You may have seen an article Medgadget published recently about a minimally invasive neuromodulation technology that has shown significant promise in improving arm and hand function in patients with spinal cord injuries. The technology, called the ARC system, has been developed by ONWARD, a medtech company started by researchers at the Swiss Federal Institute of Technology, and with offices in Switzerland, The Netherlands, and Massachusetts.
The ARC system includes external and implantable versions, and is designed to provide electrical stimulation to the spinal cord to help overcome deficits that have been caused by spinal cord injuries. So far, the external system, which includes minimally invasive patches that are affixed to the skin over the spinal cord, has shown a lot of promise in restoring function to spinal cord injury patients, with one patient being able to play a musical instrument for the first time in years.
See a video below about a study performed by the University of Washington that employed the external ARC technology in spinal cord injury patients:
Medgadget had the opportunity to speak with Dave Marver, CEO of ONWARD, about the company’s technology.
Conn Hastings, Medgadget: Please give us an overview of spinal cord injuries and their consequences for patients and caregivers.
Dave Marver, ONWARD: Spinal cord injury (SCI) results from damage to any part of the spinal cord. Depending on the severity of the injury, it becomes challenging or even impossible to transmit signals across the lesion and the injured person can lose muscle control and sensation.
While it is common to associate SCI with paralysis, people with SCI are impacted in many ways. They can experience difficulty breathing and swallowing. It can be difficult for them to modulate their temperature and blood pressure. And they frequently experience incontinence and loss of sexual function. All of these impacts of SCI affect activities of daily life in profound ways and require expensive assistance and caregiver support.
There are nearly 300,000 people in the US living with SCI today. Our vision at ONWARD is to help people with SCI enjoy life in every way that matters to them.
Medgadget: What inspired these technologies?
Dave Marver: ONWARD was created in 2014 by researchers and surgeons in Switzerland working together at the Swiss Federal Institute of Technology (EPFL) and Centre Hospitalier Universitaire Vaudois (CHUV). Their work is led by a collaboration between ONWARD’s two leading science partners, Grégoire Courtine and Jocelyne Bloch. Building on many years of groundbreaking pre-clinical research, they showed ONWARD’s technology could help people with SCI regain the ability to walk.
In the course of those studies, our research partners also discovered targeted spinal cord stimulation could help people with SCI recover other functions, not just the ability to walk. ONWARD is now making the investments required to conduct clinical trials and commercialize these technologies so they can be broadly available to people with SCI.
Medgadget: How are spinal cord injury patients treated at present? What are the limitations with these approaches?
Dave Marver: Following a SCI, people undergo intensive physical therapy for 3–6 months. Despite the effort of incredibly dedicated rehabilitation professionals, progress often plateaus at that point.
Targeted spinal cord stimulation is the first new therapy that has shown promise in driving improvements in chronically injured people and we look forward to demonstrating the safety and effectiveness of these therapies in large scale clinical trials.
Medgadget: Please give us an overview of the implantable and minimally invasive ARC systems. How do they differ and how do they work?
Dave Marver: ONWARD’s ARC Therapy, which can be delivered by implantable (ARCIM) or external (ARCEX) systems, is designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions with SCI, ultimately improving quality of life. Both of ONWARD’s technology platforms have been awarded Breakthrough Device Designation by the FDA.
The external, non-invasive platform called ARCEX consists of a wearable stimulator and wireless programmer, and in the Up-LIFT trial, which is currently enrolling, we aim to assess its potential to restore hand and arm function in people with SCI.
ARCIM consists of an implantable pulse generator and lead that is placed in direct contact with the spinal cord. The system is controlled by wearable components and a smartwatch. Potential indications we may explore for ARCIM include walking, standing, reduction in spasticity, improved blood pressure regulation, sexual function, and bladder/bowel control.
Medgadget: Please discuss the trials of the ARC systems, past, present and future.
Dave Marver: Earlier this month, ONWARD announced the first patient has been enrolled in the pivotal Up-LIFT study, which will evaluate the safety and effectiveness of ARC Therapy in restoring hand and arm function in people with SCI. This is the first large-scale pivotal trial of non-invasive (ARCEX) spinal cord stimulation technology. ONWARD plans to enroll 65 subjects at up to 15 sites in the United States, Canada, UK, and Europe.
The STIMO study demonstrated the ability of ARCIM to enable long-paralyzed people to stand and walk again with little or no assistance. We expect to begin our FDA pivotal trial for the highest priority indications within 24 months.
Last week, we announced the publication of data in Nature which demonstrated this same technology stabilized blood pressure. Loss of movement and sensation are the most commonly known impacts of SCI, but SCI is also frequently accompanied by other effects that challenge activities of daily living. Blood pressure instability is one such effect, making it difficult for people with SCI to change body position – moving from lying to sitting to standing. In this study, researchers from University of Calgary, EPFL, and CHUV demonstrated they could quickly and accurately normalize blood pressure with electrical spinal cord stimulation. Stabilization was observed in rodents and non-human primates for extended periods after acute and chronic SCI, and the approach also showed promise in humans. We look forward to moving toward clinical trials in humans so this approach can be translated into a viable therapeutic option for people with SCI.
Medgadget: When do you envisage that such technology will be widely available?
Dave Marver: Should the Up-LIFT trial be successful, we expect to make the ARCEX therapy commercially available by 2023, working side-by-side with regulators to provide the therapy as soon as possible to those who need it most.
Link: ONWARD company homepage…