Item 8.01. Other Events.
On
Warning Concerning Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995 and federal securities laws. For example, forward-looking
statements are being used when the registrant discusses the expected reporting
of topline results from the full clinical study during the first quarter of
calendar year 2021. These forward-looking statements and their implications are
based on the current expectations of the management of the registrant only, and
are subject to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the forward-looking
statements. The following factors, among others, could cause actual results to
differ materially from those described in the forward-looking statements:
changes in technology and market requirements; the registrant may encounter
delays or obstacles in launching and/or successfully completing its clinical
trials; the registrant's products may not be approved by regulatory agencies,
the registrant's technology may not be validated as it progresses further and
its methods may not be accepted by the scientific community; the registrant may
be unable to retain or attract key employees whose knowledge is essential to the
development of our products; unforeseen scientific difficulties may develop with
our process; the registrant's products may wind up being more expensive than the
registrant anticipates; results in the laboratory may not translate to equally
good results in real surgical settings; results of preclinical studies may not
correlate with the results of human clinical trials; the registrant's patents
may not be sufficient; the registrant's products may harm recipients; changes in
legislation; inability to timely develop and introduce new technologies,
products and applications; loss of market share and pressure on pricing
resulting from competition, which could cause the actual results or performance
of the registrant to differ materially from those contemplated in such
forward-looking statements. In addition, historic results of scientific research
do not guarantee that the conclusions of future research would not suggest
different conclusions or that historic results would not be interpreted
differently in light of additional research or otherwise. Except as otherwise
required by law, the registrant undertakes no obligation to publicly release any
revisions to these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events. For
a more detailed description of the risks and uncertainties affecting the
registrant, reference is made to the registrant's reports filed from time to
time with the
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