PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ: CTSO), a medical device company specializing in blood purification technology, has announced that its CytoSorb® device has received regulatory approval from the Taiwan Food and Drug Administration (TFDA). The device, which is used to remove cytokines, bilirubin, and myoglobin from blood, aims to treat critically ill and cardiac surgery patients.
The TFDA approval covers the extracorporeal removal of cytokines during conditions such as cytokine storm and sepsis, as well as the removal of bilirubin in liver disease and myoglobin in trauma cases. Additionally, CytoSorb® has been approved for use in removing antithrombotic drugs like Brilinta® and Xarelto® during cardiothoracic surgery, with the objective of reducing perioperative bleeding.
Hemoscien Corporation, which has a significant presence in Taiwan's critical care network, will distribute CytoSorb throughout the country.
Bettina Sabisch, Vice President of International Distributor Sales at CytoSorbents, expressed enthusiasm for the partnership and the potential impact on Taiwanese patients. Tom Juan, Managing Director of Hemoscien, highlighted the critical need for more effective therapies in the region and the anticipated benefits of CytoSorb in addressing infections and preventing organ failure.
CytoSorb is already approved in the European Union and available in 75 countries, with more than 237,000 devices used globally as of March 31, 2024. The technology is designed to reduce cytokine storm and cytokine release syndrome, which are common in critical illnesses that can lead to organ failure and death. It also serves as an extracorporeal liver support therapy and is used during and after cardiothoracic surgery to reduce postoperative complications.
Taiwan's healthcare system, known for its progressive approach and universal coverage, is expected to benefit from the introduction of CytoSorb, particularly in the treatment of sepsis—a significant health concern in the country.
This expansion into the Taiwanese market represents a strategic growth opportunity for CytoSorbents and underscores the global reach and potential impact of its blood purification technology.
The information in this article is based on a press release statement from CytoSorbents Corporation.
In other recent news, CytoSorbents Corporation reported a 14% increase in product sales in the first quarter of 2024, totaling $9 million. The company also noted an improved product gross margin of 76%.
Furthermore, CytoSorbents is preparing to submit marketing applications for its DrugSorb-ATR system in the U.S. and Canada. The company also anticipates launching its PuriFi hemoperfusion pump in select international markets.
With a cash balance of $10.1 million, the firm believes it has sufficient funding until the fourth quarter of 2024 and is actively seeking non-dilutive financing options. The company has delivered over 237,000 devices and expects to reach a quarter million devices this year.
Also, positive data on the CytoSorb product has been published, indicating its effectiveness in various medical applications.
InvestingPro Insights
As CytoSorbents Corporation (NASDAQ: CTSO) celebrates its regulatory approval in Taiwan, the company's financial health and stock performance provide a broader context for investors. According to InvestingPro data, CytoSorbents has a market capitalization of $43.45 million and is trading near its 52-week low, reflecting a challenging period for the stock. The company's P/E ratio stands at -1.37, indicating that it is not currently profitable, a sentiment echoed by analysts who do not anticipate profitability for this year.
InvestingPro Tips suggest the company is quickly burning through cash and has not been profitable over the last twelve months. Additionally, the stock has taken a hit over the last six months, with a six-month price total return of -54.55%. These financial metrics suggest that while the company's technology is gaining international traction, its financial performance is under scrutiny by investors.
For those interested in a deeper analysis, there are additional InvestingPro Tips available on the company's profile at https://www.investing.com/pro/CTSO. To access these insights, investors can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. With these resources, investors can better gauge whether the company's recent market expansion aligns with a potential financial turnaround or if caution should be exercised due to its recent performance.
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