TrainHealth Announces FDA Clearance of TrainFES Advanced, Improving Results in Neurological Rehabilitation
PALO ALTO, Calif., March 18, 2025 (GLOBE NEWSWIRE) -- TrainHealth (www.trainhealth.ai), a commercial-stage neurological rehabilitation company, seeks to disrupt the neurological rehabilitation market with its new "TrainFES Advanced" device, which today they announced has been cleared by the U.S. Food and Drug Administration (FDA). They aim to impact the more than 8 million people with sequelae of stroke and spinal cord injury in the United States.
TrainHealth’s new medical device addresses a critical need in neurological clinics and hospitals and allows them to optimize 3 to 5 times the cost-efficiency of their therapies through its use. As part of the wider TrainHealth platform, the device uses smart electrical stimulation that moves the paralyzed limbs of patients, thus enabling daily training that is both effective and entertaining, increasing both adherence and functional results. TrainHealth is currently in the process of commercial expansion and has advanced in studies with important universities globally and in the United States.
“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,” explains TrainHealth's CEO, Matias Hosiasson, who has led agreements with top tier universities and hospitals from his offices located in Palo Alto. The company has been accelerated by prestigious accelerator programs such as Stanford’s StartX, MassChallenge and UCSF Innovator’s.
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 over $140,000 dollars per patient.
About TrainHealth
TrainHealth’s rehabilitation method includes the technology and allows significant improvements in the outcomes of patients with 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 6 weeks with an 84% adherence and improvements of up to 40% in motivation, acceptance and usability of the system.
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,” explains TrainHealth’s Clinical Director Felipe Covarrubias, PhD(c), who has implemented the technology and clinical protocols for rehabilitation in several clinics worldwide.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/25c98b88-faab-4b4a-b9f2-87253996a2ad
CONTACT: Matias Hosiasson matt@trainhealth.ai
