Nightingale's path to regulatory approval in the US is becoming clearer and progressing

Translation: Original published in Finnish on 02/10/2025 at 9:09 am EET

As promised, Nightingale provided further information on plans to obtain regulatory approvals in the US on Friday. In practice, a clear path seems to be opening for the company to receive regulatory approvals and establish a local laboratory in the State of New York.

Opening of a laboratory in the US is progressing

Nightingale has already received regulatory approvals for its blood analysis in the past, so in our view, the uncertainty about regulatory expansions has been primarily related to the duration of these processes rather than the success of the approvals themselves. Previously, Nightingale sought FDA 510(k) clearance (Medical devices) in the US, but the clearance, originally targeted by June 30, 2022, was delayed several times.

With the 2024 regulatory change, Nightingale can now proceed faster through laboratory regulation (CLIA), as FDA approval is only required after the transition period. Nightingale now intends to utilize an exception whereby the State of New York's CLEP permit, which exceeds the CLIA requirements, replaces the CLIA requirement in the state. The company intends to first obtain a CLEP permit for its New York laboratory. The CLEP permit already enables the company to offer its services in the US. The next step in the plan is to submit to FDA an application for premarket review by November 2027, which will be significantly supported by the CLEP approval once obtained.

With the new FDA regulation, Nightingale expects to receive the regulatory approvals in the US on an “accelerated timeline”. The company said it would comment on the regulatory process timeline as the process progresses, but based on other regulatory processes, the laboratory could be up and running during 2025. However, in addition to several pilots, Nightingale already has a partnership with Boston Heart in the US, which has progressed to the production phase, where the company's Health Check service is offered in the US. Even though Nightingale’s local laboratory is not yet operational, we understand that it can send samples for analysis to its accredited laboratories in Europe. Fundamentally, the clarification of the regulatory process in the US, which has been unclear for a long time, is positive for the company, but we will assess the impact of this more closely in light of the additional information received in connection with the March earnings release.