Nexstim received diagnostic approval also in the US
Summary
- We expect the recent US diagnostic approval for Nexstim's NBS 6 system to align with the company's strategic objectives and our expectations, following similar MDR certification in Europe.
- The company now has comprehensive regulatory approvals for both diagnostic and therapeutic applications of the NBS 6 system in key markets, which supports its market expansion goals.
- We assess that the financial impact of upgrading existing NBS 5 systems to NBS 6 will be minor, though delayed demand may materialize as customers awaited diagnostic approval.
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Translation: Original published in Finnish on 10/13/2025 at 7:40 am EEST.
Nexstim announced on Friday that it had received diagnostic approval for its NBS 6 system in the United States. The news follows the recent similar MDR certification in Europe, which we commented on here. With these new marketing authorizations, Nexstim can now sell the NBS 6 system with diagnostic modules, in addition to the previously approved therapy modules.
NBS 6 now has all regulatory approvals in key markets
The company already received approvals for the therapeutic use of the NBS 6 system in Europe and the United States in 2023. The company was already aiming for diagnostic marketing authorizations last year, but the regulatory processes have been somewhat delayed, which is typical for the industry. We have commented on the content and delays of the EU MDR at a general level in this article.
Regulatory approvals for diagnostic applications in the EU and the US have been one of Nexstim's key strategic objectives for this year. These approvals are thus in line with the company's own targets and our expectations.
Some customers can update existing equipment with new features
Nexstim's customers have been able to order the NBS 5 system with the option to upgrade it later to NBS 6. We estimate that there is a limited number of upgradable systems and that the financial significance of the upgrade for Nexstim is minor. Despite the upgrade possibility, some customers may have waited to purchase until NBS 6 diagnostic approval, which could lead to delayed demand materializing in the coming months. We have tried to take this into account in our forecasts, so the expected news does not affect our view of the stock at this stage.
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Nexstim operates in medical technology. The company has developed a non-invasive brain stimulation technology called SmartFocus®. It is a navigated transcranial magnetic stimulation (nTMS) technology with 3D navigation providing targeting of the TMS to the specific area of the brain. The technology is aimed for the treatment of major depression and chronic neuropathic pain. The company was founded in 2000 and has its headquarters in Helsinki.
Read more on company pageKey Estimate Figures18.08.
| 2024 | 25e | 26e | |
|---|---|---|---|
| Revenue | 8.7 | 15.7 | 18.2 |
| growth-% | 20.5 % | 79.3 % | 16.5 % |
| EBIT (adj.) | -0.5 | 4.2 | 4.7 |
| EBIT-% (adj.) | -6.1 % | 27.1 % | 25.7 % |
| EPS (adj.) | -0.12 | 0.56 | 0.63 |
| Dividend | 0.00 | 0.00 | 0.00 |
| Dividend % | |||
| P/E (adj.) | neg. | 25.4 | 22.9 |
| EV/EBITDA | 189.9 | 20.1 | 16.7 |
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