Wandercraft SAS

Kevin Piette, 35, has been paraplegic since a motorcycle accident 11 years ago, according to Le Parisien. He works for Wandercraft, the company that built what it calls a Personal Exoskeleton that could help disabled people walk. Wandercraft already offers the FDA-cleared Atalante X exoskeleton for individuals with spinal cord injuries (SCIs). Atalante X, a self-balancing robotic exoskeleton, enables those with limited mobility to stand up and walk again. The Personal Exoskeleton device used by Piette is a prototype in the final stages of R&D. According to a spokesperson, the company plans to enter into usability and clinical trials soon.

The expanded FDA approval enables the use of Atalante X self-balancing robotic exoskeleton beyond stroke rehabilitation for the rehabilitation of individuals with spinal cord injuries (SCI) at levels T5 to L5 Atalante X is the world's first self-balancing exoskeleton. (Credit: Wandercraft) France-based medical robotic solutions provider Wandercraft has received expanded US Food and Drug Administration (FDA) approval for Atalante X, its self-balancing robotic exoskeleton. Atalante X is the world’s first self-balancing, hands-free, multi-directional gait and balance exoskeleton that enables people with limited mobility to stand up and walk again. The device leverages advanced self-stabilising technology to enable hands-free walking in patients with severe mobility impairments. It is currently used in rehabilitation institutions and clinical research centres across the US, Europe, and Brazil. In December 2022, Atalante X received FDA approval to treat cerebrovascular accident (CVA). The current approval expands its previous indication to include rehabilitation in individuals with spinal cord injuries (SCI) at levels T5 to L5. Wandercraft CEO Matthieu Masselin said: “Today’s FDA clearance for individuals with spinal cord injuries speaks volumes about the amazing possibilities for Atalante X. “In addition to the successful unveiling of our Personal Exoskeleton in December, Wandercraft has achieved several key milestones over the last year, and we have no plans of slowing down. “Today represents a decade of hard work and I am so proud of the entire Wandercraft team. “What was once a dream of helping people walk again is becoming a reality as we relentlessly pursue our mission of supporting people with walking impairments through every step of their mobility journey.” The expanded FDA approval is supported by safety and effectiveness data of Atalante X in patients with SCI at levels T5-L5, evaluated in more than 500 patients. Atalante X is the only FDA-approved exoskeleton with a powered ankle mechanism that can perform complex ankle movements that mimic a natural human gait. Its unique ankle motion, together with intelligent self-balancing technology, enables patients to experience the benefits of walking once-again in a rehabilitation setting. Kessler Foundation Centre for Mobility and Rehabilitation Engineering Research associate director and Tim and Caroline Reynolds Centre for Spinal Stimulation director Gail Forrest said: “The FDA clearance of Atalante X for spinal cord injury is welcome news for the future of robotics in rehabilitation research. “At Kessler, we are committed to researching promising advances in robotics technology that offer innovative approaches to improving functional recovery. “This new indication greatly expands our opportunities to study the optimal use of this innovative exoskeleton in this population with challenging mobility deficits. “The insights we are gaining from our investigation of Atalante X are not only advancing our research in spinal cord injury but also enriching our understanding of neuro/functional recovery across other populations as well.”

The Atalante X robotic exoskeleton is designed to mimic a natural human gait, thanks to its built-in self-balancing technology and powered ankle mechanism. Only about a year after earning its first FDA nod, Wandercraft’s Atalante X robotic exoskeleton has broadened that clearance. The initial clearance came at the end of 2022 and made the Atalante X suit available in the U.S. to help restore mobility in people who’d experienced a stroke. The latest FDA OK, which Wandercraft announced Tuesday, expands its use to those with spinal cord injuries between the T5 and L5 vertebrae. The Atalante X device is currently confined to use within rehabilitation institutions and clinical research centers, though Wandercraft recently debuted another version of its self-balancing robotic exoskeleton technology that’s designed for everyday, at-home use, as an alternative to a wheelchair. “In addition to the successful unveiling of our Personal Exoskeleton in December, Wandercraft has achieved several key milestones over the last year, and we have no plans of slowing down,” CEO Matthieu Masselin said in the FDA clearance announcement this week. “What was once a dream of helping people walk again is becoming a reality as we relentlessly pursue our mission of supporting people with walking impairments through every step of their mobility journey.” The Atalante X is designed to mimic a natural human gait, thanks to its built-in self-balancing technology and powered ankle mechanism. According to Wandercraft, those features may enable patients who have been left with limited mobility after a stroke or spinal cord injury to resume hands-free walking. Many are able to stand up and begin walking in the exoskeleton during their first session with the device, per the company, and it also allows them to take steps in multiple directions and stay standing in upright, weight-bearing positions. The FDA clearance came after Wandercraft submitted a combination of real-world and clinical trial data demonstrating the Atalante X suit’s performance in more than 500 patients with T5-L5 spinal cord injuries. In one such study—the results of which were published in August 2021—a total of 11 patients with T5-T12 spinal cord injuries underwent 12 one-hour training sessions with the suit over the course of three weeks. By the last session, seven of the participants were able to successfully complete a 10-meter walk test without human assistance, while the other four still required some human help. In addition, all of the participants were able to stand up, sit down, balance and turn with the exoskeleton’s help, and five of them reported subjective improvements in their bowel function. Wandercraft’s technology isn’t the only exoskeleton suit to catch the FDA’s eye. Just last year, for example, ReWalk Robotics scored its own expanded clearance from the agency. According to the company, that new nod made its eponymous exoskeletons the first authorized for use in surmounting stairs and curbs, compared to other suits that can only be used on flat ground.