ONWARD Medical and partners awarded $1.1 million grant

Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, ONWARD Medical has developed ARC Therapy, a targeted, programmed spinal cord stimulation designed to be delivered by its external ARC-EX^® or implantable ARC-IM^® platforms. ARC Therapy can also be delivered by the company’s ARC-BCI™ platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after spinal cord injury (SCI) with thought-driven control.

The ARC-BCI System combines the investigational WIMAGINE® BCI from CEA-Clinatec with investigational ONWARD ARC-IM® Therapy to form a DigitalBridge™ that enables thought-driven movement restoration. The WIMAGINE BCI is an epidural implant with 7 years of human safety data, and ONWARD ARC-IM Therapy has been applied in more than 30 study participants. ONWARD Medical is also investigating the use of its ARC-BCI System to address lower limb mobility challenges after SCI in a separate early feasibility clinical study. The first-in-human use of ARC-IM Therapy paired with an implanted BCI in a clinical study resulted in an individual gaining augmented control over when and how he moved his paralysed legs. The results of this study were published in Nature in May 2023.

An ongoing early feasibility clinical study aims to evaluate the use of the ONWARD ARC-BCI™ System to restore thought-driven movement of the hands and arms after SCI. The study has obtained further support from the Christopher & Dana Reeve Foundation, which awarded the company and its partners CEA-Clinatec and .NeuroRestore $1.1 million grant, enabling the companies to implant the ONWARD ARC-BCI System in four additional participants. .NeuroRestore is a collaboration between the Swiss Federal Institute of Technology (EPFL) and Lausanne University Hospital (CHUV) and key research partner to ONWARD Medical.

The study is currently being supported by the European Innovation Council under the Reverse Paralysis project. The first study participant was implanted with the investigational ARC-BCI System in August 2023.

Early this year, ONWARD Medical announced that it was accepted into the US FDA’s new Total Product Lifecycle Advisory Program (TAP) for its ARC-BCI platform, which was also awarded FDA Breakthrough Device Designation (BDD).

(Press release/RAN)