European Union Approves Onward’s Innovative ARC-EX System for Spinal Cord Injury Rehabilitation and Management

Onward MedicalS ARC-EX Receives European Approval for Spinal Cord Injury Therapy

Amsterdam,Netherlands – Onward Medical has announced that it has secured the CE mark in Europe for its ARC-EX system,representing a significant advancement in the treatment of Spinal Cord Injury (SCI). the system is designed to support the restoration of movement and function in individuals living with the debilitating condition.

The regulatory approval, granted under the stringent European Union’s Medical Device Regulation (EU MDR), signifies that ARC-EX meets high safety and performance standards. It delivers electrical spinal cord stimulation (SCS) through electrodes placed on the neck, offering a non-invasive therapeutic approach.

Non-Invasive Spinal Cord Stimulation Gains Traction

ARC-EX is the first SCI-approved device in Europe specifically indicated for improving hand strength and sensation in adults with spinal Cord Injury. It is indeed intended for use alongside conventional rehabilitation programs. Currently, other devices exist on the European market, such as Aneuvo’s ExaStim, which is also indicated for restoring motor function in individuals with chronic SCI.

According to data released by the World Health Organization (WHO) in March 2024,approximately seven million people globally are affected by SCI,with an estimated 300,000 cases in the united States alone. The need for innovative treatments continues to grow as the aging population and incidence of traumatic injuries rise.

phased Rollout Across Europe

Onward Medical plans to initiate a phased rollout of ARC-EX across Europe in the coming weeks, begining with Germany. Additional countries will follow as quickly as possible, the company stated.

Dave Marner, CEO of Onward, emphasized the importance of this growth, stating, “Hand sensation and strength is a primary recovery target after SCI.The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable.”

FDA Approval and Trial Success

This European approval follows the US Food and Drug Governance’s (FDA) de novo classification for the ARC-EX system granted in December 2023. Both approvals were underpinned by the positive results from Onward’s pivotal Up-LIFT clinical trial (NCT04697472).

Published in Nature Medicine in May 2024, the Up-LIFT trial demonstrated significant improvements in patients utilizing the ARC-EX system. An notable 90% of participants showed gains in either strength or function, and 87% reported enhancements in their overall Quality of Life (QoL).

Key Trial Findings

Outcome Measure	Percentage of Patients Showing Advancement
Strength or Function	90%
Quality of Life	87%
Reduced Spasm Frequency	62%
Improved Sleep Quality	55%
Improved Upper body Sensation	78%

Furthermore,study participants reported a decrease in the frequency of muscle spasms,improved sleep patterns,and enhanced upper body sensation and touch perception. Remarkably, benefits were observed even in patients who had sustained their injuries up to 34 years prior.

GlobalData’s recent analysis identifies nine additional neurology devices currently under development by Onward, including ARC-IM, an implantable system designed to tackle challenges like blood pressure instability post-spinal cord injury.

Understanding Spinal Cord Stimulation

Spinal Cord Stimulation (SCS) involves delivering mild electrical impulses to the spinal cord to block pain signals from reaching the brain. While traditionally used for chronic pain management, its application in SCI rehabilitation is relatively new and promising. SCS can perhaps activate dormant neural pathways, promoting motor function recovery and sensory restoration.

Disclaimer: This article provides general information and should not be considered medical advice. Please consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.

Frequently Asked Questions About ARC-EX

What is ARC-EX

ARC-EX is a non-invasive spinal cord stimulation system designed to restore movement and function in individuals with Spinal cord Injury (SCI).

How does ARC-EX work?

ARC-EX delivers electrical impulses to the spinal cord through electrodes placed on the neck, aiming to activate neural pathways and improve motor and sensory function.

What are the benefits of ARC-EX?

Clinical trials have shown ARC-EX can improve hand strength, sensation, quality of life, reduce muscle spasms, and enhance sleep quality in SCI patients.

Is ARC-EX available in the US?

ARC-EX has received de novo classification from the US FDA, indicating it’s approved for use in the United States.

What type of SCI is ARC-EX suitable for?

ARC-EX has shown benefits for individuals with a range of SCI injuries, even those sustained many years ago.

What are your thoughts on the potential of non-invasive therapies for SCI recovery?
Do you beleive increased accessibility to devices like ARC-EX could considerably improve the lives of those affected by spinal Cord Injury?

Share your opinions in the comments below!

What specific populations of spinal cord injury patients have demonstrated the most significant improvements with ARC-EX therapy in clinical trials?

What is the ARC-EX System?

Onward, a leading neurotech company, has received European Union approval for its ARC-EX System, a groundbreaking technology designed to improve rehabilitation and management of spinal cord injuries (SCI). This approval marks a significant step forward in neurological rehabilitation and offers new hope for individuals living with the debilitating effects of SCI. The ARC-EX system isn’t a cure, but a sophisticated approach to restoring voluntary movement and improving quality of life. It’s a non-invasive system utilizing transcutaneous electrical stimulation (TES) paired with intensive rehabilitation.

How Does ARC-EX Work? – The Science Behind the Innovation

The ARC-EX system centers around a unique approach to neuroplasticity – the brain and spinal cord’s ability to reorganize itself by forming new neural connections. Here’s a breakdown of the process:

Targeted Electrical Stimulation: The system delivers precisely calibrated electrical pulses to the spinal cord below the level of injury. This stimulation isn’t random; it’s designed to activate dormant neural pathways.

Intensive Rehabilitation Therapy: Simultaneously, patients engage in intensive, task-specific rehabilitation exercises. This is crucial. The electrical stimulation primes the nervous system, making it more receptive to learning and adaptation during therapy.

Neuroplasticity Enhancement: The combination of stimulation and therapy encourages the spinal cord to “rewire” itself,possibly bypassing the damaged area and restoring some degree of voluntary control.

Personalized Treatment Plans: ARC-EX isn’t a one-size-fits-all solution. Treatment plans are highly individualized, based on the patient’s specific injury, neurological status, and rehabilitation goals. This personalization is key to maximizing effectiveness.

This approach differs significantly from traditional spinal injury treatment wich often focuses on managing symptoms and preventing further deterioration. ARC-EX actively aims to restore function.

Key Applications & Who Can Benefit?

The ARC-EX system is currently approved for use in individuals with chronic spinal cord injury – meaning injuries that occurred more than one year ago. Specifically, it’s indicated for:

incomplete Spinal Cord Injury: Individuals with some remaining motor or sensory function below the level of injury are most likely to benefit.

Paraplegia & Tetraplegia: The system has shown promise in both paraplegic (lower limb impairment) and tetraplegic (all four limbs impaired) individuals.

Improving Gait & standing: A primary goal of ARC-EX therapy is to improve walking ability (gait) and the ability to stand independently.

Enhancing Upper Limb Function: The system can also be used to improve hand and arm function, enabling greater independence in daily activities.

Bladder Control: Emerging research suggests potential benefits for bladder function, a common and often debilitating issue following SCI.

benefits of ARC-EX Therapy

Beyond the potential for restoring movement, ARC-EX therapy offers a range of additional benefits:

Improved Cardiovascular Health: Increased physical activity through rehabilitation can improve heart health.

Reduced Spasticity: Some patients experience a reduction in muscle spasticity, leading to greater comfort and ease of movement.

enhanced Psychological Well-being: regaining some degree of independence and control can significantly improve mood, self-esteem, and overall quality of life.

Reduced Pain: Increased activity and improved neurological function can sometimes lead to a reduction in chronic pain associated with SCI.

Potential for Long-Term Gains: While ongoing research is needed, early data suggests that the benefits of ARC-EX therapy can be sustained over time with continued rehabilitation.

Real-World Examples & Early Clinical Trial Data

early clinical trial data has been encouraging. Studies have demonstrated:

Significant Improvements in Walking speed: Participants have shown measurable increases in walking speed and distance.

Increased Voluntary Muscle Control: Improvements in the ability to voluntarily contract muscles below the level of injury.

* Enhanced Functional Independence: Participants have reported greater independence in performing daily tasks, such as transferring from a wheelchair, dressing, and bathing.

While the results are promising, it’s important to note that ARC-EX is not a cure. The degree of recovery varies significantly from person to person.

Finding a Qualified ARC-EX Treatment Center

Currently, access to ARC