The News

SpineVision® reports U.S. market penetration milestone

25/10/2005

100th spine surgeon has been trained to use the Company’s FDA-cleared PediGuard™ device, the world’s first and only free-hand drilling instrument able to detect an inadvertent breach in the vertebral pedicle or vertebral body

“In just six years we have become a prominent integrated spinal technology company in Europe. Our current product portfolio offers solutions for some 90 percent of spinal pathologies. Now, with the momentum we are achieving because of PediGuard, we are intent on successfully positioning SpineVision in the U.S. market as well.”
Gérard Vanacker, Founder and CEO, SpineVision®

ATLANTA and PARIS, Oct. 25, 2005—SpineVision® announced today that it has now trained 100 U.S. spine surgeons with its newest product, PediGuard™, the first and only FDA-cleared Class II device for real-time detection of possible penetration outside the vertebral pedicle. Accuracy of pedicle screw placement is still an 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.

From SpineVision’s inception, its strategy has been based on a controlled market release of new products to key opinion leaders in each of its international target markets prior to full-scale product launch. The support of key opinion leaders is ensuring market acceptance and endorsement of SpineVision’s products to the wider international spine surgery community. Indeed, the controlled release strategy has enabled SpineVision to be highly responsive to surgeons’ requirements while differentiating SpineVision products in the minds of spine surgeons. The Company is thus extremely pleased with this most recent milestone, now having trained 100 of the finest U.S. spine surgeons among its eight facilities across the United States: Boston, Memphis, Miami, Minneapolis, New Orleans, Palo Alto, Philadelphia and Phoenix.

“Given the significant success we had last month at EuroSpine in Barcelona and at the NASS (North American Spine Society) meeting in Philadelphia—combined, we collected nearly 500 sales leads from spine surgeons—we now have considerable momentum. We have doubled our sales annually over the past three years. Revenues in 2005 should be in the eight-figure range thanks to the recent success of PediGuard™. Indeed, we now have positioned the Company for even more rapid growth,” said Gérard Vanacker, CEO and founder of SpineVision.

“No doubt, PediGuard is a revolutionary product. This patented technology also is a great example of our strategy: To propose innovative solutions that improve the safety of a certain surgical procedure—without adding complexity for the surgeon. In short, SpineVision’s products offer innovative designs that may translate into shorter and safer surgical procedures, reduce the number of surgical steps, facilitate Minimally Invasive Surgery (MIS), and therefore reduce the time spent in surgery and overall hospital costs. PediGuard is the first of many innovative products that we expect to bring to market in the United States,” Mr. Vanacker concluded.

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.