CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan
CytoSorbents announced the regulatory approval of CytoSorb® by the Taiwan Food and Drug Administration (TFDA) for treating critically ill and cardiac surgery patients. This approval covers the extracorporeal removal of cytokines, bilirubin, and myoglobin. Additionally, it allows the removal of antithrombotic drugs during cardiothoracic surgery to reduce bleeding risks. CytoSorb will be distributed in Taiwan by Hemoscien The product, used in over 237,000 treatments worldwide, aims to address critical illnesses, including sepsis, which affects approximately 150,000 people annually in Taiwan. This approval marks a significant milestone for CytoSorbents, enhancing their market reach in a progressive healthcare system.
- Regulatory approval of CytoSorb® by Taiwan FDA.
- Covers multiple critical conditions like cytokine storm, sepsis, liver disease, and trauma.
- Partnership with Hemoscien for distribution in Taiwan.
- CytoSorb® used in over 237,000 treatments globally.
- Taiwan's progressive healthcare system provides an expansive market opportunity.
- Complex and lengthy approval process may have delayed market entry.
Insights
The regulatory approval of CytoSorb® in Taiwan by the TFDA represents a significant milestone for CytoSorbents Corporation. This approval allows the company to expand its market reach into one of the most advanced healthcare systems globally. CytoSorb® is designed for blood purification, addressing critical conditions such as cytokine storms, sepsis, liver disease and trauma. These conditions are notoriously difficult to treat and often result in high mortality rates.
CytoSorb®'s versatility in treating various life-threatening conditions, along with its application in cardiothoracic surgery to reduce perioperative bleeding, offers a substantial clinical advantage. Given Taiwan's high incidence of sepsis and the progressive nature of its healthcare system, CytoSorb® could significantly impact patient outcomes.
The broad approval indications suggest that CytoSorb® can be a multi-faceted tool in critical care. However, the company must ensure robust post-market surveillance and gather real-world evidence in Taiwan to optimize its use and further validate its efficacy.
From a financial perspective, the approval of CytoSorb® in Taiwan presents a substantial growth opportunity for CytoSorbents Corporation. Taiwan's healthcare system, known for its progressive nature and universal coverage, is an excellent market for advanced medical devices. The strategic partnership with Hemoscien Corporation, which has a deep network in Taiwan's ICU sectors, is likely to facilitate effective market penetration.
The global distribution of more than 237,000 CytoSorb devices underscores the demand and acceptance of this technology. Expanding into Taiwan could potentially lead to increased revenue streams and market share for CytoSorbents. Given the high number of sepsis cases in Taiwan, the financial outlook appears promising.
However, investors should monitor the company’s ability to scale its operations and meet the demand within Taiwan’s healthcare infrastructure. Additionally, they should consider the competitive landscape and any potential regulatory challenges that may arise in the future.
Brings a powerful blood purification technology used to treat critically ill and cardiac surgery patients in nearly a quarter million treatments across 75 countries to date to one of the most progressive healthcare systems in the world
PRINCETON, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the regulatory approval of CytoSorb® in Taiwan by the Taiwan Food and Drug Administration (TFDA). The approved indications include the extracorporeal removal of cytokines (e.g. cytokine storm, sepsis), bilirubin (e.g. liver disease), and myoglobin (e.g. trauma) from a patient’s circulating blood. The removal of the antithrombotic drugs Brilinta® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Janssen/Bayer) during cardiothoracic surgery is also approved, with the goal of reducing perioperative bleeding. CytoSorb will be distributed throughout Taiwan by Hemoscien Corporation.
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.”
Mr. Tom Juan, Managing Director of Hemoscien Corporation emphasized, “There is an ongoing critical need for more effective therapies to combat infections and to prevent or treat organ failure. I firmly believe that advanced blood purification devices such as CytoSorb® can complement the limitations of traditional pharmaceuticals by restoring peripheral blood homeostasis and balance. Given the widespread and successful application of CytoSorb therapy in numerous countries to treat life-threatening critical illnesses, we are confident in our ability to take what has been learned and to market and support CytoSorb in Taiwan's ICU sectors through our deep critical care network to help save the lives of severely ill patients.”
In addition to Taiwan, 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 such as sepsis and septic shock, trauma, acute respiratory distress syndrome, burn injury, pancreatitis, and others that can lead to massive inflammation, organ failure and patient death. CytoSorb is also used as an extracorporeal liver support therapy in acute liver disease (e.g. acute on chronic liver failure, alcoholic hepatitis) and removes both liver toxins, such as bilirubin and bile acids, as well as cytokines. It is also used to treat rhabdomyolysis (e.g. trauma) and the removal of myoglobin. In these diseases, the risk of death can be extremely high, and there are few, if any, effective or practical 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 around the world.
Taiwan, with approximately 24 million inhabitants, offers universal coverage to its citizens through its National Health Insurance System and serves them through a network of nearly 400 medical centers and regional hospitals. With rising medical standards, use of advanced technology to increase administrative and provider efficiency, and access to high quality healthcare, Taiwan boasts one of the most progressive healthcare systems globally. Like many other parts of the world, critical illness including sepsis is a major problem in Taiwan. For example, there are 150,000 estimated new cases of sepsis reported each year in Taiwan with mortality rates as high as
About Hemoscien Corporation
Hemoscien Corporation, a specialized hemo-epuration service provider, was established in 2008 as a spinoff from Smile Group Corp., originally founded in 1980. Since 1998, Hemoscien has maintained a strong partnership with Infomed S.A., a respected ICU hemo-therapy platform developer, achieving over
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. CytoSorb, the Company’s flagship product, was originally launched in the European Union under CE mark as the first cytokine adsorber. In addition to the description in the text above, CytoSorb 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.
CytoSorbents’ 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. Its technologies have received non-dilutive grant, contract, and other funding of approximately
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@cytosorbents.com
Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
ir@cytosorbents.com
FAQ
What recent approval did CytoSorb® receive in Taiwan?
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