International Journal Spinal Cord Publishes Multicenter Pan-Euro Study of EksoGT™
Data Showcases Potential Benefits in Gait Function and Balance in Broad Range of Severity and Level of Spinal Cord Injury, as well as Time since Injury
|
||||||||||
RICHMOND, Calif., Nov. 28, 2017 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (NASDAQ:EKSO), an industry leader in exoskeleton technology for medical and industrial use, today announced the publication of data from a multicenter Pan-Euro study that assessed the company’s wearable exoskeleton, EksoGT™, in a diverse and representative spinal cord injury (SCI) population. Published in the International Spinal Cord Society’s (ISCOS) peer-reviewed journal, Spinal Cord, the results showed that the EksoGT™ is safe and feasible for use, as well as improves training characteristics and changes in gait function for persons with SCI, including those with paraplegia and tetraplegia, recent and chronic injuries, as well as complete or incomplete SCI.
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/23687e16-d786-4ff6-9bbb-79da499ada87
https://www.globenewswire.com/NewsRoom/AttachmentNg/3ff474ba-70fe-4224-87ab-e7178fe07f75
“The Pan-Euro study is one of the first to evaluate wearable exoskeletons in a heterogeneous SCI population, providing additional insights across a wider range of patients. Previous exoskeleton studies focused on complete SCI,” commented Thomas Looby, president and chief executive officer of Ekso Bionics. “In combination with the 35 U.S. studies and 25 EMEA studies conducted with the EksoGT™, we are paving the way on quantifying the benefits of exoskeleton gait rehabilitation and ultimately redefining rehabilitation for a broader range of patients with SCI.”
There are now 13 publications with clinical evidence to support the use of EksoGT, for a total of 159 participants with various conditions including incomplete and complete SCI, and stroke, excluding case studies and reviews. There are 78 exoskeleton publications across the exoskeleton industry with a total of 765 participants.
Results demonstrated that all training characteristics increased significantly from baseline to the end of the training period (up time: F = 2.168, P < 0.001; walk time: F = 10.988, P < 0.001; steps: F = 15.556, P < 0.001) for all SCI subgroups: recently (<1 year) and chronically (>1 year) injured, paraplegia and tetraplegia, and incomplete and complete injury (P < 0.001). Participants with incomplete injuries had more steps per session than those with complete SCI, with a mean difference of 335 steps (95% CI 112-558, P = 0.004).
In the recently injured group, gait function increased from five participants (20%) at baseline to 14 participants (56%) by the end of the training period (test statistic = 7.11, P = 0.004). This group also showed significant improvement in the 10 Meter Walk Test (10MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS) and Lower Extremity Motor Score (LEMS) results (P < 0.05). Gait function for the chronic injury group increased from 11 participants (40%) to 12 participants (44%), including one participant with a 13 year-old T12 injury, AIS D, acquiring gait function by the end of the training period. The group observed improvements in TUG and BBS results (P < 0.05). Both groups retained improved gait function at follow-up. In addition, two participants with chronic, complete SCI reported improved sitting balance following training.
“The Pan-Euro study shows that the EksoGT™ is safe and feasible for persons with SCI with different levels and severity of injuries and that it may have potential benefits in those with incomplete SCI on gait and balance function,” commented Carsten Bach Baunsgaard, M.D., at the Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, and first author of the published paper. “Furthermore, the study also shows that it can be used by recently injured persons as well as those who have sustained their injuries several years ago. We look forward to bringing more of our patients onto their feet earlier.”
The open-label, prospective study with a pre- and post-design was conducted at nine European SCI rehabilitation centers. The multicenter study was designed to assess safety, feasibility, training characteristics and changes in gait function for SCI using the EksoGT™ exoskeleton. The study enrolled a total of 60 participants, 52 of whom completed at least 16 of the 24 exoskeleton gait training sessions that were conducted as an “add on” to their existing training three times per week over a total of eight weeks. The primary objective of the study was to assess safety and feasibility of exoskeleton training, while the secondary objective evaluated changes in gait function outside of the exoskeleton. Assessments were conducted at baseline, the twelfth training session, the final training session, and at a follow up session four weeks after the last training session.
The Spinal Cord publication, titled “Gait training after spinal cord injury: safety feasibility and gait function following 8 weeks of training with the exoskeletons from Ekso Bionics” is available online at the following link: https://www.nature.com/articles/s41393-017-0013-7.
For more information about Ekso Bionics or the EksoGT™, visit www.eksobionics.com.
About EksoGT™
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, 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.
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) 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, 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
917-371-2320
cyamond@lazarpartners.com
Investor Contact:
Matthew Ventimiglia
212-599-1265
investors@eksobionics.com
Released November 28, 2017