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ONWARD continues to progress

Two further FDA Breakthrough Device Designations secured as it pushes on towards commercialisation



Professor Gregoire Courtine, Dr Jocelyne Bloch, Dave Marver

Medtech pioneer ONWARD continues to progress towards its ambition of using its technology to change the lives of people with paralysis, with further approvals granted for its introduction. 

ONWARD has secured two additional Breakthrough Device Designations from the US FDA which advance the development of both its ARC-EX and ARC-IM devices. 

The external ARC-EX has been approved for improving or restoring lower extremity sensory and motor function in people with chronic neurological deficits resulting from spinal cord injury (SCI); and its implantable ARC-IM for treating neurogenic bladder dysfunction in people with SCI. 

ONWARD has now secured five Breakthrough Device Designations for its ARC therapy, with its first device – the ARC-EX – remaining on course to commercialise late next year. 

“We are highly encouraged to have received two additional FDA Breakthrough Device Designations, validating the pioneering nature of our work and providing a streamlined approval process for these important therapies,” said Dave Marver, CEO of ONWARD, delivering a Q3 2022 update. 

“We are looking forward to additional upcoming milestones, including the expected release of interim data from ongoing blood pressure feasibility studies.”

To gather the evidence to support its work, ONWARD has embarked on a number of studies, which have been shown to deliver often life-changing benefits to people living with SCI. 

Recently, it reported positive top-line results from its Up-LIFT pivotal study, evaluating transcutaneous stimulation with its external ARC Therapy. 

The study enrolled 65 people at 14 leading SCI centres in the US, Europe and Canada, delivering tangible gains in upper extremity strength and function in people with SCI. 

It also reported positive topline results from its LIFT Home study, evaluating the safety and feasibility of ARC-EX Therapy when used at home. The study enrolled 17 participants at five leading research centres across the US, with participants performing training on activities of daily living involving arm and hand movement three times per week over a one-month period. 

Approximately 97 per cent of these sessions were completed without usability issues, supporting the feasibility of home-based treatment.

Delivering an update for 2022 and beyond, ONWARD said it expects to continue its “strong and steady” progress through its strategy, with plans for commercialisation in late 2023, following an application for regulatory approval in the US and EU in the first half of next year. 

It also revealed it hopes to report data from its STIMO-HEMO and HemON studies, both of which explore the use of ARC-IM Therapy to normalise low blood pressure in people with SCI, which is the first planned indication for ARC-IM.

To support its plans, ONWARD will also continue to recruit in sales, marketing and field service roles across the US and Europe.