SAN FRANCISCO and PARIS, July 6, 2010 – SpineGuard, a privately held company based in San Francisco and Paris, announced today that PediGuard units sold in the second quarter of 2010 increased by 125% compared to the same period in 2009.
The boost in sales was due primarily to the broad company focus and extensive market expansion of the CE-marked and FDA-cleared PediGuard device, which is designed for safer pedicle screw placement in spine surgery. Nearly one million1 spine procedures using pedicle screws were performed in 2009. According to published studies, pedicle screws show high rates of misplacements that can lead to a number of serious complications for patients, including paralysis.
“This strong growth confirms PediGuard’s tremendous potential and the clinical need for an efficient tool to secure pedicle screw placement, the number-one challenge in spine surgery,” said Pierre Jérôme, SpineGuard co-founder and CEO. “In the coming months, we will continue to strengthen our commercial presence in the United States and Europe, while expanding our geographic coverage in the rest of the world. In the current quarter, we will be launching our new PediGuard MIS kit and are expecting additional clinical data comparing PediGuard to other pedicle screw placement modalities.”
Co-founded by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s mission is to make spine surgery safer and its primary objective to establish its FDA-cleared and CE Marked PediGuard® device as the global standard of care for safer pedicle screw placement in spine surgery.
Co-invented by Maurice Bourlion, Ph.D., and Ciaran Bolger, M.D., Ph.D., PediGuard is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. Nearly 12,000 procedures have been performed with PediGuard on all continents. Two multi-center clinical studies about PediGuard have been published: one by Ciaran Bolger, M.D., Ph.D. et al., in the European Spine Journal, and the other by Randy Betz, M.D. et al., in the Temple University Journal of Orthopaedic Surgery & Sports Medicine. These two studies demonstrated that PediGuard doubles the pedicle breach detection rate, reduces radiation exposure by 30 percent, and decreases by up to 10 percent the average time for pedicle screw placement.
1 Source: I-Data Research.