REEV Launches Pivotal Clinical Study of DREEVEN for Post-Stroke Mobility
Encompass Health, Whittier Rehabilitation Hospital in Bradford, MA, and Boston University join as clinical study
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REEV announced today that it has initiated a pivotal clinical study of DREEVEN, the company’s intelligent robotic knee-ankle-foot orthosis designed to restore mobility and independence for stroke survivors with chronic gait impairment. Stroke is among the leading causes of long-term disability in the United States. According to the American Stroke Association, more than 80% of stroke survivors experience gait impairment. Most experience some gait improvement during the first two months of recovery, but community ambulation remains compromised. Gait ability is an essential predictor of functional independence, quality of life, and long-term survival after stroke.
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The first smart, patient-centric, motorized orthosis for everyday life after stroke.
The study will evaluate how DREEVEN supports patient mobility and performance during functional activities, including walking on both flat and uneven surfaces, navigating stairs, and completing sit-to-stand transfers. In addition to in-clinic sessions, the study incorporates home monitoring, enabling evaluation of DREEVEN’s performance and safety during real-world daily activities. Data will be collected as participants move through their lives, not just in the clinic.
Lou Awad, PT, DPT, PhD, director of Boston University’s Neuromotor Recovery Laboratory, is the study’s Principal Investigator. Encompass Health of Braintree, MA, and Whittier Rehabilitation Hospital of Bradford, MA, are participating as clinical sites. These partners bring deep expertise in stroke rehabilitation and a shared understanding of meaningful recovery. This study marks a critical milestone in REEV’s journey toward FDA clearance and commercial launch.
“The clinicians in these facilities work with stroke survivors every day – they understand the gap between what patients can do today and what they need to do to live independently,” said Amaury Ciurana, CEO of REEV. “These partners are helping us generate clinical evidence while also building the pathway to real-world patient access once DREEVEN receives FDA clearance.”
Dr. Brigid Dwyer, MD notes, “One of the most valuable aspects of this study is its incorporation of home monitoring alongside in-clinic sessions. Evaluating device performance in real-world settings gives us a more complete picture of how DREEVEN may support patients in their daily lives.”
This study builds on REEV’s established clinical foundation. SENSE, the company’s FDA-registered, HIPAA-compliant gait analysis system, is already in use at rehabilitation centers across the country. It gives clinicians objective, real-time insight into each patient’s unique gait pattern. SENSE data is designed to customize DREEVEN’s motor control – calibrating the precise level of assistance each patient needs during their daily activities.
REEV is expanding access to effective mobility solutions for stroke survivors living with chronic gait impairments through this pivotal study and the Neuro-Integration Program. This clinical collaboration with leading stroke centers ensures that when DREEVEN is cleared, the infrastructure to support patients will already be in place.
Rehabilitation centers interested in learning about DREEVEN’s pivotal study or REEV’s Neuro-Integration Program are encouraged to contact megan.hoogmoed@reev.care.
DREEVEN is an investigational device that has not been cleared for commercial sale in the United States.
About REEV
REEV is a medical technology company with offices in Toulouse, France, and Boston, Massachusetts. Its mission is to reinvent mobility care for millions of people facing physical limitations due to neurological conditions, aging, or orthopedic disorders through intelligent, lightweight wearable robotics. REEV’s technology portfolio includes REEV SENSE, a precise gait analysis system, and DREEVEN, a prescription-based, intelligent robotic knee-ankle-foot orthosis, currently in clinical trials. Connect with REEV on LinkedIn.
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