Amphix Bio, a company focused on regenerative medicine, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its innovative drug-device combination product designed for bone regeneration. This designation specifically applies to the treatment of degenerative disc disease through transforaminal lumbar interbody fusion (TLIF) procedures.
The FDA's Breakthrough Devices Program aims to accelerate the development and assessment of novel medical devices and drug-device combinations that offer more effective treatment for debilitating conditions. Amphix Bio's technology is based on supramolecular peptide amphiphiles, representing a new approach to regenerative medicine.
Wellington Hsu, MD, a spine surgeon at Northwestern Medicine and Clinical Advisor for Amphix Bio, stated that the technology "could offer several critical advantages compared to products currently available for TLIF spine surgeries." He highlighted the moldability of the material, which allows surgeons to easily apply it in various surgical settings and challenging anatomies. Furthermore, the implant's ability to induce bone growth without the need for donor tissue or recombinant proteins could make it a safer, simpler, and more effective bone graft for spinal fusion.
Advantages of the Breakthrough Device Designation
With the Breakthrough Device designation, Amphix Bio will benefit from more frequent and efficient communication with the FDA, as well as priority review for future regulatory submissions. This expedited process is particularly significant as this product is the first based on supramolecular peptide amphiphiles to be evaluated by the agency.
Samuel Stupp, PhD, co-founder and Chief Scientific Officer of Amphix Bio, and a Professor at Northwestern University, emphasized the importance of this milestone: "This designation from the FDA is a major milestone for supramolecular therapeutics and validates the high unmet need that our approach addresses. The expedited assessment and review are especially important given that we are aiming to advance an entirely new regenerative medicine platform to the clinic."
About Amphix Bio
Spun out from Northwestern University in 2021, Amphix Bio is dedicated to developing supramolecular therapies that stimulate cells to initiate regenerative processes, restoring function lost due to injury, disease, or aging. Their therapies utilize tens of thousands of biological signals to trigger targeted signaling pathways while forming scaffolds that support tissue growth. Amphix Bio's overarching goal is to extend human healthspans through regenerative medicine.
