Netherlands-based Amber Implants has completed enrolment in its first-in-human trial evaluating the VCFix spinal system for the treatment of vertebral compression fractures, reporting positive short-term efficacy.
The Dutch company conducted the early-stage trial at two centres in Germany to assess the safety and efficacy of the implant in patients suffering from osteoporotic vertebral compression fractures, a break in a spinal bone caused by bone-weakening disease.
Osteoporotic vertebral compression fractures cause limited movement in the spine along with pain, which can increase with motion. There are around 1.5 million vertebral compression fractures each year in the US.
The device is the first of its kind that does not rely on bone cement, according to Amber Implants. The system restores the spine and provides flexibility with application across a wide range of fractures, from low-energy breaks to high-energy ones.
The trial enrolled ten patients with severe disabling pain arising from the condition, with Disability Ratings of 70% or higher. After being implanted with the VCFix system, all patients saw maximal pain reduction with Disability Ratings reduced to 10% or less, according to the company. Patients were also able to walk freely without impairment when leaving the hospital. The device was primarily used in stand-alone configuration without bone cement.
Amber Implants stated that further assessment will continue in the rest of the trial.
Amber Implants CEO Dr Banafsheh Sajadi said: "Short-term efficacy data from the study is very promising, with results even exceeding our expectations. Patients have experienced significant pain relief and regained the ability to walk without discomfort.”
A pivotal clinical trial in the same indication will soon be kicked off as well, in addition to a test with a posterior fixation method for high-energy traumatic fractures.
A US Food and Drug Administration (FDA) clearance for a first indication is slated by early 2025. The device has breakthrough designation status from the agency, meaning it is eligible for expedited market access and an enhanced pre-market review phase.
Sajadi added: “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.”
The vertebral compression fracture repair device market was worth $646.5m in 2022, estimated to rise to $1.1bn by 2033, according to analysis by GlobalData. The market is made up of vertebroplasty procedures and kyphoplasty procedures. GlobalData states the vertebroplasty market – which includes cement injection – is shrinking due to the rise of minimally invasive procedures using kyphoplasty devices.
A market model by Global reports that Medtronic dominates the global market. The medical device giant occupies nearly a 50% share globally, including 67.8% in North America.
