Soihtu DTx's EIC Accelerator Video Game for Treating Depression

Most depression treatments aim at mood. Soihtu DTx aims at the attention, working memory and planning problems that can persist after the mood lifts, and it does so with a video game. The Espoo company, a 2023 spin-out of Aalto University, builds on Meliora, a game its founders' research group tested on 1,001 Finnish patients. Its next version, Meliora Next, is described on CORDIS as a video game that combines executive function training with cognitive behavioural therapy.

Meliora Next appears among the winners of the EIC Accelerator's 6 May 2026 cut-off, for blended finance, in the cut-off list. CORDIS records a grant agreement signed on 23 September 2026 with an EU contribution of €2,499,875, for a project running from 1 October 2026 to 30 September 2029. The project is a month old, so this article sets out what it promises and what can already be checked.

A shooter built as a medical device

When Aalto University announced the trial in October 2022, it described a game in which players explore a three-dimensional world, solve shifting puzzles under time pressure and work with other players, and it called the product a medical software device rather than entertainment. The company's own pitch, on its website and in Aalto's innovation portfolio, is that the game is personalised, narrative-driven and designed to complement existing care rather than replace it.

What the company presents as different is the target. The CORDIS summary argues that current treatments leave out persistent cognitive impairments such as attention, working memory and executive function, and the trial preprint describes the game as personalised closed-loop neurocognitive training, in which the difficulty adjusts to the player. Meliora Next adds cognitive behavioural therapy to that training, per CORDIS.

The trial behind the award

The evidence is a three-arm trial, registered as NCT05426265 with Aalto University as sponsor and Business Finland, Helsinki University Hospital and Turku University Hospital as collaborators. It enrolled 1,001 adults with major depressive disorder between 28 June 2022 and 14 August 2024, per both the registry and the preprint on SSRN. Patients were randomised to Meliora, to an almost identical sham game with a lighter training load, or to treatment as usual alone, for 12 weeks. Both games were used on top of usual care.

The preprint reports that the trial met its predefined primary endpoints on the PHQ-9 depression questionnaire. Against the sham game, Meliora's advantage was an adjusted 0.513 points (90% confidence interval 0.018 to 1.007), an effect size of 0.19 with p=0.045. Against treatment as usual it was 1.138 points, an effect size of 0.43. An exploratory intention-to-treat analysis of 684 patients in the two game arms also favoured Meliora over the sham. Adverse events were reported by 148 of the 1,001 patients, most often frustration, and no serious adverse events were reported.

Two features of the record limit what it shows. The primary analysis counted a per-protocol cohort of 483 completers: 99 of the 337 patients enrolled in the Meliora arm, 96 of 347 in the sham arm and 288 of 317 in usual care, per the preprint. And the preprint carries the notice that it has not been peer reviewed. A search on 4 November 2026 found no journal publication of the primary results; two companion analyses, on gaming-related problems and on cost-effectiveness, were also posted as preprints, both on 18 September 2026.

The gaming-problems preprint addresses an obvious worry about prescribing a shooter: scores on a gaming addiction scale did not rise with use, and the share of patients whose scores worsened by a quarter or more was 10.4% with Meliora, 15.3% with the sham game and 9.8% with usual care, without significant differences between groups. The authors note that patients with previous gaming problems were excluded. The cost-effectiveness preprint models lower total costs of $6,248 per patient over 52 weeks for Meliora plus usual care, most of it in productivity, in a cohort of 343 patients.

What the EIC project promises

The CORDIS objective frames the market at more than 332 million people with depression worldwide and says about 22% of patients respond to treatment as usual. It describes the 1,001-patient trial as showing roughly three times the improvement of treatment as usual, with functional improvement and strong adherence, and states the aim of becoming the global leader in game-based precision digital therapeutics for depression. The preprint reports its results as score differences and effect sizes; the threefold comparison could not be found in it, and the CORDIS summary does not mention that the per-protocol cohort kept 99 of the 337 patients enrolled in the Meliora arm.

1. Large controlled trial of the first gameCompleted1,001 patients enrolled, per ClinicalTrials.gov and the preprint.
2. Peer-reviewed efficacy resultsPreprint onlyThe SSRN preprint states it has not been peer reviewed.
3. Meliora Next: training plus cognitive behavioural therapyIn developmentThe project started on 1 October 2026, per CORDIS.
4. FDA 510(k) clearanceNot publicThe company says it is advancing towards it; no clearance was found.

The regulatory route is the open question. The company website says Soihtu is building a clinical evidence package and advancing towards the FDA's 510(k) premarket notification, and the March 2026 place in the Northwestern Medicine and Techstars Healthcare Accelerator points in the same American direction. Web searches on 4 November 2026 found no FDA clearance, CE marking or breakthrough designation for Meliora, and the company has announced none.

Pre-seed money and thin accounts

In September 2024 Innovestor wrote that it had led Soihtu's pre-seed round with NewFund HEKA, a brain-health investor, and that the company had raised over €3 million; Startups Magazine reported the same figure on 22 September 2024. Newfund lists the company as an active seed-stage holding. A search for an EIC Fund investment found no announcement, so the equity part of the blended award is not public.

The filed accounts, as summarised by Luottoriskit.fi and Asiakastieto, show a company still before commercial launch: revenue of €91,000 in 2025 after none in 2024, an operating loss of €490,000 in 2025 after €305,000, and equity down from €699,000 to €200,000. Cash fell from €902,000 to €269,000 and the equity ratio from 57.8% to 14.1%. The summaries do not say where the 2025 revenue came from.

The Finnish trade register shows the company as registered, with its address moved to Vaisalantie 6 in Espoo on 30 July 2026 and no insolvency entry. CORDIS still lists the earlier Otakaari 5 A address on the Aalto campus. Staff grew to 12 in 2025, up three, per Asiakastieto, while losses widened; with a signed EIC agreement, an accelerator place and a register update in 2026, the company is active, but whether it is scaling cannot be read from these figures.

Where it fits in EU policy

On 7 June 2023 the Commission adopted a comprehensive approach to mental health with 20 flagship initiatives, including a European depression and suicide prevention initiative, and €1.23 billion of EU funding from different instruments; the Commission's health pages give the figure as almost €1.3 billion. Depression is one of the conditions that initiative names. Whether European health systems will pay for a game is a separate question, and the company has announced no reimbursement decision or health-system contract in any country.

The reporting is based on publicly available sources, listed below.