What Amphix Bio does

Amphix Bio is a preclinical-stage biotechnology company developing regenerative medicine therapies using its proprietary Supramolecular Therapeutic Peptide (STP) platform. Founded in 2021 as a spinout from Northwestern University and headquartered in Chicago, the company applies supramolecular chemistry to design peptide amphiphile molecules that self-assemble into dynamic 3D nanostructure scaffolds mimicking the natural extracellular environment, thereby activating regenerative signaling pathways in cells. The company's pipeline is led by AMFX-200, a neuroregenerative candidate for acute spinal cord injury and other neurological conditions (chronic SCI, ischemic stroke, ALS, Parkinson's disease, neuropathy), and AMFX-100, an off-the-shelf bone graft substitute for spinal fusion surgery to treat degenerative disc disease. The platform is grounded in 20+ years of research from Prof. Samuel Stupp's laboratory, supported by 100+ peer-reviewed publications and 30+ issued patents, and has been validated across 50+ animal studies and 100+ screened molecules.

AMFX-200 has received FDA Orphan Drug Designation for acute spinal cord injury, while AMFX-100 has received FDA Breakthrough Device Designation for bone regeneration, both providing exclusivity incentives and expedited development pathways. Preclinical data include unprecedented motor function recovery in spinal cord injury models and a 100-fold reduction in required recombinant BMP-2 dose versus current clinical bone graft products.

Amphix Bio is currently pre-revenue with no commercial products and 1–10 employees. Its forward business model will rely on pharmaceutical/medical device distribution channels and direct engagement with orthopedic surgeons and hospital procurement for AMFX-100, and specialty neurology channels for AMFX-200 upon regulatory approval, or alternatively on out-licensing or partnership transactions. To date the company has raised $18 million in total funding, including NSF SBIR Phase I and Phase II grants ($1M Phase II in October 2024) and a $12.5 million seed financing completed in December 2025, with proceeds directed toward IND-enabling studies, manufacturing scale-up, and pipeline expansion.

Name

Amphix Bio

Legal name

Amphix Bio, Inc.

Website

https://amphixbio.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Amphix Bio is a preclinical-stage Northwestern University spinout developing supramolecular therapeutic peptide therapies for neurological and musculoskeletal conditions, including AMFX-200 for spinal cord injury and AMFX-100 for spinal fusion bone grafting.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Neural & Spinal Cord Regeneration (HLAAAGAI)

akta.pro secondary industries

Therapeutic Peptides & Protein/Peptide Biologics (HLAAAAAH), Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL)

Keywords

• Regenerative medicine
• Peptide therapeutics
• Spinal cord injury
• Bone regeneration
• Tissue engineering

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Distribution channels1 record

Marketing channels4 records

Core offering

Amphix Bio develops regenerative medicine therapies built on a Supramolecular Therapeutic Peptide (STP) platform. Its lead candidate AMFX-200 is a neuroregenerative therapeutic targeting acute spinal cord injury and other neurological conditions (chronic SCI, ischemic stroke, ALS, Parkinson's, neuropathy) by combining peptide drugs with a nanofiber scaffold. Its second lead candidate AMFX-100 is an off-the-shelf bone graft substitute for spinal fusion in degenerative disc disease, eliminating the need for donor tissue or recombinant proteins. Both candidates are in preclinical development advancing toward human clinical trials.

Product overview

Amphix Bio is developing a peptide therapeutic platform based on Supramolecular Therapeutic Peptides (STP). The company's portfolio includes two lead product candidates: AMFX-200, a neuroregenerative treatment for acute spinal cord injury and other neurological conditions that combines peptide drugs with nanofiber scaffolds, and AMFX-100, an off-the-shelf bone graft substitute for spinal fusion surgery to treat degenerative disc disease. Both products are built on the company's STP Platform, which uses supramolecular chemistry to create nanostructures that activate cell receptors and promote tissue regeneration. The platform has been validated through extensive preclinical studies including over 50 animal studies across therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• AMFX-200 Lead neuroregenerative therapeutic candidate combining peptide drug pharmacological action with a nanofiber scaffold to promote neural regeneration. Preclinical data shows unprecedented motor function recovery, reduction in neuropathic pain and inflammatory responses, and prevention of glial scar formation in spinal cord injury models. Being developed for acute spinal cord injury, chronic spinal cord injury, ischemic stroke, ALS, Parkinson's disease, and neuropathy. Granted FDA Orphan Drug Designation.
• AMFX-100 Off-the-shelf synthetic bone graft substitute designed to enable spinal fusion in degenerative disc disease without donor tissue or recombinant proteins. Preclinical studies show induction of new bone tissue formation with a 100-fold dose reduction in recombinant BMP-2 compared to current clinical products. Granted FDA Breakthrough Device Designation.

Quantifiable outcome

• 100-fold dose reduction in recombinant BMP-2 compared to current clinical products for bone regeneration
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Northwestern University - Center for Regenerative Nanomedicine (CRN)coreStrategic or Co-development PartnerTechnology originated from Prof. Samuel Stupp's laboratory at Northwestern University with 20+ years of research; company co-founded by Northwestern researchers; ongoing collaboration with CRN for preclinical studies including spinal cord injury models and rehabilitation studies; Charlotte Chen's PhD research from Stupp Lab incorporated into bone regeneration therapy
• Christopher & Dana Reeve FoundationcoreStrategic or Co-development PartnerCo-sponsored research grant with Spinal Research to test AMFX-200 in combination with structured physical rehabilitation in acute and chronic spinal cord injury models; aligned mission to support patients and families living with spinal cord injury
• Spinal ResearchcoreStrategic or Co-development PartnerCo-sponsored research grant with Christopher & Dana Reeve Foundation to test AMFX-200 in combination with structured physical rehabilitation in preclinical spinal cord injury models

Scale indicators15 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• NervGen Pharma: Clinical-stage biotech developing NVG-291, a peptide therapeutic targeting nervous system repair, with a primary indication in acute spinal cord injury. NervGen is the most directly comparable company to AMFX-200, pursuing a peptide-based neuroregenerative mechanism for the same SCI patient population.
• Lineage Cell Therapeutics: Clinical-stage cell therapy company advancing OPC1 (oligodendrocyte progenitor cells) for acute spinal cord injury, the same indication as AMFX-200. Lineage is a direct competitor in SCI regeneration and provides a benchmark for clinical timelines and regulatory pathways in this indication.
• Cerapedics: Commercial-stage orthobiologics company whose i-FACTOR bone graft is a peptide-enhanced bone matrix used in cervical spine fusion. Cerapedics is the most directly comparable commercial-stage company to AMFX-100, using a small peptide to drive bone regeneration in spinal fusion.
• Mesoblast: Late-stage regenerative medicine company developing cellular therapies for inflammatory and degenerative conditions across multiple indications. Mesoblast shares Amphix Bio's strategy of leveraging a single platform across diverse high-unmet-need diseases, including orthopedic and inflammatory applications.

Broad incumbents

• Medtronic: Global medical device leader and the incumbent in the US spinal fusion market via its INFUSE Bone Graft / recombinant human BMP-2 product. Medtronic is the dominant competitor AMFX-100 must displace on cost, safety, and dose-efficiency grounds.
• Stryker: Major diversified orthopedic medical device company with a broad spine and biologics portfolio including bone graft substitutes and synthetic scaffolds. Stryker represents the broad incumbent competitive set that AMFX-100 will face in hospital formulary and orthopedic surgeon adoption.
• Globus Medical: Large spine-focused medical device company (post-NuVasive merger) offering an extensive portfolio of spinal fusion implants, biologics, and enabling technologies. Globus is a key customer-channel incumbent and potential strategic acquirer/partner for Amphix Bio's bone regeneration product.
• Orthofix: Spine and orthopedic device company with a biologics segment including bone graft substitutes for spinal fusion. Orthofix competes directly with AMFX-100 in the regenerative spine market and represents another potential commercial partnership or acquisition target.
• Acorda Therapeutics: Specialty neurology company historically focused on spinal cord injury and multiple sclerosis, including dalfampridine for improved walking in MS patients. Acorda represents a strategic acquirer/partner profile with deep SCI commercial expertise and is a relevant comparable for SCI market dynamics.

Emerging players

• Athersys: Clinical-stage regenerative medicine company developing MultiStem cell therapy for neurological, inflammatory, and cardiovascular indications. Athersys shares Amphix Bio's multi-indication platform thesis and serves as a relevant comparable for capital-efficient regenerative medicine development.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/amphix-bio-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Amphix Bio