SpineGuard (EPA:ALSGD) said it landed Japanese Ninsho approval for its PediGuard, a handheld surgical product that helps guide proper spine screw placement.
Paris- and San Francisco-based SpineGuard is touting it as regulatory win in the world’s 2nd-largest spine market, after the U.S., according to a release.
Japanese regulators cleared both the classic and curved versions of PediGuard, which specifically guides pedicle screw placement. Because of a spine problem common among Asian patients, surgeons in Japan often perform these pedicle screw implants in the upper part of the spine, the release said.
"We are extremely pleased to now be able to offer Japanese spine surgeons and their patients the significant safety benefits that result from using PediGuard devices, whose value in boosting the accuracy of pedicle screw placement has been unequivocally validated in several peer-reviewed medical journals," said CEO Pierre Jérôme in prepared remarks.
In April, the Paris-based company went public on Europe’s Alternext exchange, drumming up $11.4 million based on its PediGuard device.