SpineX Inc. and VIVATRONIX Tech Pvt. Ltd. Announce CDSCO Approval of xStep Device for the Treatment of Paralysis in India

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FREMONT, Calif. & BANGALORE, India--(BUSINESS WIRE)--Oct 9, 2025--

VIVATRONIX Tech Pvt. Ltd. (Bangalore, India) and SpineX Inc. (Fremont, CA, USA) proudly announce that the Central Drugs Standard Control Organization (CDSCO), India’s national regulatory authority, has approved xStep (powered by SpineX) for clinical and home use in India.

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The xStep device delivers painless, noninvasive electrical stimulation to the spinal cord—without the need for surgery— to help restore motor function, mobility, and independence in individuals living with paralysis.

Formerly known as SCiP™ or SCONE™, the xStep technology has been recognized by the U.S. Food and Drug Administration (FDA) as a Breakthrough Device for two distinct indications. It has demonstrated promising results in multiple global clinical trials, and SpineX continues to collaborate on investigator-initiated studies validating the safety, efficacy, and transformative potential of noninvasive spinal neuromodulation therapy.

“xStep’s CDSCO approval represents a breakthrough for neurorehabilitation—bringing world-class, life-changing therapy within reach for patients in India and beyond,” said Dr. Sachin Kandhari, MD, a leading Key Opinion Leader in neuromodulation and neurorehabilitation.

“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, noninvasive therapy. It’s no longer a question of if —it’s about making it happen now,” said Dr. Parag Gad, PhD, CEO of SpineX Inc. and VIVATRONIX Tech Pvt. Ltd.

With CDSCO approval, SpineX Inc. and VIVATRONIX Tech Pvt. Ltd. are poised to expand access to advanced neurorehabilitation technology in India and worldwide—marking a major step toward transforming the standard of care for individuals living with paralysis.

About SpineX Inc.

SpineX Inc., headquartered in Fremont, California, is a clinical-stage neuromodulation company developing noninvasive spinal cord stimulation technologies aimed at restoring mobility and function for individuals living with neurological disorders such as paralysis and cerebral palsy.

About VIVATRONIX Tech Pvt. Ltd.

VIVATRONIX Tech Pvt. Ltd., based in Bangalore, India, is dedicated to bringing cutting-edge neurotechnology and rehabilitation solutions to patients across India and emerging markets through collaboration, innovation, and patient-centered care.

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CONTACT: Website:www.spinex.co

Email:[email protected]:www.vivatronix.com

Email:[email protected]

KEYWORD: UNITED STATES INDIA NORTH AMERICA ASIA PACIFIC CALIFORNIA

INDUSTRY KEYWORD: NEUROLOGY MEDICAL DEVICES HEALTH PHYSICAL THERAPY HEALTH TECHNOLOGY

SOURCE: SpineX Inc.

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PUB: 10/09/2025 09:00 AM/DISC: 10/09/2025 09:02 AM

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