Last reviewed · How we verify
ExoFlo
ExoFlo is an exosome-based therapeutic that delivers regenerative factors to promote tissue repair and reduce inflammation.
ExoFlo is an exosome-based therapeutic that delivers regenerative factors to promote tissue repair and reduce inflammation. Used for Osteoarthritis of the knee, Chronic wounds and tissue repair.
At a glance
| Generic name | ExoFlo |
|---|---|
| Sponsor | Direct Biologics, LLC |
| Drug class | Exosome therapy |
| Modality | Biologic |
| Therapeutic area | Regenerative Medicine / Orthopedics |
| Phase | Phase 3 |
Mechanism of action
ExoFlo consists of allogeneic bone marrow-derived mesenchymal stem cell exosomes that carry bioactive molecules including proteins, lipids, and nucleic acids. These exosomes are designed to modulate the immune response, reduce inflammation, and promote tissue regeneration and healing in damaged tissues.
Approved indications
- Osteoarthritis of the knee
- Chronic wounds and tissue repair
Common side effects
- Injection site pain or swelling
- Mild inflammatory response
Key clinical trials
- Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) (PHASE3)
- Study of ExoFlo for the Treatment of Perianal Fistulas (PHASE1, PHASE2)
- Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease (PHASE1)
- Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis (PHASE1)
- ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome (PHASE1, PHASE2)
- Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS
- Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
- Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ExoFlo CI brief — competitive landscape report
- ExoFlo updates RSS · CI watch RSS
- Direct Biologics, LLC portfolio CI