Onward Medical’s Strategic Momentum in Neurotechnology and Commercial Scalability

The spinal cord injury (SCI) treatment market is poised for transformative growth, with forecasts predicting a compound annual growth rate (CAGR) of 4.8% to 5.4% through 2034, expanding from $7.83 billion to $12.22 billion [1]. Within this landscape, Onward Medical has emerged as a high-growth medtech innovator, leveraging its proprietary neurotechnology to address unmet needs in SCI rehabilitation. The company’s ARC-EX System, a spinal cord stimulation (SCS) platform, has demonstrated not only clinical efficacy but also commercial scalability, positioning it as a compelling investment opportunity in a sector defined by innovation and urgency.

Clinical and Regulatory Catalysts

Onward’s ARC-EX System has redefined the standard of care for chronic SCI patients. A one-year study (Pathfinder2) revealed sustained functional improvements in participants, including enhanced upper body strength, trunk control, and balance, with no evidence of therapeutic plateauing [2]. Notably, three participants improved their American Spinal Injury Association (AIS) classifications, and one transitioned from complete to incomplete SCI—a rare and groundbreaking outcome [2]. These results, corroborated by the Up-LIFT trial (72% of participants showed upper limb improvements), underscore the system’s potential to restore meaningful function rather than merely manage symptoms [3].

Regulatory progress has further accelerated Onward’s commercial trajectory. The company secured FDA de novo classification for the ARC-EX System in Q1 2025 and submitted a 510(k) application for home-use authorization, a critical step to expand accessibility [4]. Parallel efforts to obtain a CE Mark for European commercialization are underway, opening a $4.5 billion market in the EU alone [1]. Additionally, the FDA granted an investigational device exemption (IDE) for the Empower BP study, a global pivotal trial targeting blood pressure instability post-SCI, broadening the system’s therapeutic applications [4].

Commercial Traction and Financial Resilience

Onward’s commercial performance in H1 2025 reflects its ability to scale. The company sold 30 ARC-EX Systems to U.S. clinics, generating €1.2 million in revenue—a 500% increase from the same period in 2024 [5]. This growth was driven by partnerships with U.S. government agencies, including the Veterans Affairs (VA), which now facilitate procurement of the system [5]. The launch of a Level 1 ADR program on the OTCQX Best Market has also enhanced liquidity, attracting institutional investors [6].

Financially, Onward maintains a strong cash position of €40.9 million as of H1 2025, despite an operating loss of €20.0 million, reflecting strategic reinvestment in R&D and commercial infrastructure [5]. The company’s focus on capital efficiency—evidenced by its EUR 50 million investment from Ottobock and a nearly doubled cash balance—ensures it can fund pivotal trials and market expansion through 2025 [7]. Analysts project revenue to reach $7.8 million by year-end, aligning with the SCI market’s growth trajectory [5].

Competitive Advantages and Long-Term Potential

Onward’s differentiation lies in its dual focus on neurostimulation and brain-computer interface (BCI) technology. The ARC-BCI system, which enables thought-driven movement, has achieved five successful implants in 2025, supported by grants from the Michael J. Fox Foundation and the U.S. Department of Defense [8]. These advancements position Onward at the forefront of neurotechnology, with potential applications extending to Parkinson’s disease and bladder function restoration [8].

The SCI market is highly fragmented, with key players like Medtronic and Biogen focusing on surgical interventions and pharmaceuticals. Onward’s non-invasive, function-restoring approach fills a critical gap, particularly as aging populations and trauma-related injuries drive demand for advanced therapies [1]. With 30% of U.S. SCI patients in the chronic phase (injured for over two years), Onward’s ability to deliver long-term benefits—demonstrated in its one-year study—creates a durable competitive edge [2].

Investment Thesis

Onward Medical’s strategic momentum is underpinned by three pillars: clinical differentiation, regulatory progress, and market scalability. The company’s ARC-EX System has achieved what many in the field deemed impossible—restoring hand strength and sensation in chronic SCI patients—and its regulatory filings signal a path to broader adoption. Financially, the firm’s cash reserves and revenue growth outpace its operating losses, suggesting a path to profitability as home-use and EU markets open.

For investors, the key risks include clinical trial outcomes for Empower BP and the pace of reimbursement approvals. However, the company’s partnerships with government agencies and its first-mover status in BCI technology mitigate these risks. Given the SCI market’s projected $12.2 billion valuation by 2034 and Onward’s current revenue trajectory, the investment case is compelling for those seeking exposure to a medtech innovator with transformative potential.

Source:
[1] Spinal Cord Injury Market Size, Growth, Analysis 2034 [https://www.expertmarketresearch.com/reports/spinal-cord-injury-market?srsltid=AfmBOooA4_CBvi4GcRYuZ9EiEGEEmKUSBAL6fx6edzZD1fyHHj-JcmEd]
[2] ONWARD Medical Announces Publication of One-Year Study Showing Benefit of Sustained Access to ARC-EX Therapy [https://www.biospace.com/press-releases/onward-medical-announces-publication-of-one-year-study-showing-benefit-of-sustained-access-to-arc-ex-therapy]
[3] Onward's ARC-EX therapy hits success in pivotal trial for spinal cord injury [https://www.clinicaltrialsarena.com/news/onwards-arc-ex-therapy-hits-success-in-pivotal-trial-for-spinal-cord-injury/]
[4] 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]
[5] ONWARD reports strong revenue growth on ARC-EX system sales [https://www.investing.com/news/earnings/onward-reports-strong-revenue-growth-on-arcex-system-sales-93CH-4218904]
[6] 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]
[7] ONWARD Medical Reports Full Year 2024 Financial and Operating Results and Shares 2025 Year-to-Date Highlights [https://live.euronext.com/en/products/equities/company-news/2025-04-01-onward-medical-reports-full-year-2024-financial-and]
[8] ONWARD Medical's BCI Breakthroughs: A Catalyst-Driven Investment in Neurotech Leadership [https://www.ainvest.com/news/onward-medical-bci-breakthroughs-catalyst-driven-investment-neurotech-leadership-2505/]