SpineGuard (Paris), a French medical device start-up, reported today that it has raised a first funding round of $11 million and that it has used part of the proceeds to acquire the PediGuard unit from SpineVision (also Paris).

Crédit Agricole Private Equity led the financing round, with Innoven Partenaires and A Plus Finance. Aelios Finance advised SpineGuard on both transactions.

The acquisition represents a significant milestone for SpineVision, which was co-founded this year by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, with the primary objective of establishing PediGuard as the standard of care for safer pedicle screw placement in spine surgery, according to the company. PediGuard has FDA clearance and a CE mark.

According to SpineGuard, nearly 1 million spine procedures using pedicle screws were performed last year. The company says that pedicle screws show high rates of misplacements – as high as 40% – that can lead to a number of serious complications for patients, including quadriplegia.

"Pedicle screw placement is the No. 1 safety challenge today in spine surgery," said Jérôme, CEO of SpineGuard. "Now, with more than 7,000 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 says the PediGuard is the only 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. The device provides real-time feedback via audio and visual signals, giving surgeons additional information. The company notes that the device does not require any change in surgical technique.

"Technologies most used today give information to the surgeon when it is often too late," Jérôme told Medical Device Daily.

Based on electrical conductivity of tissues, the PediGuard is able to distinguish between different kinds of tissues and provides a "very clear signal" to the surgeon, Jérôme said. He added that the surgeon is immediately alerted of a vertebral pedicle breach. The surgeon is alerted by changes of sound pitch and cadence as well as a flashing LED cadence, and the device works on all spine levels (lumbar, thoracic and cervical), the company noted.

Although the PediGuard was cleared in the U.S. in 2005 and introduced in 2006, Jérôme said that in order for the product to reach its full marketing potential it needs to have a dedicated team, which is the reason SpineGuard was founded to acquire the technology from SpineVision.

"SpineGuard is totally committed to establishing PediGuard as the standard of care in pedicle screw placement," said 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."

In addition to alerting surgeons to pedicle breaches, the company says the device can also reduce radiation exposure and surgery time. It has a "stake in the ground" on all continents, SpineGuard noted: "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. The company said it is partnering with distributors to allow more spine surgeons and patients to benefit from the device.

"All the other technologies available today [for pedicle screw placement] use some form of X-ray and when you talk about X-ray you talk about radiation," Jérôme said. "So by using this instrument they can minimize the use of imaging and radiation during the surgery."

In addition to acquiring PediGuard, Jérôme told MDD that the company will use the proceeds from the financing to invest in training, R&D, marketing, clinical studies, and to expand coverage in more countries.

No Comments