Onward Medical Achieves Milestone in Nerve Stimulation Therapy
Onward Medical, an innovative startup specializing in medical technology, recently announced a significant breakthrough in its ARC nerve stimulation therapy system. The company has successfully installed its brainwave-driven implantable electrode for the first time. This groundbreaking device is designed to restore function and feeling to a patient’s hands and arms. The announcement comes on the heels of a previous implementation of a similar system aimed at reestablishing a natural walking gait.
Exploring the ARC System
The ARC system is available in two versions: ARC-EX, an external stimulator that enhances limb function and control, and ARC-IM, an implantable stimulator controlled through wearable components. These revolutionary systems work by capturing the patient’s brain signals and converting them into machine-understandable commands, facilitating the control of implanted electrodes. Onward Medical’s goal is to commercialize their external spinal cord stimulation solution, ARC-EX Therapy, by the second half of 2024.
In recognition of the potential of the ARC platforms, the FDA has granted a total of nine Breakthrough Device Designations. The ARC-EX platform, a non-invasive system consisting of a stimulator and wireless programmer, has received these designations for its potential to enhance upper and lower limb function, bladder control, blood pressure regulation, and alleviate spasticity in individuals with Spinal cord injury. The first large-scale clinical study of this non-invasive spinal cord stimulation technology, called Up-LIFT, met its primary safety and effectiveness endpoints in 2022, paving the way for regulatory submissions in the U.S and Europe.
ARC-IM: Implantable Platform with Potential
Onward Medical’s ARC-IM is an implantable platform that includes a neurostimulator and a lead placed near the spinal cord. It is controlled by wearable components and a smartwatch. The STIMO study demonstrated the ability of this therapy to enable long-paralyzed individuals to stand and walk again with little or no assistance. Following this, the FDA granted Breakthrough Device Designation for ARC-IM in 2020. The company plans to begin pivotal trials for these three indications within 24 months. Further potential applications for ARC-IM may include reduced spasticity, improved sexual function, bowel control, and Parkinson’s mobility and gait.
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