For individuals living with spinal cord injury (SCI), particularly those with tetraplegia, regaining even a fraction of hand and arm function can be life-changing. In a significant leap forward for SCI rehabilitation, the ONWARD ARC-EX System has emerged as a frontrunner, showcasing remarkable success and ushering in a new era of non-invasive neuromodulation. This innovative device, which received crucial FDA approval in late 2024, is now at the forefront of restoring independence and improving the quality of life for countless patients.

The ARC-EX System represents a paradigm shift in how we approach chronic SCI. Unlike traditional methods that often hit a plateau in recovery, this transcutaneous electrical spinal cord stimulation device, combined with activity-based rehabilitation, is demonstrating the potential for sustained and meaningful functional improvements long after injury.

A Breakthrough in Clinical Practice: FDA Approval and Early Success

The pivotal moment for the ARC-EX System came on December 19, 2024, when the US Food and Drug Administration (FDA) granted it de novo classification and market authorization for use in clinic settings. This approval was a testament to the device’s groundbreaking efficacy, making it the first and only FDA-approved technology specifically indicated to improve hand strength and sensation in people with chronic spinal cord injury. Its recognition as a TIME Magazine Best Invention in 2024 further underscored its transformative potential.

Following this landmark approval, ONWARD Medical announced its first commercial sales in early January 2025, with systems being purchased by leading rehabilitation centers like UW Medicine and Next Steps Chicago. This rapid deployment signals a strong belief in the system’s ability to translate scientific discovery into tangible patient benefits.

Sustained Gains and No Plateaus: The Pathfinder2 Study

The enthusiasm surrounding the ARC-EX System is deeply rooted in robust clinical data. In February 2025, the peer-reviewed results from the investigator-sponsored Pathfinder2 study were published in Neuromodulation: Technology at Neural Interface. This one-year trial provided compelling evidence of the long-term efficacy of ARC-EX Therapy.

Key findings from Pathfinder2 revealed that participants experienced significant functional improvements in upper body strength, trunk control, and balance, with no indication of plateau in therapeutic benefit after a full year of treatment. Some individuals also saw gains in lower body movement and enhanced hand and arm strength, particularly in grip and dexterity. Notably, three participants improved their American Spinal Injury Association Impairment Scale (AIS) classification, and four demonstrated changes in their neurological level of injury, with one even moving from complete to incomplete SCI.

These results are particularly exciting because they challenge the long-held notion that recovery in chronic SCI is limited and eventually ceases. The Pathfinder2 study demonstrated that with sustained access to ARC-EX Therapy, individuals can continue to make progress, offering a new sense of hope and redefining expectations for neurorehabilitation outcomes.

How it Works: Non-Invasive Stimulation for Enhanced Neuroplasticity

The ARC-EX System operates by delivering programmed electrical stimulation to the spinal cord through external electrodes placed on the back of the neck. This non-invasive approach bypasses the need for surgery, making it a more accessible and appealing option for many patients. The therapy is designed to work in conjunction with functional task practice and activity-based rehabilitation, amplifying the body’s natural capacity for neuroplasticity – the brain’s ability to reorganize itself by forming new neural connections. By stimulating dormant or weakened neural pathways, the ARC-EX System helps to re-establish communication between the brain and the affected limbs, facilitating improved motor control and sensation.

Looking Ahead: Home Use and Global Expansion

The journey for the ONWARD ARC-EX System is far from over. While currently authorized for clinic use, ONWARD Medical anticipates home use authorization later in 2025. This will be a critical step in democratizing access to this life-changing technology, allowing patients to continue their rehabilitation in the comfort and convenience of their own homes, potentially accelerating their progress and further enhancing their independence.

Furthermore, the company plans to seek CE Mark certification to commercialize the ARC-EX System in Europe in 2025, with a wider commercial launch expected in the second half of the year. This global expansion will bring the benefits of this innovative therapy to a broader international patient population.

The ONWARD ARC-EX System stands as a powerful testament to the advancements in spinal cord injury research. Its proven ability to deliver sustained functional improvements, combined with its non-invasive nature and impending home-use authorization, positions it as a cornerstone of modern SCI rehabilitation and a beacon of hope for a future with greater independence and improved quality of life for those living with spinal cord injuries.