Onward Medical’s Arc-Ex Platform Receives Breakthrough Nod

Onward Medical’s Arc-Ex platform gained Breakthrough Device status for its non-invasive wireless stimulator for bladder control, alleviation of abnormal increase in muscle tone or stiffness and blood pressure regulation in individuals with spinal cord injury (SCI).

Quality of life with SCI can be poor, with paralysis and loss of sensation, issues with blood pressure control and trunk stability, increased potential for infection, incontinence, and loss of sexual function.

Onward Medical is preparing regulatory submissions in the U.S. and Europe, with the expectation that the device will be cleared for release late this year.

Under the Breakthrough Devices program, the FDA speeds up the development, assessment and review of medical devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions.