CytoSorbents Receives Regulatory Approval of CytoSorb® in Taiwan ; Secures $20M Credit Facility
CytoSorbents Corporation (Nasdaq: CTSO) has secured regulatory approval from the Taiwan Food and Drug Administration (TFDA) for CytoSorb®, the company’s extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses. CytoSorb is approved in the European Union and distributed in 75 countries worldwide. CytoSorbents’ share price rose 5.69% in trading on Friday, and an additional 1.23% in after market trading.
Ms. Bettina Sabisch, Vice President of International Distributor Sales at CytoSorbents stated, “We are thrilled to announce this milestone which underscores the value and efficacy of our CytoSorb therapy and was achieved after navigating a long and complex approval process. We look forward to collaborating with Hemoscien and leveraging their long-standing customer relationships in Taiwan to bring this innovative therapy to patients in need.”
The company also announced this month that it has entered into a new $20 million credit facility with Avenue Capital Group.
Proceeds from the facility will provide non-dilutive working capital to support CytoSorbents’ ongoing global CytoSorb® franchise in critical care and cardiac surgery that generated $32.2 million in trailing 12-month sales as of March 31, 2024, planned marketing applications to the FDA and Health Canada for DrugSorb™-ATR and refinancing of the company’s existing Bridge Bank debt.
Commenting on the credit agreement, Ms. Kathleen Bloch, Chief Financial Officer of CytoSorbents said, “We are pleased to enter into this relationship with Avenue Capital Group to strengthen our financial position, expand our working capital, and to enable us to confidently pursue our regulatory and commercialization objectives.
“We believe the planned marketing applications of DrugSorb-ATR to U.S. FDA and Health Canada this summer and the prospects of opening an estimated total addressable market in the U.S. and Canada in excess of $0.5 billion if approved, represents a potential watershed event for the Company. As an FDA Breakthrough Device, DrugSorb-ATR aims to reduce serious bleeding complications in patients undergoing coronary artery bypass graft (CABG) surgery on the blockbuster blood-thinning drug Brilinta® (ticagrelor, AstraZeneca) – a major unmet medical need. The full $20 million is expected to help fund the Company through both Health Canada and U.S. FDA regulatory decisions.”
As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively around the world.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure.
