PARIS & SAN FRANCISCO--(BUSINESS WIRE)--SpineGuard (FR0011464452 – ALSGD), an innovative company that designs, develops and markets disposable medical devices intended to make spine surgery safer, announced today its consolidated full-year 2014 revenue.
| € thousands - IFRS | 2014 | 2013 |
Change as reported |
||||||||||||
| H1 | 2,108 | 2,318 | -9.1% | ||||||||||||
| H2 | 2,328 | 2,297 | +1.4% | ||||||||||||
| Full Year | 4,436 | 4,615 | -3.9% | ||||||||||||
|
Unaudited |
2014 annual revenue: back to growth in the second half
In 2014, SpineGuard recorded revenue of €4,436 thousand, down 3.9% as reported (-4.1% CC) vs. full-year 2013. Growth returned in the second half of 2014 at +10.4% compared with the first half of 2014 and +1.4% compared with the second half of 2013. Units were 6,063 in 2014 compared with 6,308 in 2013. Over 35,000 surgical procedures have been performed with PediGuard since its introduction.
Revenue totaled €3,274 thousand (-2.8%) in the USA with a notable +5.9% increase for the second half of the year vs. -11.4% in the first half. The USA accounts for 74% of total revenue and 53% of units sold.
| USA | |||||||||||||||
| € thousands - IFRS | Dec-14 | Dec-13 |
Change |
||||||||||||
| H1 | 1,499 | 1,692 | -11,4% | ||||||||||||
| H2 | 1,775 | 1,677 | +5,9% | ||||||||||||
| Full Year | 3,274 | 3,369 | -2,8% | ||||||||||||
|
Unaudited |
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In the rest of the world, revenue was €1,162 thousand (-6.8%). Growth was substantial in France (+21%), Germany (+73%) & Switzerland (+43%), and promising results were achieved in Japan and several countries in Latin America. However, these positives were more than offset by the absence of revenue in Brazil (vs. 128 k€ in 2013); the sharp decrease (-68%) in Belgium, The Netherlands and Italy as a collateral consequence of the on-going acquisition of its distributor Biomet by Zimmer and the Russian market due to a base effect for the 2013 starting order.
| Rest of world | |||||||||||||||
| € thousands - IFRS | Dec-14 | Dec-13 |
Change |
||||||||||||
| H1 | 610 | 627 | -2,7% | ||||||||||||
| H2 | 553 | 620 | -10,9% | ||||||||||||
| Full Year |
1,162 |
1,247 |
-6,8% | ||||||||||||
|
Unaudited |
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Sales growth recovered in H2 2014 and, with value-enhancing achievements, the company is favorably positioned for 2015
Pierre Jérôme, CEO and co-founder of SpineGuard, said: “2014 ended strongly with a return to growth, and the US rebound in the second half of the year indicates that we now have a better handle on the major changes affecting healthcare and the spine industry.”
Stéphane Bette, SpineGuard’s CTO and co-founder, added: “We made significant progress with our Dynamic Surgical Guidance technology platform in 2014, and our game-changing Smart Tap and Smart Screw products will be introduced in 2015. SpineGuard’s Dynamic Surgical Guidance technology will be available to surgeons through the implant itself. The company is in advanced discussions with several companies on these projects.”
Pierre Jérôme concluded: “We are actively working on national contracts with US hospital systems and on several large tenders outside the US to improve our sales predictability and growth. Our distribution network is further strengthening; our marketing capability is increasingly more impactful with stronger leverage of our clinical data and KOL network. We are very excited about translating the power and breadth of our technology platform and believe the fundamentals are in place to establish Dynamic Surgical Guidance as a standard of care in spine surgery.”
Next financial press release: 2014 annual results, on March 25, 2015
About SpineGuard®
Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its FDA-cleared and CE-marked PediGuard® device as the global standard of care for safer screw placement in spine surgery. SpineGuard’s mission is to make spine surgery safer. The company is also exploring other applications for its Dynamic Surgical Guidance technology platform. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.
About PediGuard®
Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer, PediGuard is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. Over 35,000 procedures have been performed with PediGuard worldwide. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98% of pedicle breaches, presents an average screw placement accuracy of 97% (vs. 92% for surgical navigation), provides 3-fold less pedicle perforations than with free-hand technique and a 3-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30% and decreases by 15% the time for pedicle screw placement.
About pedicle screw-based stabilization
Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities. This market is growing due to the increasing number of patients requiring surgical treatment and a larger number of surgeons being trained in pedicle screw-based technologies. Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws, further reiterate the importance of pedicle screw placement. However, accuracy of pedicle screw placement remains a critical issue in spine surgery. In recently published papers studying screw placement accuracy, the average rate of misplaced screws is approximately 20% (Verma 2010, Tian 2011, Gelalis 2011, Mason 2013) with 2-11% of patients presenting neurologic complications (Amiot 2000, Amato 2010, Waschke 2012, Oh 2013, Koktekir 2014, Nevzati 2014) and 2-6% of patients having risk of vascular complications (Sarlak 2009, Sarwahi 2014, Parker 2014) due to misplaced screws.
