Exploring the FDA Grants Breakthrough Device Designation for Amphix Bio's Bone Regeneration Product

FREMONT, CA: Amphix Bio, a startup creating a new class of regenerative medicine medicines, said today that it has been designated a Breakthrough Device by the United States Food and Drug Administration for a drug-device combination product for bone regeneration. The designation applies to using the therapeutic device to treat degenerative disc disease using transforaminal lumbar interbody fusion (TLIF) procedures. The Breakthrough Devices Program aims to speed up developing, evaluating, and reviewing innovative medical devices or drug-device combination products to treat debilitating diseases or disorders effectively.

"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."

The Breakthrough Devices initiative will enable the Amphix Bio team to communicate with the FDA more frequently and efficiently and prioritize future regulatory submissions. This is the agency's first product evaluation based on supramolecular peptide amphiphiles, Amphix Bio's primary technology platform.

"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, PhD, 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."