PARIS and SAN FRANCISCO, May 10, 2016 – SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, announced today the commercial launch of its new PediGuard Threaded device at the occasion of the “SpineWeek 2016” world conference which is scheduled to take place in Singapore from May 16 to May 20. This launch follows successful clinical evaluations performed by seven surgical teams in Europe and Asia.
“As a regular user of the DSG™ technology, I particularly appreciate the PediGuard Threaded device because this novel « three in one » instrument enables me to optimize both the insertion, the positioning and the anchorage of screws into the vertebra without the need for fluoroscopy,” said Ciaran Bolger, M.D., Neurosurgeon, Dublin, Ireland.
Pierre Jérôme, CEO and co-founder of SpineGuard, added: “PediGuard Threaded completes our range of smart drilling devices whose clinical value keeps on being reinforced by new studies in terms of implant placement accuracy, x-ray exposure diminution and OR time-reduction. Three of them will be presented next week by eminent spine surgeons at the SpineWeek world conference in Singapore.”
Eighteen major international spine societies come together every four years during the SpineWeek conference. Between 3,500 and 4,000 orthopedists and neurosurgeons are expected from all over the world next week in Singapore where the DSG™ technology will be featured in three scientific podium presentations listed below:
Monday May 16th
Accuracy of a Dynamic Surgical Guidance (DSG™) probe for screw insertion in the cervical spine
Dixon D., Darden B., Casamitjana J., Weismann K., Powell D., Baluch D. (USA, Spain & Chile)
Tuesday May 17th
Does the use of Dynamic Surgical Guidance (DSG™) assist with accurate pedicle screw placement in patients with osteoporosis or osteopenia? Defino H., Williams J., da Silva Herrero C.F., Betz R., Powell D., Gaughan J. (Brazil & USA)
Thursday May 19th
Reducing pedicle drilling radiation by using Dynamic Surgical Guidance (DSG™) with a Jamshidi needle while maintaining screw placement accuracy Williams J., Khoo L., Gaughan J., Betz R. (USA)
5 Jan. 2016
World’s first spinal fusion surgery performed with the one-step-insertion of pedicle “smart screws” guided by the DSG technology. This surgery was performed successfully by Dr. Court and his team in Paris. Additional surgeries have been performed since, in particular, by Dr. Bolger in Ireland.
16 Mar. 2016
Company received Bpifrance loan of €1.5M.
17 Mar. 2016
National stocking distribution agreement signed with OrthoPediatrics for the exclusive commercialization of its PediGuard probes in pediatric institutions in the US.
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Next financial press release: 2016 Half-year revenue: July 12, 2016
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, initially for 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. Over 45,000 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.
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.
Pierre Jérôme Manuel Lanfossi
CEO Chief Financial Officer
Tel: +33 (0)1 45 18 45 19 email@example.com
Investor relations & Financial communication
Florent Alba / Pierre Laurent Tel: +33 (0)1 44 71 94 94
Ronald Trahan, APR, Ronald Trahan Associates Inc.