Amber Implants has finished enrollment for its first-in-human trial of the VCFix spinal system for osteoporotic vertebral compression fractures.
 
The study, which began in October 2023, enrolled 10 patients suffering from severe, disabling pain with Disability Ratings of 70% and above. After the procedure, patients has maximal pain reduction with Disability Ratings lowered to 10% or less. They were also able to walk freely without disability at discharge, the company reported.
 
The trial was staged at two German Centers with Prof. Dr. Med. Robert Pflugmacher (Orthopaedic surgeon, Kreiskrankenhaus Mechernich GmbH.) and Dr. Med. Ardeshir Ardeshiri (Neurosurgeon, Wilhelmsburger Krankenhaus Groß-Sand Hamburg).
 
Short-term efficacy data and the device’s performance has shown favorable results and will be further assessed in the trial. VCFix also touts breakthrough designation from the U.S. Food and Drug Administration (FDA).
 
“VCFix represents a remarkable innovation, significantly improving the reconstruction of fractured vertebrae,” said Prof. Dr. Med. Robert Pflugmacher.
 
“This technology has proven to be user-friendly and has yielded exceptional short-term outcomes for our patients,” added Dr. Med. Ardeshir Ardeshiri.
 
VCFix is the first device that doesn’t rely on bone cement to treat vertebral compression fractures. Today, these fractures are managed with Polymethyl Methacrylate (PMMA) bone cement injection into the affected vertebra and/or with multi-level posterior fixation. Two-thirds of patients can have side effects from this post-treatment.
 
The device can be used for indications from osteoporotic low-energy fractures to traumatic high-energy fractures, according to Amber Implants.
 
“Short-term efficacy data from the study is very promising, with results even exceeding our expectations,” said Amber Implants co-founder and CEO Dr. Banafsheh Sajadi. “Patients have experienced significant pain relief and regained the ability to walk without discomfort. VCFix has the potential to be a disruptive technology for the millions of patients who suffer from vertebral fractures each year. We are now focused on preparing for pivotal trials in Europe to bring the benefits of this technology to the many more patients who would otherwise suffer from the high rate of complications associated with other treatment options available.”