| Press Release - To post on March 11, 2025 |
Interim analysis of 1-level BAGUERA®C IDE study meets threshold for non-inferiority
Geneva, March 11, 2025 - Spineart, a fast-growing company in spine surgery innovation, today announces that it has completed a planned interim analysis for its 1-level BAGUERA®C IDE study, which showed that BAGUERA® C, its innovative cervical disc prosthesis, met the threshold for a non-inferiority claim against the study control.
Spineart has now agreed on a timeline with the U.S. FDA for the submission of Premarket Approval (PMA) for BAGUERA® C in three components (modules) which will be submitted and reviewed separately. Completion of the PMA submission is now scheduled for the end of August 2025, potentially enabling an earlier approval than had originally been anticipated.
The BAGUERA®C 1-level IDE trial is a prospective, multi-center, randomized clinical study evaluating the safety and efficacy of BAGUERA®C compared with the Mobi-C® cervical disc in the treatment of symptomatic cervical disease at a single level in the cervical spine. The study enrolled 285 patients at 25 sites in the U.S. Results of this clinical trial are intended to be the basis of a PMA submission to the U.S. FDA.
Jerome Trividic, Chief Executive Officer at Spineart, commented: "This interim analysis data is extremely promising. We look forward to working with the FDA as we prepare to submit our PMA modules later this year, bringing us closer to making our innovative cervical disc prosthesis available to patients in the United States."
CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.
About the BAGUERA®C Cervical Disc Prosthesis
The BAGUERA®C cervical disc prosthesis, developed by Spineart, is an investigational device in the U.S., designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA®C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations).
About Spineart
Spineart is a global fast-growing company in spine surgery innovation, dedicated to accelerating the adoption of cutting-edge technologies for surgeons and hospitals worldwide for the benefit of their patients. Renowned for its commitment to Quality, Innovation, and Simplicity, Spineart continues to push the boundaries of spinal surgery with its comprehensive portfolio of procedural solutions and digital technologies. Spineart was awarded the "Prix de l'Economie Genevoise 2022" for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles.
Please visit www.spineart.comand follow on LinkedIn. For media inquiries or further information, contact press@spineart.comor visit www.spineart.com/media
