SpineGuard Obtains Regulatory Clearance to Sell Pediguard® Curved and Curved XS in Mexico
PARIS & SAN FRANCISCO--(BUSINESS WIRE)--
SpineGuard (FR0011464452 – ALSGD) announced today that it has obtained additional regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its Curved and Curved XS PediGuard® devices in Mexico. SpineGuard has previously received clearances for its Classic and Cannulated PediGuard devices.
“This additional regulatory approval completes our offering into the substantial market of Mexico. Mexico’s spine surgeons will now benefit from all of the PediGuard features, including directionality and miniaturization, thus minimizing complications due to cortical breaches and reducing their exposure to radiation as a result of less dependence on fluoroscopy,” said Pierre Jérôme, CEO and co-founder of SpineGuard.
About the PediGuard® Platform
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 28,000 procedures have been performed with PediGuard on all continents. 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. 92% on average for navigation), provides 3-times fewer pedicle perforations than with free-hand technique and a 3-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30% and decreases by 15% the time for pedicle screw placement.
About SpineGuard®
Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its FDA-cleared and CE-marked PediGuard® device as the global standard of care for safer screw placement in spine surgery. 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.
Disclaimer
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.
Contact:
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108
or
Europe
NewCap.
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
Investor Relations & Financial Communication
Help employers find you! Check out all the jobs and post your resume.