SpineGuard® DSG™ Screw Recognized as One of the Best New Spine Technologies for 2016

Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD) announced today that it has received an award from Orthopedics this Week, one of the most widely read publications in the Orthopedics industry, recognizing SpineGuard’s innovative DSG™ (Dynamic Surgical Guidance) Screw as one of the BEST new spine care technologies for 2016. The award was received during the 31^st annual meeting of the North American Spine Society (NASS) in Boston.

The DSG™ Screw is a pedicle screw with a unique combination of a bipolar sensor with a pedicle screw—in just one device. The technology gives surgeons real-time guidance and the ability to insert the screw directly into a vertebra without drilling a pilot hole.

The DSG™ sensor differentiates various tissue types based on an analysis of the local electrical conductivity (cancellous bone, cortical bone, blood and soft tissues). Real-time feedback informs the surgeon of changes in tissue type by changes in the pitch and cadence of an audio signal and a flashing LED light. This in turn alerts the surgeon of potential pedicular or vertebral breaches during pedicle screw placement.

Moreover, the use of the DSG™ screw in MIS (Minimally Invasive Spine surgery) obviates the need for a k-wire. The outcome is a single-step pedicle screw insertion with an unprecedented degree of accuracy along with the added benefits of the potential for reduced radiation exposure and streamlined surgical steps, with resulting time- and cost-savings.

The US FDA clearance process for the DSG™ Screw is in progress. The FDA dossier was submitted in conjunction with Zavation, a spinal implant company that Spineguard has partnered with to license and co-develop a DSG-enabled Zavation SmartScrew. Once cleared, Zavation will market and sell the first DSG-enabled screw in the USA.

Pierre Jérôme, Co-founder and CEO of SpineGuard, concluded: "This award is a great recognition for the SpineGuard R&D and marketing teams, the co-inventors of the DSG™ technology, the surgeons involved in the product design, as well as NeuroFrance and Zavation, our pedicle screw partners. Given the quality of the panel who made the selection, this award is very encouraging for the future adoption of our DSG™ integration system.”

A DSG™-enabled SmartScrew co-developed with Neuro France Implants (La ville-aux-Clercs, France) is currently in alpha launch in Europe with five surgeons having started to use the system.

More information on the DSG™ technology, its new applications and surgeons’ testimonials here.

Recent events:

SpineGuard reports 50,000 spine procedures performed using its family of PediGuard devices for accurate pedicle screw placement. The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated, and PediGuard Threaded.

Latest news release: SpineGuard® expands "PediGuard®” franchise, will launch "PediGuard Threaded” drilling device at North American Spine Society (NASS) annual meeting, October 19, 2016

Next financial press release: 2016 full year revenue, January 5, 2017

About SpineGuard®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. 50,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard 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.

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