Amber Implants has announced that its VCFix spinal system, which aims to improve the treatment of vertebral fractures, has been granted breakthrough device designation by the US Food and Drug Administration (FDA).
The FDA breakthrough device program aims to provide 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.
The decision allows Amber Implants to have direct and interactive communications with the US 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.
Banafsheh Sajadi, founder & CEO of Amber Implants, said: “Receiving US 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 US, taking us one step closer to improving the quality of life of patients with vertebral fractures.”
The VCFix spinal system is the first solution to treat vertebral fractures that does not rely on bone cement say Amber Implants. 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.