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On March 11, 2020, the World Health Organization declared the outbreak a pandemic.
−Removed: The COVID-19 pandemic is affecting the United States and global economies has affected and is likely to continue to affect our operations and those of third parties on which we rely, including by causing disruptions in our raw material supply, the manufacturing of our lead product, CytoSorb, the commercialization of CytoSorb, and the conduct of current and future clinical trials.
+Added: The COVID-19 pandemic is affecting the United States and global economies and is likely to continue to affect our operations and those of third parties on which we rely, including by causing disruptions in our raw material supply, the manufacturing of our lead product, CytoSorb, the commercialization of CytoSorb, and the conduct of current and future clinical trials.
In addition, the COVID-19 pandemic has affected and is likely to continue to affect the operations of the U.S.
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Such facilities and offices have and may continue to be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, and may not be available, in whole or in part, for clinical trial services.
−Removed: In particular, due to delays resulting from impacts of the COVID-19 pandemic, analysis of the study data for the 250 patient, multi-center randomized, controlled study (“REMOVE”) using CytoSorb during valve replacement open heart surgery in patients with infective endocarditis is now anticipated to be completed in mid-2021(rather than by mid-2020 that we initially anticipated), with top-line data potentially in the second quarter of 2021 and the full study report thereafter, and there may be further delays in patient enrollment in the REFRESH 2, CYTATION and STAR clinical trials.
−Removed: For example, we have decided to stop the TISORB single arm study due to continued delays and poor enrollment caused by the COVID-19 pandemic in the U.K., in favor of redirecting those resources to the U.S.
+Added: In particular, due to delays resulting from impacts of the COVID-19 pandemic, results from the 250 patient, multi-center randomized, controlled study (“REMOVE”) using CytoSorb during valve replacement open heart surgery in patients with infective endocarditis is now anticipated to be released during the second half of 2021 (rather than by mid-2020 that we initially anticipated).
+Added: There may be further delays in patient enrollment in the REFRESH 2, CYTATION and STAR clinical trials.
+Added: For example, we have stopped the TISORB single arm study due to continued delays and poor enrollment caused by the COVID-19 pandemic in the U.K., in favor of redirecting those resources to the U.S.
STAR-T randomized, controlled trial.
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However, these effects could have a material impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely.
−Removed: The Company estimated that approximately $9.4 million of its 2020 product sales and approximately $1.8 million of its product sales in the three months ended March 31, 2021 were related to the treatment of COVID-19 patients.
−Removed: Should the pandemic ease, it is uncertain whether the Company will be able to replace some or all of this revenue in the future.
+Added: The Company estimated that approximately $9.4 million of its 2020 product sales and approximately $1.7 million and $3.5 million of its product sales in the three and six months ended June 30, 2021, respectively, were related to the treatment of COVID-19 patients.
+Added: As the pandemic continues to ease, it is uncertain whether the Company will be able to replace some or all of this revenue in the future.
Unregistered Sales of Equity Securities and Use of Proceeds.
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.