Amber Implants has received clearance from the US Food and Drug Administration (FDA) for its VCFix Spinal System. The VCFix Spinal System is a vertebral augmentation system designed to treat a broad spectrum of vertebral compression fractures. This minimally invasive solution is used with bone cement and provides strong anterior and posterior column support. It integrates seamlessly into existing surgical workflows, with the potential to improve spinal stabilisation, reduce patient risk and shorten procedure times, compared to current options.

One-year follow-up data from initial clinical trials of the VCFix Spinal System, announced in June 2025, demonstrated immediate and sustained reduction in pain, improved spinal stability and faster recovery, underscoring its potential for lasting functional benefits. The company is also working towards CE marking in the European Union (EU), aiming for broad labeling that supports both stand-alone use of VCFix and integration with posterior fixation systems.

Dr Banafsheh Sajadi, Co-Founder and Chief Executive Officer (CEO), Amber Implants, said, "The VCFix Spinal System is a ground-breaking vertebral augmentation solution with the potential to establish a new standard of care in vertebral fracture management, reinforcing Amber Implants's role as a global innovator in spinal fracture solutions. The US, as the world's largest medtech market, provides an ideal platform for growth with a potential market in excess of €800m, and this clearance lays the foundation to initiate our commercial launch activities."

Each year, more than nine million people worldwide suffer vertebral compression fractures, including around two million across North America and Europe. Despite this high prevalence, up to two-thirds of cases remain undiagnosed and undertreated, leaving elderly and frail patients—most often with osteoporosis—at risk of chronic pain, spinal deformity, disability and loss of independence. Current treatment options are limited: kyphoplasty is minimally invasive but fails to provide posterior support for fractures, while posterior fixation is invasive, restricts motion and prolongs recovery with higher morbidity. The VCFix Spinal System addresses these gaps as a minimally invasive solution that uniquely supports both anterior and posterior columns, integrates seamlessly into existing surgical workflows and delivers greater stability with less patient risk.

Dr Mohammad Ahmadi, Co-Founder and Chief Technology Officer (CTO), Amber Implants, added, "We will begin our US commercial launch with a pilot programme in early 2026, accompanied by the expansion of the EXPAND pivotal trial into the US. This will be followed by broader physician availability from later in 2026. At the same time, we continue to pursue EU label expansion for stand-alone use and integration with one level fixation."

Amber Implants is now a commercial stage company, preparing for its US launch in 2026. The company is on track to capture a significant share of the global €2 billion+ vertebral compression fracture market by 2029.