Onward Medical ARC-EX US home use label expansion broadens commercial potential

Onward announced that it has received 510(k) clearance to expand the ARC-EX system indication for home use in SCI patients in the US. This follows the initial approval for clinic use obtained in 4Q24, and we believe this expansion could unlock sales beyond rehabilitation clinics and to individual patients, which in our view is key to broaden the commercial potential of the ARC-EX system. With 70 devices sold in 9M25, we believe FY25 CSS of 150 devices sold is within reach, and look forward to next year as sales ramp up with the addition of home use purchases – we est. FY26 sales of € 20m. All in all, a positive development and we reiterate our € 9.3 TP and BUY rating.