100U.S. PATIENTS TREATED IN THE SINGLE LEVEL IDE CLINICAL TRIAL OF THE BAGUERA® C CERVICAL DISC PROSTHESIS

LAGUNA HILLS, CA., April 21, 2022 /PRNewswire/ — Spineart UNITED STATES Inc. today announced that surgery has been performed on 100 patients in the single-level U.S. investigational device exemption (IDE) clinical trial of the BAGUERA® C Cervical Disc Prosthesis. The BAGUERA ® C implant is an investigational device in the United States designed to reconstruct the cervical disc after discectomy for symptomatic cervical disc disease.

Spineart is currently conducting a concurrent one- and two-level IDE clinical trial of the BAGUERA ® C Cervical Disc Prosthesis at more than 20 sites in the United States. The two-tier study is also expected to reach the benchmark of 100 patients. in the coming month, bringing the total number of surgeries performed to more than 200.

Surgery to treat cervical degenerative disc disease is usually considered when neurological symptoms are present, such as persistent arm numbness and/or weakness, or when chronic pain is severe and not sufficiently relieved after at least six months of non-surgical treatments and daily activities. become difficult. Artificial cervical disc replacement involves removing the problematic disc and replacing it with an artificial prosthesis. The goal of this surgery is to restore height and preserve motion at this level of the spine.

ABOUT THE BAGUERA ® C CERVICAL DISC PROSTHESIS:

The BAGUERA ® C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device in the United States designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- and two-level discectomy for symptomatic cervical disc disease. The BAGUERA® C is designed to maintain the natural behavior of a functional vertebral unit. This design allows the BAGUERA® C core to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral flexion and axial rotation) as well as independent translational movements (antero-posterior and lateral translations).

To find a clinical study site near you or to learn more about IDE, visit: https://www.spineart.com/us/ide-clinical-investigation/

CAUTION—Investigative device. Limited by United States right to use for investigative purposes.

SOURCE Spineart

Elna M. Lemons