Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents Corporation (NASDAQ: CTSO) announced that the FDA has granted conditional approval for its investigational device exemption (IDE) application to initiate the STAR-T trial. This trial focuses on removing ticagrelor, a potent antithrombotic, during cardiothoracic surgery to mitigate perioperative bleeding complications. The trial is expected to enhance CytoSorbents' U.S. commercialization strategy, targeting a market potential of $1 billion. The company aims to address all FDA conditions within 45 days and is prepared to move forward with clinical site engagements.

CytoSorbents Corporation (NASDAQ: CTSO) has announced the lease of a new global headquarters in Princeton, NJ, on March 26, 2021. The 15-year lease will encompass approximately 48,500 square feet at Princeton Forrestal Village and is set to commence on June 1, 2021. This facility will consolidate all U.S. operations, including manufacturing and research, and allow for production capacity expansion from $80 million to between $300-$400 million annually. This strategic move is aimed at supporting the company's growth and launching new product lines.

CytoSorbents Corporation (NASDAQ: CTSO) has filed an Investigational Device Exemption (IDE) application to conduct the STAR-T clinical study in the U.S., aiming for FDA approval regarding the removal of ticagrelor during cardiopulmonary bypass in cardiac surgeries. The filing follows the FDA's Breakthrough Designation granted for this purpose. The company anticipates completing discussions with the FDA by Q2 2021 and starting patient enrollment in the latter half of the year across multiple U.S. institutions interested in participating.

CytoSorbents Corporation (NASDAQ: CTSO), a leader in critical care immunotherapy, will present at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, from 10:40 AM to 11:10 AM EST. CEO Dr. Phillip Chan will discuss the company’s advancements and future outlook. CytoSorbents specializes in blood purification technology, notably CytoSorb®, which is approved in the EU and used in 67 countries. The platform aims to mitigate severe inflammation in critically ill patients and during cardiac surgery, with over 121,000 treatments administered.

CytoSorbents Corporation (NASDAQ: CTSO) announced record growth in 2020, achieving total revenue of approximately $41 million, a 64% increase from 2019. Product sales soared to $39.5 million, driven by a 73% rise, with COVID-19-related sales accounting for $9.4 million. Q4 2020 saw product gross margins reach 82%. The company maintains a healthy cash balance of $71.4 million post-debt repayment. Their FDA Breakthrough Designation for ticagrelor removal and partnerships for global sales are pivotal for future growth.

B. Braun Avitum AG and CytoSorbents Corporation (NASDAQ: CTSO) have established a global co-marketing agreement to promote CytoSorb^® in conjunction with B. Braun's OMNI^® continuous blood purification platform. This partnership aims to leverage B. Braun's advanced medical technology to enhance the treatment of severe inflammation by utilizing the CytoSorb^® adsorber, already CE Mark certified and available in 67 countries. Financial details of the agreement were not disclosed.

CytoSorbents Corporation (NASDAQ: CTSO) will announce its Q4 2020 and fiscal 2020 financial results on March 9, 2021 at 4:45 PM EST. Management will host a conference call to discuss operational and financial achievements, as well as a Q&A session. CytoSorbents specializes in critical care immunotherapy with its flagship product, CytoSorb®, approved in the EU, utilized in over 121,000 treatments worldwide. The company has received significant funding of over $38 million for its innovative blood purification technologies.

CytoSorbents Corporation (NASDAQ: CTSO) will participate in the Cowen 41st Annual Health Care Conference on March 3, 2021. CEO Dr. Phillip Chan will provide insights into the company's advancements and future outlook, followed by a discussion with Dr. Joshua Jennings of Cowen. The company has made significant progress in critical care immunotherapy with its CytoSorb® blood purification technology, already utilized in over 121,000 human treatments. This technology is designed to treat severe inflammatory conditions and is approved in the EU, distributed across 67 countries.

CytoSorbents Corporation (NASDAQ: CTSO) announced a strong performance in 2020 with a preliminary revenue of $40.8 million, a 73% increase from 2019. The company aims for sales growth in 2021, focusing on U.S. FDA approval for CytoSorb to remove ticagrelor in cardiothoracic surgeries. The company plans to expand its manufacturing capacity and has already achieved FDA Emergency Use Authorization for CytoSorb in treating critically-ill COVID-19 patients. Upcoming earnings details will be disclosed on March 9, 2021.