VIVATRONIX Tech Pvt. Ltd. and SpineX Inc. 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.

VIVATRONIX科技私人有限公司和SpineX公司自豪地宣布，印度国家监管机构——中央药品标准控制组织（CDSCO）已批准xStep（由SpineX提供技术支持）在印度用于临床和家庭使用。

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.

xStep设备无需手术即可向脊髓提供无痛、非侵入性的电刺激，帮助瘫痪患者恢复运动功能、行动能力和独立性。

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..

之前被称为SCiP™或SCONE™的xStep技术已被美国食品和药物管理局（FDA）认定为两项不同适应症的突破性设备。该技术在全球多项临床试验中展示了令人鼓舞的结果，SpineX继续与研究者发起的研究合作，验证非侵入性脊髓神经调节疗法的安全性、有效性和变革潜力。

“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.

“xStep获得CDSCO批准代表了神经康复领域的突破——为印度及全球患者带来了世界级的、改变生活的治疗，”神经调控和神经康复领域的权威意见领袖Sachin Kandhari博士表示。

“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..

“这是我们的一个决定性时刻。随着CDSCO的批准，那些长期等待希望和康复的患者现在可以使用经过验证的非侵入性疗法。这不再是一个‘是否可能’的问题，而是关于如何立即实现，”SpineX Inc.和VIVATRONIX Tech Pvt. Ltd.首席执行官Parag Gad博士表示。

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.

在获得CDSCO批准后，SpineX公司和VIVATRONIX科技私人有限公司准备在印度乃至全球扩大先进神经康复技术的使用范围——这标志着为瘫痪患者改变护理标准迈出了重要一步。

About SpineX Inc.

关于SpineX公司

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.

总部位于加利福尼亚州弗里蒙特的SpineX公司是一家临床阶段的神经调节公司，正在开发非侵入性脊髓刺激技术，旨在恢复患有瘫痪和脑瘫等神经系统疾病患者的行动能力和功能。

About VIVATRONIX Tech Pvt. Ltd.

关于VIVATRONIX科技私人有限公司

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.

总部位于印度班加罗尔的VIVATRONIX科技私人有限公司致力于通过合作、创新和以患者为中心的护理，为印度及新兴市场的患者带来尖端的神经技术和康复解决方案。

Contacts

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Website: www.spinex.co

网站：www.spinex.co

Email:

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[email protected]

[email protected]

Website: www.vivatronix.com

网站：www.vivatronix.com

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[email protected]

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Source: businesswire.com

来源：businesswire.com