Amber Implants VCFix Spinal System Earns FDA Breakthrough Nod

Amber Implants, a medical technology company developing next-generation spinal implants for spinal injuries, said its VCFix spinal system, which aims to improve the treatment of vertebral fractures, has been granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
 
The FDA’s Breakthrough Device program provides patients more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This enables Amber Implants to have direct and interactive communications with the FDA and priority review. Amber Implants will also have more flexibility with regard to clinical studies, a dedicated team for reviewing the application, and reimbursement through Medicare for four years.
 
Dr. Banafsheh Sajadi, founder and CEO of Amber Implants, said: “Receiving FDA Breakthrough Designation is a tremendous recognition that will boost our efforts to bring VCFix to patients. This development speeds up our timeline significantly, with our first-in-human clinical trial expected to commence in early 2022 both in Europe and the U.S., taking us one step closer to improving the quality of life of patients with vertebral fractures.”
 
Yearly, more than 1.5 million people suffer from vertebral fractures, which cause the patients severe back pain, limited mobility, and increased rate of mortality in an already vulnerable elderly population. Currently, these injuries are treated with injection of PMMA bone cement into the vertebra, and 65 percent of the patients are facing different types of side-effects after treatment.  
 
VCFix spinal system is the first solution to treat vertebral fractures that does not rely on bone cement. Through its 3D-printed perforated structure, the VCFix implant aims to stimulate bone ingrowth as a more natural healing process, while providing better stability and better distribution of loads in the spine. It is optimized for mechanical strength, maximum fracture reduction and anatomical restoration. VCFix provides pedicle anchorage for better stability, better distribution of loads on the middle and posterior columns of the spine and also, possibility for posterior fixation for more unstable fractures. The VCFix spinal system is provided with a user-friendly single-use sterile surgical kit for perfect traceability and reduced risks of infection.  

Amber Implants is located in the Netherlands and United States. Founded in 2018, the company has developed the next generation of spinal implants for vertebral compression fractures (VCF), and is focussed on improving patient outcomes through implants that provide more natural healing and stability. Using additive manufacturing (AM) and higher precision CNC technologies, Amber Implants has developed expandable implants used to create solutions for spinal and other orthopedic disorders.