SpineGuard Obtains Regulatory Clearance to Sell PediGuard® in the World’s Second-Largest Spine Market: China

Regulatory News:

Spineguard (Paris:ALSGD) (FR0011464452 – ALSGD) announced today that it has received regulatory clearance to market its Classic PediGuard® products in China.

"This regulatory clearance is the result of a diligent collaborative process with General Care International (GCI),” said Pierre Jérôme, Co-founder and Chief Executive Officer of SpineGuard. "It is a major milestone for SpineGuard and further validates the value of our DSG™ (Dynamic Surgical Guidance)-based PediGuard device for making spine surgery safer.”

The China spine market has become the second-largest market in spine after the USA and is projected to be worth over $1 billion by 2019 according to IData Research, driven by an ageing population, increasing disease, improving treatment rate and growing affordability. "The number of spine fusions is growing rapidly across China, and I believe there is a strong need for a simple smart device like PediGuard consistently ensuring safe and accurate placement of pedicle screws,” added Professor Yong Qiu, Chief Spinal Surgeon at the Nanjing University Hospital.

About SpineGuard®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer. Its primary objective is to establish its proprietary Dynamic Surgical Guidance (DSG™) technology as the global standard of surgical care, initially for safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Close to 40,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015 SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

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