“New implant offers promise for the paralyzed” – This was a headline that went around the globe last week. Profs Courtine and Bloch treated 3 patients with complete spinal cord injury, and they were able to stand and walk again. What is the importance of this study for the company ONWARD?
Research in the past has already shown that people with only incomplete spinal cord injury, which is the most frequent case, can stand and walk again. The recent announcement means that also people with complete spinal cord injury can expect to regain motor function. This breakthrough gives hope to many and considerably expands the population of people that might benefit from ONWARD’s therapies in the future. The neurostimulation leads that Prof Bloch implanted in the 3 patients have been developed by ONWARD and the Neurorestore research center specifically for this therapy. They were longer and broader than the leads usually used for pain management, in order to better capture the anatomy of the spinal cord. The results clearly show the benefit of our purpose-built technology. In the next studies, our specifically designed implantable pulse generator, a sort of small computer that generates the electrical stimulation, will also be used.

How large is ONWARD’s potential market?
There are about 7 million people with spinal cord injuries worldwide, 650’000 in the US and Europe alone. The annual incidence of new cases in the US and Europe is 50,000. The ability to treat complete spinal cord injury has enlarged our market potential by about 40%.

When will this new treatment be commercially available for patients?
It is one of three treatments that are part of our business plan. We expect the first device, an external stimulation device, will be available in Europe and the US in 2023. Its goal is to restore arm and hand function in paralyzed patients. We have finished the enrolment of patients for our clinical trial “Up-LIFT” in December 2021, ahead of schedule despite Covid. This shows the enthusiasm of the spinal cord injury community for the therapy.

The implantable device should be available within the next 3 to 4 years. First, we will pursue the indications of restoring normal blood pressure and trunk control, and second, the ability to stand and walk again. There are several other potential indications we can address at a later point, for example, incontinence and restoration of sexual function. Neurostimulation could also provide benefits to different neurological conditions, which again, would greatly increase the size of our total addressable market.

Are the benefits of the implantable therapy the same for patients with complete or incomplete spinal cord injury?
It has been shown that stimulation combined with training allows patients with incomplete SCI to recover some motor functions even after the stimulation is turned off. This hasn’t been observed in the patients with complete SCI, which means that they benefit from stimulation only as long as it is active.

ONWARD is still a year away from first revenues, is that a problem for a listed company?
Our IPO investors are focused on our long-term potential. They understand we do not expect revenues until 2023. Our commercialization plan is also straightforward. Our external stimulation device will be first labeled for use in rehabilitation clinics. There are around 200 of those in the US and Europe. We expect clearance for home use afterward, which will dramatically expand the customer base. These first steps will foster familiarity of the SCI community with our devices and lay the foundation for the launch of the implantable device later. ONWARD is very well capitalized, having raised more than USD 100 million thanks to last year’s pre-IPO private placement and the IPO proceeds, which gives us ample capital for several years of operation.