The extensive intellectual property surrounding proprietary methods for obtaining concentrated growth factors and exosomes from human mesenchymal stem cells and their utility have made Direct Biologics a leader in therapeutic innovation around this ground breaking new technology.
Direct Biologics’ ExoFlo are complex naturally occurring allograft extracellular vesicles, commonly called exosomes. These extracellular vesicles carry mRNA, miRNA a myriad of cytokines or proteins that help modulate the inflammatory process of the local tissue.
AmnioFlo is an acellular amniotic fluid that contains no harmful preservatives. AmnioFlo is for the treatment of inflammatory environments commonly associated with pain and help provide additional lubrication and cushioning.
AmnioWrap2™ is a minimally manipulated allograft comprised of unseparated amniotic membrane and chorionic membrane with the intact intermediate layer.
Regulatory & Safety
Direct Biologics is committed to quality and patient safety. Our recently acquired manufacturing facility is an FDA registered facility. We have robust cGMP quality systems in place for every aspect of manufacturing, storage and shipping of our products. Our facilities are environmentally controlled and monitored for temperature and humidity with all freezers and storage equipment being monitored and maintained and our tissue is processed in our ISO:9001/13485 certified facility with Class 7 cleanrooms and ISO 5 GMP equipment. Part of our quality system includes document control, record control and process deviation control with quarantine system that can only be released with approval by our Quality Engineering team.
Tissue tracking and traceability is a requirement of the FDA. Every tissue that we deliver to our customers is traceable back to the tissue donor and our strict donor acceptance criteria. Our donor screening includes the highly sensitive nucleic acid testing (NAT) for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV1.
Our current facilities include a 30,000sqft advanced cGMP manufacturing facility in Florida. All of these facilities are registered with the FDA for their specific product specialties and will be under our strict document control and GMP processes.
Articles & Education
6070 Telegraph Rd, Suite B
St. Louis, MO 63129
Our office: Monday-Friday
10am to 5pm (Central)