The Breakthrough Devices Program is intended to accelerate the development, assessment, and review of new medical devices or drug-device combination products for more effective treatment of debilitating diseases or conditions.

“The technology that Amphix Bio is developing could offer several critical advantages compared to products currently available for TLIF spine surgeries,” said Wellington Hsu, MD, a spine surgeon at Northwestern Medicine and Clinical Advisor for Amphix Bio. “The moldability of the material will enable surgeons to easily apply it in various surgical settings and challenging anatomies, and the implant can induce bone growth without the use of donor tissue or recombinant proteins. All these factors could make this a safer, simpler, and more effective bone graft for spinal fusion.”