Ekso Bionics® Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Acquired Brain Injury Patients...
June 25 2020 - 8:30AM
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 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. ™
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
917-371-2320cmas@eksobionics.com
Investor Contact: David Carey 212-867-1768
investors@eksobionics.com
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