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Onward Medical has received a green light from the American FDA. The company has been accepted into a program to develop its breakthrough brain-computer interface (BCI) technology for patients with spinal cord injuries. This accelerated approval could dramatically reduce the time and cost of bringing this innovative solution to market. Onward is one of the first participants in the program aimed at a more efficient premarket review process. Onward can now identify and mitigate risks faster, paving the way for faster assistance for people with paralysis. Onward Medical won a Gerard & Anton Award in 2016.

Admission to the US Food and Drug Administration’s (FDA) Total Product Lifecycle Advisory Program (TAP) marks a significant step forward in the development of Onward’s revolutionary BCI technology. The company’s technology, intended for patients with spinal cord injuries, has the potential to change lives by helping paralyzed patients regain mobility. “We are honored to be one of the first BCI companies to be included in this important program,” said CEO Dave Marver.

Faster access to innovative therapies

TAP admission means Onward Medical can more quickly navigate the regulatory processes leading up to market launch. The program provides early strategic engagement with the FDA, patients, healthcare providers, and insurance companies, facilitating development and patient access to medical devices. The benefits to Onward Medical are significant, including getting feedback faster and identifying and reducing development risks early.

Onward Medical’s ARC-BCI technology restores communication between the brain and damaged nerve pathways. It pairs BCI technology with ARC-IM® therapy to regain mobility after spinal cord injury. The technology has already shown potential in clinical feasibility studies in 2021 and 2023, restoring lower and upper limb movement after spinal cord injury.

FDA approval could pave the way for faster access to these therapies for patients worldwide. With headquarters in Eindhoven and facilities in Lausanne and Boston, Onward Medical is well positioned to expand its influence.