Onward Trans Spinal Stimulation (TSS)

ARC EX Device used for the Up-LIFT Study, is the External system for
non-invasive, programmed stimulation of the spinal cord from Onward Medical.

All studies are done with this trans spinal stimulation device from Onward which is actually Version 1 from Spinex Inc. - Onward bought the IP (Intellectual property) from SpineX for version one and uses it now for their clinical trials.

The Equipment was developed by SpineX at UCLA and is manufactured in India and is now developed further by onward.

It is a two channel device.

The application of the electrodes it’s on the spine itself (non-invasive) depending on which part of the body wants to be trained, the electrodes (hydrogel electrode) are placed further up or down the spine. The grounds (ground electrodes) are placed left and right on the low abdominal muscles. Both channels can be used to separately adjust the amplitude mA and thus change the intensity of the stimulation.

The ARCEX  technology platform is designated by the FDA as a Breakthrough Device technology which is a big step in the process of bringing it to the market.

Possibilities

Clinical Trials:

Up-Lift study general informations:

ONWARD's ARC Therapy is designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions in people with spinal cord injury

ARCEX is our external, non-invasive platform consisting of a stimulator and wireless programmer. We have been granted Breakthrough Device Designation status from the FDA for the use of the ARCEX platform to improve upper and lower limb function, for bladder control and blood pressure regulation and for alleviation of spasticity in people with spinal cord injury.  

In 2022, the first large-scale clinical study of non-invasive spinal cord stimulation technology, called Up-LIFT, achieved its primary safety and effectiveness endpoints of improvement in upper extremity strength and function after a spinal cord injury. We are preparing regulatory submissions for the U.S. and Europe, with the expectation that this therapy may be approved for commercialization in late 2023.

The Up-LIFT pivotal study evaluated the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARCEX Therapy) to improve upper extremity strength and function in people with spinal cord injury. [1]

Up-Lift Study results presented at Annual SCI Investor Symposium – June 29, 2023, San Diego, CA: