FDA grants Breakthrough Device designation to Amphix Bio's bone regeneration product

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Oct 03, 2024, 13:46 ET

CHICAGO, Oct. 3, 2024 /PRNewswire/ -- 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.

"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 is the first product based on supramolecular peptide amphiphiles — Amphix Bio's core technology platform — to be evaluated by the agency.

"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."

About Amphix Bio

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.

Learn more at www.amphixbio.com, or contact us at [email protected].

SOURCE Amphix Bio