Sooma closes 2025 with major milestones in improved access to better depression and pain care globally
Sooma, a world-leading provider of safe and effective brain stimulation treatments for depression and chronic pain, concludes a breakthrough year marked by international expansion, commercial growth, and pioneering progress in depression care delivery.
Breakthrough progress in international expansion
Sooma accelerated its global reach in 2025, with the number of patients treated outside Finland increasing by 40%. Demand surged across Europe, and Sooma doubled its sales in both Germany and France, two of the company’s fastest-growing European markets. Growing demand was driven by heightened clinical adoption and growing recognition of Sooma’s safe, effective, and easy-to-administer tDCS therapy.
Today, Sooma’s brain stimulation devices are the most prescribed tDCS therapies worldwide, used to treat more than 30,000 patients across over 250 clinics in 35 countries.
Pivotal FDA IDE approval signals entry into North America
In a major expansion and regulatory milestone, Sooma received FDA approval for an Investigational Device Exemption (IDE), enabling Sooma to begin a pivotal study of its treatment and device. This builds on Sooma’s earlier FDA Breakthrough Device Designation, reinforcing the therapy’s potential to significantly improve treatment for patients with severe or life-threatening depression in the US.
This trial marks a critical step toward full FDA clearance and Sooma’s entry into the North American market, opening the path for broader clinical adoption and future commercialization in one of the world’s largest healthcare landscapes.
Improving access through primary care and direct-to-patient model
This year, Sooma set a new standard for early-stage depression treatment by integrating tDCS therapy into primary care across Finland. Today, the therapy is available in over 65 specialized and primary healthcare facilities, bringing advanced, non-invasive depression treatment to patients much earlier in their care journey.
Sooma also introduced a groundbreaking direct-to-patient treatment model for depression and chronic pain in Finland and Germany, making the treatment accessible without the need for referrals or long treatment queues. This new approach enables individuals to begin treatment sooner, reduces bottlenecks in care pathways, and expands access for those who might otherwise struggle to receive timely support.
Strengthened leadership for the next phase of growth
Sooma further strengthened its global leadership team with the appointment of Andreas Hartlep as Chief Executive Officer. With the support of Hartlep’s extensive experience in leading and scaling health tech companies, Sooma has accelerated its European expansion and North American market entry.
“Sooma’s progress in 2025 reflects the dedication of our team, the trust of our clinical partners, and the urgent need for accessible, effective depression and pain care worldwide,” said CEO Andreas Hartlep. “As we move into 2026, we are positioned stronger than ever to expand access to safe, non-invasive brain stimulation across continents.”
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