Unternehmen

Spineart today announces that it has completed a planned interim analysis for its 2-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.

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.

Spineart and eCential Robotics proudly announce the 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Spineart PERLA® TL application (PERLA® App) for use with the new eCential Robotics Op.n^TM robotic navigation platform.

This clearance marks a significant milestone in advancing robotic-assisted spine surgery and demonstrating new ways to innovate by combining Spineart’s and eCential Robotics‘ expertise. The newly approved PERLA® App, which further integrates the Spineart PERLA® TL Open and MIS screw systems with the eCential Op.n^TM platform, offers a Spineart navigation-specific interface and dedicated Spineart navigated instruments, aiming to enhance surgical precision and procedural workflow. Additionally, by expanding the range of 3D C-arms compatible with the system, Spineart and eCential underscore their ability to provide cutting-edge solutions while optimizing available resources at medical facilities through modular solutions.

„We are excited to announce the 510(k) clearance for our first PERLA® App on the eCential Op.n^TM platform. This underscores our commitment to delivering advanced procedural solutions to spine surgeons, ultimately benefiting their patients. Our partnership with eCential Robotics in surgical and robotic navigation has empowered us to pursue an innovative approach that enhances precision and workflow efficiency in the operating room while utilizing our implants and instruments for spine surgery.“ said Jerome Trividic, CEO of Spineart.

„This 510(k) clearance shows our dedication to innovation and increasing the capabilities and modularity of our Op.n^TM platform for surgical and robotic navigation,“ said Clement Vidal, CEO of eCential Robotics. „By combining our partner Spineart’s spine systems with our expertise in advanced robotic navigation, we are bringing a transformative solution to the operating room, benefiting both surgeons and patients while optimizing cost for medical facilities.”

Building on this successful collaboration, Spineart and eCential Robotics will continue to join forces to drive further innovation on the Op.n^TM platform.

Spineart 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).