AUSTIN, Texas, July 8, 2019 /PRNewswire/ — Direct Biologics, LLC announces the launch of ExoFloTM Exosomes. The mission of Direct Biologics is to deliver disruptive and innovative products that unlock the healing potential within a patient’s own cells with an emphasis on reduced chronic inflammation and promoting regeneration.
ExoFlo Exosomes are allograft isolated extracellular vesicles involved in cell-to-cell communication. Exosomes are naturally found in every part of the body, but the source of the exosomes intended for regenerative medicine is critical. The mesenchymal stem cell is the most studied cell in science because of the role it plays in tissue regeneration and repair as well as the local anti-inflammatory and healing signals produced. These complex tissue-derived vesicles are composed of phospholipid bilayers with transmembrane proteins and receptors, integrated growth factors as well as micro-RNA and messenger-RNA. ExoFlo Exosomes, which are between 30nm and 150nm in size, act locally to augment the body’s natural regenerative processes assisting to decrease extracellular matrix breakdown and chronic inflammation while facilitating the angiogenesis and tissue restoration.
Patient safety and product consistency are paramount in the process that was developed by Direct Biologics. Extensive product characterization, cGMP and cGTP processes, as well as strict quality controls have been put into place for this assurance. ExoFlo is sterile filtered and tested to meet the United States Pharmacopeia (USP<71>) sterility requirements as well as extracellular vesicle characterization to deliver a minimum of 10 billion exosomes per milliliter (mL).
Direct Biologics is an industry leader focused upon the development of innovative tissue-based technologies designed to stimulate and orchestrate natural tissue restoration and regeneration across various applications in burns, orthopedics, plastic surgery, general surgery, chronic wounds, podiatry, and more. ExoFlo Exosomes is intended to be administered as an allograft used in the repair of damaged or lost soft tissue. Direct Biologics’ allograft technologies work with your body by stimulating your inherent regenerative ability to achieve natural tissue restoration. Our goal is to change the treatment paradigm for this market through scientific initiatives and clinical based evidence. Additionally, Direct Biologics owns a comprehensive intellectual property portfolio and is developing additional products with plans to revolutionize the aesthetics market with technologies that have been scientifically proven to minimize skin aging and restore hair loss.