Ongoing progress for ONWARD

Medtech pioneer ONWARD has announced the first in-human use of one of its breakthrough technologies to support people living with spinal cord injury (SCI), while also predicting “steady and consistent” progress towards its ambitions across its range of innovations. 

ONWARD has successfully used its investigational ARC-IM Lead in a patient, a device which delivers targeted electrical pulses to the spinal cord and is a key component of the ONWARD ARC-IM system. 

The ARC-IM Lead is designed to be used with the ARC-IM neurostimulator and is purpose-built for placement along the spinal cord to stimulate the dorsal roots. 

ONWARD is developing a portfolio of ARC-IM Leads in a range of sizes, shapes, and electrode arrays for the many indications the company is developing or exploring, such as improved blood pressure management, mobility, upper extremity function, and bladder control.

The announcement, alongside its Q1 2023 update which revealed ongoing progress across its portfolio, shows how ONWARD continues to deliver on its ambitions of restoring movement, function and independence in people living with SCI. 

“The shape and electrode placement of the ARC-IM Lead are unique, providing characteristics I have long wanted for my patients with spinal cord injury, while exhibiting the same feel as the leads I have implanted for many years,” said Dr Jocelyne Bloch, neurosurgeon at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, who carried out the procedure to benefit a patient with poor blood pressure regulation following SCI.

The development, which is part of the ongoing HemON study, builds further on the positive outcomes achieved to date by targeted ARC-IM Therapy to improve blood pressure regulation following SCI, following the release of study results last year in which all participants reported improved quality of life. 

The Q1 update also revealed plans to begin its pivotal clinical study in the next year to evaluate the safety and effectiveness of the implantable ARC-IM system to better regulate blood pressure after SCI.

ONWARD also revealed ongoing progress for its ARC-EX device, with further details given of its Up-LIFT pivotal study to investigate the impact of non-invasive neuromodulation for improving upper extremity strength and function after SCI. 

In addition to meeting all primary safety and effectiveness endpoints, the study demonstrated that 72 per cent of participants responded to ARC-EX Therapy, which is targeting commercialisation before the end of this year – although the update said that may go into early 2024. 

It also confirmed its intention to begin clinical feasibility studies to investigate the ability for a brain-computer interface (BCI) to communicate with the ARC-IM system, to enable a person with SCI to more naturally control when and how they move.

Dave Marver, CEO of ONWARD, said of the Q1 update: “We were especially pleased to announce that the Up-LIFT pivotal study met all primary endpoints including a 72% per cent responder rate. 

“We expect to achieve several important milestones in the months ahead, including FDA submission of our de novo application for ARC-EX Therapy and initiation of a groundbreaking clinical feasibility study that includes first-in-human use of a brain-computer interface in combination with ARC-IM Therapy to restore hand and arm function.”