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Quotes & Info
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| NSPR > SEC Filings for NSPR > Form 8-K on 4-Dec-2012 | All Recent SEC Filings |
4-Dec-2012
Other Events, Financial Statements and Exhibits
On December 4, 2012, InspireMD, Inc. (the "Company") issued a press release announcing its presentation of thirty-day results of the randomized 432-patient MASTER trial of its embolic protective MGuardTM stentat a satellite symposium on such date at the ICI, Innovations in Cardiovascular Innovation, Meeting in Tel-Aviv. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.
Certain statements contained in the press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995 and involve a number of risks and uncertainties. Such statements may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes,"
"potential" or similar words. Forward-looking statements are not guarantees of
future performance, are based on certain assumptions and are subject to various
known and unknown risks and uncertainties, many of which are beyond the
InspireMD, Inc.'s control, and cannot be predicted or quantified and
consequently, actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and uncertainties
include, without limitation, risks and uncertainties associated with (i) market
acceptance of our existing and new products, (ii) negative clinical trial
results or lengthy product delays in key markets, (iii) an inability to secure
regulatory approvals for the sale of our products, (iv) intense competition in
the medical device industry from much larger, multi-national companies, (v)
product liability claims, (vi) our limited manufacturing capabilities and
reliance on subcontractors for assistance, (vii) insufficient or inadequate
reimbursement by governmental and other third party payers for our products,
(viii) our efforts to successfully obtain and maintain intellectual property
protection covering our products, which may not be successful, (ix) legislative
or regulatory reform of the healthcare system in both the U.S. and foreign
jurisdictions, (x) our reliance on single suppliers for certain product
components, (xi) the fact that we will need to raise additional capital to meet
our business requirements in the future and that such capital raising may be
costly, dilutive or difficult to obtain and (xii) the fact that we conduct
business in multiple foreign jurisdictions, exposing us to foreign currency
exchange rate fluctuations, logistical and communications challenges, burdens
and costs of compliance with foreign laws and political and economic instability
in each jurisdiction. More detailed information about the Company and the risk
factors that may affect the realization of forward-looking statements is set
forth in the Company's filings with the Securities and Exchange Commission,
including the Company's Transition Report on Form 10-KT For the transition
period from January 1, 2012 to June 30, 2012 and its Quarterly Reports on Form
10-Q. Investors and security holders are urged to read these documents free of
charge on the SEC's web site at http://www.sec.gov. The Company assumes no
obligation to publicly update or revise its forward-looking statements as a
result of new information, future events or otherwise.
(d) Exhibits
Exhibit Number Description
99.1 Press release dated December 4, 2012.
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