ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), a neurotechnology company focused on therapies for movement disabilities, announced its first-half 2025 results. The company achieved its goal of selling 30 ARC-EX Systems to US clinics, indicating strong market demand.
This success followed the company’s establishment of a US sales team, sales processes, and a network of reference clinics. ONWARD also secured access to major US government procurement platforms, expanding its market reach. Positive user feedback suggests continued strong sales momentum.
Significant regulatory progress was also reported. The company submitted a 510(k) application to the FDA for home use clearance of the ARC-EX System and a CE Mark application for European commercialization. The FDA also granted an investigational device exemption (IDE) for the ARC-IM System, paving the way for the Empower BP study.
The Empower BP study, a global pivotal trial, will evaluate the safety and efficacy of the ARC-IM System in addressing blood pressure instability after spinal cord injury (SCI). The study is expected to involve numerous research centers across the US, Canada, and Europe, with the first patient enrollment anticipated before year’s end.
Positive findings from the Pathfinder2 study, published in Neuromodulation: Technology at the Neural Interface, further supported the ARC-EX System’s efficacy. The study showed sustained functional improvements after one year of treatment. Additionally, the company achieved a milestone with the first human implant of the ARC-IM Lumbar Lead, designed to improve lower limb mobility. Two additional patients received the investigational ARC-BCI Therapy.
ONWARD also strengthened its leadership team, appointing Professor Tim Denison and Lucas Buchanan to its Board of Directors. Financially, the company reported revenues and cash balance in line with expectations, despite an operating loss. The company established a sponsored Level 1 American Depositary Receipt (ADR) program, allowing trading of its ADRs on the OTCQX Best Market under the symbol ONWRY.
Looking ahead, ONWARD expects to meet its sales targets, secure regulatory approvals for the ARC-EX System, and commence patient enrollment in the Empower BP study. Further implants of the ARC-IM and ARC-BCI systems are also planned. CEO Dave Marver expressed confidence in the company’s continued progress and its ability to deliver on its goals.
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