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# Breakthrough Status for Bone Regeneration Product
- URL: https://www.fdaweb.com/breakthrough-status-for-bone-regeneration-product/
- Published: 2024-10-03T12:00:00.000Z
- Updated: 2026-09-14T14:43:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157914

FDA has granted Amphix Bio a breakthrough device designation for its supramolecular peptide amphiphiles-based drug-device combination product for bone regeneration. The designation applies to the product’s use to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures, according to the company. “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,” Amphix says.