TrainHealth, a commercial-stage neurological rehabilitation company based in Palo Alto, California, has received U.S. Food and Drug Administration (FDA) clearance for its innovative "TrainFES Advanced" device, designed to transform rehabilitation for patients with neurological conditions.
The newly cleared device employs smart electrical stimulation technology to move paralyzed limbs, enabling effective daily training that the company describes as both functional and engaging. This approach aims to address the rehabilitation needs of more than 8 million Americans living with sequelae of stroke and spinal cord injury.
Addressing Critical Gaps in Neurological Rehabilitation
According to TrainHealth, their technology addresses a significant unmet need in post-discharge care. While approximately 795,000 people are admitted to hospitals annually for neurological conditions such as stroke, less than 10% receive rehabilitation services after discharge. This gap in care contributes to the staggering $103.5 billion annual expenditure on stroke care in the United States, with per-patient costs exceeding $140,000.
"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," said Matias Hosiasson, CEO of TrainHealth.
The company claims their device can optimize therapy cost-efficiency by 3 to 5 times while improving patient outcomes through increased adherence and functional results.
Clinical Evidence Supporting Efficacy
TrainHealth's rehabilitation approach has demonstrated promising results in clinical studies. Research conducted by the University of Illinois Chicago showed significant improvements in gait and balance among patients using the device for home rehabilitation over a 6-week period. The study reported 84% adherence rates and improvements of up to 40% in motivation, acceptance, and usability of the system.
These findings suggest the technology may help overcome common challenges in rehabilitation, including patient engagement and consistency in therapy.
Commercial Expansion and Implementation
Following FDA clearance, TrainHealth is pursuing commercial expansion and implementation in clinical settings. The company has established collaborations with universities and hospitals both in the United States and internationally.
Felipe Covarrubias, PhD(c), Clinical Director at TrainHealth, emphasized the significance of this regulatory milestone: "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."
The company has received support from prestigious accelerator programs, including Stanford's StartX, MassChallenge, and UCSF Innovator's, positioning it to potentially disrupt the neurological rehabilitation market.
Technology Platform and Patient Experience
The TrainFES Advanced device is part of a broader TrainHealth platform designed to make rehabilitation more accessible and effective. By enabling paralyzed limb movement through electrical stimulation, the technology allows patients to engage in daily training exercises that may otherwise be impossible.
The system's design focuses on making rehabilitation not only effective but also engaging, which the company believes contributes to higher adherence rates and better functional outcomes. For post-stroke patients with paralyzed limbs, the device provides a means to participate in consistent, daily training—a crucial factor in neurological recovery.
As TrainHealth moves forward with implementing its technology in larger clinics and rehabilitation centers, the company aims to address the significant gap between the need for neurological rehabilitation services and their current availability, potentially improving outcomes for millions of patients with limited access to traditional rehabilitation options.
