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Company also gained FDA clearance of its DSG integration module during the quarter.
April 4, 2017
By: SpineGuard Inc.
SpineGuard’s 2017 sales are off to a strong start. The developer of disposable medical devices designed to make spine surgery safer reported first-quarter 2017 revenue of 2.2 million euros, a 23 increase compared with Q1 2016. “In line with former quarters, SpineGuard is starting 2017 with strong growth driven by great momentum in the U.S. and the traction of PediGuard Threaded, the latest addition of our smart, single-use drilling probes,” said Pierre Jérôme, CEO and co-founder of SpineGuard. “This is very promising given that our DSG integration module for ‘single-step’ screw insertion is in limited release and therefore not yet significantly contributing to our revenue.” Global revenue in the first quarter of 2017 swelled to 2.17 million euros compared with 1.76 million euros in the first quarter of 2016. At constant exchange rate (cc), the growth rate was 20 percent. Company executives said 2,397 PediGuard units were sold in the first quarter of 2017 compared with 2,134 in the first quarter of 2016, including 1,377 (57 percent) in the United States, where revenue grew 30 percent (25 percent cc) to 1.9 million euros compared with 1.37 million euros. Milestones during the first quarter (ended March 31) included the Jan. 16 U.S. Food and Drug Administration 510(k) clearance of the DSG (Dynamic Surgical Guidance) integration module to use in combination with Zavation’s spinal fusion system to make its pedicle screws “smart,” and the Feb. 6 issuance of a U.S. patent to use the DSG technology in bone quality measurements. Co-founded in 2009 in France and the United States by Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, a biomedical engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. More than 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco, Calif., and Paris, France.
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