Sooma's EIC Accelerator Home Depression Therapy, Six Years On

Sooma makes a soft cap that passes a weak direct current through the front of the skull, a technique called transcranial direct current stimulation (tDCS), to treat depression without drugs. In the European Innovation Council's March 2020 round, the Helsinki company was one of the projects the Commission listed under "COVID19-related projects", with a grant-only award, according to the EC list of selected companies. Sooma Oy is the only beneficiary named for the project. CORDIS files the SOOMA project under "Crisis response" and records an EU contribution of €1,612,625 towards a total cost of €2,303,750, from 1 July 2020 to 31 March 2023, according to the CORDIS fact sheet.

The aim was to take the treatment out of the clinic. The protocol is 10 to 20 daily 30-minute sessions, the first at a doctor's office. Sooma wanted to build "Sooma Online", a platform that would let doctors prescribe the course for home use, monitor patients remotely and adjust treatment, and it said home treatment could cut the hospital resources needed "by up to 90%". Six years after the award, the home system exists and carries an EU certification, and a US pivotal trial is running. The company's accounts show revenue smaller than in 2022 and losses more than twice its sales.

Where Sooma Stands in 2026

Sooma is active. The Finnish trade register lists Sooma Oy as registered, with no insolvency or liquidation entry, according to the PRH open data service, and Asiakastieto names Andreas Hartlep as managing director and Inka Mero as board chair. In July 2026 the company announced a pilot with the European care group Clariane in France, Spain, Italy, Belgium and the Netherlands, with 33 devices placed in more than 35 clinics, rehabilitation centres and nursing homes. Sooma says the contact came through the EIC's Corporate Partnership Programme, where it was one of 14 EIC-backed health companies chosen to present to Clariane, and that a framework agreement was signed in June 2026.

Leadership changed in 2025. Hartlep, a medical technology manager who previously ran companies including Cerbomed and Sensile Medical, took over as chief executive in July 2025, and co-founder Tuomas Neuvonen, chief executive since 2013, became chief technology officer, according to the company's announcement. In December 2025 Sooma began selling its treatment directly to patients in Finland and Germany, without a doctor's referral, it said.

The Technology: A Weak Current, Worn at Home

tDCS sends a weak constant current through electrodes on the scalp. In depression it targets the dorsolateral prefrontal cortex, a region linked to mood disorders, as Scientific American describes it. The established alternatives are antidepressants, psychotherapy, transcranial magnetic stimulation (TMS) and, for severe cases, electroconvulsive therapy (ECT), the SOOMA CORDIS report notes. Sooma's case, set out in its CORDIS objective, is that a treatment patients can carry out at home addresses the main bottleneck of psychiatric care, because after the first session the patient no longer needs a clinic visit.

The evidence for tDCS in depression is contested. Scientific American reports that a 2023 trial in The Lancet found tDCS "no better than a placebo", while other studies, some funded by manufacturers, showed benefit, and it quotes Boston University researcher Robert Reinhart: "the evidence base is mixed." The one depression paper CORDIS lists for the SOOMA project, a 2022 real-world study co-authored by Neuvonen, had no placebo group, Psychiatric Times notes. The other two publications CORDIS lists for the project concern spinal stimulation for nerve pain and home tDCS in Alzheimer's disease.

What the EIC Project Promised, and What CORDIS Shows

The project had three work packages, according to the closing periodic report for July 2021 to March 2023. The first was the remote platform. Sooma found that the technical stack of its prototype could not be reused "mostly due to the regulatory compliance reasons" and rebuilt it, alongside a new hardware design that passed verification and validation. By the end of the project it had "built a Sooma Online digital therapy platform consisting of the treatment device, clinical platform for managing Sooma tDCS treatments and a mobile application for patient users", but the product was still "in the design transfer phase", waiting for CE approval before launch.

That approval came after the project ended. Sooma became the first tDCS maker to receive certification under the EU Medical Device Regulation in September 2023, according to EU-Startups and Tech.eu. On 26 October 2023 it launched Sooma Duo, an MDR-certified system made up of a medical device, a treatment management platform and a patient app, available to doctors across Europe, according to its release carried by PR Newswire and Forbes España. The release does not use the name Sooma Online, but the three components match the CORDIS description.

The second work package was manufacturing of the hydrogel that sits between electrode and scalp. CORDIS reports a drying process that handles five times more material, a new production laboratory approved in June 2022 and a subcontractor for cutting and packing. The third was clinical: trials to show that the platform is usable, has "therapeutic and predictive value", and produces "cost-effective data that supports therapy reimbursement applications". On this package the report says only that Sooma "successfully recruited a new team member". It adds that public healthcare bodies had "initiated multiple public tender processes", without naming them.

1. Remote therapy platform: device, clinician portal, patient appDeliveredBuilt by March 2023 per CORDIS; launched as MDR-certified Sooma Duo in October 2023, seven months after the project ended.
2. Scaled, cheaper hydrogel productionDeliveredNew lab approved June 2022 and five times the drying capacity, as reported by the company to CORDIS.
3. Clinical trials of the platform's usability and therapeutic valueNot achievedNo trial results reported to CORDIS; the only depression paper listed is an uncontrolled real-world study.
4. Cost-effectiveness data for reimbursementNot achievedNo cost-effectiveness data or reimbursement decision announced by Sooma or third parties.
5. Mass-market use beyond early adoptersPartlyPatient numbers rose by the company's count, but revenue fell from 2023 to 2025.

The engineering was delivered, late against the project timeline because certification fell outside it. The clinical and economic evidence that the work plan promised, the part that would persuade payers, is not public.

What Sooma Has Achieved Since the Award

Regulators moved first. Sooma received an FDA Breakthrough Device Designation in March 2023, according to Sooma and Psychiatric Times. In March 2025 the FDA approved an investigational device exemption for a pivotal home trial of its Sooma 2GEN cap in about 200 people across the US, run with the contract research firm Lindus Health, Medical Device Network and Psychiatric Times report. The trial, REACH-tDCS, is randomised, sham-controlled and quadruple-blinded; it began on 27 June 2025, was still recruiting at its last update in August 2026 and has an estimated primary completion of 10 October 2026, according to ClinicalTrials.gov. In June 2025 Australia's TGA added Sooma's next-generation home device to its register, Sooma said.

The US race went to a European rival first. On 11 December 2025 the FDA approved Flow Neuroscience's headset for at-home treatment of major depression, the first such approval, according to Medical Economics and Scientific American. Sooma's own post on the decision carries the headline "FDA approved tDCS for at-home depression treatment" and only names Flow in its last paragraph. Sooma's device remains limited to investigational use in the US, its website states.

In Europe, Sooma says it has treated "more than 30,000 patients across over 250 clinics in 35 countries", that patients treated outside Finland rose by 40% in 2025 and that it "doubled its sales in both Germany and France", according to its 2025 review, which also counts more than 65 Finnish specialist and primary care sites offering the treatment. Its website now claims more than 35,000 patients and 300 hospitals and clinics. None of these figures has been independently verified.

The Money

In March 2024 Sooma raised €5 million in a round led by Voima Ventures, with Singapore's Verge HealthTech Fund and the existing investor Stephen Industries, a Helsinki family office, according to EU-Startups and AIN. Tech.eu reported that the round brought Sooma's total funding to €7.5 million. Sooma is not among the 323 organisations on the EIC Fund's list of invested companies, consistent with its grant-only award. CORDIS lists no other EU project for the company.

The filed accounts, summarised by Asiakastieto and Finder, run against the growth story. Revenue rose to €1.567 million in 2022, then fell to €1.486 million in 2023, €1.276 million in 2024 and €1.082 million in 2025, a drop of 31% from the peak. The operating loss widened every year, from €130,000 in 2021 to €2.257 million in 2025, and Finder puts the 2025 net loss at €2.274 million. Over five years the company lost just over €6 million at operating level. Asiakastieto puts the 2025 equity ratio at 34%. The accounts do not break revenue down by country, so the reported growth in Germany and France cannot be checked against them.

Why Europe Should Care

Mental illness is one of the EU's largest health costs. In June 2023 the Commission adopted a comprehensive approach to mental health with 20 flagship initiatives and €1.23 billion of EU funding, including a European depression and suicide prevention initiative; it put the cost of mental health problems at more than 4% of GDP, over €600 billion a year, according to the Commission and Alzheimer Europe. A home treatment that one clinician can supervise at scale speaks directly to the access goal in that strategy.

Sooma's EIC award was also followed by an EIC-brokered route to a European care group, Clariane, through the Corporate Partnership Programme. Whether that becomes a European industry depends on evidence that payers accept, which is what Sooma's US trial is meant to provide.

The Verdict

Sooma has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.