Amber Implants Receives FDA Breakthrough Status for Spinal System
The US FDA 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 US FDA and priority review. Amber Implants will also have more flexibility regarding clinical studies, a dedicated team for reviewing the application, and reimbursement through Medicare for four years.
Dr. 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.”
Yearly, over 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% 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, 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.
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