Onward Medical Receives CE Mark certification for ARC-EX in the EU

Onward announced it has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR), enabling commercialisation in the European Union and certain other countries. We note the label includes home use as well as clinic use which is an important driver for broader commercial uptake. Onward plans to begin EU launch in the coming weeks, starting with Germany. From our conversations with management, we don't expect a significant delta on EU pricing vs. US, but do expect EU roll out to be more gradual as more experience is gained with the device over time. We reiterate our € 10.4 TP and BUY rating.