Amphix Bio’s Bone Regeneration Product Wins FDA Breakthrough Nod

Amphix Bio has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for a drug-device combination product for bone regeneration.
 
The designation covers use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures. The company said it’s the first product based on supramolecular peptide amphiphiles.
 
“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.”
 
Through the Breakthrough Devices program, the Amphix Bio team will have more frequent and efficient communication with the FDA, as well as priority review for future regulatory submissions.
 
“This designation from the FDA is a major milestone for supramolecular therapeutics, and validates the high unmet need that our approach addresses,” said Samuel Stupp, Ph.D., co-founder and chief scientific officer of Amphix Bio, and a Professor at Northwestern University. “The expedited assessment and review are especially important given that we are aiming to advance an entirely new regenerative medicine platform to the clinic.”