Chicago-based biotech company receives FDA recognition for innovative spinal implant
In a significant development for the field of regenerative medicine, Amphix Bio announced on October 3, 2024, that it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its novel bone regeneration product. This designation applies to the company’s drug-device combination product designed to treat degenerative disc disease in transforaminal lumbar interbody fusion (TLIF) procedures.
Breakthrough Device Program
The FDA’s Breakthrough Devices Program aims to accelerate the development, assessment, and review of promising medical devices or drug-device combination products. This program is specifically designed for technologies that offer more effective treatment options for debilitating diseases or conditions.
Potential Advantages
Dr. Wellington Hsu, a spine surgeon at Northwestern Medicine and Clinical Advisor for Amphix Bio, highlighted the potential advantages of the company’s technology:
- Moldability: The material can be easily applied in various surgical settings and challenging anatomies.
- Bone growth induction: The implant can stimulate bone growth without the need for donor tissue or recombinant proteins.
- Improved safety and efficacy: These factors could lead to a safer, simpler, and more effective bone graft for spinal fusion procedures.
Benefits of Breakthrough Designation
With this designation, Amphix Bio will enjoy several benefits:
- More frequent and efficient communication with the FDA
- Priority review for future regulatory submissions
This marks a significant milestone for Amphix Bio, as it’s the first product based on their core technology platform of supramolecular peptide amphiphiles to be evaluated by the FDA.
Amphix Bio’s Innovative Approach
Dr. Samuel Stupp, co-founder and Chief Scientific Officer of Amphix Bio, as well as a Professor at Northwestern University, emphasized the importance of this designation:
“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
Founded in 2021 as a spin-out from Northwestern University in Chicago, Amphix Bio is at the forefront of developing a new class of supramolecular therapies. These innovative treatments are designed to instruct cells to initiate regenerative processes and restore function lost due to injury, disease, or aging.
The company’s therapies contain thousands of biological signals that trigger targeted signaling pathways while forming scaffolds to support tissue growth. Amphix Bio’s ultimate goal is to use regenerative medicine to increase human healthspans, allowing people to live longer, more productive, and fulfilling lives.
For more information about Amphix Bio and their groundbreaking work in regenerative medicine, visit www.amphixbio.com or contact them at [email protected].
Note: This article was created based on a press release issued by Amphix Bio on October 3, 2024