Item 8.01 Other Events.
On
Information appearing on the CMS website is not part of this Form 8-K.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits 99.1 Press release datedApril 20, 2021 issued by the Company. Forward-Looking Statements
This Form 8-K contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance, or achievements, and may contain the words "anticipate," "believe," "estimate," "expect," "intend," "the facts suggest," "will be," "will continue," "will likely result" or, in each case, their negative, or words or expressions of similar meaning.
These statements reflect the Company's current view of future events and are subject to certain risks and uncertainties, which include, among others, the following:
? the coverage of autologous PRP beyond 20 weeks for DFUs and for the treatment of all chronic, non-healing wounds, which will be determined by local Medicare Administrative Contractors (MACs); ? significant uncertainty surrounding an agreed path forward for Aurix as an accessible product option for physicians treating Medicare beneficiaries with chronic wounds - in the absence of such a path, the Company will likely have to cease operations; ? the Company's nominal cash resources, the Company's need for immediate and substantial additional financing and its ability to obtain that financing, including in light of the low share price and significant volatility with respect to its common stock; ? the fact that the Company has no assets left to monetize other than the Aurix System itself; and ? the fact that the Company has not filed its annual reports on Form 10-K for the years endedDecember 31, 2019 and 2020 and has not filed any quarterly reports since its Form 10-Q for the quarter endedSeptember 30, 2019 , as well as other risks and uncertainties referenced in the Company'sSEC filings.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements, and the Company's business, results of operations, financial condition and cash flows may be materially and adversely affected. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results. Except to the extent required by applicable law or rules, the Company undertakes no obligation and does not intend to update, revise or otherwise publicly release any revisions to its forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events.
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