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AMFX-100

Development stage: Preclinical
Lead developer: Amphix Bio
Modality: Implantable Devices → Device-based Delivery → Drug Delivery Systems, Transdermal Patches → Device-based Delivery → Drug Delivery Systems, Peptides, Inhalation Devices → Device-based Delivery → Drug Delivery Systems
Administration: Implant

Overview

**AMFX-100** is an off-the-shelf bone graft substitute developed by Amphix Bio for spinal fusion surgery to treat degenerative disc disease. It utilizes supramolecular therapeutic peptides (STPs) that function dually as pharmacological agents activating cell receptors and as nanofiber scaffolds promoting tissue regeneration and new bone formation. This enables orthopedic procedures without donor tissue or recombinant proteins like rhBMP-2, addressing safety concerns of current options. AMFX-100 received FDA Breakthrough Device Designation in October 2024.[3][5][7][10]

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