SpineGuard receives Regulatory Ninsho Approval to sell its PediGuard® platform in Japan

Regulatory News:

SpineGuard (FR0011464452 – ALSGD) announced today that it has received product certification ("Ninsho") to market its Classic and Curved PediGuard® products in Japan.

"This regulatory clearance is the result of a diligent collaborative process with our Japanese partners, notably Surgical Spine Inc. (S2I), who played an instrumental role in this achievement and will be launching PediGuard at the Nagoya Spine Meeting later this week¹,” said Pierre Jérôme, Co-founder and Chief Executive Officer of SpineGuard. "We are extremely pleased to now be able to offer Japanese spine surgeons and their patients the significant safety benefits that result from using PediGuard devices, whose value in boosting the accuracy of pedicle screw placement has been unequivocally validated in several peer-reviewed medical journals.”

Japan is the second-largest market in spine after the USA and as indicated in an article by David Cassak in the July/August 2013 issue of IN VIVO magazine entitled "Taming of the Screw”, "Japan is a particularly promising market [for PediGuard] because surgeons there implant a lot of pedicle screws in the upper part of the spinal column as a result of specific problems that affect Asian patients.”

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.

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 27,000 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 pedicle screw-based stabilization

Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities. This market is growing due to the increasing number of patients requiring surgical treatment and a larger number of surgeons being trained in pedicle screw-based technologies. Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws further reiterate the importance of pedicle screw placement. However, accuracy of pedicle screw placement remains a critical issue in spine surgery. In recently published papers studying screw placement accuracy, the average rate of misplaced screws is approximately 20% (Tian 2011, Gelalis 2011, Verma 2010) with 2-7% of patients presenting neurologic complications (Amato 2010, Amiot 2000, Waschke 2012) and 4-5% of patients having vascular complications (Sarlak 2009, Samdani 2009, Belmont 2002) due to misplaced screws.

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.

¹ 20^th Annual Meeting of the Japan Society for the Study of Surgical Studies for the Spinal Nerves (JPSTSS) in Nagoya, on September 6-7, 2013