Ekso Bionics Announces First Patient Enrolled in Important Multi-Center WISE Trial
August 22 2016 - 8:30AM
Ekso Bionics Holdings, Inc. (NASDAQ:EKSO), a robotic exoskeleton
company, today announced enrollment of the first patient in its
first company-sponsored clinical trial, which will be led by Dr.
Dylan Edwards, Ph.D., P.T., of The Burke Medical Research
Institute, a leading institution for neuro-rehabilitation.
The randomized, controlled study, entitled WISE (Walking
Improvement for SCI with Exoskeletons), will evaluate improvement
in independent gait speeds of spinal cord injury (SCI) patients
undergoing rehabilitation with the Ekso GT™, the company’s medical
robotic exoskeleton, and will be compared to both conventional
therapy and usual care control groups. The US-based study, which
will be conducted in up to 8 centers, seeks to enroll approximately
160 community dwelling people with chronic incomplete SCI.
“We are thrilled to partner with Ekso Bionics to further study
the Ekso GT, a cutting-edge technology that can offer life-changing
benefits to patients,” said Dr. Edwards. “We have observed physical
and psychosocial benefits of gait training with the Ekso
GT, and we are excited to expand upon our early findings and to
help support the pathway for exoskeletons as part of standard
care for these patients.”
The multicenter WISE study incorporates three randomized
clinical arms as follows:
- Participants randomized to Group 1 will receive the Ekso GT for
rehabilitation three times a week for 12 weeks;
- Participants randomized to Group 2 will receive standard gait
training for rehabilitation three times a week using a combination
of body-weight supported treadmill training and overground training
for 12 weeks;
- Participants randomized to Group 3 will be a passive control
group in which participants continue with daily activities as
normal over 12 weeks with no therapy.
In
addition there will be a “run in” group of up to 40 participants
who will serve to help with protocol refinement. Participants
in the “run in” group will receive the Ekso GT for rehabilitation
and will be followed for 12 weeks.
All groups will be evaluated at baseline, 6 weeks, and 12 weeks.
The primary endpoint of the WISE study seeks to demonstrate that a
12-week robotic gait training regimen can lead to a clinically
meaningful improvement in independent walking speed. Secondary
endpoints from the trial will examine economic factors such as
number of physical therapists (PTs) and staff required during
training, the physical burden on PTs assisting and supervising
during training and the influence of factors that may modify the
gait recovery.
“The initiation of the WISE study – our first ever
company-sponsored clinical trial - is an important and exciting
milestone for our company as we execute our strategy and
commercialize our products. We believe this study will
continue to demonstrate the clinical and economic benefits of our
medical robotic exoskeletons,” said Thomas Looby, CEO and President
of Ekso Bionics.
About Burke Rehabilitation Hospital and the Burke
Medical Research Institute Burke Rehabilitation Hospital
is a not-for-profit, acute rehabilitation hospital in White Plains,
NY. Founded in 1915 through an endowment from philanthropist John
Masterson Burke, it is the only hospital in Westchester County
dedicated solely to adult rehabilitation medicine. As of 2016, the
hospital is now a part of the Montefiore Health system, Inc. Burke
offers both inpatient and outpatient programs for those who have
experienced a disabling illness, traumatic injury or surgery. Burke
serves patients from around the metropolitan New York area and
throughout the world. The hospital’s renowned physicians, clinical
researchers and therapists provide state-of-the-art treatment and
all share the Burke mission to ensure that every patient makes the
fullest possible recovery from illness or injury.
Burke Medical Research Institute (BMRI) is a nonprofit leading
scientific research institute devoted to advancing the study of
neurological diseases and injuries, pioneering novel rehabilitation
therapies and developing innovative clinical programs and clinics.
Based at Burke Rehabilitation Hospital and working synergistically
with its academic affiliate Weill Cornell Medical College, BMRI is
comprised of several neurological disease, injury and functional
recovery focused research laboratories.
For additional information on Burke Rehabilitation Hospital,
please visit burke.org.
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. 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, 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 Nasdaq Capital Market under the symbol EKSO. For more
information, visit: www.eksobionics.com.
About Ekso™ GT
Ekso™ GT is the first
FDA cleared exoskeleton cleared for use with stroke
and spinal cord injuries from L5 to C7. The Ekso GT with
smart Variable Assist™ (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 55 million
steps in over 120 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.
Media Contact:
Carrie Yamond/Rajni Dhanjani
212-867-1788
cyamond@lazarpartners.com
Investor Contact:
Debbie Kaster
415-937-5403
investors@eksobionics.com
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