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 timing of the Phase
II study clinical readout. 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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