Amber Implants’ VCFix Spinal System Designated Breakthrough Device by FDA

The FDA has designated Amber Implants’ VCFix spinal system for improving the treatment of vertebral fractures as a breakthrough device.

The 3D-printed device treats vertebral fractures without relying on bone cement. The implant is intended to stimulate bone ingrowth while providing better stability and better distribution of loads in the spine, the company said.

“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.,” said Banafsheh Sajadi, the company’s CEO and founder.