EKSO FDA Clearance for EksoNR™ for Brain Injuriy Patients
Jun 25, 2020 13:31:18 GMT
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Post by highskier on Jun 25, 2020 13:31:18 GMT
The stk is up 78% in early trading.
Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Acquired Brain Injury Patients
RICHMOND, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (EKSO) (the “Company”), an industry leader in exoskeleton technology for medical and industrial use, today announced it has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EksoNRTM robotic exoskeleton for use with patients with acquired brain injury (ABI). EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use with ABI, significantly expanding the device’s indication to a broader group of patients.
EksoNR is the next generation device of the most clinically used robotic exoskeleton, and was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016. The device was the first of its kind to receive a stroke indication and is now also the first to receive an ABI indication.
ABI is the broadest category of brain injury and is comprised of both traumatic (TBI) and non-traumatic (n-TBI) causes. TBI includes severe head injuries and concussions, while n-TBI includes a broader subset of conditions, such as stroke, aneurysms, brain tumors, anoxia, degenerative and metabolic conditions, infections, and surgical injuries, among others. Combined annual incidence of TBI and stroke alone represent an estimated patient population of 3.7 million in the U.S. and 84 million globally.
“At Ekso Bionics, we are committed to maximizing patient access to our technology. With the expanded indications to include the broad category of acquired brain injuries, the EksoNR has the potential to mobilize significantly more patients and improve patient recovery,” said Jack Peurach, CEO and president of Ekso Bionics. “Based on their experience with EksoNR, customers at leading rehabilitation centers have acknowledged the benefits our technology can offer during recovery from brain injuries. We are excited to see the device used more widely in neurorehabilitation.”
EksoNR is cleared by the FDA for stroke, spinal cord injury, and acquired brain injury rehabilitation. The device is also CE-marked and available in Europe. Utilized by over 270 rehabilitation centers around the world, the Ekso device has helped patients take more than 120 million steps, while supporting patients’ hopes of early mobility and independence.
About Ekso Bionics®
Ekso Bionics® is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical and industrial applications. Founded in 2005, the Company continues to build upon its industry-leading expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe. The Company is headquartered in the San Francisco Bay Area and is listed on the Nasdaq Capital Market under the symbol “EKSO.” For more information, visit: www.eksobionics.com or follow @eksobionics on Twitter. ™
EksoNR is the next generation device of the most clinically used robotic exoskeleton, and was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016. The device was the first of its kind to receive a stroke indication and is now also the first to receive an ABI indication.
ABI is the broadest category of brain injury and is comprised of both traumatic (TBI) and non-traumatic (n-TBI) causes. TBI includes severe head injuries and concussions, while n-TBI includes a broader subset of conditions, such as stroke, aneurysms, brain tumors, anoxia, degenerative and metabolic conditions, infections, and surgical injuries, among others. Combined annual incidence of TBI and stroke alone represent an estimated patient population of 3.7 million in the U.S. and 84 million globally.
“At Ekso Bionics, we are committed to maximizing patient access to our technology. With the expanded indications to include the broad category of acquired brain injuries, the EksoNR has the potential to mobilize significantly more patients and improve patient recovery,” said Jack Peurach, CEO and president of Ekso Bionics. “Based on their experience with EksoNR, customers at leading rehabilitation centers have acknowledged the benefits our technology can offer during recovery from brain injuries. We are excited to see the device used more widely in neurorehabilitation.”
EksoNR is cleared by the FDA for stroke, spinal cord injury, and acquired brain injury rehabilitation. The device is also CE-marked and available in Europe. Utilized by over 270 rehabilitation centers around the world, the Ekso device has helped patients take more than 120 million steps, while supporting patients’ hopes of early mobility and independence.
About Ekso Bionics®
Ekso Bionics® is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical and industrial applications. Founded in 2005, the Company continues to build upon its industry-leading expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe. The Company is headquartered in the San Francisco Bay Area and is listed on the Nasdaq Capital Market under the symbol “EKSO.” For more information, visit: www.eksobionics.com or follow @eksobionics on Twitter. ™