About Us
Direct Biologics is a market leading innovator and science based biologics manufacturer of regenerative medical products including a robust line of biologic products. Direct Biologics was created to expand the science of cutting edge biologic technologies
Innovative
Direct Biologics was created to expand the science of cutting edge biologic technologies through research and commercialization of medical devices and the naturally occurring proteins from allograft tissues compliant with FDA standards for 361 HCT/P products.
Safety
Direct Biologics is committed to quality and patient safety. Our manufacturing facility is an FDA registered CGMP facility that is compliant with the highest standards.
Quality
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.
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.
Technologies
Exosomes are…
micro-vesicles (30-150nm) that are involved in cell communication. This is a new frontier in regenerative medicine. These exosomes have been recently discovered to be involved in direct cell signaling. The ExoFlo exosomes are isolated from donated human mesenchymal stem cells (MSCs) and purified using proprietary processing. The unique benefit to these exosomes is that they are stem cell-derived and bring a wide array of growth factors to stimulate and modulate many processes within the healing cascade.
Exosomes are not cells but are micro-vesicles, which are about 1/1,000th the size of a cell and contain no nucleus or DNA. They can be regarded as the purest form of cellular therapy available, because their function is to direct tissue and wound healing by activating the patient’s own regenerative cell response. This is one of the latest generations of naturally bioactive stem cell-based products for patient treatment.
Stem cells and stem cell therapy work by paracrine signaling (local cell-to-cell communication to induce changes in nearby cells) to create the appropriate healing environment to restore tissue. The exosomes in ExoFlo are those paracrine signals isolated from stem cells that can be delivered without the need for delivering stem cells. As the technology and discovery of new methods of treating patients has evolved, the science shows that the optimal way to provide true “stem cell therapy” is to directly provide the signals as its own therapy and avoid potential issues with delivering and keeping transplanted cells alive.
Stem cells by nature work to heal, repair, and restore the body. But, in some cases where there is a chronic abnormality, these cells fall into an inflammatory state, work in an unregulated capacity and inhibit healing. The 1000+ growth factor proteins found to naturally occur in healthy tissue and in ExoFlo have shown to help modulate the inflammatory healing process. This is accomplished by activating and recruiting the patients’ own cells to the area, revascularizing the area and reducing the inflammatory response to allow natural healing.
Our Products
Direct Biologics is an innovative technology company focused on developing and
providing regenerative biologic products for the medical market.
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.
AmnioWrap2™ is a minimally manipulated allograft comprised of unseparated amniotic membrane and chorionic membrane with the intact intermediate layer.
Resources
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.
Articles & Education
published: 08 July 2019
https://www.newswire.com/news/direct-biologics-llc-announces-the-launch-of-exoflo-exosomes-20942231
Contact Us
Our Address
6070 Telegraph Rd, Suite B
St. Louis, MO 63129
Our Hours
Our office: Monday-Friday
10am to 5pm (Central)
