Item 7.01. Regulation FD Disclosure.

Cardiovascular Systems, Inc. (the "Company") is providing an update regarding the impact of COVID-19 on its business in the three months ending September 30, 2021. The volume of procedures involving the Company's products has been adversely impacted by hospital capacity constraints due to increased hospitalizations caused by the COVID-19 Delta variant, particularly in Florida, Texas and other areas significantly impacted by COVID-19. In addition to constraints in hospital capacity, the Company has observed disruption of referral patterns, deferral of elective procedures, staffing shortages and heightened summer seasonality. The impact of these factors is more pronounced because procedure volumes involving the Company's products tend to be heavily weighted in September, relative to July and August. The Company believes that these factors will result in lower than anticipated revenue in the first quarter of fiscal 2022, with the potential adverse impact on anticipated revenue for the full quarter to be greater than 10% of our prior expectations. The Company believes that the effects of the Delta variant, or future variants, as well as these other factors, create additional uncertainty with respect to the Company's revenue performance throughout the current fiscal year.

The Company's financial guidance for the full fiscal year ending June 30, 2022, issued on August 4, 2021, did not contemplate an impact from COVID-19, given that the waves of COVID-19 cases experienced in fiscal 2021 caused transient sales declines which were followed by a recovery and more normalized sales trends over the full 12-month period. The Company anticipated that it would experience a similar trend in fiscal 2022; however, in the first quarter, the negative impact due to the Delta variant was larger than anticipated and may, or may not, normalize over the course of the full fiscal year. Accordingly, the Company is not at this time withdrawing or updating its guidance and will continue to monitor and assess the situation. The Company will provide an update with its earnings release for the first quarter.

Forward-Looking Statements

Statements in this Form 8-K regarding the potential future impact of COVID-19 on the Company's business and financial results are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the pendency and impact of COVID-19, government actions, material delays and cancellations of procedures, delayed spending by healthcare providers, supply chain disruptions, and other factors detailed from time to time in the Company's SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this Form 8-K. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this Form 8-K. The forward-looking statements made in this Form 8-K are made only as of the date of this Form 8-K, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances.

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