Ekso GT(TM) Robotic Exoskeleton Cleared by FDA for Use With Stroke and Spinal Cord Injury Patients
(Thomson Reuters ONE) -
First robotic exoskeleton cleared for use with stroke and spinal cord injury
levels to C7
RICHMOND, Calif., April 04, 2016 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc.
(OTCQB:EKSO), a robotic exoskeleton company, today announced that it has
received clearance from the U.S. Food and Drug Administration (FDA) to market
its Ekso GT robotic exoskeleton for use in the treatment of individuals with
hemiplegia due to stroke, individuals with spinal cord injuries at levels T4 to
L5, and individuals with spinal cord injuries at levels of T3 to C7 (ASIA D), in
accordance with device's labeling. The Ekso GT is the first exoskeleton cleared
by the FDA for use with stroke patients.
A video accompanying this release is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/ef10bbd6-741a-4386-ae1c-
46a9a7e542ba
Photos accompanying this release are available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/482c1e99-62ea-4dd6-887f-
bab8e17f3c71
http://www.globenewswire.com/NewsRoom/AttachmentNg/556d5d4a-fd02-
45ce-8316-1a8c53ddf890
http://www.globenewswire.com/NewsRoom/AttachmentNg/a5b9e110-8bb4-44dc-9ea7-
ba4ca3038d33
Ekso GT is a wearable robotic exoskeleton that enables individuals to stand up
and walk over ground with a full weight bearing, reciprocal gait in a clinical
setting. The Ekso GT with smart Variable Assist* software, which was designed
for rehabilitation institutions, provides adaptive amounts of power to either
side of the patient's body, engaging the patient throughout his or her continuum
of care. The technology provides the ability to mobilize patients early in their
recovery, frequently, with a significant number of high intensity steps. To
date, the Ekso has helped patients take more than 41 million steps in over 115
rehabilitation institutions around the world.
"This clearance marks a major milestone towards our goal of establishing
exoskeletons as standard of care in the rehabilitation clinic," commented Thomas
Looby, president and interim chief executive officer of Ekso Bionics. "Our
strategy has been to concentrate on the rehabilitation clinic, with a focus on
ease of use, rapid turn over between sessions, and efficacy for a range of
patients. Clinics using the Ekso GT are able to offer exoskeleton therapy to the
widest patient population among all exoskeletons on the market, which we believe
will translate into broader adoption of exoskeletons by hospitals and
rehabilitation clinics and better outcomes for patients."
Each year, an estimated 375,000 people suffer a spinal cord injury globally and
an estimated 17 million people suffer a stroke.(1) Over 60% of acute stroke
survivors are unable to walk or need intervention in walking. Impaired
ambulation is greatly associated with fall risks, dependency, limited
participation in social activities, and poor quality of life. As a consequence,
assisting with ambulation in the clinical environment may aid in the recovery of
ambulation that is one of the most desired goals for stroke survivors undergoing
rehabilitation.(2)
"We appreciate the collaboration with the leading rehabilitation institutions
who helped contribute to our submission," added Mr Looby.
"I congratulate Ekso Bionics for being the first exoskeleton to receive
clearance for stroke," said W. Zev Rymer, Director, Research Planning and
Sensory Motor Performance Program, Rehabilitation Institute of Chicago. "When we
partnered with Ekso at the beginning of 2012, they had the first exoskeleton
that was uniquely optimized for the rehabilitation clinic. We have seen the
clinical value of the technology, and Ekso Bionic's continued innovation now
brings us the ability to provide this advanced technology to a broader patient
population."
(1. )(Feigin VL et al. Lancet)
(2. )(Psychometric Comparisons of 3 Functional Ambulation Measures for Patients
With Stroke Jau-Hong Lin et al.)
* Marketed as SmartAssist outside of US
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, industrial and defense applications. Founded in 2005, the company
continues to build upon its unparalleled expertise to design some of the most
cutting-edge, innovative wearable robots available on the market. They are 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, to providing research for the advancement of R&D
projects intended to benefit U.S. defense capabilities.
The company is headquartered in the Bay Area and is listed on the OTCQB under
the symbol EKSO. For more information, visit: www.eksobionics.com.
About Ekso(TM) GT
Ekso(TM) GT is the first FDA cleared exoskeleton cleared for use with stroke,
and spinal cord injury levels to C7. The Ekso GT with smart Variable Assist(TM)
(marketed as SmartAssist outside the U.S.) software is the only exoskeleton
available for rehabilitation institutions that can provide adaptive amounts of
power to either side of the patient's body, challenging the patient as they
progress through their continuum of care. The suit's patented technology
provides the ability to mobilize patients earlier, more frequently and with a
greater number of high intensity steps. To date, this device has helped patients
take more than 41 million steps in over 115 rehabilitation institutions around
the world.
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 (i) the plans and objectives
of management for future operations, including plans or objectives relating to
the design, development and commercialization of human exoskeletons, (ii) a
projection of financial results, financial condition, capital expenditures,
capital structure or other financial items, (iii) the Company's future financial
performance and (iv) the assumptions underlying or relating to any statement
described in points (i), (ii) or (iii) above. 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 to fund the Company's operations and
necessary to develop or enhance our 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 our sales and marketing organization or partners to market our
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, failure to obtain or maintain
regulatory approval to market the Company's medical devices, 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
SEC. To learn more about Ekso Bionics please visit us at www.eksobionics.com.
The Company does not undertake to update these forward-looking statements.
The photos are also available at Newscom, www.newscom.com, and via AP
PhotoExpress.
CONTACT:
Media Contact:
Heidi Darling, Director of Marketing Communications
Phone: 510-984-1761 x317
hdarling(at)eksobionics.com
Investor Contact:
Debbie Kaster
415-706-5530
investors(at)eksobionics.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ekso Bionics via GlobeNewswire
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Unternehmensinformation / Kurzprofil:
Datum: 04.04.2016 - 13:00 Uhr
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News-ID 461630
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