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ONWARD ARC-EX study reveals remote use potential

The positive results of the LIFT Home Study come shortly after endorsement from the Up-LIFT study

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The potential of the ARC-EX device from medtech pioneers ONWARD has grown even further with the conclusion of its trial for at-home use endorsing its feasibility and safety. 

The ARC-EX device, set to be launched commercially next year, delivers non-invasive stimulation of the spinal cord, targeted to help restore movement and other functions in people with spinal cord injury (SCI) and other movement disabilities. 

Recently, the results of its Up-LIFT pivotal study confirmed its efficacy when used in clinics, with a global trial – including two sites in the UK – endorsing its ability to make statistically significant and clinically meaningful improvement in upper extremity strength and function. 

And now, through its LIFT Home Study, its potential in the home setting has also been clearly shown, with 97 per cent of therapy sessions successfully completed and 100 per cent of participants completing the study with no serious adverse effects. 

“Today’s results from the LIFT Home study support the potential for ARC-EX Therapy to be used safely at home, which would enable people with spinal cord injury to live even more independently,” said Dave Marver, CEO of ONWARD. 

“We expect to launch first in clinics, but as the community gains more experience with ARC-EX Therapy, we envision many patients will also want to use this technology at home.”

The ARC-EX device is set to launch in the second half of 2023 and will be the first commercial launch by ONWARD, which is using years of research and innovation to create innovative therapies to restore movement, independence and health in people with SCI. 

Its other main device, the ARC-IM, delivers stimulation of the spinal cord through implant, and its huge promise was shown through the STIMO-BRIDGE study, which restored the ability of three paralysed patients to walk, run and swim, when combined with intensive rehabilitation. 

In its LIFT Home Study, 17 patients were enrolled from five leading spinal cord injury research centres in the United States – Craig Hospital in Denver, Colorado; Shepherd Center in Atlanta, Georgia; Spaulding Research Institute in Boston, Massachusetts; University of Minnesota; and the University of Washington.

Participants performed training on activities of daily living three times per week over a one-month period.

“To maximize recovery after spinal cord injury, it’s critical that we develop treatments that can be safely and effectively delivered in the home environment,” said principal investigator Candy Tefertiller, executive director of research and evaluation at Craig Hospital.

“Integrating home-based therapy not only facilitates opportunities for ongoing recovery, but also allows therapy to focus on more relevant activities for that specific individual.”

ONWARD said it now plans to discuss the findings from the LIFT Home study with regulatory authorities to define the appropriate approval pathway for home use.

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