PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ: CTSO), a critical care therapy leader, announced the FDA has started reviewing their De Novo application for DrugSorb-ATR, a device aimed at mitigating perioperative bleeding in coronary artery bypass graft (CABG) surgery patients on ticagrelor. The FDA's acceptance for substantive review follows the breakthrough designation granted to DrugSorb-ATR, which is expected to expedite the review process with a decision anticipated in 2025.
DrugSorb-ATR is designed to reduce the need for delayed surgery in patients taking ticagrelor, a blood thinner, by rapidly eliminating the drug from the bloodstream. Current protocol suggests delaying CABG surgery for several days to allow the drug to naturally clear from the body, reducing the risk of severe bleeding. The investigational device's safety and efficacy were evaluated in the STAR-T trial, a North American pivotal study involving 140 patients.
CytoSorbents CEO Dr. Phillip Chan expressed confidence in the device's potential to safely hasten necessary surgeries, thus conserving hospital resources and reducing patient risk. The company also plans to seek Health Canada Medical Device Licensure for DrugSorb-ATR, pending the receipt of the Medical Device Single Audit Program (MDSAP) certification.
The FDA De Novo pathway is intended for novel medical devices that demonstrate low to moderate risk and do not have a comparable device on the market. Devices that receive a breakthrough designation are eligible for expedited development and review to provide timely access to important new therapies.
CytoSorbents' blood purification technologies, including their flagship product CytoSorb, have been used in various critical care applications worldwide. CytoSorb is approved in the European Union and has been used in over 250,000 treatments globally. However, it is not yet approved in the United States. The company's portfolio is protected by multiple U.S. and international patents and trademarks, with several products in development.
This article is based on a press release statement and provides a summary of the key facts regarding CytoSorbents' FDA review process for DrugSorb-ATR and its regulatory status.
In other recent news, CytoSorbents has experienced a series of significant developments. The medical device company has reported a 5% increase in total revenue to $9.9 million and a 10% rise in product sales to $8.8 million in the second quarter of 2024, while the operating loss has decreased by 48% to $3.4 million compared to the same period last year. B.Riley has reaffirmed a Buy rating for CytoSorbents, following the company's submission of its DrugSorb-ATR De Novo application to the U.S. FDA. The company has also initiated an "at the market" equity offering that could raise up to $20 million.
The company has amended its royalty agreement with ROKK, LLC, concerning perpetual royalty payments for the CytoSorb device. CytoSorbents has also appointed Peter J. Mariani as its new CFO and implemented cost-saving measures that resulted in $5 million in annual savings.
Notably, the company anticipates decisions from both the FDA and Health Canada on DrugSorb-ATR in 2025. CytoSorbents has also released preliminary figures for third-quarter product revenue for 2024, projecting sales between $8.3 million and $8.5 million, reflecting a year-over-year growth of 7% to 10% from the third quarter of 2023. These are the recent developments shaping the company's steady financial progress and product development pipeline.
InvestingPro Insights
As CytoSorbents Corporation (NASDAQ: CTSO) progresses with its FDA review for DrugSorb-ATR, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $57.15 million, reflecting its current position in the medical devices sector.
Despite the potential of DrugSorb-ATR, CytoSorbents faces financial challenges. An InvestingPro Tip indicates that the company is "quickly burning through cash," which could be a concern as it navigates the regulatory process and prepares for potential commercialization. This aligns with another InvestingPro Tip suggesting that analysts do not anticipate the company will be profitable this year.
On a positive note, CytoSorbents' revenue for the last twelve months as of Q2 2024 was $37.16 million, with a modest revenue growth of 2.17% over the same period. The company's gross profit margin is robust at 64.56%, indicating strong pricing power for its existing products.
However, investors should be aware that the company's operating income margin stands at -65.15%, underscoring the current unprofitability of its operations. This is further reflected in the negative return on assets of -48.23%.
It's worth noting that while the stock has experienced a significant 29.63% price increase over the last six months, it has also seen a 32.26% decline in the past month. This volatility may be attributed to market reactions to regulatory developments and financial performance.
For those interested in a deeper analysis, InvestingPro offers additional tips and metrics. In fact, there are 8 more InvestingPro Tips available for CTSO, providing a comprehensive view of the company's financial health and market position.
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