(above, Onward CEO Dave Marver)
A big skin-surface spinal cord stimulation study called Up-LIFT, targeting hand and arm function in people with cervical spinal cord injuries, has reached full enrollment of 65 participants. The company Onward, a major sponsor of the annual U2FP Science and Advocacy Symposium, said 14 SCI research sites carried out the trial, in the United States, Canada, the United Kingdom, and the Netherlands. Enrollment was ahead of schedule, despite COVID lock-downs and travel restrictions. What this means, says Onward, is that enthusiasm is high for the therapy and that the company is on track to bring stim to the market in just over a year. Full press release here.
Below is the announcement from Onward CEO Dave Marver:
Today we are pleased to announce we have completed enrollment in the Up-LIFT Study, a multi-center trial to evaluate the safety and effectiveness of ONWARD’s ARC Therapy in restoring hand and arm function in people with spinal cord injury (SCI). Up-LIFT is the first large-scale pivotal trial of non-invasive spinal cord stimulation technology.
We have now reached the study’s enrollment ceiling of 65 subjects, enrolled at 14 leading SCI research sites throughout the United States, Canada, the United Kingdom, and the Netherlands.
The study reached its enrollment objective ahead of schedule and in less than 12 months despite lock-downs, travel restrictions, and other COVID-related challenges. This demonstrates the SCI community’s enthusiasm for this important and innovative new therapy.
We will now work with determination over the coming months to complete the study, analyze the data, and prepare submissions to regulatory authorities in the US and Europe so we can bring this important therapy to market for the benefit of people with SCI and their loved ones.
We expect to initially commercialize ARC Therapy in the US, Germany, France, UK, Switzerland, and the Netherlands in the first half of 2023. To learn more about ONWARD’s ARC Therapy and the company’s vision to restore movement, independence and health in people with spinal cord injury, please visit ONWD.com.
The press release we issued to announce this important milestone can be read here.
Please join me in thanking and recognizing our research partners around the world and ONWARD’s clinical team on this achievement.