5 unchanged sentences
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 potential disruptions in our raw material supply, the manufacturing and 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 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.
In addition, the COVID-19 pandemic has affected and is likely to continue to affect the operations of the U.S.
Food and Drug Administration and other health authorities, which could result in delays of reviews and approvals, including with respect to CytoSorb and our product candidates.
−Removed: The evolving COVID-19 pandemic has impacted and is likely to continue to directly or indirectly impact our clinical trials, including but not limited to, the pace of enrollment and anticipated start and completion date of these trials, for at least the next several months and possibly longer.
−Removed: For example, patients may avoid or be unable to travel to hospitals for elective procedures or health emergencies, or clinical trial staff may no longer be able to work on site at hospitals, or hospitals may halt clinical trial activity in favor of spending scarce resources on COVID-19 patients.
−Removed: In particular, due to delays caused by the COVID-19 pandemic, analysis of the study data and issuance of top-line data for the 289 enrolled patients, fifteen-center randomized, controlled study (“REMOVE”) using CytoSorb during valve replacement open heart surgery in patients with infective endocarditis is now anticipated to be available in the fourth quarter of 2020 (rather than by mid-2020 that was initially anticipated), with full analysis of data expected in early 2021.
−Removed: There may also be further delays in patient enrollment in the REFRESH 2, TISORB, and CYTATION clinical trials as a result of the COVID-19 pandemic.
−Removed: In addition, COVID-19 disruptions to our workforce, including but not limited to federal, state and local responses to the pandemic, could materially impact our productivity, including our ability to manufacture CytoSorb, or to develop our product pipeline.
+Added: The evolving COVID-19 pandemic has impacted and is likely to continue to directly or indirectly impact our clinical trials, including but not limited to, the anticipated completion date of these trials and the pace of enrollment in our clinical trials for at least the next several months and possibly longer as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff can no longer get to the clinic.
+Added: 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.
+Added: 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.
+Added: 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: STAR-T randomized, controlled trial.
+Added: In addition, employee disruptions and remote working environments related to the COVID-19 pandemic and the federal, state and local responses to such virus, could materially impact the efficiency and pace with which we work and develop our product candidates, our ability to execute and invoice upon government grants and contracts, and the manufacturing of CytoSorb.
As of the date of this filing, our manufacturing facilities remain operational and we have resumed certain research and development activities that were temporarily suspended as a result of the COVID-19 pandemic.
−Removed: The overall impact of the COVID-19 pandemic across our business, healthcare systems, and the global economy is complex, highly uncertain, and subject to change.
−Removed: These effects could have a material negative impact on our liquidity, capital resources, operations, and business as well as those third parties on which we rely.
−Removed: For example, although the Company is currently well-capitalized, a protracted COVID-19 pandemic and a volatile stock market could make it difficult to raise additional capital, if needed, which could negatively impact our liquidity.
−Removed: To date, during certain periods of the COVID-19 pandemic, our stock price fluctuated significantly, and such volatility may continue.
+Added: Further, while the potential economic impact brought on by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity.
+Added: Additionally, the stock market has been unusually volatile during the COVID-19 outbreak and such volatility may continue.
+Added: To date, during certain periods of the COVID-19 pandemic, our stock price fluctuated significantly, and such fluctuation will likely continue to occur.
+Added: The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change.
+Added: We do not yet know the full extent of potential delays or impacts on our business, financing or clinical trial activities or on healthcare systems or the global economy as a whole.
+Added: 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.
+Added: 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.
+Added: Should the pandemic 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.