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Description of the Business and Management's Plans
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6 Months Ended | 12 Months Ended |
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Jun. 30, 2012
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Dec. 31, 2011
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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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1.
Description of the Business and Management’s
Plans
MRI
Interventions, Inc. (the “Company”), formerly
SurgiVision, Inc., was formed on March 12, 1998. The
Company registered its name change with the state of
Delaware, where the Company is incorporated, in May
2011.
The
Company operates in the medical device industry and 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’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, or the FDA, to market the ClearPoint system
in the United States for general neurological
interventional procedures. The Company’s ClearTrace
system is a product candidate 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.
Liquidity
and Management’s Plans
The
accompanying financial statements have been prepared
assuming the Company will continue as a going concern. For
the years ended December 31, 2011, 2010 and 2009, the
Company incurred net losses of $8,311,410, $9,454,235, and
$7,159,060, respectively, and the cumulative net loss since
the Company’s inception through December 31,
2011 is $59,788,609, which has resulted in a negative
working capital position of $13,053,306 at
December 31, 2011. 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.
Since
inception, the Company has financed its activities
principally from the sale of equity securities, borrowings,
and license arrangements. The Company recently completed a
private offering of its securities (see Note 8) in which it
received net proceeds, before expenses, of approximately
$4,887,000, of which approximately $3,425,000 was received
subsequent to December 31, 2011. The Company intends
to finance its future commercialization and development
activities and its working capital needs largely from
borrowings and from the sale of equity securities until
funds provided by operations are sufficient to meet working
capital requirements. In December 2011, the Company filed a
Form 10 registration statement 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”). Upon the
effectiveness of the Form 10 registration statement, the
Company will become a public reporting company subject to
the periodic reporting requirements of the Exchange Act.
There can be no assurance that the Company will be
successful in achieving its financing goals on reasonable
commercial terms, if at all, or that the Company will
generate revenues sufficient to cover its costs.
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