SAN FRANCISCO and PARIS–(BUSINESS WIRE)–SpineGuard™ announced today that it has signed an agreement with MBA to exclusively distribute SpineGuard’s breakthroughPediGuard® device in Italy, Portugal, Spain and the UK, effective immediately. PediGuard, which is CE-Marked and FDA-cleared, is designed for safer pedicle screw placement in spine surgery. MBA is a prominent international medical device marketing-and-distribution organization that specializes in the sale of products used for the treatment of spine.
In January, SpineGuard announced that the 10,000th case had been performed using its PediGuard device. Nearly one million1 spine procedures using pedicle screws were performed in 2009. According to published studies, pedicle screws show high rates ofmisplacements that can lead to a number of serious complications for patients, including quadriplegia. Consequently, liability risks for spine surgeons are high.
“I believe MBA has the right attributes to be successful with PediGuard,” said Pierre Jérôme, CEO of SpineGuard. “MBA has built a robust sale and marketing organization over the years, and they have strong credibility among spine surgeons. I have been particularly impressed by the quality of MBA’s management team and by their state-of-the-art training facilities. I look forward to a fruitful collaboration between SpineGuard and MBA and seeing PediGuard become a standard of care for pedicle screw placement in the UK, Spain, Portugal and Italy.”
“MBA is delighted that SpineGuard has chosen our organization as its marketing and distribution partner for these territories,” added Paul Griffin, MBA’s Chief Operating Officer and a member of the Board of Directors of MBA. “This exciting and highly innovative technology has the potential to significantly reduce serious complications in patients undergoing major spine surgery. Our exclusive agreement opens the way for MBA to immediately begin introduction of this very useful product to specialists throughout the UK, Spain, Italy and Portugal,” said Griffin. “We feel confident that the combination of the SpineGuard product portfolio together with MBA’s experienced team and marketing know-how will allow us to develop and grow a successful business together, helping to potentially reduce the risk of life-changing complications for spine surgery patients. SpineGuard has state-of-the-art technology and MBA has the resources to bring this exceptional product quickly and successfully into regular use in some of the principal and most competitive markets outside the U.S.”
Co-founded by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s mission is to make spine surgery safer and its primary objective is to establish its FDA-cleared and CE Marked PediGuard device as the global standard of care for safer pedicle screw placement in spine surgery. The company has offices in San Francisco and Paris. For further information, visit www.spineguard.com.
MBA was founded in 1987 as an organization committed to the distribution and sale of products for orthopedic and neurosurgery. The company’s corporate headquarters and state-of-the-art distribution facilities are located in Gijón, Spain. MBA’s sales and distribution network incorporates offices throughout the world. The company is expanding its network rapidly into many countries. MBA’s goal is to continue to challenge the standard for product delivery efficiency, sales excellence and product training in this highly specialized healthcare sector. Contact: Info@MBA.EU
Co-invented by Maurice Bourlion, Ph.D., and Ciaran Bolger, M.D., Ph.D., 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. Two multi-center clinical studies about PediGuard have been published: one by Ciaran Bolger, M.D., Ph.D. et al., in the European Spine Journal, and the other by Randy Betz, M.D. et al., in the Temple University Journal of Orthopaedic Surgery & Sports Medicine. These two studies demonstrated that PediGuard doubles the pedicle breach detection rate, reduces radiation exposure by 30 percent, and decreases by up to 10 percent the average time for pedicle screw placement.