Ekso Bionics Announces First Patient Enrolled in Important Multi-Center WISE Trial
Ekso Bionics Sponsors U.S.-based study of patients with chronic incomplete Spinal Cord Injury
RICHMOND, Calif., Aug. 22, 2016 (GLOBE NEWSWIRE) -- 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
Released August 22, 2016