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ONWARD secures latest boost on road to commercialisation

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Healthtech business ONWARD has secured its third Breakthrough Device Designation status as it continues towards its goal of commercialising its technology which could allow paralysed patients to walk again. 

The venture secured Breakthrough Device Designation for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury.

It is the third such status awarded to ONWARD from the US Food and Drug Administration (FDA), following previous awards for ARC-EX for upper extremity function and ARC-IM for mobility.

ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The system is operated via a tablet programmer and smartwatch. 

A study demonstrated the ability of this technology to enable long-paralysed people to stand and walk again with little or no assistance and a further recently-published paper showed the potential for this same therapy to normalise blood pressure in people with spinal cord injury.

ONWARD has previously spoken of its hope that ARC-IM would be commercially available in 2024. 

“Blood pressure and trunk control are two of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” says Dave Marver, chief executive officer of ONWARD. 

“We are excited about this award and thankful to the FDA for recognising the potential of our technology to improve the quality of life for those with spinal cord injury.”

The FDA endorsement comes as the latest breakthrough for ONWARD, following the backing of $32million earlier this year through a fundraising round to help it continue with its journey. 

The ARC EX device is expected to be commercially available in late 2023, with its Up-LIFT trial underway in the UK – at the Queen Elizabeth University Hospital in Glasgow – United States, Canada and the Netherlands.

The trial began in January with plans to enrol 65 people at up to 15 centres worldwide. 

An external, non-invasive platform, the ARC EX is set to deliver movement and strength in the hands and upper body of people with spinal cord injury, compared to rehabilitation training alone.

And in one of the most keenly-awaited health tech breakthroughs of recent years, its ARC IM technology is set to go into trials mid next year, with its commercial launch anticipated in 2024.

Both platforms are designed to deliver targeted, programmed stimulation of the spinal cord to restore movement, independence, and health in people with spinal cord injury, ultimately improving their quality of life. 

Breakthrough Device Designation is an FDA program designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of great unmet need, such as spinal cord injury. 

As part of this designation, the FDA will provide ONWARD with priority review and the opportunity to interact with FDA’s experts throughout the premarket review phase as the technology moves toward eventual commercialisation.

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