Extension to add the Curved and XS PediGuard models
Designation change
Regulatory News:
SpineGuard (FR0011464452 ALSGD), an innovative company that deploys its DSG (Dynamic Surgical Guidance) local conductivity sensing technology to secure and streamline the placement of bone implants, today announced that the Chinese authorities (NMPA) have cleared the Curved and XS PediGuard models, as well as a designation change for its products.
Stéphane Bette, Deputy CEO and cofounder of SpineGuard, stated: "This key milestone is a great satisfaction for the SpineGuard team. Our product offering in China will be upgraded by the clearance of PediGuard models which were not yet available in China, while they were in other geographies such as Europe or the United States where they have encountered true commercial success. Indeed, the curved tip features an asymmetrical sensor that provides the surgeon with a directional information, allowing to detect a cortical bony wall and to redirect away from it in order to avoid the breach. This is particularly useful in scoliosis treatment where the vertebral anatomy can be complex and deformed. The "XS" models benefit a miniaturized sensor allowing for utilization in pediatric surgery or in the cervical spine, where the anatomy is tiny. In addition, the designation change that we obtained for our entire product range should facilitate hospital registration and purchase process. This approval should have a positive impact on our 2026 revenue, once we have launched these new products on the Chinese market, trained our sales force and surgeons, and obtained their listing in hospitals."
About SpineGuard
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative company deploying its proprietary radiation-free real time sensing technology DSG (Dynamic Surgical Guidance) to secure and streamline the placement of implants in the skeleton. SpineGuard designs, develops and markets medical devices embedding its technology. Over 110,000 surgical procedures have been secured worldwide thanks to DSG and 39 studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSG offers to patients, surgeons, surgical staff and hospitals. Building on these strong fundamentals and several strategic partnerships, SpineGuard is expanding the scope of its DSG technology to the treatment of scoliosis via anterior approach, sacroiliac joint fusion, dental implantology and innovations such as the smart pedicle screw and power drill or surgical robotics. DSG was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. SpineGuard has engaged in multiple ESG initiatives.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251204095146/en/
Contacts:
SpineGuard
Pierre Jérôme
CEO Chairman
Tel: +33 1 45 18 45 19
p.jerome@spineguard.com
Anne-Charlotte Millard
CFO
Tél.: +33 1 45 18 45 19
ac.millard@spineguard.com
NewCap
Investor Relations Financial Communication
Mathilde Bohin Aurélie Manavarere
Tel: +33 1 44 71 94 94
spineguard@newcap.eu
