SpineGuard and Zavation Partner for Product Development

SpineGuard has entered a co-development partnership with Zavation for the integration of its Dynamic Surgical Guidance (DSG) technology into Zavation’s pedicle screw system.

Zavation is an employee-owned spine company based in Brandon, Miss.

According to SpineGuard officials, their company’s DSG technology will be embedded into Zavation’s pedicle screw system to “provide unprecedented accuracy, enhance spine surgery workflow, and match healthcare economic trends.”

The partnership with Zavation represents the first such deal with a U.S.-based spine company. SpineGuard officials called the partnership a “key milestone” in the firm’s progression toward the launch of its smart screw platform in the U.S. market.

“We are delighted to partner with Zavation for the introduction of dynamically guided screws into the U.S. market. Our early interaction is promising, as our two companies are moving at the same pace,” said Pierre Jérôme, CEO and co-founder of SpineGuard. “This partnership will provide us with a beachhead for future expansion as our technology gains increased exposure and triggers new revenue streams.”

Jeffrey Johnson, president of Zavation, said: “The combination of Zavation’s pedicle screw system and SpineGuard’s innovative technology creates a new option for spine surgeons. Together, our companies are able to offer surgeons a product that aids in their effort to achieve positive results for their patients. While the professional healthcare community is excited about our ‘smart screw,’ the ultimate benefit is, of course, to the patient undergoing spinal surgery.”

Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, co-founded SpineGuard in 2009. PediGuard has U.S. Food and Drug Administration clearance and CE mark in Europe.

PediGuard is a handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. More than 36,000 procedures have been performed with PediGuard worldwide, according to the company. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98 percent of pedicle breaches, presents an average screw placement accuracy of 97 percent (vs. 93 percent for surgical navigation), provides threefold fewer pedicle perforations than with the free-hand technique and a threefold reduction in neuromonitoring alarms. It also limits radiation exposure by 25-30 percent and decreases the time for pedicle screw placement by 15 percent.

SpineGuard has offices in San Francisco, Calif., and Paris, France.