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. (Original Source)
Shares of Ekso Bionics closed last Friday at $4.05, down $0.02 or -0.49%. EKSO has a 1-year high of $4.35 and a 1-year low of $3.85. The stock’s 50-day moving average is $5.49 and its 200-day moving average is $5.87.
On the ratings front, Rodman & Renshaw analyst Amit Dayal reiterated a Buy rating on EKSO, in a report issued on July 29. According to TipRanks.com, Dayal has a yearly average return of -19.1%, a 29% success rate, and is ranked #3934 out of 4122 analysts.
Ekso Bionics Holdings, Inc. designs, develops and sells wearable bionic human exoskeletons that have applications in healthcare, industrial, military, and consumer markets. The company operates through Engineering Services and Medical business segments. The Engineering services segment engages in research and development service arrangements, technology license agreements, and government grants. The Medical service segment designs, engineers, and manufactures exoskeletons for applications in the medical and military markets.