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Note 1 - Description of the Business and Management's Plans
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9 Months Ended |
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Sep. 30, 2012
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| Nature of Operations [Text Block] |
1.
Description
of the Business and Management’s Plans
MRI
Interventions, Inc. (the “Company”) is a medical
device company that is focused on the development and
commercialization of technology that enables physicians to
see inside the brain and heart using direct, intra-procedural
magnetic resonance imaging, or MRI, guidance while performing
minimally invasive surgical procedures. The Company was
incorporated in the State of Delaware on March 12,
1998.
The
Company’s ClearPoint system, an integrated system
comprised of reusable components and disposable products, is
designed to allow minimally invasive procedures in the brain
to be performed in an MRI suite. In 2010, the Company
received 510(k) clearance from the Food and Drug
Administration (“FDA”) to market the ClearPoint
system in the United States for general neurological
interventional procedures. The Company’s ClearTrace
system is a product candidate under development that is
designed to allow catheter-based minimally invasive
procedures in the heart to be performed in an MRI suite. The
Company has also entered into exclusive licensing and
development agreements (see Note 5) with affiliates of Boston
Scientific Corporation (“BSC”), pursuant to which
BSC may incorporate certain of the Company’s MRI-safety
technologies into BSC’s implantable leads for cardiac
and neurological applications.
Basis
of Presentation and Use of Estimates
In
the opinion of management, the accompanying unaudited
condensed financial statements (“condensed financial
statements”) have been prepared on a basis consistent
with the Company’s December 31, 2011 audited financial
statements and include all adjustments, consisting of only
normal recurring adjustments, necessary to fairly state the
information set forth therein. The condensed financial
statements have been prepared in accordance with the
Securities and Exchange Commission (SEC) rules for interim
financial information, and, therefore, omit certain
information and footnote disclosure necessary to present the
statements in accordance with generally accepted accounting
principles in the United States (“GAAP”). These
condensed financial statements should be read in conjunction
with the audited financial statements and notes thereto
included in Amendment No. 2 to the Company’s
Registration Statement on Form 10 (“Form 10”)
filed with the SEC on February 28, 2012. The accompanying
condensed balance sheet as of December 31, 2011 has been
derived from the audited financial statements at that date,
but does not include all information and footnotes required
by GAAP for complete financial statements. The results of
operations for the three and nine month periods ended
September 30, 2012 may not be indicative of the results to be
expected for the entire year or any future periods.
Liquidity
and Management’s Plans
Since
inception, the Company has financed its activities
principally from the sale of equity securities, borrowings,
and license arrangements. In July 2012, the
Company completed a private offering (see Note 8) in which it
sold securities for net proceeds of approximately $5,516,000.
The Company intends to fund its future commercialization and
development activities and its working capital needs largely
from existing cash on hand, borrowings and/or from the sale
of equity securities until funds provided by operations are
sufficient to meet working capital requirements. Management
believes that the Company’s existing cash resources
together with cash generated from sales of products, will be
sufficient to meet anticipated cash requirements through the
first quarter of 2013. There can be no assurance that the
Company will be successful in meeting its financing
requirements on reasonably commercial terms, or at all, or
that the Company will generate revenues sufficient to cover
its costs.
The
accompanying condensed financial statements have been
prepared assuming the Company will continue as a going
concern. For the nine month period ended September 30, 2012
and for the years ended December 31, 2011 and 2010, the
Company incurred net losses of $5,148,923, $8,311,410, and
$9,454,235, respectively, and the cumulative net loss since
the Company’s inception through September 30, 2012 is
$64,937,533. In view of these matters, the ability of the
Company to continue as a going concern is dependent upon its
ability to generate additional financing sufficient to
commercialize its developed products, support its
research and development activities and obtain future
regulatory clearances or approvals, and ultimately to
generate revenues sufficient to cover all costs.
In
December 2011, the Company filed a Form 10 with the SEC to
register the Company’s common stock as a class of
equity securities under the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). On February 27,
2012, the Form 10 became effective. As such, the
Company became a public reporting company subject to the
periodic reporting requirements of the Exchange Act.
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