Onward Medical: Pioneering the Spinal Cord Injury Neurotech Market with ARC-EX and ARC-IM

The spinal cord injury (SCI) neurotechnology sector is undergoing a transformative phase, driven by innovations that address unmet medical needs and regulatory advancements enabling broader patient access. At the forefront of this movement is Onward Medical, a company leveraging non-invasive and implantable neurostimulation technologies to redefine treatment paradigms for SCI patients. With its flagship products, ARC-EX and ARC-IM, Onward is positioned to capitalize on a rapidly expanding market while navigating a favorable regulatory landscape.

Regulatory Tailwinds: Clearing Pathways for ARC-EX and ARC-IM

Onward’s ARC-EX System, the first FDA-cleared non-invasive spinal cord stimulation device for SCI patients, has secured critical regulatory milestones. In Q3 2025, the company submitted a 510(k) application to the FDA to expand the device’s indication for home use, a move expected to significantly enhance accessibility for patients. Clearance for this expansion is anticipated by year-end 2025, building on the device’s de novo classification in December 2024 [2]. Simultaneously, Onward has filed for a CE Mark, enabling commercialization in Europe, where the ARC-EX system has already demonstrated robust clinical outcomes. A pivotal trial, the Up-LIFT study, published in Nature Medicine, reported that 90% of patients experienced improved strength or function, with 87% noting quality-of-life enhancements [1].

For its implantable counterpart, ARC-IM, Onward has received FDA IDE approval for the Empower BP pivotal study, targeting blood pressure instability in SCI patients. This trial, set to enroll patients before year-end 2025, will evaluate ARC-IM’s ability to manage chronic orthostatic hypotension and autonomic dysreflexia—conditions affecting up to 70% of SCI patients [3]. The study’s design, spanning 20 global sites, underscores Onward’s strategic focus on addressing high-prevalence, underserved conditions.

Commercial Traction: Scaling Sales and Market Access

Onward’s commercial progress in 2025 has been equally compelling. The company sold 30 ARC-EX systems to U.S. clinics in the first half of the year, meeting its sales target and generating €1.2 million in revenue [4]. Notably, it secured access to U.S. government procurement platforms, allowing entities like the Veterans Affairs to purchase the device—a critical step for scaling adoption among high-need populations. In Europe, the CE Mark approval in Q4 2025 has enabled a phased commercial rollout, starting in Germany, with plans to expand to other markets [1].

Financially, Onward ended H1 2025 with a cash balance of €40.9 million, providing runway to advance its pipeline while maintaining operational flexibility [4]. These metrics highlight the company’s ability to translate clinical innovation into commercial value, even in a capital-intensive sector.

Market Dynamics: A High-Growth Opportunity

The SCI neurotech market is poised for substantial growth, with the broader neurotechnology sector projected to expand at a 13.23% CAGR from 2025 to 2034, reaching $53.18 billion by 2034 [1]. Specifically, the SCI therapeutic market is valued at $3.5 billion in 2024 and expected to grow to $5.8 billion by 2033, driven by advancements in regenerative medicine and neurostimulation [3]. Onward’s dual focus on non-invasive and implantable solutions positions it to capture a significant share of this growth.

Disruptive Innovation: Beyond the Status Quo

Onward’s technology stack represents a departure from traditional SCI treatments. The ARC-EX System offers a non-invasive alternative to surgical interventions, with clinical data showing sustained functional improvements over time [4]. Meanwhile, ARC-IM targets autonomic dysfunction—a condition historically managed with limited efficacy. The company’s ARC-BCI platform further cements its leadership in brain-computer interface (BCI) technologies, enabling movement restoration for patients with severe paralysis [5].

Investment Thesis: Aligning with High-Growth Criteria

Onward Medical embodies the hallmarks of a high-growth medtech innovator:
1. Regulatory Momentum: Key clearances for home use and European commercialization are imminent, reducing time-to-market barriers.
2. Clinical Differentiation: Pivotal trial results in Nature Medicine and FDA IDE approval for ARC-IM validate its therapeutic potential.
3. Market Access: Government procurement partnerships and a scalable business model position it to address large patient populations.
4. Financial Resilience: A strong cash position supports continued R&D and commercial expansion.

As the SCI neurotech sector matures, companies like Onward that combine regulatory agility, clinical rigor, and commercial execution will outperform. With a $5.8 billion market horizon by 2033 and a pipeline addressing multiple unmet needs, Onward Medical is not just a participant in this transformation—it is a catalyst.

**Source:[1] 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][2] FDA-Cleared Noninvasive Spine Stimulation System Could Transform Spinal Cord Injury Treatment [https://www.embs.org/pulse/articles/fda-cleared-noninvasive-spine-stimulation-system-could-transform-spinal-cord-injury-treatment/][3] ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System [https://www.biospace.com/press-releases/onward-medical-receives-fda-ide-approval-to-initiate-the-empower-bp-pivotal-study-with-the-arc-im-system][4] ONWARD Medical Sells 30 ARC-EX Systems in H1 2025 [https://www.stocktitan.net/news/ONWRY/onward-medical-demonstrates-commercial-traction-and-advances-tkxu4hzlwwtd.html][5] ONWARD Medical Builds Commercial Momentum for the ARC-EX System [https://live.euronext.com/en/products/equities/company-news/2025-06-17-onward-medical-builds-commercial-momentum-arc-ex-system]