The News

SpineVision® reports a market penetration milestone: 1000th spine surgery performed using Company’s PediGuard™ device, world

23/12/2005

“Given that we have become a prominent integrated spinal technology company in Europe, and given that our current product portfolio offers solutions for some 90 percent of spinal pathologies, we believe significant momentum is now in place because of PediGuard to successfully position and establish SpineVision in the U.S. market as well.”
Gérard Vanacker, Founder and CEO, SpineVision®

ATLANTA and PARIS, Dec. 23, 2005—SpineVision® announced today that its proprietary technology, PediGuard™, the first and only FDA-cleared Class II device for real-time electronic detection of possible penetration outside the vertebral pedicle, was recently used in the 1000th spine surgery procedure since its launch.

Accuracy of pedicle screw placement is an important issue in spine surgery: published rates of intraoperatively ‘misplaced’ pedicle screws range from 10 to 40 percent, some of which result in pathological consequences such as spinal cord damage, including paraplegia or quadriplegia. Consequently, liability risks for spine surgeons are high. PediGuard is the first patented, wireless, handheld instrument capable of accurately detecting changes in tissue type, thus alerting surgeons to potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback is provided to surgeons via audio and visual signals, giving them new additional information. The use of PediGuard requires no change in surgical technique.

“We are very pleased to report this significant milestone, as it underscores the tremendous reception that PediGuard received at the most recent NASS (North American Spine Society) annual scientific meeting. Additionally, this milestone also validates our market-penetration strategy in the United States—that is, to enter the U.S. spine market with a breakthrough product along with our metal implant portfolio,” said Gérard Vanacker, CEO and founder of SpineVision. “Indeed, PediGuard is a great example of our success strategy: To propose innovative solutions that improve the safety of a certain surgical procedure—without adding complexity for the surgeon. Our products offer innovative designs that may translate into shorter and safer surgical procedures, reduction of the number of surgical steps, facilitation of Minimally Invasive Surgery (MIS), as well as reduction of time spent in surgery and overall hospital costs. PediGuard is the first of many innovative products that we will be bringing to market in the  nited States.”

Beyond these readily available technologies, SpineVision® also develops motion-preservation solutions and announced on Dec. 6, 2005, that it recently raised more than $16 million to spin off its New Technologies Business Unit, creating a new wholly owned subsidiary—FlexSpine—to be headquartered in Singapore. Products to be further developed through FlexSpine include an innovative hybrid dynamic stabilization system and interspinous spacer (both of which are expected to be commercialized in Europe next year and, soon thereafter, in the U.S.), as well as prosthetic discs. Investors were led by Bio*One Capital, the biomedical sciences investment arm of the Singapore Economic Development Board. Other institutional investors included Sofinnova Partners, HBM Ventures, Innoven Partenaires, and HealthCap.

About SpineVision®
SpineVision® is a privately owned, integrated spinal technology company focused on design, development and marketing of implants and instrumentation for spinal surgery. The Company’s international headquarters are in Paris, and the Company’s U.S. headquarters are located in Atlanta.