INTERIM ANALYSIS OF 2-LEVEL BAGUERA® C IDE STUDY MEETS THRESHOLD FOR NON-INFERIORITY

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16 Apr, 2025, 10:00 GMT

GENEVA, April 16, 2025 /PRNewswire/ -- Spineart, a fast-growing company in spine surgery innovation, today announces that it has completed a planned interim analysis for its 2-level BAGUERA^® C IDE study, which showed that BAGUERA^® C, its cervical disc prosthesis, met the threshold for a non-inferiority claim against the study control.

Last month, Spineart announced that its interim analysis for its 1-level BAGUERA^® C IDE study had also showed that BAGUERA^® C had met the threshold for a non-inferiority claim against the study control and that it had agreed on a timeline with the U.S. FDA for the submission of a modular Premarket Approval (PMA) for BAGUERA^® C.

Spineart has agreed with the U.S. FDA to submit the interim results from both IDE studies under the same PMA. Completion of this combined PMA submission remains scheduled for the end of August 2025, potentially enabling an earlier approval than had originally been anticipated.

The BAGUERA^® C 1-level and 2-level IDE trials are prospective, multi-center, randomized clinical studies evaluating the safety and efficacy of BAGUERA^® C compared with the Mobi-C^® cervical disc in the treatment of symptomatic cervical disease at one level and two contiguous levels in the cervical spine. The studies enrolled close to 600 patients at 30 sites in the U.S. Results of these clinical trials are intended to be the basis of a PMA submission to the U.S. FDA.

Jerome Trividic, Chief Executive Officer at Spineart, commented: "The interim analysis data from our 2-level study is a significant milestone for Spineart, coming less than a month after the promising interim results of our 1-level study. These findings bring us closer to providing patients with a highly effective solution for treating symptomatic cervical disease at multiple levels, potentially improving their quality of life. We are committed to advancing spinal health and working with the FDA to bring BAGUERA^® C to patients in the United States."

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.

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.com and follow on LinkedIn.

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