VIVATRONIX Tech and SpineX have announced approval from India’s Central Drugs Standard Control Organisation (CDSCO) for the xStep device to treat individuals with paralysis.
The xStep device, which offers painless, non-invasive electrical stimulation to the spinal cord, is approved for both clinical and home use in the country.
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It provides an alternative to surgical interventions to restore motor function and mobility.
Previously known as SciP or SCONE, the technology has achieved the US Food and Drug Administration’s breakthrough device designation for two indications.
SpineX and VIVATRONIX Tech CEO Parag Gad said: “This is a defining moment for us. With CDSCO approval, patients who have long been waiting for hope and recovery now have access to proven, non-invasive therapy.”
Multiple global clinical trials have shown promising outcomes for the device.
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By GlobalDataSpineX is actively involved in ongoing studies to further assess the efficacy and safety of non-invasive spinal neuromodulation therapy.
Located in the US, the company focuses on creating non-invasive spinal cord stimulation technologies for neurological disorders including paralysis and cerebral palsy.
VIVATRONIX Tech, based in India, aims to deliver advanced neurotechnology and rehabilitation solutions to patients in the country and other markets.
With the CDSCO approval, both companies plan to enhance access to neurorehabilitation technology in India and beyond.
Last year, SpineX announced positive results from a first-in-human study evaluating the use of its electrical neuromodulation device in a patient with cerebral palsy.
The data showed significant functional improvements in a 60-year-old woman with the neurodevelopmental disorder who did not adequately respond to previous treatments.
