Translation: Original published in Finnish on 03/28/2025 at 10:18 am EET

As expected, the FDA cleared Revenio's new iCare MAIA microperimeter. Thus, the new iCare MAIA microperimeter is now available for sale in the US, with deliveries starting in mid-April 2025, according to the company. The schedule is in line with the estimates Revenio provided in connection with its financial statement and our forecasts, so the news does not warrant any action. However, this is a positive step toward expected earnings growth this year. In addition, FDA approval eliminates one risk, especially since overall FDA processes have been exceptionally unpredictable in recent times.

Marketing authorization obtained on schedule

iCare, a subsidiary of Revenio,  announced today that the U.S. Food and Drug Administration (FDA) has cleared the new iCare MAIA microperimeter. According to the company the new iCare MAIA microperimeter is now available for sale in the US, with deliveries starting in mid-April 2025. From this, we can also deduce that the company will soon be able to mass-produce the product.

iCare MAIA has also been authorized in other key countries such as Canada, the UK and Australia. The microperimeter is expected to receive CE marking within a few weeks, which will allow sales to begin in the EU. Presumably, European sales can thus also start around the same time.

Features of the renewed MAIA

The new iCare MAIA microperimeter has a renewed hardware platform with fully automated operations and a 15’’ multi-touch display enabled by an intuitive user interface. The device should be very easy to use. The structure-function correlation is now improved thanks to the introduction of the 60° field of view and the TrueColor confocal technology. Clinical validation of the new iCare MAIA indicates full interchangeability with the previous MAIA generation with equivalent sensitivity results in mesopic testing. The new iCare MAIA can also import data from the previous model and use it as a reference for follow-up examination, guaranteeing full continuity with clinical historical data.

No changes to estimates

We have previously estimated that the new MAIA product will generate some 5 MEUR in annual revenue when it returns to iCare's product portfolio. This in itself is a fairly high level historically, as MAIA is a so-called niche product, but we believe customers have been waiting for the product after the previous version sold out. In 2024, MAIA was not in Revenio’s product range, so sales represent direct year-on-year growth. We have assumed that deliveries will start in Q2’25, so the news does not warrant forecast changes. However, it strengthens Revenio’s near-term earnings growth outlook.