ONWARD Medical: A High-Growth Neurotechnology Play in Spinal Cord Injury Innovation

ONWARD Medical (ONWRY) has emerged as a compelling investment opportunity in the neurotechnology sector, driven by its innovative pipeline, regulatory progress, and commercial traction. The company’s flagship product, the ARC-EX System, has achieved a critical milestone as the first and only FDA-cleared technology to improve hand strength and sensation in chronic spinal cord injury (SCI) patients [4]. With 30 units sold in U.S. clinics during the first half of 2025—meeting its sales target—and EUR 1.2 million in revenue generated, ONWARD has demonstrated robust commercial momentum [1]. This growth is further amplified by partnerships with U.S. government procurement platforms, enabling the Veterans Affairs (VA) and other agencies to adopt the technology [1].

Regulatory momentum is another key catalyst. The company submitted a 510(k) application to the FDA in June 2025 to expand the ARC-EX label for home use, a move that could significantly broaden patient access and reduce healthcare costs [3]. Simultaneously, ONWARD filed for a CE Mark under EU Medical Device Regulation (MDR), aiming to commercialize the system in Europe by late 2025 [1]. These dual-track regulatory strategies position the company to scale globally. Additionally, the FDA approved an investigational device exemption (IDE) for the Empower BP study, a pivotal trial evaluating the ARC-IM System’s efficacy in addressing blood pressure instability post-SCI. First patient enrollment in this trial is expected before year-end 2025 [1].

Pipeline depth further strengthens ONWARD’s long-term value proposition. Beyond the ARC-EX and ARC-IM systems, the company is advancing the ARC-BCI Therapy, a brain-computer interface (BCI) that enables thought-driven movement. Five patients have already received ARC-BCI implants, with early feasibility studies showing promise in restoring mobility for SCI patients [3]. The technology has received Breakthrough Device Designation from the FDA, accelerating its regulatory pathway [2]. Meanwhile, the ARC-IM Lumbar Lead, designed to restore standing and lower limb mobility, achieved its first human implant in 2025 [1]. Grants from The Michael J. Fox Foundation and the U.S. Department of Defense also support exploratory studies for Parkinson’s disease applications [4].

Financially, ONWARD ended H1 2025 with EUR 40.9 million in cash despite an operating loss of EUR 20.0 million, reflecting its prioritization of R&D and commercial expansion [1]. The company’s recent sponsored Level 1 ADR program, allowing trading on the OTCQX Best Market under the symbol ONWRY, enhances liquidity and investor accessibility [2].

While risks remain—such as the high costs of clinical trials and regulatory uncertainties—the confluence of commercial traction, regulatory progress, and a deepening pipeline positions ONWARD Medical as a high-growth play in a market with significant unmet medical needs. For investors seeking exposure to neurotechnology innovation, the company’s strategic execution and scientific leadership make it a compelling candidate for long-term value creation.

Source:
[1] ONWARD Medical Sells 30 ARC-EX Systems in H1 2025, Demonstrates Commercial Traction and Advances Pipeline [https://www.stocktitan.net/news/ONWRY/onward-medical-demonstrates-commercial-traction-and-advances-tkxu4hzlwwtd.html]
[2] ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline in the First Half of 2025 [https://www.globenewswire.com/news-release/2025/09/02/3142318/0/en/ONWARD-Medical-Demonstrates-Commercial-Traction-and-Advances-Pipeline-in-the-First-Half-of-2025.html]
[3] ONWARD Medical Seeks FDA and CE Mark Approval for ... [https://www.stocktitan.net/news/ONWRY/onward-medical-files-510-k-with-us-fda-for-arc-ex-system-home-use-pkf567zb1w6s.html]
[4] ONWARD Medical Announces First Commercial Sales of ARC-EX System in the United States [https://ir.onwd.com/news-releases/news-release-details/onward-medical-announces-first-commercial-sales-arc-ex-system]