Amber Implants Advances Pivotal European EXPAND Study of VCFix® Spinal System in Standalone Vertebral Reconstruction

The Hague, Netherlands, (ZEEST MEDIA) — Amber Implants, a medical technology company redefining vertebral fracture treatment through minimally invasive reconstruction and targeted stabilization, today announced the advancement of its pivotal EXPAND clinical study evaluating the VCFix® Spinal System in defined patients with vertebral compression fractures.

The EXPAND study is a prospective, multicenter European clinical evaluation of the VCFix® Spinal System to assess safety, performance, and clinical outcomes associated with vertebral reconstruction using VCFix® in patients with 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 enrollment continues across Europe.

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

“The EXPAND study represents an important step in the maturation of our clinical program,” said Dr. Banafsheh Sajadi, Co-Founder and Chief Operating Officer of Amber Implants. “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® is intended to address limitations associated with 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,” said Dr. Mo Ahmadi, Co-Founder and Chief Technology Officer of Amber Implants. “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.

About the VCFix® Spinal System
The VCFix® Spinal System is a vertebral augmentation system designed to treat 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 across participating European centers. The system is designed to integrate into existing procedural workflows while providing physicians with a flexible approach to anatomic restoration and targeted structural support.

About Amber Implants
Amber Implants is a medical technology company redefining 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.

Contact Data

Vincent Gardès
Amber Implants
(+31) 6 48 48 2799
v.gardes@amberimplants.com