Note 1 - Description of the Business and Liquidity
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12 Months Ended | ||||||||||||||||||
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Dec. 31, 2012
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Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] |
1.
Description
of the Business and Liquidity
MRI
Interventions, Inc. (the “Company”) is a
medical device company 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.
In
December 2011, the Company filed a Form 10 registration
statement with the Securities and Exchange Commission
(“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”). Such Form 10 registration
statement became effective on February 27,
2012. As a result, the Company became a public
reporting company subject to the periodic reporting
requirements of the Exchange Act.
Liquidity
and Management’s Plans
For
the years ended December 31, 2012, 2011 and 2010, the
Company incurred net losses of $5,707,136, $8,311,411,
and $9,454,235, respectively, and the cumulative net loss
since the Company’s inception through December 31,
2012 was $65,495,746. The Company expects such losses to
continue through at least the year ended December 31,
2013 as it continues to commercialize its ClearPoint
system and pursue research and development activities.
Net cash used in operations was $7,433,816, $6,239,595,
and $7,707,253 for the years ended December 31, 2012,
2011, and 2010, respectively. Since inception, the
Company has financed its activities principally from the
sale of equity securities, the issuance of convertible
notes and license arrangements.
The
Company’s primary financing activities during the
years ended December 31, 2012, 2011, and 2010
were:
In
January 2013, the Company completed a private offering
(see Note 11) in which it sold securities for net
proceeds of approximately $9,900,000. While the Company
expects to continue to use cash in operations, the
Company believes its existing cash and cash equivalents
at December 31, 2012 of $1,620,005, combined with the net
proceeds from the January 2013 private offering, will be
sufficient to meets its anticipated cash requirements
through at least March 2014. During 2013, the Company
plans to increase its spending on sales and marketing
activities as it completes the commercial rollout of its
ClearPoint system, from which the Company expects to
increase ClearPoint system product revenues. Certain
planned expenditures are discretionary and could be
deferred if the Company is required to do so to fund
critical operations. To the extent the Company’s
available cash and cash equivalents are insufficient to
satisfy its long-term operating requirements, the Company
will need to seek additional sources of funds, from the
sale of additional equity, debt or other securities or
through a credit facility, or modify its current business
plan. There can be no assurances that the Company will be
able to obtain additional financing on commercially
reasonable terms. The sale of additional equity or
convertible debt securities will likely result in
dilution to the Company’s current
stockholders.
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