SpineGuard Reports Solid First Half Results

SpineGuard has had quite the run of good fortune in the first half of this year.

In the first six months of 2013, the company’s revenue grew 27 percent compared with the same period last year and a 21 percent reduction of its operating loss. Revenue for the half year ended June 30 totaled 2.3 million euros ($3.01 million), according to earnings data released earlier this week.

Gross margin for the first half of 2013 came in at 87.5 percent, reflecting the evolution of SpineGuard’s product mix, particularly the “increasing weight” of its cannulated PediGuard system, executives said. The company sold more than 3,000 PediGuards in the first six months of the year, nearly half of which (49 percent) were distributed in the UnitedStates.

Operating expenses amounted to 3.53 million euros ($4.59 million) compared with 3.51 million euros ($4.41 million) in H1 2012. Net loss fell slightly, from 1.9 million euros ($2.4 million) in 2012 to 1.6 million euros ($2.1 million) in the first half of 2013. Working capital fell dramatically, plummeting to 13,653 euros ($17,758) as of June 30 from 392,283 euros ($493,355) the previous mid-year. Inventory was down as well, slipping to 378,996 euros ($492,964) from 498,180 euros ($626,536) as of June 30, 2012.

Cash and cash equivalents more than tripled, reaching 7.8 million euros ($10.1 million) from 2.3 million euros ($2.9 million) in 2012, thanks to funds raised in an April IPO (initial public offering) that brought in 8.1 million euros to the firm.

Some of the company’s financial good fortune undoubtedly stemmed from the various product approvals it received during the first six months of the year. They included:

• U.S. Food and Drug Administration approval in the United States for three new extensions of the PediGuard platform: the miniaturized versions of the Classic and Curved ranges, as well as a directional version of the Cannulated PediGuard;
• Regulatory approval in Japan (“Ninsho”) to market the Classic and Curved versions of the PediGuard platform. Japan represents the world’s second-largest market for spine surgery after the United States and one of the most demanding countries in terms of regulatory clearance;
• Approval of the Cannulated PediGuard by Mexican healthcare regulatory authorities, and of the entire range by Columbian health regulatory officials.

The company also made significant progress in further cementing its foothold in the global market with its “smart screw” patents in both the United States and China, and coverage of the PediGuard in Coluna Columna, a respected SouthAmerican scientific journal for spine surgery.

“SpineGuard has recorded solid revenue growth in the first half-year while controlling its cost structure and working capital requirements,” said SpineGuard co-founder/CEO Pierre Jérôme. “We are rolling out our business plan in accordance with what we announced during the IPO. Some major breakthroughs have been made in the last few months, notably in the United States, Asia and Latin America. They are reinforcing our vision to ‘establish the PediGuard technology as a standard of care to make spine surgery safer.’”

Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, biomedical engineer, PediGuard is a handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. More than 27,000 procedures have been performed with PediGuard on all continents. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98 percent of pedicle breaches, presents an average screw placement accuracy of 97 percent (vs. 92 percent on average for navigation), provides three-fold less pedicle perforations than with free-hand technique and a three-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25 percent to 30 percent and decreases the time for pedicle screw placement by 15 percent.

Founded in 2009, SpineGuard has offices inSan Francisco,Calif., and Paris, France. The company has been listed on the New York Stock Exchange since April 29.