VIVATRONIX Tech Pvt. Ltd. and SpineX Inc. Celebrate Landmark CDSCO Approval of xStep for Noninvasive Spinal Neuromodulation Therapy in India
In a transformative milestone for neurorehabilitation and medical innovation in India, VIVATRONIX Tech Pvt. Ltd., based in Bangalore, and its U.S. partner SpineX Inc., headquartered in Fremont, California, have jointly announced that the Central Drugs Standard Control Organization (CDSCO)—India’s apex national regulatory authority for pharmaceuticals and medical devices—has granted approval for the xStep device for both clinical and home use across the country. This landmark regulatory clearance paves the way for individuals living with paralysis to access a groundbreaking, noninvasive therapy that promises to restore motor function, enhance mobility, and reclaim independence—without the need for surgery or implanted hardware.
The xStep device, powered by SpineX’s proprietary spinal neuromodulation platform, delivers precisely calibrated, painless electrical stimulation to the spinal cord through the skin. Unlike traditional neuromodulation approaches that require invasive surgical implantation of electrodes and pulse generators, xStep leverages advanced waveform engineering and targeted stimulation protocols to activate dormant neural circuits below the level of injury. This noninvasive methodology not only reduces patient risk and recovery time but also dramatically lowers the cost and complexity of treatment, making it accessible to a far broader population.
Originally developed under the names SCiP™ (Spinal Cord Interneuron Platform) and later SCONE™ (Spinal Cord Neuromodulation), the technology has undergone rigorous scientific validation and clinical scrutiny over the past decade. Its innovative approach has earned it the prestigious “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA) for two distinct neurological indications—a rare and significant recognition reserved for medical technologies that offer substantial improvements over existing alternatives for life-threatening or irreversibly debilitating conditions.
Multiple global clinical trials have demonstrated xStep’s remarkable potential. In studies conducted across the United States, Europe, and Asia, patients with chronic spinal cord injuries—including those with complete motor paralysis—have shown measurable improvements in voluntary movement, standing balance, and even assisted walking after undergoing xStep therapy. These outcomes, once considered medically improbable, are now being replicated consistently across diverse patient populations, underscoring the robustness and reproducibility of the underlying science.
Dr. Sachin Kandhari, MD, a nationally recognized Key Opinion Leader in neuromodulation and neurorehabilitation, hailed the CDSCO approval as a watershed moment for Indian healthcare. “xStep’s CDSCO approval represents a breakthrough for neurorehabilitation—bringing world-class, life-changing therapy within reach for patients in India and beyond,” he stated. “For decades, individuals with spinal cord injuries have faced a future defined by limited options and diminishing hope. With xStep, we are not just managing symptoms—we are actively re-engaging the nervous system to restore function. This is not incremental progress; it is a paradigm shift.”
Echoing this sentiment, Dr. Parag Gad, PhD, Founder and CEO of both SpineX Inc. and VIVATRONIX Tech Pvt. Ltd., emphasized the human impact behind the regulatory achievement. “This is a defining moment for us,” Dr. Gad said. “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.” As a biomedical engineer and entrepreneur deeply committed to democratizing advanced medical technologies, Dr. Gad has spearheaded the development and global commercialization strategy for xStep, ensuring that cutting-edge neuroscience translates into real-world patient benefit.
The significance of CDSCO approval extends beyond regulatory compliance. In India, where an estimated 25,000 new cases of spinal cord injury occur annually—and where access to advanced rehabilitation services remains uneven—xStep offers a scalable, cost-effective solution that can be deployed in urban hospitals, rural clinics, and even patients’ homes. The device’s user-friendly interface, combined with remote monitoring capabilities and clinician-guided protocols, enables personalized therapy without requiring patients to travel long distances or incur prohibitive expenses.
Moreover, the approval aligns with India’s broader vision of “Atmanirbhar Bharat” (Self-Reliant India) in healthcare innovation. VIVATRONIX Tech Pvt. Ltd., as the Indian arm of the partnership, will lead local manufacturing, distribution, training, and post-market surveillance, ensuring that the technology is not only available but also sustainable within the Indian healthcare ecosystem. This localized approach fosters job creation, builds indigenous technical expertise, and accelerates the adoption of next-generation medical devices across the subcontinent.
SpineX continues to invest heavily in clinical evidence generation. Beyond company-sponsored trials, the organization actively supports investigator-initiated studies at leading academic and rehabilitation centers worldwide. These independent studies are critical for validating the safety, efficacy, and long-term outcomes of noninvasive spinal neuromodulation across varied etiologies—including traumatic spinal cord injury, stroke-related motor deficits, and neurodegenerative conditions such as multiple sclerosis. Early data suggest that xStep may also improve bladder control, reduce neuropathic pain, and enhance overall quality of life—benefits that extend well beyond mobility.
The therapeutic mechanism of xStep hinges on the concept of “neuromodulation-enabled neuroplasticity.” By delivering precisely timed electrical pulses to specific regions of the lumbar and thoracic spinal cord, the device primes neural networks to respond more effectively to residual signals from the brain or to external cues such as physical therapy. Over time, repeated stimulation sessions appear to strengthen synaptic connections and reawaken dormant pathways, enabling patients to regain voluntary control over muscles previously deemed nonfunctional. This process is synergistic with rehabilitation: xStep doesn’t replace physiotherapy—it amplifies its effects.
Looking ahead, VIVATRONIX and SpineX plan to launch a nationwide rollout of xStep in India, beginning with specialized neurorehabilitation centers in major metropolitan areas before expanding to tier-2 and tier-3 cities. Comprehensive training programs for physicians, physiotherapists, and biomedical engineers are already underway, ensuring that healthcare providers are equipped to deliver optimal care. Additionally, the companies are engaging with India’s public health infrastructure and insurance providers to explore coverage pathways that will maximize patient access.
Globally, the CDSCO approval serves as a catalyst for regulatory submissions in other emerging markets, where similar unmet needs exist. SpineX is concurrently pursuing CE Mark certification in Europe and additional FDA clearances in the United States, with the ultimate goal of establishing xStep as the global standard of care for noninvasive spinal neuromodulation.
