Item 7.01 Regulation FD Disclosure
Given the late October timing of the ON MED prespecified interim data analysis,
these results will not be known by the time TCT releases its late-breaking
clinical trial agenda. As a result, the ON MED study will not be on the list of
TCT late-breaking clinical trials. However, the Company has been working with
the
Following the prespecified interim data analysis in late October, the Company intends to communicate whether the ON MED study primary endpoint has achieved statistical significance at that point in time. If the primary endpoint achieves statistical significance, enrollment in the ON MED study will cease, and the Company will prepare for data presentation at TCT. The ON MED trial is a Bayesian-designed clinical study, and if its primary endpoint has not yet reached statistical significance at that point in time, trial enrollment will continue until the full, predefined sample size is reached.
The information in this Item 7.01 of this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, which are
subject to risks and uncertainties, including risks related to difficulties and
delays inherent in the development, testing, approval, manufacturing, marketing
and sale of medical products, government regulation and general economic
conditions and other risks and uncertainties described in the Company's periodic
reports on file with the
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