Wandercraft, a company in healthcare exoskeletons, announced today that the US Food and Drug Administration (FDA) cleared the gait-training exoskeleton, Atalante, for stroke rehabilitation. Since 2020, the French company has already deployed 22 copies of its Atalante exoskeleton in clinical settings, and five in other research settings. The year 2022 has seen major growth for the deep tech, with more than 330 patients treated and 12 exoskeletons deployed, more deployments than in Wandercraft's entire history.
Every year, more than 795,000 people in the United States have a stroke, a leading cause of serious long-term disability.
"Strokes reduce mobility in more than half of stroke survivors aged 65 and older. With the input of many healthcare teams worldwide, Wandercraft has designed a next-generation, self-balancing, multi-directional gait exoskeleton to enable intensive, early, and specific gait training for neurorehabilitation therapy and improve recovery in stroke patients, especially for those with significant upper extremity involvement," said Matthieu Masselin, CEO, Wandercraft. "This clearance is a significant milestone for Wandercraft, but it's only the start, as we are working on more indications."
CE-marked since 2019, Atalante has been used to treat hundreds of patients with various medical conditions across multiple European rehabilitation hospitals. Its unique self-balancing feature enables patients to move in multiple directions hands-free, without an assistive device, and includes a dynamic balance mode unavailable elsewhere in the market.
"I am happy to hear the Wandercraft Atalante exoskeleton has been approved for use in the U.S. market. It will add an innovative treatment option for stroke patients, especially for those with significant upper extremity involvement needing gait rehabilitation,"explained Arun Jayaraman, PT, PhD, Executive Director ofTechnology & Innovation Hub at Shirley Ryan Ability Lab.
"Quadrant led Wandercraft's last funding round, in large part, to bring this breakthrough technology to the American market, which is by far the largest in the world," said Alan Quasha, Chairman and CEO, Quadrant Management. "Now with the FDA's 510(k) clearance, Wandercraft has the opportunity to significantly scale its business within the next 12-24 months."
"I'm thrilled to see that the Wandercraft Atalante exoskeleton is receiving FDA approval. This means that many patients with paralysis in the United States will be able to take advantage of this technology to help them recover. We're also excited to partner with Wandercraft's team to further explore this technology and to help as many people as we can,"commented Kenneth Ngo, MD, FAAPM&R, Medical Director, Brooks Rehabilitation Hospital.
Wandercraft is now launching its commercial operations in the U.S. with a corporate office in New York, led by Matthieu Masselin, and expects to deliver the first Atalante exoskeletons during the first quarter of 2023.