Avobis Bio

What Avobis Bio does

Avobis Bio, LLC is a privately held, clinical-stage biotechnology company founded in November 2019 as a joint venture between Mayo Clinic and W. L. Gore & Associates, Inc., and headquartered at 551 Paper Mill Rd, Newark, Delaware. The company is developing implantable cell therapies for conditions caused by impaired tissue healing, with its lead candidate AVB-114 — an autologous mesenchymal stem cell (MSC) therapy combined with a plug-shaped bioabsorbable matrix — aimed at healing perianal fistulas in patients with Crohn's disease who have failed conventional and biologic treatments. The platform combines living MSCs that produce localized healing signals with a bioabsorbable scaffold framework, and the technology is designed to be customizable across multiple high-potential indications including rectovaginal fistulas and acute healing applications.

Avobis Bio is pre-revenue and does not yet have a commercial product. Its lead asset AVB-114 has progressed through a Phase I trial (STOMP-I, run by Mayo Clinic, reporting 76% clinical healing at one year and a ten-fold reduction in annualized exams under anesthesia with no serious therapy-related serious adverse events) and a Phase II trial (STOMP-II) whose primary analysis was completed in August 2025 across 14 US clinical sites. The company received FDA Fast Track Designation in February 2025 and RMAT Designation in October 2025, and is currently planning Phase III development. AVB-114 is positioned as the only clinical-stage implantable cell therapy for Crohn's perianal fistulas with FDA IND clearance and both designations.

The business model is a standard clinical-stage biotech model: future revenue will come from commercialization (likely through specialty pharmacies and healthcare providers) of AVB-114 once FDA approval is secured. Currently, "access" to the therapy is limited to clinical trial participation, and the company generates no product revenue. Go-to-market activity is focused on top-of-funnel channels — industry conferences (BIO International Convention, Cell and Gene Meeting on the Mesa, LSI USA Summit, ACG Annual Scientific Meeting), PR Newswire-issued press releases on regulatory milestones, a LinkedIn corporate presence, and ClinicalTrials.gov listings — consistent with a company building investor and KOL awareness ahead of a future commercial launch. Avobis Bio's customer base today consists of clinical trial participants and their providers; the future commercial customer base will be gastroenterologists, colorectal surgeons, and Crohn's disease patients with refractory perianal fistulas.

Name

Avobis Bio

Legal name

Avobis Bio, LLC

Website

https://avobisbio.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

Avobis Bio is a clinical-stage biotech joint venture of Mayo Clinic and W. L. Gore & Associates developing AVB-114, an implantable cell therapy that combines autologous mesenchymal stem cells with a bioabsorbable matrix to heal Crohn's perianal fistulas.

Ownership category

akta.pro rank

Product category

Regenerative Medicine / Cell Therapy

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro industry

PRIMARYHLAAAGAD

Organoids & Organ-on-Chip (regenerative models)

Healthcare & Life Sciences/Biotechnology & Biologics/Regenerative Medicine & Tissue Engineering

Keywords

• Regenerative medicine
• Implantable cell therapy
• Mesenchymal stem cells
• Crohn's disease treatment
• Bioabsorbable scaffolds

Headquarters

HQ city

Newark

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Future therapeutic product revenue: Pre-revenue clinical-stage company. AVB-114 is an investigational drug limited by US law to investigational use. Safety and effectiveness have not been established, and it is not commercially available in any markets. Revenue expected upon FDA approval and commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Avobis Bio is developing AVB-114, an investigational implantable cell therapy that combines a patient's own (autologous) mesenchymal stem cells with a plug-shaped bioabsorbable material to locally generate tissue and produce healing signals for the treatment of Crohn's perianal fistulas. The company is clinical-stage, with its lead candidate currently in Phase II trials (STOMP-II) at 14 US sites, and has received FDA Fast Track and RMAT designations. The product is not yet commercially available and is limited by US law to investigational use.

Product overview

Avobis Bio is developing implantable cell therapies for debilitating conditions caused by impaired tissue healing. The company's core product is AVB-114, an implantable cell therapy combining autologous mesenchymal stem cells with bioabsorbable materials (BioMesh) in a plug-shaped matrix. AVB-114 represents a novel therapeutic approach targeting perianal fistulas in Crohn's disease, with clinical trials progressing through Phase I (STOMP-I) and Phase II (STOMP-II). The technology is designed to overcome impaired healing by delivering living cells that produce healing signals in a localized treatment system.

Differentiator

Problem solved

Functional benefit

Products and services

• AVB-114 Implantable Cell Therapy AVB-114 is the company's lead therapeutic candidate, an implantable cell therapy combining living autologous mesenchymal stem cells with a plug-shaped bioabsorbable material (BioMesh) to generate tissue and produce healing signals for localized treatment of Crohn's perianal fistulas. It is an investigational drug limited by US law to investigational use, with safety and effectiveness not yet established.

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Mayo CliniccoreStrategic or Co-development Partner · 1 November 2019Avobis Bio was formed as a joint venture between Mayo Clinic and W. L. Gore & Associates. Mayo Clinic brings clinical experience, infrastructure, and scientific research and development related to cell therapy. Mayo Clinic conducted the Phase I STOMP-I trial that demonstrated 76% clinical healing.
• W. L. Gore & Associates, Inc.coreStrategic or Co-development Partner · 1 November 2019Joint venture partner with experience applying material science expertise in developing and commercializing products in biopharmaceutical and medical device industries. Contributed bioabsorbable material technology to the implantable cell therapy platform.

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Mesoblast: Commercial-stage cell therapy company developing remestemcel-L, an allogeneic MSC product, across inflammatory and immune-mediated indications. Comparable as a clinical-stage-to-commercial MSC platform peer pursuing biologic approvals in inflammatory diseases.
• Athersys: Clinical-stage regenerative medicine company developing MultiStem, a proprietary adult stem cell therapy for inflammatory and immune-mediated conditions. Comparable as a peer developing off-the-shelf cell therapies with a similar late-preclinical/early-clinical trajectory.
• Takeda Pharmaceutical (darvadstrocel / Alofisel): Takeda acquired TiGenix and markets darvadstrocel (Cx601/Alofisel), the only MSC-based cell therapy approved (EU 2018, Japan 2021) for complex perianal fistulas in Crohn's disease — the same indication Avobis Bio is pursuing. This is the most direct clinical and commercial competitor.
• Lineage Cell Therapeutics: Clinical-stage cell therapy company developing allogeneic cell transplants for serious conditions including retinal, spinal cord, and oncology indications. Comparable as a peer cell therapy developer with a pipeline of investigational biologic products targeting specialty indications.

Broad incumbents

• Organogenesis Holdings: Commercial-stage regenerative medicine company selling wound care and surgical biologics (e.g., Apligraf, Dermagraft). Comparable as a broad incumbent in the regenerative wound healing/tissue repair space that targets overlapping chronic wound and surgical indications.
• MiMedx Group: Commercial-stage regenerative medicine company marketing dehydrated amniotic membrane allografts for wound care and surgical applications. Comparable as a broad incumbent commercializing regenerative tissue products across chronic wound and surgical healing indications.
• Vericel: Commercial-stage cell therapy company marketing MACI (autologous cartilage cell therapy) and Epicel. Comparable as a broad incumbent in autologous cell therapy commercialization with similar operational challenges in scaling patient-derived cell products.

Emerging players

• InGeneron: Clinical-stage regenerative medicine company developing autologous cell therapies using adipose-derived stem cells for orthopedic and wound healing indications. Comparable as an emerging peer using autologous cell + matrix approaches for tissue repair.
• Capricor Therapeutics: Clinical-stage cell and exosome therapy company developing CAP-1002 (allogeneic cardiosphere-derived cells) for Duchenne muscular dystrophy and other indications. Comparable as an emerging peer in cell-based regenerative therapeutics.
• Pluristem Therapeutics: Clinical-stage company developing placenta-derived MSC-like cell therapies (PLX products) for inflammatory and ischemic conditions. Comparable as an emerging MSC platform peer with overlapping regenerative medicine positioning.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/avobis-bio

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

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 Avobis Bio