Ekso Bionics® Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Acquired Brain Injury Patients

Rhea-AI Summary

Ekso Bionics (Nasdaq: EKSO) announced FDA 501(k) clearance for its EksoNR robotic exoskeleton for rehabilitation in patients with acquired brain injury (ABI). This marks the first exoskeleton approved for ABI rehabilitation, expanding its applications beyond stroke and spinal cord injury. The company highlights the estimated 3.7 million annual incidences of TBI and stroke in the U.S., potentially increasing patient accessibility to the technology. The EksoNR is already in use at over 270 rehabilitation centers globally, aiming to enhance recovery outcomes.

Positive

• FDA clearance for EksoNR allows for expanded use in ABI rehabilitation.
• Access to a potential patient population of 3.7 million annually in the U.S. alone.
• Existing use in over 270 rehabilitation centers indicates strong market presence.

Negative

• None.

RICHMOND, Calif., June 25, 2020 (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 501(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EksoNR^TM 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. ™

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 he potential benefits, performance and effectiveness of the Company’s products and systems, including the EksoNR. 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 Company’s inability to obtain adequate financing or maintain operating revenues (including as a result of the COVID-19 pandemic) to fund the Company’s operations and necessary to develop or enhance the Company’s technology, 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 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, disruptions in the Company’s supply chain due to the outbreak of the COVID-19 virus and other delays that may result from the COVID-19 pandemic, the Company’s lack of product diversification, existing or increased competition, 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 U.S. Securities and Exchange Commission. To learn more about Ekso Bionics please visit the Company’s website at www.eksobionics.com or follow @EksoBionics on Twitter. The Company does not undertake to update these forward-looking statements.

Media Contact:
Carrie Yamond Mas
917-371-2320
cmas@eksobionics.com

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

 

FAQ

What is the significance of Ekso Bionics' FDA clearance for EKSO stock?

The FDA clearance for the EksoNR exoskeleton expands its market potential, which may positively impact EKSO stock by increasing revenue potential.

How many patients can benefit from the EksoNR robotic exoskeleton?

The EksoNR targets an estimated 3.7 million patients in the U.S. suffering from TBI and stroke.

When was the EksoNR first cleared by the FDA?

The EksoNR was first cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016.

What is the current application of the EksoNR exoskeleton?

The EksoNR is now cleared for rehabilitation use in patients with acquired brain injuries, including both traumatic and non-traumatic causes.

How many rehabilitation centers are using Ekso Bionics technology?

The EksoNR is utilized in over 270 rehabilitation centers worldwide.