SpineGuard Continues its Rapid Market Ascent

The second quarter of 2010 was a profitable one for SpineGuard S.A.

The privately held French firm sold more than 1,000 PediGuard devices between April 1 and June 30, a 125 percent increase compared with the same period last year, according to the company. The device—SpineGuard’s signature product—has been a growth driver over the last year, having been used in 10,000 spinal procedures worldwide in just 12 months.

“This strong growth confirms PediGuard’s 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.”

The handheld device, which received U.S. Food and Drug Administration approval in 2005, enables surgeons to accurately place pedicle screws during spinal procedures. PediGuard prevents pedicle screw misplacements by analyzing the electrical conductivity of surrounding tissues in real time through audio and visual signals. The device detects changes in tissue type and alerts surgeons to the change during preparation of the screw site.

The market for pedicle screw-based stabilization devices has been growing in recent years due to the prevalence of spine instabilities and deformities as well as the increasing number of surgeons being trained in pedicle screw-based technologies.

The criticality of pedicle screw placement has been highlighted by published reports showing that high rates of misplacements can lead to such serious complications as quadriplegia.

SpineGuard was founded last year by Jérôme and Stephane Bette, former executives of Medtronic Sofamor-Danek. The company, which has its U.S. headquarters in San Francisco, Calif., received $15 million in venture capital funding through July 2009 from four private equity and investment firms. SpineGuard executives said they expect to launch a PediGuard MIS (minimally invasive surgery) kit by the end of the third quarter.