The spine market in China is the 2nd-largest behind the U.S., the Vincennes, France-based company said, and is projected to be worth more than $1 billion by 2019.
“This regulatory clearance is the result of a diligent collaborative process with General Care International. It is a major milestone for SpineGuard and further validates the value of our DSG-based PediGuard device for making spine surgery safer,” CEO Pierre Jérôme said in a press release.
“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,” chief spinal surgeon Yong Qiu of the Nanjing University Hospital said in a prepared statement.
In September 2013, SpineGuard won Japanese Ninsho approval for its PediGuard device after going public on Europe’s Alternext exchange in April, drumming up $11.4 million.