Paris (France) and Boulder (CO, USA), December 14, 2020 – SpineGuard (FR0011464452 – ALSGD), an innovative company that deploys its DSG® (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, announces the first surgery performed at the Trousseau Hospital in Paris with the new DSG Connect platform as part of the collaboration between SpineGuard and ISIR (Institut des Systèmes Intelligents et de Robotique) affiliated with the Sorbonne University.
Professor Raphael Vialle, assisted by Dr. Elie Saghginy, performed the surgery at the Trousseau Hospital in Paris, the first in a series of surgeries to cultivate the SpineGuard robotics program in collaboration with ISIR. Through the DSG Connect interface, researchers have access to bone electrical conductivity data typically measured in all surgeries with the PediGuard devices. Previously unavailable after surgery, this valuable data that is now accessible affords algorithm optimization of the joint SpineGuard/ISIR robotics project in collaboration with the Clinical Research Group ” Robotique et Innovation Chirurgicale ” of Sorbonne University.
Professor Raphael Vialle said: “I really appreciate this new platform as it allows us to record very useful data for many applications in clinical research”.
It is the 4th French center adopting DSG Connect, a wireless tablet-based software interface that adds the visual signal to the audio to optimize the interpretation of the signal emitted by the PediGuard during the placement of screws in the vertebrae. DSG Connect also allows for data recording of bone impedance values as evidence of optimal screw placement within the pedicle and for bone quality studies.
New surgeries with the DSG Connect interface will also soon take place in Germany.
As for the submission of the FDA approval file, it is on track for an outcome expected in the first quarter of 2021. The Company has been in regular communication with the FDA since July to provide the reviewers with the requested answers. We have successfully completed some additional tests relating to electromagnetic coexistence and are preparing for a meeting in December. Some administrative delays have been extended due to the pandemic and have contributed to some schedule shifts.
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 that have been used in over 80,000 surgical procedures worldwide. Sixteen studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSG® offers to patients, surgeons, surgical staff and hospitals. Building on these solid fundamentals and several strategic partnerships, SpineGuard has expanded its technology platform in a disruptive innovation: the « smart » pedicle screw launched late 2017 and is broadening the scope of applications in dental implantology and surgical robotics. DSG® was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer.
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.
Contacts
SpineGuard
Pierre Jérôme
CEO & Chairman
Tel.: +33 1 45 18 45 19
[email protected]
SpineGuard
Manuel Lanfossi
CFO
Tél.: +33 1 45 18 45 19
[email protected]
NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel.: +33 1 44 71 94 94
[email protected]