Amphix Bio, a company developing a new class of regenerative medicine therapies, announced today it has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for a drug-device combination product for bone regeneration. The designation covers the use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures.
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.
Amphix Bio spun out from Northwestern University in Chicago, IL in 2021. The company is developing a new class of supramolecular therapies that instruct cells to initiate regenerative processes and restore function lost from injury, disease, or aging. These therapies contain tens of thousands of biological signals that trigger targeted signaling pathways while forming scaffolds to support tissue growth. Amphix Bio’s goal is to use regenerative medicine to increase human healthspans — the length of time that people can live productive, fulfilling lives.
