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Note 1 - Description of the Business and Management's Plans
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6 Months Ended |
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Jun. 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
SEC’s 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 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 six
month periods ended June 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 10) in which
it sold securities for net proceeds of approximately
$5,520,000 ($989,520 of which was received prior to June 30,
2012 in anticipation of the July closing). The Company
intends to fund its future commercialization and development
activities and its working capital needs largely from
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, including funds
received in July 2012, 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 six month period ended June 30, 2012 and for
the years ended December 31, 2011 and 2010, the Company
incurred net losses of $4,074,368, $8,311,410, and
$9,454,235, respectively, and the cumulative net loss since
the Company’s inception through June 30, 2012 is
$63,862,978, which has resulted in a negative working capital
position of $6,206,466 at June 30, 2012. 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 Registration Statement on
Form 10 (“Form 10”) with the Securities and
Exchange Commission (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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