Ekso Bionics® to Expand Clinical Trial Sites for Comparative Multicenter WISE Study
RICHMOND, Calif., Feb. 12, 2018 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (NASDAQ:EKSO), an industry leader in exoskeleton technology for medical and industrial use, today announced that it will be expanding the first company-sponsored randomized, controlled clinical trial, the WISE (Walking Improvement for SCI with Exoskeletons) study, to TIRR Memorial Hermann and Barrow Neurological Institute. Led by Dylan Edwards, Ph.D., P.T., of the Burke Medical Research Institute, the U.S. based-study, which will now be conducted at ten centers, will evaluate improvement in independent gait speeds of patients with spinal cord injuries (SCI) who are receiving rehabilitation with the EksoGT™, the Company’s wearable exoskeleton, compared to standard of care.
In addition to the two new participating WISE study sites, the following centers have been initiated:
- Burke Medical Research Institute
- Courage Kenny Rehabilitation Institute
- DMC Rehabilitation Institute of Michigan
- Gaylord Hospital
- Kennedy Krieger Institute
- Kessler Foundation
- Marianjoy Rehabilitation Hospital, part of Northwestern Medicine
- Shirley Ryan AbilityLab
“We have witnessed a significant level of interest in this trial evaluating the EksoGT™, which enables individuals with stroke or spinal cord injuries to stand up and walk with a full weight bearing, reciprocal gait,” remarked Dr. Edwards. “We look forward to reporting data from this trial in Q2 2019.”
The multicenter WISE study incorporates three randomized clinical arms. Participants in Group 1 will undergo rehabilitation with a combination of the EksoGT™ and overground walking three times a week for 12 weeks. Group 2 will undergo rehabilitation consisting of standard gait training three times a week utilizing a combination of body-weight supported treadmill training and overground training for 12 weeks. Group 3 will be a passive control group; participants will continue with normal daily activities for 12 weeks with no therapy.
Separately, a “run in” group of up to 40 participants will help with protocol refinement. Participants in the “run in” group will receive the EksoGT™ for rehabilitation and will be tracked 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 and staff required during training, the physical burden on physical therapists assisting and supervising during training, and the influence of factors that may modify the gait recovery.
“We are pleased to extend our research into the role of exoskeleton-assisted walking in the rehabilitation of individuals with spinal cord injury,” said Gail Forrest, PT, Ph.D., associate director of Human Performance & Engineering Research at Kessler Foundation. “The multi-center WISE study is an important step toward determining the impact of the EksoGT™ on recovery of mobility,” Dr. Forrest noted. “Since our initial partnership with Ekso Bionics in 2011, our capabilities for conducting mobility research have grown exponentially. Combined with our expertise in spinal cord injury, gait analysis, locomotor training, robotic technology, and therapy training requirements, we are well positioned to contribute to outcomes of the WISE study.”
Building upon the success of the WISE study and the EksoGT™, Ekso Bionics will be showcasing the EksoGT™ at the following conferences:
- Association of Academic Physiatrists (AAP) 2018 Meeting
February 13-17, 2018 in Atlanta, GA
- American Physical Therapy Association Combined Sections Meeting (CSM) 2018
February 21-24, 2018 in New Orleans, LA
For more information about Ekso Bionics or the EksoGT™, visit: www.eksobionics.com.
EksoGT™ is the first exoskeleton cleared by the FDA for use with stroke and spinal cord injuries from L5 to C7. The EksoGT with SmartAssist™ software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of a 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 80 million steps in over 185 rehabilitation institutions around the world.
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 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. 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.
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) estimates or 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, changes resulting from the Company’s finalization of its financial statements for and as of the period and year ended December 31, 2017, information or new changes in facts or circumstances that may occur prior to the filing of the Company’s Annual Report on Form 10-K that are required to be included therein, 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.
Released February 12, 2018