ONWARD Medical, a MedTech company creating innovative therapies to restore movement, function in people with spinal cord injury (SCI), has carried out a successful first-in-human use of its investigational ARC-IM Lead.

The ARC-IM Lead delivers targeted electrical pulses to the spinal cord and is a key component of the ONWARD ARC-IM system, an innovative platform engineered to deliver ARC therapy to address multiple indications. The ARC-IM Lead is designed to be used with the ARC-IM neurostimulator (IPG) and is purpose-built for placement along the spinal cord to stimulate the dorsal roots, with specific parameters designed for each anatomical location. 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 ARC-IM Lead was implanted by Jocelyne Bloch, MD, neurosurgeon at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, to benefit a patient with poor blood pressure regulation following 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 Bloch.

During surgery, the ARC-IM Lead was placed in the “Hemodynamic Hotspot” along the thoracic spinal cord, an area in which targeted electrical stimulation may restore better blood pressure regulation after an SCI. This specific location and accompanying mechanism of action were first discovered by the Company’s research partners at the Swiss Federal Institute of Technology Lausanne (EPFL) and University of Calgary and published in Nature in January 2021.

In December 2022, ONWARD announced positive interim results from the first 10 people treated with targeted ARC-IM Therapy to improve blood pressure regulation following SCI. All participants reported improved quality of life. ONWARD received an FDA Breakthrough Device Designation in 2021 for this indication.

“The purpose-designed ARC-IM Lead will unlock our ability to optimally deliver ARC Therapy to address many of the challenges faced by people with spinal cord injury,” said Dave Marver, CEO of ONWARD. “We look forward to using the lead to pursue restoration of mobility and other indications in the future.” Thought-controlled walking after SCI And in other news, ONWARD announced the publication in Nature  https://doi.org/10.1038/s41586-023-06094-5  of a study showing that a wireless brain-computer interface (BCI) can use thought
to modulate ARC Therapy. Researchers reported that when paired with ARC Therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved his paralyzed legs. “This publication shows the remarkable potential of ARC Therapy to be enhanced with the introduction of a BCI, facilitating more natural movement based on the thoughts of a person living with paralysis,” said Dave Marver, CEO of ONWARD.

“We have positioned ONWARD as a leader in the BCI field with our unique under­standing of spinal cord stimulation for people with SCI.”

“The BCI establishes a continuous link between movement intentions and spinal cord stimulation, allowing for more natural restoration of mobility,” said neuroscientist Grégoire Courtine, professor at EPFL, and co-author of the Nature paper. “I look forward to working with the ONWARD team to advance this important new technology.”

The data published are part of an ongoing clinical feasibility study investigating the safety and preliminary effectiveness of brain-controlled spinal cord stimulation after SCI.