Critical care immunotherapy company CytoSorbents Corp. (CTSO:NASDAQ), which is focused on blood purification technology to treat cytokine storm and deadly inflammation in critically ill and cardiac surgery patients, announced that "the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorbŪ for use in patients with COVID-19 infection."
The firm indicated that "under the EUA, CytoSorbents can make CytoSorb available, through commercial sales, to all hospitals in the U.S. for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit with confirmed or imminent respiratory failure who have early acute lung injury or acute respiratory distress syndrome, severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure, as described in FDA's authorization."
The company explained that "patients with COVID-19 infection often exhibit a cytokine storm with severe hyperinflammation that can contribute to worsened injury to vital organs like the lungs, heart, and the kidneys and that the goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented."
The company's COO Vincent Capponi commented, "We greatly appreciate the FDA's recognition, through this EUA, of the potential of CytoSorb and extracorporeal blood purification to help patients stricken with this terrible illness. It was clear in this truly collaborative process with the FDA that the Agency was committed to urgently providing physicians and patients with new treatment options in the fight against COVID-19."
CytoSorbents' CEO Phillip Chan, MD, Ph.D., remarked, "As a U.S. based company with CytoSorb device manufacturing in New Jersey, we are eager to expand the availability of CytoSorb to U.S. hospitals and patients as a treatment option to fight cytokine storm and deadly inflammation that is believed to exacerbate COVID-19 infection. With more than 555,000 documented coronavirus infections, the U.S. leads the world with over 22,000 deaths, and urgently needs new therapies to reduce the severity of this disease."
"CytoSorb has been used in critically ill and cardiac surgery patients in more than 80,000 human treatments abroad, to help treat the same complications seen in COVID-19 patients such as lung failure, shock, and multi-organ failure. With CRRT, and in many cases ECMO, being standard in ICUs worldwide, CytoSorb can be easily implemented with minimal training. More than 200 COVID-19 patients have been treated with CytoSorb outside the U.S., resulting in the inclusion of CytoSorb into the COVID-19 treatment guidelines in Italy, Panama, and China," Dr. Chan added.
CytoSorbents is a critical care immunotherapy firm based in Monmouth Junction, N.J., that specializes in blood purification. The company advised that its "flagship product" CytoSorbŪ is approved in the EU with distribution in 58 countries throughout the world. The company explained that "its purification technologies are 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."
CytoSorbents has a market capitalization of around $231 million with approximately 35.05 million shares outstanding and a short interest of about 8.8%. CTSO shares opened 30% higher today at $8.59 (+$2.00, +30.35%) over Friday's $6.59 closing price and reached a new 52-week high price this morning of $9.40. The stock has traded today between $7.87 to $9.40 per share and is currently trading at $8.04 (+$1.44, +21.93%).[NLINSERT]
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