Onward said that, in late 2023, a study participant received the investigational ARC-IM neurostimulator and lead implant. This study aims to assess the safety and effectiveness of the therapy to address hemodynamic instability after spinal cord injury (SCI).
The Eindhoven, the Netherlands-based company is conducting its study at Sint Maartenskliniek in Nijmegen, the Netherlands. Dr. Erkan Kurt of Radboud University Medical Center performed the surgery. Dr. Ilse van Nes of Sint Maartenskliniek serves as the principal investigator of HemOn NL.
Onward said that HemON NL builds on its Swiss HemON clinical feasibility study. It also prepares the company for the expected initiation of the Empower BP global pivotal trial. The company designed Empower BP to provide the evidence to submit a pre-market approval application to the FDA.
“Sint Maartenskliniek has long been an outstanding research partner, and we are delighted to work with them on this new and exciting study to evaluate the use of ARC-IM Therapy to stabilize disruptive and potentially life-threatening fluctuations in blood pressure after SCI,” said Dave Marver, CEO of Onward. “This is an important but underappreciated recovery target after SCI. We hope this research and the expected upcoming pivotal study will shine a light on the importance of hemodynamic stability in this population.”
Onward develops ARC-IM for a range of therapies, including the restoration of movement and other functions after spinal cord injury. The company believes it could also restore thought-driven movement through a combination of ARC-IM and brain-computer interface (BCI).
