Frank Clark is an original co-founder of CytoSorbents, Inc. and its predecessor companies (WEIT, LLC, RenalTech, MedaSorb).
CytoSorbents, Inc. is a medical device company that has developed a novel hemoperfusion device for blood purification. The device is currently being used in Europe, Asia and the Middle East (30 countries) to treat cytokine storm and related conditions, including sepsis, severe sepsis and septic shock, complications from influenza, pneumonia and other viral infections, acute respiratory distress syndrome (ARDS), acute lung injury (ALI), multiple organ dysfunction syndrome (MODS), acute kidney failure, acute pancreatitis, trauma and rhabdomyolysis.
The US human clinical trials began enrolling patients in 2015, and the company has applied for an Expedited Access Pathway with the FDA because of the extraordinary life saving nature of this device.
Frank raised more than $50 million in equity capital from venture capital firms, hedge funds, and high net worth individuals, built the original management team, developed strategic business relationships, negotiated agreements, and oversaw the development of a GMP manufacturing facility and research laboratory near Princeton, NJ. That company is currently publicly traded. Frank continues to consult for this company on business development initiatives.
CytoSorbents – US Government Validation CytoSorbents, Inc. has secured more than $8.5 million in US government contracts and grants from agencies including DARPA, US Army, HHS, and the NIH.
In October 2015, the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded the Company a Phase II SBIR (Small Business Innovation Research) contract, that will help advance the Company’s HemoDefend™ blood purification technology towards commercialization for the purification of packed red blood cell (pRBC) transfusions. The project, entitled “pRBCs Contaminant Removal with Porous Polymer Beads”, is valued at $1,521,671 over 2 years, with funding to start immediately.
In June 2013, the company announced that the United States Food and Drug Administration (FDA) has granted approval to begin a U.S.-based human pilot study using CytoSorb® for the treatment of rhabdomyolysis as a result of trauma under an Investigational Device Exemption (IDE). Rhabdomyolysis is caused by the massive release of myoglobin from severely injured skeletal muscle that can lead to kidney failure. The study was initiated by and will be funded by the U.S. Air Force. CytoSorb® has demonstrated the ability to efficiently remove myoglobin in pre-clinical testing and will be evaluated on its ability to reduce myoglobin levels in human trauma patients with rhabdomyolysis.
About CytoSorbents Corporation
CytoSorbents Corporation (NASD: CTSO; Monmouth Junction, NJ) is a publicly-traded, critical care immunotherapy company using blood purification to treat life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Each polymer bead contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies from blood. These beads are synthesized at its ISO 13485 certified manufacturing facility in New Jersey. The technology is protected by 32 issued U.S. patents and multiple patent applications pending.
CytoSorb®, the Company’s flagship product, is approved for sale under a CE Mark in all 28 countries of the European Union (E.U.) as an extracorporeal cytokine filter, to be used in any situation where cytokines are elevated. CytoSorb® is being sold directly in Germany, Austria and Switzerland, and through distributors in the United Kingdom, Ireland, France, Italy, Poland, Sweden, Denmark, Norway, and Finland and the Netherlands.
With registration, it can also be sold outside of the E.U. in countries that accept European medical device approval. CytoSorb® is currently being sold in India and select emerging markets through its strategic partner, Biocon Ltd, Asia’s largest biotechnology company, and in Russia, Taiwan and Turkey. It is also being distributed in eight countries in the Middle East including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, and Oman (the Gulf Cooperation Council or GCC) and Yemen, Iraq, and Jordan.
CytoSorb® is approved for use in clinical situations where cytokines are elevated, and can be used for a diverse range of inflammatory conditions, including critical illnesses, cancer, cancer cachexia, and others. The goal of CytoSorb® is to modulate the immune system by removing excessive cytokines, often called “cytokine storm”, in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death in common illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death.