FDA Clears TrainHealth’s Neurological Rehab Device

TrainHealth has won U.S. Food and Drug Administration clearance for its “TrainFES Advanced” device, which is designed to help the more than 8 million U.S. stroke and spinal cord injury victims regain movement in their paralyzed limbs.

TrainHealth claims its new medical device addresses a critical need in neurological clinics and hospitals and allows the institutions to optimize three to five times the cost efficiency of their therapies. As part of the wider TrainHealth platform, the device uses smart electrical stimulation that moves patients’ paralyzed limbs, thus enabling daily training that is both effective and entertaining, increasing both adherence and functional results. Palo Alto, Calif.-based TrainHealth is currently working to commercialize the product and has organized studies with domestic (U.S.) and overseas universities.

“TrainHealth is at the forefront of innovation, development and implementation of new technology, and the clearance of TrainFES Advanced is only a first step towards changing the paradigm of neurological rehabilitation,” explained TrainHealth CEO Matias Hosiasson, who has led agreements with top universities and hospitals. Accelerator programs such as Stanford’s StartX, MassChallenge and UCSF Innovator’s has helped the company grow.

Annually, 795,000 people are admitted to clinics and hospitals for neurological conditions such as stroke, but less than 10% of them have access to post-discharge rehabilitation. This insufficient coverage generates an annual expenditure of $103.5 billion dollars in the United States, with costs of more than $140,000 dollars per patient, according to TrainHealth.

TrainHealth’s rehabilitation method includes the technology and allows significant improvements in patients suffering from stroke and other neurological disorders. According to a study conducted by the University of Illinois Chicago, significant improvements in gait and balance were observed while using the device in the home rehabilitation of patients for six weeks with an 84% adherence and improvements of up to 40% in motivation, acceptance, and system usability.

TrainHealth’s technology and method will soon be implemented in large clinics and rehabilitation centers. “We have been collaborating with national and international clinics and hospitals for some time, and this milestone corroborates the quality of our technology and enables strategic partners to increase their efficiency in the neurological rehabilitation of their patients,” said TrainHealth Clinical Director Felipe Covarrubias, Ph.D., who has implemented the technology and clinical protocols for rehabilitation in several clinics worldwide.