PARIS & SAN FRANCISCO--(BUSINESS WIRE)--SpineGuard (FR0011464452 – ALSGD), an innovative company that designs, develops and markets disposable medical devices intended to make spine surgery safer, announced today its co-development partnership with Neuro France Implants (NFI) for the integration of its Dynamic Surgical Guidance (DSG) technology into NFI’s pedicle screw system.
SpineGuard’s DSG technology will be embedded into NFI’s pedicle screw system to provide unprecedented accuracy, enhance the surgical work-flow, and match health economic trends.
“We are very pleased to partner with NFI on the development of this game-changing technology in a global annual market of one million pedicle screw-based procedures. Our common ambition is to perform the first surgeries with our dynamically guided screws this year,” said Pierre Jérôme, CEO and Co-founder of SpineGuard. “Our R&D collaboration with Neuro France, initiated a few months ago, has already been fruitful with four labs, three generations of functional prototypes and very positive feedback from the surgeons involved in the pre-clinical evaluation.”
Patrice Moreau, CEO and Co-founder of Neuro France Implants, said, “We are delighted to bring our solid expertise in developing and manufacturing spinal implants into this very exciting partnership. Making our G2S pedicle screw system dynamically guided thanks to SpineGuard’s unique technology will offer enhanced safety and assurance to spine surgeons.”
“This is another demonstration of SpineGuard’s continued development and execution of instruments to make spine surgery safer for patients and provide confidence to the surgical team. The pedicle screw with Dynamic Surgical Guidance will truly change the way we think about spine and orthopaedic surgery,” said Randal Betz, M.D., Pediatric Orthopaedic Surgeon, Philadelphia, USA.
“The PediGuard has shown its accuracy in pedicle preparation. The partnership between SpineGuard and NFI is a great development for the spine surgeon community with the integration of two technologies into one device - a new screw with an original design combined with the Dynamic Surgical Guidance technology. This first dynamically guided screw will be the most innovative device of the year in Spine surgery, as it will further reduce complications and associated costs. We look forward to using it,” said Patrick Tropiano M.D., Professor of Orthopaedic Surgery at Marseille La Timone University Hospital – France.
Co-founded in 2009 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 to establish its FDA-cleared and CE-marked PediGuard® device as the global standard of care for safer screw placement in spine surgery. Co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer, 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. Over 35,000 procedures have been performed with PediGuard worldwide. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98% of pedicle breaches, presents an average screw placement accuracy of 97% (vs. 93% 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% and decreases by 15% the time for pedicle screw placement. The company also focuses on developing and exploring other applications for its Dynamic Surgical Guidance technology platform. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.