PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ: CTSO), a medical device company, has announced the submission of its DrugSorb-ATR De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, 2024. The application seeks to market the device for reducing perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery. The FDA has granted DrugSorb-ATR Breakthrough Device Designation, which qualifies it for priority review due to its potential to address a significant unmet medical need.
The submission is based on data from the STAR-T trial, a North American pivotal study that evaluated the safety and efficacy of DrugSorb-ATR in urgent CABG surgery patients. The product aims to decrease the risk of severe bleeding by removing ticagrelor, a blood-thinning medication, from the patient's system.
In addition to the FDA application, CytoSorbents is preparing to submit a Medical Device License application to Health Canada, pending the anticipated receipt of Medical Device Single Audit Program certification. Both FDA and Health Canada decisions on DrugSorb-ATR are expected in 2025.
CytoSorbents also provided a business update, estimating that their Q3 2024 product sales will show a growth of 7% to 10% compared to the same quarter in the previous year. However, a temporary production slowdown and a manufacturing issue have led to a decrease in the number of devices produced and a reduction in product gross margins compared to Q3 2023. The company expects to resolve these issues and return to normal production levels and margins in Q4 2024.
About CytoSorbents, the company specializes in blood purification technologies to treat life-threatening conditions in the ICU and during cardiac surgery. Their lead product, CytoSorb, is already approved and distributed in the European Union and other countries but is not yet approved in the U.S. or Canada. The DrugSorb-ATR system, based on similar technology, is intended to reduce bleeding complications in surgeries involving antithrombotic drugs.
This news article is based on a press release statement and contains only factual information without any endorsement of claims.
In other recent news, CytoSorbents Corporation has seen significant developments. The company has reported a 5% increase in total revenue to $9.9 million in the second quarter of 2024, and a 10% rise in product sales to $8.8 million. The operating loss has also decreased by 48% to $3.4 million compared to the same period last year.
In addition, CytoSorbents has amended its royalty agreement with ROKK, LLC. This amendment modifies the original contract concerning the perpetual royalty payments for the company's CytoSorb device, offering a clarified definition of "gross revenue" for the calculation of royalty payments.
CytoSorbents has also appointed a new CFO, Peter J. Mariani, and is preparing for upcoming regulatory submissions for their DrugSorb-ATR system to the FDA and Health Canada. The company anticipates the DrugSorb-ATR system to receive FDA breakthrough designation for a faster review process.
Lastly, CytoSorbents has implemented cost-cutting measures that resulted in $5 million in annual savings, and ended the period with a cash balance of $14.9 million. These are among the recent developments contributing to the company's steady financial progress and product development pipeline.
InvestingPro Insights
CytoSorbents Corporation's recent FDA submission for DrugSorb-ATR comes at a time when the company is experiencing mixed financial signals. According to InvestingPro data, CTSO's revenue growth has been modest, with a 2.17% increase over the last twelve months as of Q2 2024, and a slightly better 5.03% growth in the most recent quarter. This aligns with the company's estimate of 7% to 10% product sales growth for Q3 2024 mentioned in the article.
Despite the revenue growth, CytoSorbents faces profitability challenges. An InvestingPro Tip indicates that the company is "quickly burning through cash," which is reflected in its operating income margin of -65.15% for the last twelve months. This financial strain may explain the temporary production slowdown and manufacturing issues mentioned in the business update.
On a more positive note, another InvestingPro Tip highlights that "liquid assets exceed short term obligations," suggesting that CytoSorbents maintains a degree of financial stability despite its current challenges. This could be crucial as the company awaits regulatory decisions and works to resolve its production issues.
The market seems to be responding positively to CytoSorbents' recent developments, with InvestingPro data showing strong returns over various timeframes. The stock has seen a 42.86% price return over the last month and an impressive 114.29% over the last three months. This investor optimism may be tied to the potential of DrugSorb-ATR and its Breakthrough Device Designation.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and metrics. There are 10 more InvestingPro Tips available for CTSO, providing a deeper understanding of the company's financial health and market position.
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