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CytoSorbents Continues Strong Trajectory of Growth in the Third Quarter 2017

Company achieved record quarterly total sales of $3.8 million, and record quarterly and trailing twelve-month product sales of $3.4 million and $11.7 million, respectively

MONMOUTH JUNCTION, N.J., Nov. 9, 2017 /PRNewswire/ -- CytoSorbents Corporation (CTSO), a critical care immunotherapy leader using blood purification to prevent or treat life-threatening injury and infection in critically-ill and cardiac surgery patients around the world, reports financial and operational results for the quarter ending September 30, 2017.

Third Quarter 2017 Financial Highlights:

  • Total Q3 2017 revenues increased 59% to $3.8 million, which includes both product sales and grant income, up from $2.4 million in Q3 2016
  • Q3 2017 product sales were $3.4 million, an increase of 61% or $1.3 million, compared to $2.1 million in Q3 2016, driven by record unit sales
  • Product gross margins for Q3 2017 were approximately 69% as compared to 68% for Q3 2016, a result of the mix of direct and distributor sales
  • Trailing twelve month product sales for the period ending September 30, 2017 were $11.7 million, compared to $7.1 million for the period ending September 30, 2016
  • As of September 30, 2017, the Company had $15.4 million in cash and cash equivalents, which is expected to provide sufficient working capital to fund our operations and clinical trials into 2019

Third Quarter 2017 Operational Highlights:

  • More than 31,000 CytoSorb treatments have been delivered worldwide for critical care illnesses and cardiac surgery, an increase from 17,000 a year ago
  • Awarded $1 million Small Business Technology Transfer (STTR) Phase II contract to advance development of life-saving universal plasma
  • Awarded $0.7 million grant from the US Army Medical Research and Materiel Command to develop therapies to acutely stabilize severe burn victims
  • Entered into a co-development agreement with Aferetica to use CytoSorbents' adsorptive technologies to enhance the success of solid organ transplant
  • Launched the CytoSorb Therapeutic ECMO™ kit to enable the quick and safe exchange of CytoSorb with extracorporeal membrane oxygenation (ECMO), as a way to reduce inflammation and improve gas exchange
  • In support of World Sepsis Day, sponsored the Sepsis Heroes Gala hosted by the Sepsis Alliance to raise awareness of sepsis, and sponsored the Roger Bone Prize, awarded by the German Sepsis Society to a young investigator for excellence in clinical sepsis research

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "CytoSorb® usage continues to expand as a potent treatment of deadly inflammation in both critical care and cardiac surgery, powering our strongest quarterly results to date. In the first three quarters of 2017, we have already exceeded 2016 full year CytoSorb sales. With an expected solid finish to the year, and with numerous catalysts such as higher reimbursement in Germany, the recent launch of our co-marketing agreement with Fresenius Medical Care in 5 countries with more to come, new product releases such as our CytoSorb Therapeutic ECMO™ kit, continued geographic expansion with our distribution partners, and increased capacity with anticipated product gross margin improvements, we believe we are well-positioned to achieve continued rapid growth and our target of operating profitability in 2018.

"Meanwhile, we are working diligently to initiate our U.S.-based, REFRESH 2 cardiac surgery trial by the end of 2017. This pivotal, registration trial is designed to support U.S. regulatory approval of CytoSorb for complex cardiac surgeries like valve replacement. We have already met with the FDA to discuss our proposed trial design and will provide an update when we have more information on our investigational device exemption (IDE) application.

"With now more than 31,000 CytoSorb treatments delivered in a wide range of life-threatening illnesses and open heart surgeries, we can look back and see how far we have come from the first clinical studies, done many years ago, when we were treating patients very late in the course of their disease, and for only six hours a day. Our knowledge and understanding of how and when to treat has advanced tremendously, where today, physicians are using CytoSorb early, aggressively, and continuously, and obtaining positive clinical outcomes. We continue to see an acceleration of publications highlighting the use of CytoSorb in a wide range of indications. For example, we have had some extremely exciting data recently where CytoSorb has helped to tip the balance of life in many patients by improving hemodynamic stability, organ dysfunction, and survival.

  • Reversal of refractory shock (20 patients) - a condition that kills more than 80% of patients
  • Infective endocarditis (39 patients) – a heart valve infection that often requires open heart valve replacement surgery, increasing in frequency due to dirty needles and the heroin/opioid epidemic
  • Acute exacerbation of multiple sclerosis (case report) – The first documented case report using CytoSorb in a debilitating autoimmune disease that attacks the central nervous system
  • H1N1 influenza (7 patients) – the deadly flu strain responsible for the 2009 "swine flu" pandemic that still continues to infect thousands of people each year, as reported by partner Biocon

"In addition, we reported impressive survival data using CytoSorb in rat models of traumatic brain injury and hemorrhagic shock. Given that these two injuries are the leading causes of death in trauma, we hope to demonstrate similar benefits in humans in the future."

Dr. Chan concluded, "Finally, we are very pleased with the growing recognition of our company as a leading innovator in the treatment of critical illnesses and complications of cardiac surgery by major organizations, with the 2017 Global Frost & Sullivan Product Leadership Award in Blood Purification, and today's announcement of being named to the Deloitte Technology Fast 500™ as one of the fastest growing, innovative and impactful companies in North America."