Amber Implants Moves Forward With European Study of its VCFix Spinal System

Amber Implants today announced the advancement of its pivotal EXPAND clinical study evaluating the VCFix Spinal System in patients with vertebral compression fractures.

The EXPAND trial is a prospective, multicenter European clinical evaluation of the VCFix Spinal System to assess the safety, performance, and clinical outcomes tied to vertebral reconstruction using VCFix in vertebral compression fractures where anatomic restoration and structural support may be clinically meaningful, including use in a standalone configuration (with or without bone cement). Additional clinical participation is expected as European enrollment continues.

The EXPAND study builds on Amber Implants’ first-in-human clinical program, which demonstrated sustained pain reduction, improved spinal stability, and durable functional outcomes. The pivotal trial was initially launched at two clinical sites, where the first 15 patients were enrolled. Following these early results, Amber Implants expanded the study to eight centers across Germany and France, broadening patient access and ensuring the VCFix Spinal System’s evaluation across a more diverse patient population and clinical settings.

“The EXPAND study represents an important step in the maturation of our clinical program,” Amber Implants Co-Founder/Chief Operating Officer Dr. Banafsheh Sajadi said. “By evaluating VCFix in a standalone configuration, with or without bone cement, EXPAND reflects an important evolution in vertebral reconstruction, focused not only on treating the fracture, but also supporting three-column spinal stability. As we continue building evidence across Europe, we are simultaneously preparing for focused clinical adoption of VCFix in appropriately selected patients. The combination of encouraging patient outcomes, physician interest, and growing clinical experience reinforces our belief that VCFix represents an important advancement for physicians seeking new options in vertebral reconstruction.”

Vertebral fractures are a growing health burden, with an estimated 5.4 million people affected worldwide in 2021 and approximately 7.5 million new cases annually.ⁱ Despite this prevalence, many fractures remain undiagnosed or undertreated, leaving patients at risk of chronic pain, spinal deformity, disability, and loss of independence. Current treatment options often require a compromise between minimally invasive procedures that may not provide comprehensive structural support and more invasive fixation approaches associated with greater procedural burden and reduced mobility. VCFix aims to address the limitations of current treatment approaches through a minimally invasive procedure while integrating seamlessly into existing procedural workflows.

“EXPAND represents the next critical step in validating a treatment philosophy centered on vertebral reconstruction rather than augmentation alone,” Amber Implants Co-Founder/Chief Technology Officer Dr. Mo Ahmadi stated. “By generating clinical evidence across multiple centers, we aim to further demonstrate how the new technology of VCFix may benefit appropriately selected patients while helping physicians address important unmet needs in vertebral fracture care.”

Amber Implants continues to advance regulatory and commercialization activities in both Europe and the United States. The company expects ongoing clinical experience and evidence generation to support physician education, market development initiatives, and disciplined adoption in defined vertebral fracture populations.

The VCFix Spinal System is a vertebral augmentation solution that treats a broad spectrum of vertebral compression fractures. In the EXPAND study, VCFix is being evaluated in a standalone configuration, with or without bone cement, to assess safety, performance, and clinical outcomes in participating European centers. The system integrates into existing procedural workflows while providing physicians with a flexible approach to anatomic restoration and targeted structural support.

Amber Implants is a medical technology company developing vertebral fracture treatment through an integrated, minimally invasive platform designed to restore spinal anatomy and enable targeted stabilization. Rather than treating fractures as a void-filling problem alone, Amber addresses spinal biomechanics by supporting structural integrity, load-bearing function, and motion preservation. Led by VCFix, its flagship vertebral reconstruction system, and supported by Spinoza fixation (under development) for more complex cases, Amber provides anatomic restoration based on physician preference and clinical indication—advancing a more complete, targeted approach to spine care.

Reference
ⁱ Lei H, Huang Z, Wang F, et al. Global burden of vertebral fractures from 1990 to 2021 and projections for the next three decades. Journal of Orthopaedic Surgery and Research. 2025;20:480.