Ekso Bionics Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Multiple Sclerosis Patients

Rhea-AI Summary

Ekso Bionics Holdings has received 510(k) clearance from the FDA for its EksoNR robotic exoskeleton, marking it as the first device approved for rehabilitation use in Multiple Sclerosis (MS) patients. This approval expands the exoskeleton’s application, previously cleared for stroke and spinal cord injury rehabilitation. With nearly 1 million MS patients in the U.S. and more than 2.8 million globally, EksoNR aims to enhance patient mobility and rehabilitation outcomes.

Available in over 375 centers worldwide, the device has already supported patients in taking nearly 200 million steps.

Positive

• Received FDA clearance for EksoNR robotic exoskeleton, expanding its use to MS patients.
• EksoNR is the first exoskeleton approved for rehabilitation in MS, enhancing market potential.
• Already in use at over 375 rehabilitation centers globally, demonstrating market adoption.
• Has supported patients taking nearly 200 million steps, showing effectiveness in mobility improvement.

Negative

• None.

First FDA Cleared Exoskeleton for Rehabilitation Use in Patients with Multiple Sclerosis

RICHMOND, Calif., June 13, 2022 (GLOBE NEWSWIRE) -- 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.

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. Ekso Bionics 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.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding the potential benefits of EksoNR for MS patients, maximizing patient access to Company technology and the assumptions underlying or relating to the foregoing. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the significant length of time and resources associated with the development of the Company's products, the Company's failure to achieve broad market acceptance of the Company's products, the failure of the Company’s sales and marketing efforts or of partners to market the Company’s products effectively, adverse results in future clinical studies of the Company's medical device products, the failure of the Company to obtain or maintain patent protection for the Company's technology, the failure of the Company to obtain or maintain regulatory approval to market the Company's medical devices, lack of product diversification, existing or increased competition, disruptions in the Company’s supply chain due to the ongoing COVID-19 pandemic, and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC. To learn more about Ekso Bionics please visit the Company’s website at www.eksobionics.com or refer to the Company’s Twitter page at @EksoBionics. The Company does not undertake to update these forward-looking statements.

Contact:
David Carey
212-867-1768
investors@eksobionics.com 

Media:
Erich Sandoval
917-497-2867
erich.sandoval@finnpartners.com 

FAQ

What FDA clearance did Ekso Bionics receive for the EksoNR exoskeleton?

Ekso Bionics received 510(k) clearance to market the EksoNR robotic exoskeleton for rehabilitation use in patients with Multiple Sclerosis.

How does the EksoNR exoskeleton benefit Multiple Sclerosis patients?

The EksoNR exoskeleton enhances mobility and rehabilitation outcomes for Multiple Sclerosis patients.

When was the EksoNR robotic exoskeleton cleared by the FDA?

The FDA clearance for the EksoNR robotic exoskeleton was announced on June 13, 2022.

How many rehabilitation centers use the EksoNR exoskeleton?

The EksoNR exoskeleton is used in more than 375 rehabilitation centers worldwide.

What is the significance of the EksoNR exoskeleton's FDA clearance?

The clearance significantly expands the device's market potential by allowing its use in the treatment of Multiple Sclerosis, alongside existing indications for stroke and spinal cord injuries.