Spineart completed a planned interim analysis for its 1-level BAGUERA-C IDE study, which showed that the cervical disc prosthesis met the threshold for a non-inferiority claim against the study control (Mobi-C, Highridge Medical).
Spineart has now agreed on a timeline with FDA for the submission of Premarket Approval for BAGUERA-C in three 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 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.”
Spineart completed a planned interim analysis for its 1-level BAGUERA-C IDE study, which showed that the cervical disc prosthesis met the threshold for a non-inferiority claim against the study control (Mobi-C, Highridge Medical).
Spineart has now agreed on a timeline with FDA for the submission of Premarket Approval for BAGUERA-C in three...
Spineart completed a planned interim analysis for its 1-level BAGUERA-C IDE study, which showed that the cervical disc prosthesis met the threshold for a non-inferiority claim against the study control (Mobi-C, Highridge Medical).
Spineart has now agreed on a timeline with FDA for the submission of Premarket Approval for BAGUERA-C in three 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 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.”
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