual needs," Neuvonen stated. "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."
A Growing Track Record
Sooma Medical, founded in 2013, is a Finnish medical device company specializing in non-invasive brain stimulation devices for neurological and psychiatric disorders. The company works closely with leading medical experts to develop effective treatment solutions, with devices manufactured in Finland under strict ISO 13485 and MDSAP quality management standards.
To date, more than 25,000 patients have reportedly found relief with Sooma's treatments, which are 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.
Lindus Health has established itself as an innovative player in the clinical trial space, having delivered full-service clinical trials across the US, UK, and Europe for a range of conditions including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome, and insomnia. The company has raised over $24 million from investors including Peter Thiel, CREANDUM, Firstminute Capital, and others.
The collaboration between these two innovative companies represents a significant step forward in exploring non-pharmacological approaches to treating one of the most common and debilitating psychiatric conditions worldwide.
