Boston — REEV has launched a pivotal clinical study of DREEVEN, an intelligent robotic knee-ankle-foot orthosis designed to improve mobility and independence for stroke survivors with chronic gait impairment.
Boston University, Encompass Health of Braintree and Whittier Rehabilitation Hospital in Bradford, Massachusetts, are participating in the study.
DREEVEN is a motorized orthosis designed for use during everyday activities following a stroke. The study will evaluate its ability to support patients while walking on flat and uneven surfaces, climbing stairs and completing sit-to-stand movements.
The research will include both in-clinic assessments and home monitoring, allowing investigators to evaluate the device’s performance and safety during real-world daily activities.
Lou Awad, PT, DPT, Ph.D., director of Boston University’s Neuromotor Recovery Laboratory, is serving as principal investigator.
The company said the study represents an important step toward seeking clearance from the U.S. Food and Drug Administration and preparing for a 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.”
Stroke is a leading cause of long-term disability in the United States, and more than 80% of stroke survivors experience some form of gait impairment, according to the American Stroke Association.
Dr. Brigid Dwyer, M.D., said the inclusion of home monitoring would help researchers better understand how the device may perform outside a controlled clinical environment.
“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,” Dwyer said.
The study builds on REEV’s SENSE gait analysis system, an FDA-registered and HIPAA-compliant platform already used at rehabilitation centers in the United States.
SENSE provides clinicians with real-time information about a patient’s gait pattern. The data is intended to help customize DREEVEN’s motor controls and determine the level of assistance needed during daily activities.
REEV said it is also developing a Neuro-Integration Program intended to expand access to mobility technologies for stroke survivors with chronic gait impairment.
