Société

Spineart has successfully raised a CHF20 million convertible financing. The funding comes on the heels of the completion of enrollment in the two BAGUERA® C IDE studies, underlining Spineart’s commitment to advancing spinal surgery through large scale investments in research and development. More than CHF15 million of the funding was contributed by existing shareholders and employees, with the remaining portion sourced from new investors, above its CHF20 million initial target.

« We are thrilled to announce the successful closure of our CHF20 million convertible financing round, which underscores the confidence and support of our investors in Spineart’s vision and innovative technologies, » said Jerome Trividic, CEO of Spineart. « The overwhelming participation from existing shareholders, as well as the addition of new investors, is a testament to the potential of our BAGUERA® C cervical disc prosthesis and our commitment to improve spinal surgery through enabling technologies and robotic navigation. »

The proceeds from the financing round will be used for several strategic initiatives. These include investments in novel enabling technologies, continued follow-up of patients enrolled in the two BAGUERA® C IDE studies, completion by the end of 2024 of a new 43,000sqft / 4,300 m² factory currently under construction near Geneva and the opening this summer of Spineart’s new R&D and Training Center for Enabling Technologies in Dallas, Texas.

About the BAGUERA® C IDE studies:

The BAGUERA® C IDE studies are pivotal in evaluating the safety and efficacy of Spineart’s innovative BAGUERA® C cervical disc prosthesis, designed to address degenerative cervical disc disorders. The completion of enrollment in these studies marks a crucial step forward in bringing this new technology to market in the United States.

Spineart SA today announced it has completed enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with cervical disc disease at two contiguous levels between C3 to C7 compared to a commercially marketed cervical disc implant.

The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint of the study is the clinical success rate of BAGUERA®C in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The Company announced the completion of enrollment for its one-level IDE trial at the end of February 2024.

Jerome Trividic, CEO of Spineart, said, “The enrollment completion of our two-level BAGUERA®C IDE study marks a significant milestone in Spineart’s ambition to emerge as a global leader in spine arthroplasty. Coupled with the ongoing one-level BAGUERA®C IDE study, Spineart is spearheading the gathering of crucial long-term clinical evidence from nearly 600 artificial disc recipients across the United States. This unprecedented achievement underscores our commitment to advancing the adoption of cutting-edge technologies in spinal surgery. We extend our sincere gratitude to our esteemed investigators and their teams whose dedicated participation has been instrumental in this endeavor. We eagerly anticipate bringing these two studies to fruition. »

Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, NC, and co-lead investigator of the IDE trials, stated, “The outcomes from this study will further build the level I evidence supporting the safety and effectiveness of cervical disc arthroplasty with its head-to-head comparison against another cervical implant with similar design features.”

The BAGUERA®C Cervical Disc prosthesis is evaluated in two separate IDE trials in the U.S. for one- and two-level cervical disc disease. The BAGUERA®C implant has been commercially available in selected European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.

Spineart SA today announced it has completed enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with cervical disc disease at two contiguous levels between C3 to C7 compared to a commercially marketed cervical disc implant.

The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint of the study is the clinical success rate of BAGUERA®C in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The Company announced the completion of enrollment for its one-level IDE trial at the end of February 2024.

Jerome Trividic, CEO of Spineart, said, “The enrollment completion of our two-level BAGUERA®C IDE study marks a significant milestone in Spineart’s ambition to emerge as a global leader in spine arthroplasty. Coupled with the ongoing one-level BAGUERA®C IDE study, Spineart is spearheading the gathering of crucial long-term clinical evidence from nearly 600 artificial disc recipients across the United States. This unprecedented achievement underscores our commitment to advancing the adoption of cutting-edge technologies in spinal surgery. We extend our sincere gratitude to our esteemed investigators and their teams whose dedicated participation has been instrumental in this endeavor. We eagerly anticipate bringing these two studies to fruition. »

Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, NC, and co-lead investigator of the IDE trials, stated, “The outcomes from this study will further build the level I evidence supporting the safety and effectiveness of cervical disc arthroplasty with its head-to-head comparison against another cervical implant with similar design features.”

The BAGUERA®C Cervical Disc prosthesis is evaluated in two separate IDE trials in the U.S. for one- and two-level cervical disc disease. The BAGUERA®C implant has been commercially available in selected European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.