FAQs
Discover the answers to some frequently asked questions.
What is spinal cord stimulation?
Spinal cord stimulation, also called neurostimulation or neuromodulation, is a medical therapy that sends electrical signals to select areas of the spinal cord.
What is spinal cord injury?
Spinal cord injury, or SCI, is a devastating condition that affects millions of people worldwide, leading to partial or complete loss of motor and sensory functions.
What is ARC Therapy?
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.
What is the evidence behind ARC Therapy?
The benefits of ONWARD ARC Therapy have been observed in published pre-clinical and human feasibility studies. A human pivotal clinical study has been completed, called Up-LIFT, designed to evaluate the safety and effectiveness of our ARCEX Therapy to improve upper limb mobility. Learn more about it on the External ARCEX page. Clinical results may vary.
What is the evidence behind ARCEX Therapy?
Positive results of the Up-LIFT pivotal trial were published in Nature Medicine in May of 2024. Visit the External ARCEX page to learn more. Clinical results may vary.
How does ARCEX work?
Transcutaneous spinal cord stimulation excites the spinal cord so that signals weakened or interrupted by a spinal cord injury (SCI) are able to drive movement. That movement enables rehabilitation that results in improvement in hand strength and sensation.
How is ARCEX Therapy different than other therapies that address mobility and function for people with spinal cord injuries?
The ARCEX System offers several important advantages over other electrical stimulation therapies currently available:
• SCI specific: designed for individuals with spinal cord injury (SCI), with the Up-LIFT study confirming safety and effectiveness in this population
• Volitionally driven: stimulation excites the spinal cord so that signals from the brain to the body weakened or interrupted by an SCI can produce voluntary movement
• Stimulation comfort: carrier frequency makes longer electrical pulses, which are more effective at activating target sensory nerves, more comfortable
• Convenient setup: a quick and easy non-invasive setup with just four electrodes, allowing full freedom of motion to interact with objects and perform tasks while training
• Muscle engagement: stimulating the spinal cord activates multiple muscle groups simultaneously, leveraging natural muscle recruitment for fine motor control and reduced fatigue
• Persisting benefits: demonstrated improvements in hand strength and sensation without active stimulation
• SCI specific: designed for individuals with spinal cord injury (SCI), with the Up-LIFT study confirming safety and effectiveness in this population
• Volitionally driven: stimulation excites the spinal cord so that signals from the brain to the body weakened or interrupted by an SCI can produce voluntary movement
• Stimulation comfort: carrier frequency makes longer electrical pulses, which are more effective at activating target sensory nerves, more comfortable
• Convenient setup: a quick and easy non-invasive setup with just four electrodes, allowing full freedom of motion to interact with objects and perform tasks while training
• Muscle engagement: stimulating the spinal cord activates multiple muscle groups simultaneously, leveraging natural muscle recruitment for fine motor control and reduced fatigue
• Persisting benefits: demonstrated improvements in hand strength and sensation without active stimulation
What is the indicated use for ARCEX?
The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
What is Functional Task Practice?
Functional task practice is considered the standard of care for rehabilitation during the chronic SCI phase and includes the practice of customizable tasks as defined by the clinician and based on each patient’s individual goals.
What are the contraindications for use for ARCEX?
The ARCEX System should not be used on patients with active implantable devices or wearable defibrillators. During the clinical studies, pregnant patients were excluded, therefore, safety of the ARCEX was not established during pregnancy. Always consult with a healthcare professional before using the ARCEX during pregnancy. Please refer to the Instructions for Use for a complete list of warnings and precautions.
How can I get access to ARCEX Therapy?
Please navigate to the Contact page to send your request for more information.
How do I find a rehabilitation center that has ARCEX available?
Complete the webform on our Contact page to receive more information about the rehabilitation centers where ARCEX is currently available in your area. Please register for regular updates to continue receiving the latest information.
Can ARCEX be used at home?
The ARCEX System is currently authorized for professional use within clinics. In July, we submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand the indication for home use.
Can ARCEX be used for other indications?
Use of the ARCEX System is limited to the indications detailed in the Instructions for Use document.
ONWARD continues to explore and evaluate the ability for ARCEX to improve other functions in people with SCI in current and future clinical studies.
ONWARD continues to explore and evaluate the ability for ARCEX to improve other functions in people with SCI in current and future clinical studies.
What is ARCIM?
ARCIM is an investigational spinal cord stimulation system, which includes an implantable Neurostimulator that generates electrical pulses that are programmed to target areas of injury on the spinal cord. The system is designed to improve functional recovery of strength, function, and movement after spinal cord injury.
The ONWARD® Medical ARCEX® System is FDA cleared for use in the United States and CE marked in accordance with EU Medical Device Regulation 2017/745. ONWARD ARCIM® and ARCBCI™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
Indication for Use (US): The ARCEX® System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
Indication for Use (EU): The ARCEX® System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).