Amber Implants, a developer of next-gen implants for spinal injuries, completed one-year follow-up for all patients enrolled in its first-in-human trial of its VCFix spinal system for vertebral compression fractures.

VCFix was designed to restore fractured vertebra and stabilize affected spinal segments. Its design supports treatment of a range of vertebral fracture types, both with and without cement and with or without posterior fixation.

No device-related adverse events were reported at one year. Improvements in key clinical performance outcomes were also seen, regardless of cement augmentation.

Patients both with and without cement had immediate, sustained pain level reduction, assessed by the Numeric Pain Rating Scale (NPRS). By the six-month follow-up, pain scores dropped by over eight points.

Disability scores measured with the Oswestry Disability Index (ODI) also demonstrated pot-op improvement, with 84-point reduction from baseline to six months. The improvements were maintained through the one-year follow-up, showing lasting functional benefits.

“Behind every data point is a patient whose quality of life has been improved,” said Dr. Mohammad Ahmadi, co-founder and chief technology officer of Amber Implants. “These one-year results reinforce our mission to provide safer, more effective solutions for people suffering from painful spinal fractures. The encouraging data provides a solid foundation as we move towards our goal of bringing this innovative technology to many more patients across Europe and beyond.”

The company is preparing to begin its pivotal trial at multiple European sites. The study will evaluate VCFix’s safety and efficacy in its standalone configuration—with or without bone cement—in a larger number of patients.

“This milestone marks a critical inflection point for Amber Implants,” said Dr. Banafsheh Sajadi, co-founder and CEO of Amber Implants. “With a clean safety profile and encouraging early clinical outcomes, we are well-positioned to advance VCFix into the pivotal stage and unlock significant clinical and commercial value. Our vision is to establish a new standard of care in vertebral fracture management.”