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Description of the Business and Management's Plans
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9 Months Ended | 12 Months Ended |
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Sep. 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 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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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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