CytoSorbents has developed a unique and powerful blood filtration and purification technology based on its proprietary biocompatible, highly porous polymer bead platform. Each of these spherical beads are approximately the size of a grain of salt and synthesized to contain millions of optimally-sized pores and channels. These pores and channels collectively have a massive surface area that enable the bead to behave like a tiny sponge to bind and remove a broad range of inflammatory and toxic substances from whole blood and plasma via pore capture and surface adsorption. Large substances, such as blood cells cannot get into the pores and go around the bead unaffected. Similarly, very small substances, such as electrolytes, are too small to be captured and go through the beads unaffected. But appropriately sized substances migrate into the pores of the beads and get adsorbed to the external and internal surfaces of the pores and channels, never to come out. Variations of these beads form the basis of CytoSorbents’ flagship product, CytoSorb®, for the treatment of deadly conditions seen in critical illnesses and cardiac surgery, and HemoDefend™, for the purification of transfused blood products of contaminants that can cause potentially dangerous transfusion reactions.
State-of-the-Art Blood Purification Technology
CytoSorbents’ advanced bead technology combines numerous advantages into a single blood purification platform.
- Proprietary polymer technology: CytoSorbents’ beads are composed of a specially modified, chemically inert, polystyrenic co-polymer protected by 16 issued U.S. patents and multiple issued and pending applications worldwide
- Highly biocompatible: The beads are ISO 10993 certified for biocompatibility, hemocompatibility, no genotoxicity, no cytotoxicity, no acute sensitivity, and no complement activation
- Massive surface area: A single 300 mL cartridge filled with CytoSorb® beads has more than 45,000 square meters of internal and external surface area on which to adsorb and remove toxic substances
- Selective, multi-modal separation: Blood is composed of a wide range of substances, ranging from water, cells, electrolytes, hormones, sugars, lipids, and proteins. The technology achieves selectivity by using size exclusion as the first step in separation. Next, the hydrophobic “water-fearing” polymer effectively adsorbs hydrophobic substances and excludes hydrophilic “water-loving” ones. Substances that do not adsorb leave the bead, while those that do adsorb will migrate further and further into the beads, lost in the vast network of channels, unable to escape
- Excellent adsorption of proteins, bioactive lipids, and toxins: Many of the inflammatory mediators that drive the deadly inflammatory process, including cytokines, toxins, activated complement, enzymes, and bioactive lipids, are preferentially removed by the technology
- Superior kinetics: Beads are in direct contact with blood, actively removing substance with no need for them to diffuse across a semi-permeable membrane as with dialysis and hemofiltration
- Concentration Dependent Removal: High concentrations of toxins provide a driving force gradient to push substances into the pores of the bead. Because of this, the technology is very good at removing toxic levels of substances. As the concentration of the substance decreases, so does the ability of the device to extract it. This creates an inherent “self-titrating” aspect to the technology that reduces the risk of excessive removal of substances and overtreatment
- Gamma stable, thermostable, and chemically inert: The polymer is very robust and stable, allowing easy gamma sterilization, stability at a broad range of temperatures, and resistance to chemical change in most physiologic environments
- Rapidly customized: The beads can be easily modified during polymer synthesis to create beads with identical chemical structure, but with very different porous structures. In addition, the beads can be further modified to incorporate most major mechanisms to separate substances including polarity, charge, size-exclusion, and affinity
- Broad spectrum “mix and match” capability: The ability to mix and match beads with different extraction capabilities provides a flexibility to remove a broad range of substances that is difficult to achieve with other technologies
- High flow, low resistance: Blood can flow rapidly through a bead-filled device with low resistance, achieving flow rates of 100-700 mL/min without causing hemolysis or high pressure drops across the device
- Stable with Long Shelf Life: Solid state chemistry with no cells, biologics or other perishable materials, gamma sterilized with 3-year shelf life at room temperature.
Technology is the Beneficiary of ~$48M in Government Funding
CytoSorbents’ blood and physiologic fluid purification technology aims to solve some of the most important unmet medical needs in medicine, from treating life-threatening illnesses in the intensive care unit, to reducing dangerous complications of surgery, to ensuring the quality and safety of the blood supply. It combines the company’s proprietary hemocompatible porous polymer bead platform with robust and cost-effective manufacturing, compatibility with a worldwide infrastructure of existing dialysis and heart-lung machines, and ease of use.
CytoSorbents’ purification technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.