The external stimulation device ARC-EX © ONWARD

ONWARD has completed another important step in its mission to help people regain mobility. The company recently announced that it completed a 32 million dollar round of financing. With this money, ONWARD can develop and commercialize their two technologies ARC-EX and ARC-IM. Both these external and internal technologies are designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions with spinal cord injury (SCI).

The financing round was led by Invest-NL, a Dutch investment agency as well as Olympic Investments, a private part of the Onassis Foundation. Other contributors included medical technology investors LSP and Dutch investors InkefCapital, among others. The company has headquarters in Lausanne, Switzerland and Eindhoven, the Netherlands.

“The funding provides ONWARD an approximately 18-month runway,” Dave Marver, the company’s CEO estimates. “The proceeds will be used to complete ONWARD’s research and development initiatives, fund the Up-LIFT pivotal trial, which is currently running, and complete preliminary studies for the next pivotal trial,” says Marver. The company has developed both internal and external stimulation technology.

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    Implant and wearable

    ARC-IM uses a wireless implant. During surgery, electrodes are implanted over the spinal cord. In a study, three patients with SCI who had little function remaining in their legs were able to stand and even walk with bodyweight support again. Another technology ONWARD developed is referred to as ARC-EX. This device consists of a wearable stimulator that uses high-frequency waveform to numb the skin in combination with a lower frequency stimulation pulse which targets and sends energy through the spinal cord. This wearable device requires no surgery. An initial study showed significantly improved and sustained improvement in patients` arm and hand movement.

    Trial facilities

    Earlier this year, ONWARD started its large scale clinical trial with this wearable stimulation technology. “Should the Up-LIFT trial be successful, ONWARD expects to make ARC-EX therapy commercially available by early 2023,” says Marver. Trials are taking place across the US, Canada, the UK, and the Netherlands, with plans to enroll 65 patients. Of the two trial facilities in Europe, one is located in St. Maartenskliniek in Nijmegen, the Netherlands. “Both should start enrolling subjects soon. We plan to enroll between ten to twenty participants across European sites,” says Marver. “It is possible we will add additional sites in Europe as the year progresses.”

    Read also: ONWARD’s technology can restore the independence of those paralyzed due to spinal cord injury

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