REEV 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.
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 expertise in stroke rehabilitation and a shared understanding of meaningful recovery. This study marks a 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, in a statement. “These partners are helping us generate clinical evidence while also building the pathway to real-world patient access once DREEVEN receives FDA clearance."
"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," said Dr. Brigid Dwyer, MD, in a statement.
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.
DREEVEN is an investigational device that has not been cleared for commercial sale in the United States.
