SAN FRANCISCO & PARIS--(BUSINESS WIRE)--SpineGuard, a French medical device start-up, announced today that it has raised a first funding round of $11 million with Crédit Agricole Private Equity (lead), Innoven Partenaires (co-lead), and A Plus Finance. The company has used part of the proceeds to acquire the PediGuard unit from SpineVision. SpineGuard was advised on both transactions by Aelios Finance.
Co-founded this year by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish PediGuard as the standard of care for safer pedicle screw placement in spine surgery. PediGuard has FDA clearance and a CE Mark.
Nearly one million1 spine procedures using pedicle screws were performed last year. According to published studies, pedicle screws show high rates of misplacements—as high as 40 percent—which can lead to a number of serious complications for patients, including quadriplegia. Consequently, liability risks for spine surgeons are high.
“Pedicle screw placement is the number-one safety challenge today in spine surgery,” said Pierre Jérôme, CEO of SpineGuard. “Now, with more than 7,0002 spine procedures performed in 20 countries using PediGuard, including the U.S., this innovative device is clearly emerging as the most compelling solution to the significant clinical need for safer pedicle screw placement.”
“SpineGuard is totally committed to establishing PediGuard as the standard of care in pedicle screw placement,” added Stéphane Bette, Chief Technology Officer and General Manager of U.S. Operations for SpineGuard. “Toward this end, we have a team of 15 accomplished individuals divided between San Francisco and Paris, all of them very experienced in spine.”
Several peer-reviewed publications now validate the value proposition of PediGuard for spine professionals and their patients: pedicle breach anticipation plus reduction of radiation exposure and surgery time. It has a stake in the ground on all continents: impressive ramping-up of sales in the U.S., a strong base in Europe, a great start in Latin America, and significant interest from the Pacific Rim. SpineGuard is partnering with the best distributors to allow more spine surgeons throughout the world to use PediGuard and more patients to benefit from a safer spine stabilization.
“SpineGuard’s investors know that PediGuard is a game-changer: the product serves an unmet clinical need with a sizable market opportunity,” said Alain Lostis, Managing Director at Aelios Finance.
“We are delighted to have carried through this funding round to support the development of the PediGuard. The unique positioning of this proprietary product in the spine field matched to the know-how of the Franco-American team convinced us and our co-investors,” commented Alexia Perouse, Director at Crédit Agricole Private Equity.
Thomas Balland, Investment Director at Innoven Partenaires, added, “We look forward to working actively with the Company to help it achieve its long-term commercial and financial objectives.”
Jean-Michel Pimont, Partner at A Plus Finance, said: "Their product positioning and the quality of the management team have convinced us to join the pool of investors and support their development strategy.”
Alexia Perouse, Thomas Balland and Jean-Michel Pimont will be joining SpineGuard’s board of directors.
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. More than 7,000 procedures have been performed with PediGuard in 20 countries. 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.
SpineGuard’s mission is to make spine surgery safer. The company has offices in San Francisco and Paris. For further information, visit www.spineguard.com.
Ronald Trahan Associates Inc.
Ronald Trahan, APR, 508-359-4005, x108