ONWARD Medical, a company creating therapies to restore movement, function, and independence in spinal cord injury (SCI) patients, has completed a successful first-in-human use for its investigational ARC-IM lead.
 
The ARC-IM lead delivers targeted electrical pulses to the spinal cord and is a critical component for the ONWARD ARC-IM system, a platform of ARC Therapy for multiple indications. Used with the ARC-IM neurostimulator (IPG), the lead is placed along the spinal cord to stimulate the dorsal roots with parameters designed for each location.
 
The company is developing a portfolio of ARC-IM leads in a variety of sizes, shapes, and electrode arrays for the many indications the company is developing or exploring, like improved blood pressure management, mobility, upper extremity function, and bladder control.
 
The 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,” Dr. Bloch told the press.
 
The ARC-IM lead was placed in the “hemodynamic hotspot” along the thoracic spinal cord, where targeted electrical stimulation may restore better blood pressure after SCI, according to the researchers.
 
In December 2022, ONWARD released positive interim results from the first ten patients treated with targeted ARC-IM therapy to improve blood pressure after SCI. All reported improved quality of life—ONWARD earned breakthrough designation in 2021 for this indication.
 
The company also earned breakthrough status for its ARC-EX platform for bladder control, spasticity alleviation, and blood pressure regulation in people with SCI in February 2023.
 
“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.”