SpineGuard receives Regulatory Ninsho Approval to sell its PediGuard® platform in Japan
SpineGuard has announced that it has received product certification ("Ninsho") to market its Classic and Curved PediGuard® products in Japan.
“This regulatory clearance is the result of a diligent collaborative process with our Japanese partners, notably Surgical Spine Inc. (S2I), who played an instrumental role in this achievement and will be launching PediGuard at the Nagoya Spine Meeting later this week 1,” said Pierre Jérôme, Co-founder and Chief Executive Officer of SpineGuard. “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.” Japan is the second-largest market in spine after the USA and as indicated in an article by David Cassak in the July/August 2013 issue of magazine entitled “Taming of the Screw”, “Japan is a particularly promising market [for PediGuard] because surgeons there implant a lot of pedicle screws in the upper part of the spinal column as a result of specific problems that affect Asian patients.” About SpineGuard® Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its FDA-cleared and CE-marked PediGuard® device as the global standard of care for safer screw placement in spine surgery. SpineGuard’s mission is to make spine surgery safer. The company has offices in San Francisco and Paris. For further information, visit www.spineguard.com.