Spinal Research funds breakthrough UK Trial

When somebody has a spinal cord injury (SCI), functions beneath the level of injury are affected, and yet the spinal cord itself and the nervous system are intact, just not receiving enough signal from the brain to activate a given movement or function.

Transcutaneous (through the skin) spinal cord stimulation excites the spinal cord so that signals weakened or interrupted by a SCI are able to drive movement and enable rehabilitation.

ONWARD Medical ARC-EX Therapy is designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions in people with spinal cord injury.

● The first and only system approved for non-invasive spinal cord stimulation for people with SCI. The ARC-EX System is indicated to improve hand sensation and strength for people with a chronic cervical SCI and can be used in the clinic to enable personalized functional rehabilitation.

● The System is comprised of a stimulator that delivers electrical pulses to the cervical spinal cord via electrodes placed on the skin at the back of the neck. A programmer allows clinicians to personalize the therapy according to each individual’s needs.

● The ARC-EX System was selected as a TIME Magazine Best Invention in 2024.

● Last December, it received FDA approval for use in US clinics, in conjunction with functional task practice.

● ONWARD Medical plans to seek CE Mark certification to commercialize the ARC-EX System in Europe this year with authorization expected by the end of 2025.

● Spinal Research are talking to the regulatory bodies and working closely with ONWARD to ensure this promising therapy is available to paralysed people in the UK as quickly and safely as possible.

● ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with SCI and other movement disabilities.

● Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).

● In addition to the ARC-EX System, which is now cleared for commercial sale in the US, the Company is developing an implantable system called ARC-IM with and without an implanted brain-computer interface (BCI).

● Spinal Research has a close relationship with ONWARD, having been an early investor and funder of the Pathfinder2 pilot study.

● Spinal Research are a co-founder of SCI Ventures, the world’s first philanthropic venture capital fund to accelerate the development and commercialisation of innovative treatments for spinal cord injuries and an investor in ONWARD.

● The charity continues to work closely with the company in further research trials and developments

Neurokinex is a specialist rehabilitation centre offering activity-based rehab for people with neurological injuries, including spinal cord injury. It focuses on promoting functional recovery, independence and long-term wellbeing

Spinal Research would like to thank everyone who took the time to engage in the webinar and to ask a question.  Your participation and enthusiasm are very much appreciated.  

For those who asked questions about the actual trial itself – for example what type and frequency of measurements were done, what types/levels of spinal injuries the 10 participants had, how many sessions, what gains were made, when gains appeared and whether they persisted etc. please find the trial debrief and results here.  All the available details on the trial can be found within this.  

Understandably there were a lot of questions about the device itself – how it was developed, how it works, how it has been tested, when and where it will be available and to whom, what it can and cannot be paired with etc.  All of these questions can only be answered by Onward, the manufacturer and developer of the device.  If the information you are looking for isn’t below, please do reach out to them directly here.

All the other questions broadly fell into a number of similar areas which we have answered below.  Thank you once again for your involvement and interest. 

 Where/How Can I participate in a Trial/When is the next trial? 

We are currently working on a Clinical Trial Registry, you can register your interest for it here.  In the meantime you can visit SCItrials.org where all approved, robust trials for SCI patients across the world can be found.  Here you can register your injury details and location and find all the trials relevant/eligible for you along with their location and current status.  This is a publicly available website accessible to all.  

Is the ARC-EX the same as FES stimulation or other electrical implants? 

No.  The ARC-EX is not the same as FES.  It is a unique type of electrical stimulation developed specifically for spinal cord injury. 

Can complete injuries use the device? 

Yes.  There was a patient with a complete injury on the Pathfinder trial. 

Do I have to pair use of the device with Activity Based Rehabilitation? 

Yes.  The device enhances the spared spinal cord tissue’s ability to react – it’s been described as like a hearing aid for the nervous system.  However, it is the specialist task based rehab that does the retraining to regain function.   

How can I get hold of a device?  

Current clearances are for in clinic use only in the US.  The device is not currently available privately.   

Can the device help all spinal injuries – whether traumatic or otherwise? 

To date yes, we have seen results on both traumatic and non-traumatically acquired spinal injuries and on levels from C4 to T12 but please note that sample sizes are still very small. 

Can I see the webinar again? 

Yes – it was recorded and is available here on our Youtube channel.

Insurance questions 

We regret that we cannot speak for individual insurance companies. Please contact your provider to discuss.  

When will it be available in Europe and the UK? 

As we said on the webinar, CE and UKCA clearance is needed first.  Onward are working on those processes and currently estimate end 2025 for Europe and first half 2026 for the UK. 

How can I access the device in the US? 

Please contact Onward to find out which clinics in the US have their device available currently or pending. 

When will the device be cleared for other countries? 

Please contact Onward for details of their planned global rollout. 

How were results measured on the Pathfinder trial? 

All participants were tested before and after the trial and at intervals within it. Measurements also included psychological and lifestyle assessments.  Please see the attached trial results for full details. 

Did the gains from the study persist? 

In the main, yes, they did – as they did in other studies that Onward have carried out.  Participants did not receive any further stimulation after the end of the study. Please see the trial results for full details. 

How do you know which gains were due to just the rehab and how much to the stimulation? 

Most of the Pathfinder participants had been regularly participating in active rehab, some regularly for years, before starting the study.  In other Onward trials of the device, for example, the recent UPLIFT trials that lead to FDA clearance, the trial incorporated a period of just active rehab on its own before then adding in the stimulation for direct comparison. The results of this can be seen in the short video shown during the webinar. 

Are the same electrodes used for different levels? 

Yes.