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.
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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 and Safety
Direct Biologics is committed to quality and patient safety. Our recently acquired manufacturing facility and partnership processing facility are FDA registered facilities. We have robust cGMP/cGTP quality systems in place for every aspect of manufacturing, storage and distribution 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 an FDA inspected ISO:9001/13485
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 HIV. Our products are tested for sterility, post-packaging, to meet USP<71> requirements.
Our current facilities include a 30,000 square foot advanced cGTP processing facility in Florida, a cGMP manufacturing facility in California, Tissue storage and distribution facility in Missouri as well as offices in California and Texas. All of the required facilities are registered with the FDA for their specific product specialties and will be under our strict document control and cGMP/cGTP processes.
Our product packaging has been created and validated in accordance with ISO 11607 and have been tested for sealing parameters in line with ISO 16775 Annex Q, Transportation Feasibility testing to ASTM D42169 DC13 AL1 with Climate Conditioning to ASTM D4332 and Package Integrity testing and inspections to ASTM F1886, ASTM F88 and ASTM F2096.
The extensive intellectual property surrounding our proprietary methods for isolating allograft extracellular vesicles from human mesenchymal stem cells and their utility have made Direct Biologics a leader in therapeutic innovation around this ground breaking new technology.
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St. Louis, MO 63129
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