Direct Biologics
Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products. The company is dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research, harnessing the healing properties of extracellular vesicles (EVs) to reduce overactive inflammatory responses and restore the body's natural healing process. They focus on developing naturally bioactive products for regenerative therapies, with a mission to revolutionize the treatment of human disease.
Industries
Nr. of Employees
small (1-50)
Direct Biologics
Austin, Texas, United States, North America
Patents
Preparations comprising mesenchymal stem cells and cannabinoids and methods of their use
US-12213995-B2
View Details
Preparations comprising mesenchymal stem cells and cannabinoids and methods of their use
US-12213995-B2
View DetailsProducts
Investigational EV therapeutic for moderate-to-severe ARDS
An investigational extracellular vesicle-based therapy developed to treat moderate-to-severe acute respiratory distress syndrome (ARDS); evaluated in randomized and expanded-access clinical programs.
Investigational EV therapeutic for perianal fistulizing Crohn’s disease
An investigational extracellular vesicle-based therapy under clinical evaluation for medically refractory perianal fistulizing Crohn’s disease (early-phase clinical study clearance noted).
Investigational EV therapeutics for medically refractory Crohn’s disease and ulcerative colitis
Investigational extracellular vesicle-based therapies being evaluated in early-phase clinical trials for medically refractory Crohn’s disease and ulcerative colitis.
Natural Intelligence
An investigational extracellular vesicle (EV)-enriched secretome derived from adult bone marrow mesenchymal stem cells, developed for therapeutic research.
DB-3Q
An investigational secretome-based product being evaluated in clinical trials for Perianal Fistulizing Crohn’s Disease and Medically Refractory Crohn’s Disease.
DB-3Y
An investigational secretome-based product being evaluated in clinical trials for Medically Refractory Ulcerative Colitis.
Investigational EV therapeutic for moderate-to-severe ARDS
An investigational extracellular vesicle-based therapy developed to treat moderate-to-severe acute respiratory distress syndrome (ARDS); evaluated in randomized and expanded-access clinical programs.
Investigational EV therapeutic for perianal fistulizing Crohn’s disease
An investigational extracellular vesicle-based therapy under clinical evaluation for medically refractory perianal fistulizing Crohn’s disease (early-phase clinical study clearance noted).
Investigational EV therapeutics for medically refractory Crohn’s disease and ulcerative colitis
Investigational extracellular vesicle-based therapies being evaluated in early-phase clinical trials for medically refractory Crohn’s disease and ulcerative colitis.
Natural Intelligence
An investigational extracellular vesicle (EV)-enriched secretome derived from adult bone marrow mesenchymal stem cells, developed for therapeutic research.
DB-3Q
An investigational secretome-based product being evaluated in clinical trials for Perianal Fistulizing Crohn’s Disease and Medically Refractory Crohn’s Disease.
DB-3Y
An investigational secretome-based product being evaluated in clinical trials for Medically Refractory Ulcerative Colitis.
Services
GMP-compliant production, enrichment and purification of extracellular vesicle therapeutics derived from human MSC secretomes for clinical development.
Design and execution support for clinical studies evaluating investigational EV therapies across multiple indications, including oversight of patient safety and data generation.
GMP-compliant production, enrichment and purification of extracellular vesicle therapeutics derived from human MSC secretomes for clinical development.
Design and execution support for clinical studies evaluating investigational EV therapies across multiple indications, including oversight of patient safety and data generation.
Expertise Areas
- Regenerative medicine
- Clinical trial management (Phase I–III)
- Biologics manufacturing (cGMP)
- Extracellular vesicle (EV) therapeutics
Key Technologies
- Extracellular vesicle (EV) production
- Mesenchymal stem/stromal cell (MSC) secretome
- Acellular biologic therapeutics
- cGMP biomanufacturing processes