A New Frontier in Regenerative Medicine
Exosomes are regarded as the purest form of cellular signaling available because their function is to direct tissue and wound healing by activating cell responses. This is the newest generation of naturally bioactive products for regenerative therapies.
The exosomes in ExoFlo are paracrine signals that assist with local cell-to-cell communication. Exosomes induce changes in nearby cells that create the appropriate healing environment and aid in tissue repair. As the technology and discovery of new methods of treating patients has evolved, scientific evidence shows that the optimal way to provide true regenerative therapy is to directly provide the signals as its own therapy and avoid potential issues with delivering and keeping transplanted cells alive.1,2
Regulatory and Safety
Exosomes are extracellular micro-vesicles (30-150nm) that are involved in direct cell to cell communication. Direct Biologics’ ExoFlo™ exosomes are isolated from human bone marrow mesenchymal stem/ stromal cells (MSCs). They are purified using proprietary cGMP processing and are sterile filtered and tested per USP<71> sterility testing. The unique benefit to Direct Biologics exosomes is they provide a wide array of regulatory proteins to stimulate and modulate many processes within the normal healing cascade.
Exosomes by nature work to heal, repair, and restore the body. The 1,000+ regulatory proteins, RNAs and other biomolecules found to naturally occur in healthy tissue and in ExoFlo have been shown preclinically to help modulate inflammatory healing processes.2 This is accomplished by activating and recruiting local cells to revascularize the area and reduce the inflammatory response to allow natural healing.
Exosomes are not cells. Exosomes are tiny lipid vesicles that are secreted from a cell and are about 1/1,000th the size of a cell.
Direct Biologics is committed to quality and patient safety. 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 certified facility with cGMP equipment in ISO 7 and ISO 5 cleanrooms. Part of our quality system includes document control, record control and process deviation control with a robust quarantine system that manages inventory only be released with approval by our Quality and Engineering teams.
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.
The extensive intellectual property surrounding our proprietary methods for isolating allograft extracellular vesicles from human bone marrow MSCs and their utility have made Direct Biologics a leader in therapeutic innovation and this groundbreaking new technology.
The Science of Exosomes
Meet Our Doctors
Dr. Beams experience includes acute primary care, walk-in and urgent care clinics, vein clinics, Stem Cell Therapy for Hair Restoration, Joint Therapy with Stem Cells Growth Factors, and his private anti-aging medical spa. His expertise includes treating men and women with bio-identical hormone pellets, functional medicine for all ages in treating many chronic diseases and deficiencies. He enjoys educating patients on customized dietary changes and exercise recommendations. LEARN MORE
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