SpineGuard Obtains Regulatory Clearance to Sell Cannulated PediGuard® in Mexico

Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), announced today that it has obtained regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its Cannulated PediGuard® device in Mexico. Spineguard has previously received clearance for its Classic PediGuard device, and over 50 Mexican spine surgeons have been trained on the technology.

"PediGuard’s guidance allows us to place pedicle screws in an optimal way, designed to ensure superior outcomes for our patients,” said Ricardo Flores Escamilla, M.D., Neurosurgeon, Chief of Neurosurgery Service, Hospital Almater Mexicali, Baja California, Mexico.

The use of minimally invasive surgical (MIS) techniques provides substantial benefits for patients, including shorter surgery times and quicker recovery. However these new procedures also induce increased use of fluoroscopy by surgeons to compensate for their lack of direct visual landmarks and tactile feel, exposing OR teams to excessive doses of radiation.

"The regulatory approval of Cannulated PediGuard expands our product offering in the important market of Mexico, where minimally invasive spine surgery is progressing rapidly. Cannulated PediGuard is designed to facilitate and secure this challenging procedure, providing real-time information that empowers spine surgeons to accurately place pedicle screws while avoiding 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 25,000 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-fold less 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 wíll 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.