ExoFlo™ is an extracellular signal product isolated from human bone marrow MSCs that contains growth factors and extracellular vesicles including exosomes.
ExoFlo™ represents a new frontier in regenerative health solutions. This new investigational product for COVID-19 associated Acute Respiratory Distress Syndrome (ARDS) uses extracellular vesicles isolated from human bone marrow mesenchymal stromal/stem cells (BM-MSCs) to reduce inflammation and facilitate paracrine signaling capable of strengthening the body’s defenses and advancing its healing processes. Studies have indicated that BM-MSC derived extracellular vesicles can downregulate inflammation and upregulate tissue repair in humans.
Extracellular vesicles are 30-150 nm in size and are involved in direct cell-to-cell communication.
- Provide over 1,000 regulatory proteins
- Involved in cell-to-cell communication
- Approximately 30-150nm in size (sterile filtered)
- Natural signals with no preservatives
Growth factors and EVs, including exosomes, are known to stimulate bioactivity and direct cellular communication.
ExoFlo™ is isolated from living human bone marrow mesenchymal stem/stromal cells (MSCs) donors. The extracellular vesicles are purified using proprietary cGMP processing and are sterile filtered and tested per USP<71> sterility testing.
Investigational use only. Direct Biologics was granted FDA approval to conduct a clinical trial under an Investigational New Drug (IND) application for use of ExoFlo™ in the treatment of COVID-19 associated moderate to severe ARDS.
Regulatory Proteins Found in ExoFlo
Name | Description | Function |
---|---|---|
VEGFR | VEGF Receptor | Angiogenesis |
VEGF | Vascular Endothelial Growth Factor | Angiogenesis & Chemotaxis |
ANG1 | Angiopoietin 1 | Angiogenesis and Supports VEGF |
TIMP‑1 | Collagenase Inhibitor | Blocks matrix breakdown |
TIMP‑2 | Collagenase Inhibitor | Blocks matrix breakdown |
IL‑1B | Interleukin 1B | Cell Proliferation, Differentiation, Modulates Inflammation |
PDGF‑AA | Platelet Derived Growth Factor | Cell Survival & MSC Proliferation – Mitogenic |
TGFb3 | Transforming Growth Factor Beta 3 | Immunology – Modulates Inflammation |
bFGF | Basic Fibroblast Growth Factor | Mitogenic Cell Survival and Tissue Regeneration |
HGF | Hepatocyte Growth Factor | Wound Healing – Tissue Regeneration & Organ Survival |
Frequently Asked Questions
How are ExoFlo Extracellular vesicles processed?
MSCs naturally produce extracellular vesicles and Direct Biologics isolates and purifies them from the cells using a propriety process. This process protects the 3D structure and bioactivity of these proteins and extracellular vesicles from enzymatic breakdown, oxidation and possible damage that could occur during the freezing process.
What differentiates ExoFlo from other exosome products?
The 3 Ps: Purity, Potency and Performance:
Purity: Processed in a cGMP facility and sterile filtered
Potency: Every mL delivers over 10 billion extracellular vesicles
Performance: Direct Biologics’ processing delivers consistency with every vial and every order
How is ExoFlo stored?
ExoFlo allograft is supplied frozen and can be stored below -40 °C in an ultra-low temperature freezer (down to -80 °C, +/- 5 °C) for up to 5 years or between -20 °C and -40 °C for up to 6 months. ExoFlo should not be stored in liquid nitrogen. Each box is marked with an expiration date that is determined and validated from the time the product is processed and packaged.
For additional product information, please review the full Instructions for Use.
Restricted to sale by or on the order of a physician or Licensed Medical Professional.