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In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, which could materially affect our business, financial condition or future results.
−Removed: There have been no material changes in our risk factors from those disclosed in that report, except as set forth below.
−Removed: The potential effects of the COVID-19 pandemic are likely to impact, and may exacerbate or trigger, many of our risk factors that were included in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2019.
−Removed: In addition, the following risk factor is added:
−Removed: The COVID -19 pandemic has adversely affected, and we expect that it will continue to adversely affect, our business, financial condition and results of operations.
−Removed: The COVID-19 pandemic, and efforts taken to address the pandemic, have negatively impacted the global economy and our business, and are expected to continue to have negative effects.
−Removed: The pandemic has caused us to modify many of our business practices, but we cannot assure you that those modifications will be successful in mitigating the negative impacts of COVID-19.
−Removed: As described elsewhere in this report, as a result of the COVID-19 pandemic, a number of healthcare facilities and clinics have restricted access to their clinicians, reduced patient consultations and treatments, or closed temporarily due to the pandemic.
−Removed: We have seen adverse impacts as it relates to the decline in the number of patients that healthcare facilities and clinics are able to treat due to enhanced safety protocols.
−Removed: Further, due to the impact of COVID-19, patient recruitment for our clinical studies involving our products and clinical outcomes has been suspended.
−Removed: Further, the extent to which the COVID-19 pandemic will impact our business, financial condition and results of operations in the future will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to, the duration, spread, severity, and impact of the COVID-19 pandemic, the effects of the COVID-19 pandemic on our clinician customers and their patients, our suppliers and our payers, and the remedial actions and stimulus measures adopted by governmental authorities, and to what extent normal economic and operating conditions can resume.
−Removed: Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future.
−Removed: The potential negative impacts of the COVID-19 pandemic on us include, but are not limited to:
−Removed: ● further reduced demand for our products;
−Removed: ● reductions in coverage or reimbursement of our products by payers;
−Removed: ● our inability to effectively conduct virtual patient demonstrations and trainings;
−Removed: ● continued restricted access to clinicians, further reduced patient consultations and treatments, and additional or further closures of healthcare facilities and clinics;
−Removed: ● disruptions to our supply chain;
−Removed: ● limitations on the ability of our workforce to perform their duties effectively;
−Removed: ● disruptions in the timely delivery of our products to patients;
−Removed: ● increased risks of phishing and other cybersecurity attacks;
−Removed: ● delayed reviews and approvals by the U.S.
−Removed: Food and Drug Administration;
−Removed: ● increased unemployment rates in the U.S., which may lead to a reduced number of patients with available insurance coverage, resulting in a reduction in the demand for our products;
−Removed: ● significant stock market volatility, resulting in extreme price and volume fluctuations;
−Removed: ● our inability to focus on or expend resources toward the expansion of our business;
−Removed: ● continued adverse impact on liquidity or sources of capital.
−Removed: Given the evolving health, economic, social and governmental impacts of the COVID-19 pandemic, the potential impact that the COVID-19 pandemic could have on us remains uncertain, but it could have a material adverse effect on our business, financial condition and results of operations.
+Added: There have been no material changes in our risk factors from those disclosed in that report.
Unregistered Sales of Equity Securities and Use of Proceeds.
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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.