UNEEG Medical boosts European commercialization and is on track for launch in the U.S.

COPENHAGEN, MARCH 9, 2026 – In the 2024/25 financial year, UNEEG Medical sharpened the company's focus on ensuring sustainable, early commercialization in Europe and preparing for launch on the US market, building on previous years' significant technological developments and successful clinical trials. UNEEG Medical develops and delivers data-based solutions for the treatment of epilepsy patients through continuous remote monitoring of EEG data transmitted from an implantable device and utilizes an AI-developed analytics platform.

The company's main product, UNEEG 24/7 EEG™ SubQ, was granted "Breakthrough Device Designation" by the US Food and Drug Administration (FDA) in November 2024, and at the end of 2025, UNEEG Medical applied for marketing authorization in the US in a process with the FDA.

In Europe, UNEEG Medical increased clinical sales significantly after focusing efforts in the financial year. The early commercialization was thus concentrated in fewer selected European markets, and clinical sales accounted for a larger share of total revenue.

UNEEG Medical reduced operating and personnel costs in 2024/25, while the accelerated FDA process resulted in increased clinical and regulatory costs. In addition, the financial statements were affected by the transfer of a deferred tax asset and the adjustment of depreciation periods for development assets. Based on the accelerated FDA process and the technical accounting changes, the loss after tax amounted to DKK 224 million in 2024/25 compared to DKK 111 million in 2023/24. The reduced operating and personnel costs will have full effect in the 2025/26 financial year, where tight financial management and effective commercialization in selected countries continue to be crucial.

"Over the past year, we have worked determinedly to create momentum in the early commercialization in the European markets and move towards the important launch in the US market. We have adapted our operations and focused our efforts on these two main areas, where UNEEG Medical is now showing progress with increased clinical sales in Europe and a clear path to commercial launch in the US during 2027," says Martin Stenfeldt, CEO of UNEEG Medical.

UNEEG Medical continues to invest in regulatory compliance, ongoing clinical studies and commercialization in the financial year 2025/26, where the loss before tax is expected to amount to DKK 105-120 million after adjusting the organization in February 2025 to streamline commercialization in selected markets in Europe and obtain FDA approval in the US. In March 2026, the owners of UNEEG Medical secured the company's financing by implementing a capital increase and converting debt into equity.