Amphix Bio secures SBIR award to advance regenerative technology for spinal fusion
February 24, 2022
Amphix Bio has received a Small Business Innovation Research (SBIR) Phase I grant from the National Science Foundation (NSF) to advance a new bone regeneration technology for treating debilitating back pain caused by degenerative disc disease.
The company is developing a bone graft substitute that will enable orthopedic surgeons to perform spinal fusion with low doses of recombinant growth factor and without the use of donor tissue, which could significantly improve the safety of these procedures. The product is part of a novel treatment platform based on supramolecular peptide nanofibers, each of which contains thousands of biological signals that communicate with cells to initiate regenerative processes.

Charlotte Chen, Lead R&D Scientist at Amphix Bio, will be principal investigator of the NSF grant.
​This cell-free technology is markedly different from small-molecule drugs and other peptide therapies on the market, and therefore requires new strategies for scale-up. With the SBIR grant, the Amphix team will establish larger-scale manufacturing and purification processes for the peptide amphiphile molecules in the spinal fusion product and ensure that the final materials are equivalent to those previously synthesized at smaller scales for academic research.
The molecules will be synthesized using methods that are compatible with large-scale GMP production. In addition, the Amphix team will aim to develop a shelf-stable, clinically viable formulation of the material that can be easily handled and applied within operating rooms.
Charlotte Chen, PhD, Lead R&D Scientist at Amphix Bio, is the principal investigator of the NSF award and will lead the materials development and characterization. Erin Hsu, PhD, professor of orthopedic surgery at Northwestern University, will perform preclinical spinal fusion experiments at her Northwestern-based lab under a subaward from the grant.