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Onward recently secured US Food and Drug Administration breakthrough device designation for its ARC-IM platform for blood pressure and trunk control in people living with spinal cord injuries.

This marks the firm’s third breakthrough designation. On 29 May 2020, the US Food and Drug Administration granted breakthrough designation for Onward’s implantable system (ARC-IM) for mobility; on 5 October 2017 the firm received the first breakthrough designation for an external system (ARC-EX) to assess the potential to restore hand and arm function in people with spinal cord injuries.

The Up-LIFT prospective study aims to evaluate the safety and effectiveness of ARC therapy to treat upper extremity functional deficits in people with chronic tetraplegia.

Onward CEO Dave Marver told Medtech Insight that blood pressure and trunk control affects 75% and 80% of people with spinal cord injuries, respectively. There are about 300,000 people living with a spinal cord injury in the US; each year, there are about 17,900 new cases, according to the National Spinal Cord Injury Association.

ARC-IM targets orthostatic hypotension, which is caused by blood vessels failing to constrict when the person stands up. The conventional treatment for orthostatic hypotension is slow-acting medications.

“Working in concert with our research partners, we’re looking at a host of other indications that leverage our technologies, either the implantable or the external, that we are hopeful will also help people with spinal cord injury.” – Dave Marver

“[The drugs] don’t work quickly enough to help people when they want to change body position to get up in the morning, for example, and they also can’t be turned off easily – the effect [of the drug] lasts for one to two hours,” Marver explained.

Restoration of trunk control is also a very important consideration for activities of daily living, such as reaching forward or moving back, which is also aided by the ARC-IM implantable device, he added.

Results of the STIMO study showed the potential of the ARC-IM platform to enable long-paralyzed people to stand and walk again with little or no assistance. A paper published in Nature in January also showed the potential for the same therapy to normalize blood pressure after a spinal cord injury.

ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The clinician uses a tablet programmer to program the device parameters and the patient can use a smartwatch to turn therapy on or off, Marver said.

Dave Marver, CEO of Onward Onward

He expects that for the blood pressure and trunk indication, the FDA will require a premarket approval (PMA) from the FDA. Onward will sponsor a pivotal trial in the “next couple of years," he said, adding that, in the meantime, the company will embark on multi-center feasibility studies to learn more about the therapy in preparation for the forthcoming pivotal trial.

Study partners include the Swiss Federal Institute of Technology, where the technology was spun out off in 2014, and the University of Calgary in Alberta, Canada, he said.

He expects the device will eventually be implanted by functional neurosurgeons in hospitals or ambulatory surgery centers and will then be used by patients at home. Marver noted that he is not aware of any other company deploying implantable spinal cord stimulation technology to restore movement or autonomic function in people with spinal cord injury.

Onward was founded in 2014 by researchers at the Swiss Federal Institute of Technology. It has offices in Eindhoven, the Netherlands, Lausanne, Switzerland and Boston.

The company announced on 22 April it completed a $32m financing, led by Invest-NL, the Dutch impact investor, and Olympic Investments, the private investment arm of the Onassis Foundation. New investors and existing investors, including LSP, INKEF Capital, Gimv and Wellington Partners, also participated in the financing.

The company said it would use the proceeds to fund the continued development and commercialization of its ARC therapies.

"Working in concert with our research partners, we’re looking at a host of other indications that leverage our technologies, either the implantable or the external, that we are hopeful will also help people with spinal cord injury,” Marver said.

 

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