SpineGuard Posts Sales Gains for FY2013

SpineGuard reported fiscal 2013 full-year revenue (ended Dec. 31) of approximately $6.4 million (4.6 million euros) compared to $5.3 million (3.9 million euros) for the full-year 2012, a 20 percent constant currency increase. The company reported a total of 6,308 PediGuard units sold compared to 5,225 for the full year 2012, including 3,142 in the United States; 1,341 in Europe; 973 in Latin America; 616 in the Middle East; and 236 in the Asia-Pacific region.

The gross margin remained “very solid,” over the year, according to the company’s leadership, at 87.3 percent. It was stable compared to the previous six-month results and continues to reflect PediGuard’s relatively low manufacturing costs, including for the recently launched new versions (Cannulated PediGuard and the XS Range) whose manufacturing costs could be reduced as volumes grow, officials reported.

The company reported a net loss of 3.5 million euros for the full-year 2013 compared to a loss of roughly $4.8 million (3.3 million euros) for the full-year 2012, after an interest charge of roughly $382,009 (278,000 euros) and a foreign currency charge of $115,600 (84,000 euros).

“We are really pleased with our financial and strategic performance in 2013. Our enhanced resources and visibility since the IPO (initial public offering) are enabling us to exploit the amazing potential of our technology platform at a faster pace,” said Pierre Jérôme, CEO of SpineGuard. “The development of the PediGuard SmartScrew is well underway. We are convinced it represents a major breakthrough for patients undergoing back surgery. This project also offers particularly promising perspectives in traumatology, the fastest-growing orthopedic segment. These new applications are based on a solid clinical foundation and represent a true medium-term opportunity of growth for SpineGuard and its partners.”

The company went public with an IPO in April last year.

Among the milestones the company recorded for the year, were U.S. Food and Drug Administration 510(k) clearance for the new XS Classic and XS Curved PediGuard versions; regulatory approval in Japan for the Classic and Curved versions, including XS; registration in Mexico for the Cannulated, Curved and XS Curved ranges; and approval in Russia for the entire PediGuard bone-monitoring platform.

During the year, the company began sales in Russia, Japan, Chile, Ecuador, Turkey and Kuwait.

The company also began four prospective randomized studies aimed at proving the PediGuard’s clinical superiority with a better placement of the screws, reduction in radiation and shorter operating time. These studies cover the following areas: thoracic (France), thoraco-lumbar (Germany), osteoporosis (United States, Brazil) and learning curve (United States).

Founded in 2009 and based in Paris, France, and San Francisco, Calif, SpineGuard develops disposable bone-monitoring devices intended to make spine surgery safer. Its core PedGuard technology is designed to allow orthopedic spine surgeons and neurosurgeons to insert pedicle screws more accurately. Equipped with a sensor at its tip and electronics in its handle, PediGuard measures changes in the electrical conductivity of surrounding tissue in real time and alerts the surgeon using audio feedback and a flashing light.