Ekso Bionics Holdings, Inc. (Nasdaq: EKSO) (the “Company”), an industry leader in exoskeleton technology for medical and industrial use, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EksoNR™ robotic exoskeleton for use with Multiple Sclerosis (MS) patients.
EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, an indication which significantly expands the device’s use to a broader group of patients.
EksoNR is the latest-generation device of the most clinically used robotic exoskeleton on the market. It was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016 and acquired brain injury (ABI) in 2020. The device was the first of its kind to receive a stroke indication, is the only exoskeleton with an ABI indication, and now is the first to receive an indication for MS.
“As a leader in early-to-market wearable robotic solutions for medical rehabilitation, we are committed to maximizing patient access to our technology,” said Steven Sherman, Chairman and Chief Executive Officer of Ekso Bionics. “With the indications for use now expanded to include MS, the EksoNR has the potential to assist significantly more patients and improve patient mobility. We are excited to see the device benefit MS patients, providing critically needed rehabilitation solutions just as it has for patients suffering from stroke, spinal cord injury and acquired brain injury.”
MS is a neurodegenerative disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Commonly diagnosed between ages 20 and 40, symptoms of MS can include neurological deficits, from vision impairment and fatigue to numbness and difficulty walking. According to the National MS Society, there are nearly 1 million people in the U.S. living with MS and more than 2.8 million globally. Every five minutes someone is diagnosed with MS.
In addition to its FDA clearances, EksoNR is CE-marked and available in Europe. Used by more than 375 rehabilitation centers globally, Ekso devices have helped patients take nearly 200 million steps, while supporting patients’ hopes of mobility and independence.