Amphix Bio earned FDA breakthrough device designation for a bone regeneration drug-device combination, according to an Oct. 3 news release.
The designation applies to the use of a therapeutic device for degenerative disc disease in transforaminal lumbar interbody fusion.
"The technology that Amphix Bio is developing could offer several critical advantages compared to products currently available for TLIF spine surgeries," Wellington Hsu, MD, a clinical advisor for Amphix Bio, said in the release. "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."
Breakthrough device designation will help accelerate the development, assessment and review for Amphix Bio's biologic.