Amber Implants, an innovative medical technology company developing next-generation spinal implants for spinal injuries, announces its VCFix spinal system, which aims to improve the treatment of vertebral fractures, has been granted the Breakthrough Device Designation by the US FDA.

The US FDA Breakthrough Device program provides patients with 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 US FDA and priority review. Amber Implants will also have more flexibility concerning clinical studies, a dedicated team for reviewing the application, and reimbursement through Medicare for 4 years.

Dr. Banafsheh Sajadi, Founder & CEO of Amber Implants, said, "Our First-In-Human clinical trial is expected to commence in early 2022 both in Europe and the US, taking us one step closer to improving the quality of life of patients with vertebral fractures."

VCFix spinal system is the first solution to treat vertebral fractures that do not rely on bone cement. Through its 3D-printed perforated structure, 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. The promise of Amber Implants is to bring an easier, more efficient and safer treatment for a broader type of fractures to the market.