SpineGuard 2013 Revenues Reach 4.6 Million Euros

SpineGuard generated 4.6 million euros in revenue last year, a 20 percent increase compared with 2012, according to the company’s latest earnings release. Executives said the total met their expectations.

U.S. revenue grew 19 percent to 3.36 million euros and “rest of the world” revenue jumped 22 percent to 1.24 million euros. PediGuard sales were split almost evenly between America and the rest of the world, with 3,142 units sold in the United States and 3,166 units sold elsewhere in the world. The company reports that surgeons have performed 30,000 PediGuard procedures since its 2009 introduction.

Since going public in April last year, SpineGuard has expanded its U.S. coverage with an additional 20 agencies. Executives also strengthened the sales management team and instituted various training opportunities for staff. Moreover, the company claims its PediGuard device now is used in more than 20 percent of back surgery teaching institutions that have adopted it in their curriculum.

Perhaps the most important 2013 achievement, however, was the U.S. Food and Drug Administration’s 510(k) clearance last August of the PediGuard Classic XS and Curved XS devices. The XS Classic PediGuard penetrates bone more easily while the miniaturized sensor of the XS Curved PediGuard allows doctors to access the smallest and most difficult pedicles encountered in deformity cases. The Curve device also gives surgeons essential directional information as well as the ability to redirect.

Regulatory approvals for PediGuard also occurred in Russia (the entire product line), Mexico (Cannulated, Curved and Curved XS) and Japan (Classic, Curved and the new XS versions). Plus, the company added a sales manager to oversee its worldwide distribution network.

“We are pleased with the revenue recorded in 2013; it is in line with our expectations” SpineGuard CEO/co-founder Pierre Jérôme said. “2013 not only saw the success of our IPO, but also the realization of breakthroughs, notably in R&D, clinical studies, regulatory approvals and marketing. We envision the continuous deployment of our roadmap in 2014 and the creation of value expected by our shareholders, clients, staff and partners.”

Founded in 2009 and based in Paris, France, and San Francisco, Calif., SpineGuard designs, develops and markets disposable spinal devices. Its PediGuard core technology allows orthopedic spine surgeons and neurosurgeons to accurately insert pedicle screws. Equipped with a sensor at its tip and electronics in its handle, PedGuard measures changes in the electrical conductivity of surrounding tissue in real time and alerts the surgeon using audio feedback and a flashing light.

Several clinical studies have established the reliability and accuracy of PediGuard for pedicle screw placement, demonstrating significantly less radiation exposure of medical teams and shorter surgery time when it is used. The Pediguard platform is protected by eight international patent families, approved and sold in 45 countries, CE Marked in Europe, and has received 510(k) clearance from the FDA in the United States.