FDA Clears Atalante Hands-Free Self-Balancing Device

Wandercraft has received U.S. Food and Drug Administration (FDA) clearance for its gait-training exoskeleton, Atalante, for stroke rehabilitation. The French company has deployed 22 copies of its Atalante exoskeleton in clinical settings and five in other research settings since 2020. More than 330 patients were treated and 12 exoskeletons deployed last year, the largest number of deployments than in Wandercraft’s history.
 
Every year, more than 795,000 people in the United States have a stroke, a leading cause of serious long-term disability.¹
 
“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,” Wandercraft CEO Matthieu Masselin said. “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 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,” stated Arun Jayaraman, PT, Ph.D., executive director of Technology & 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,” Quadrant Management Chairman/CEO Alan Quasha said. “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 Atlante 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, M.D., FAAPM&R, medical director, Brooks Rehabilitation Hospital.
 
Wandercraft is now launching its commercial operations in the United States with a corporate office in New York, led by Masselin. 
 
Founded in 2012, Wandercraft is a patient-focused company with the goal of providing better access to mobility and autonomy for patients with gait disorders. Wandercraft builds autonomous walking exoskeletons. Its first version, Atalante, was commercialized in 2019 and is used by rehabilitation and neurological hospitals in Europe and U.S. clinical research institutes. Atalante provides care for many patients based on realistic, hands-free, multi-direction locomotion.
 
For more than 40 years, Quadrant has invested in companies worldwide with an opportunistic investment philosophy, investing primarily in control positions of private companies. Quadrant’s portfolio includes investments in manufacturing, healthcare, logistics and infrastructure, education, insurance, financial services, neurotechnology, telecommunications, business services, and alternative energy. Quadrant has a global portfolio, with active investments in the United States, South America, East, and Southeast Asia, and Europe.

Reference
¹ Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, et al. Heart Disease and Stroke Statistics—2022 Update: A Report From the American Heart Association. Circulation. 2022;145(8):e153–e639.