x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
58-2394628
|
(State or Other Jurisdiction
|
(IRS Employer
|
of Incorporation or Organization)
|
Identification Number)
|
One Commerce Square, Suite 2550
|
|
Memphis, Tennessee
|
38103
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
(901) 522-9300
|
|
(Registrant's Telephone Number, Including Area Code)
|
Large accelerated filer
o
|
Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller Reporting Company
x
|
Page Number
|
||
PART I – FINANCIAL INFORMATION | ||
Item 1. |
Financial Statements (unaudited).
|
|
Condensed Balance Sheets as of March 31, 2012 and December 31, 2011
|
1
|
|
Condensed Statements of Operations for the three months ended March 31, 2012 and 2011
|
2
|
|
Condensed Statement of Stockholders’ Deficit for the three months ended March 31, 2012
|
3
|
|
Condensed Statements of Cash Flows for the three months ended March 31, 2012 and 2011
|
4
|
|
Notes to Condensed Financial Statements
|
6
|
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
19
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk.
|
25
|
Item 4. |
Controls and Procedures.
|
26
|
PART II – OTHER INFORMATION | ||
Item 1. |
Legal Proceedings.
|
26
|
Item 1A. |
Risk Factors.
|
26
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds.
|
47
|
Item 3. |
Defaults Upon Senior Securities.
|
48
|
Item 4. |
Mine Safety Disclosures.
|
48
|
Item 5. |
Other Information.
|
48
|
Item 6. |
Exhibits.
|
48
|
SIGNATURES |
49
|
●
|
demand and market acceptance of our products;
|
●
|
our ability to successfully complete the development of, and to obtain regulatory clearance or approval for, future products, including our current product candidates;
|
●
|
product quality or patient safety issues, which could lead to product recalls, withdrawals, launch delays, sanctions, seizures, litigation, or declining sales;
|
●
|
our dependence on collaboration partners;
|
●
|
sufficiency of our cash resources to maintain planned commercialization efforts and research and development programs;
|
●
|
the healthcare reform legislation and its implementation, and possible additional legislation, regulation and other governmental pressures in the United States or globally, which may affect pricing, reimbursement, taxation and rebate policies of government agencies and private payors or other elements of our business;
|
●
|
our ability to identify business development and growth opportunities for existing or future products;
|
●
|
individual, group or class action alleging products liability claims;
|
●
|
future actions of the FDA or any other regulatory body or government authority that could delay, limit or suspend product development, manufacturing or sale or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities;
|
●
|
our ability to enforce our patent rights or patents of third parties preventing or restricting the manufacture, sale or use of affected products or technology;
|
●
|
retention of our sales representatives and independent distributor; and
|
●
|
any impact of the commercial and credit environment on us and our customers and suppliers.
|
March 31,
2012
|
December 31,
2011
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$ | 1,681,887 | $ | 145,478 | ||||
Accounts receivable
|
158,630 | 401,580 | ||||||
Inventory
|
959,718 | 968,818 | ||||||
Prepaid expenses and other current assets
|
56,928 | 19,773 | ||||||
Total current assets
|
2,857,163 | 1,535,649 | ||||||
Property and equipment, net
|
1,158,914 | 1,218,830 | ||||||
Deferred costs
|
- | 214,469 | ||||||
Other assets
|
55,880 | 61,481 | ||||||
Total assets
|
$ | 4,071,957 | $ | 3,030,429 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 3,556,164 | $ | 4,037,168 | ||||
Accrued compensation
|
995,186 | 1,011,413 | ||||||
Accrued interest
|
- | 971,733 | ||||||
Other accrued liabilities
|
1,792,665 | 2,015,046 | ||||||
Related party deferred revenue
|
3,346,374 | 2,600,000 | ||||||
Convertible notes payable, net of unamortized discount of
$117,405 at December 31, 2011
|
- | 3,953,595 | ||||||
Total current liabilities
|
9,690,389 | 14,588,955 | ||||||
Related party deferred revenue
|
- | 1,396,374 | ||||||
Related party accrued interest
|
- | 799,102 | ||||||
Other accrued liabilities
|
553,511 | 209,143 | ||||||
Related party convertible notes payable, net of unamortized
discount of $0 and $432,706 at March 31, 2012
and December 30, 2011, respectively
|
4,338,601 | 4,377,294 | ||||||
Convertible notes payable, net of unamortized discount
of $0 and $316,610 at March 31, 2012 and
December 31, 2011, respectively
|
2,000,000 | 3,308,390 | ||||||
Junior secured notes payable, net of unamortized
discount of $2,806,783 and $2,805,686 at March 31, 2012
and December 31, 2011, respectively
|
193,217 | 194,314 | ||||||
Total liabilities
|
16,775,718 | 24,873,572 | ||||||
Commitments and contingencies (Note 5)
|
- | - | ||||||
Stockholders' deficit:
|
||||||||
Series A convertible preferred stock; $.01 par value;
8,000,000, 7,965,000 and 7,965,000 shares authorized, issued and outstanding, respectively, at December 31, 2011
|
- | 7,965,000 | ||||||
Common stock, $.01 par value; at March 31, 2012, 100,000,000,
40,773,547, and 40,447,717 shares authorized, issued, and
outstanding, respectively; at December 31, 2011, 70,000,000
16,410,820, and 16,084,990 shares authorized, issued, and
outstanding, respectively
|
407,735 | 164,108 | ||||||
Additional paid-in capital
|
51,830,737 | 31,495,593 | ||||||
Treasury stock, at cost, 325,830 common shares
|
(1,679,234 | ) | (1,679,234 | ) | ||||
Accumulated deficit
|
(63,262,999 | ) | (59,788,610 | ) | ||||
Total stockholders' deficit
|
(12,703,761 | ) | (21,843,143 | ) | ||||
Total liabilities and stockholders' deficit
|
$ | 4,071,957 | $ | 3,030,429 |
Three Months Ended March 31,
|
||||||||
2012
|
2011
|
|||||||
Revenues:
|
||||||||
Related party license revenues
|
$ | 650,000 | $ | 650,000 | ||||
Service revenues
|
108,330 | - | ||||||
Product revenues
|
221,669 | 126,194 | ||||||
Total revenues
|
979,999 | 776,194 | ||||||
Costs and operating expenses:
|
||||||||
Cost of product revenues
|
101,669 | 82,940 | ||||||
Research and development
|
689,669 | 1,165,107 | ||||||
Selling, general, and administrative
|
1,340,103 | 1,235,555 | ||||||
Total costs and operating expenses
|
2,131,441 | 2,483,602 | ||||||
Operating loss
|
(1,151,442 | ) | (1,707,408 | ) | ||||
Other income (expense):
|
||||||||
Other income (expense), net
|
1,170 | (2,420 | ) | |||||
Interest income
|
1,619 | 1,085 | ||||||
Interest expense (see Note 8)
|
(2,325,736 | ) | (541,875 | ) | ||||
Net loss
|
$ | (3,474,389 | ) | $ | (2,250,618 | ) | ||
Net loss per share attributable to common stockholders:
|
||||||||
Basic and diluted
|
$ | (0.14 | ) | $ | (0.14 | ) | ||
Weighted average shares outstanding:
|
||||||||
Basic and diluted
|
25,187,547 | 15,859,990 |
Convertible Preferred
Stock Series A
|
Common Stock |
Additional
Paid-in
|
Treasury | Accumulated | ||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stock | Deficit | Total | |||||||||||||||||||||||||
Balances, January 1, 2012
|
7,965,000 | $ | 7,965,000 | 16,084,990 | $ | 164,108 | $ | 31,495,593 | $ | (1,679,234 | ) | $ | (59,788,610 | ) | $ | (21,843,143 | ) | |||||||||||||||
Employee share-based compensation
|
- | - | - | - | 228,633 | - | - | 228,633 | ||||||||||||||||||||||||
Fair value of beneficial conversion feature
of convertible notes payable issued
|
- | - | - | - | 383,204 | - | - | 383,204 | ||||||||||||||||||||||||
Fair value of warrants issued with
convertible notes payable
|
- | - | - | - | 383,204 | - | - | 383,204 | ||||||||||||||||||||||||
Fair value of warrants issued to
placement agents and subagents
|
- | - | - | - | 237,299 | - | - | 237,299 | ||||||||||||||||||||||||
Conversion of convertible notes and
accrued interest into common stock
|
- | - | 16,397,727 | 163,977 | 11,216,232 | - | - | 11,380,209 | ||||||||||||||||||||||||
Conversion of Series A preferred stock
into common stock
|
(7,965,000 | ) | (7,965,000 | ) | 7,965,000 | 79,650 | 7,885,350 | - | - | - | ||||||||||||||||||||||
Fair value of warrants issued for
services provided
|
- | - | - | - | 1,222 | - | - | 1,222 | ||||||||||||||||||||||||
Net loss for the three months
ended March 31, 2012
|
- | - | - | - | - | - | (3,474,389 | ) | (3,474,389 | ) | ||||||||||||||||||||||
Balances, March 31, 2012
|
- | $ | - | 40,447,717 | $ | 407,735 | $ | 51,830,737 | $ | (1,679,234 | ) | $ | (63,262,999 | ) | $ | (12,703,761 | ) |
Three Months Ended March 31,
|
||||||||
2012
|
2011
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$ | (3,474,389 | ) | $ | (2,250,618 | ) | ||
Adjustments to reconcile net loss to net cash flows
from operating activities:
|
||||||||
Depreciation and license amortization
|
98,633 | 70,963 | ||||||
Share-based compensation
|
229,855 | 254,743 | ||||||
Amortization and write-off of debt issuance costs
and original issue discounts (see Note 8)
|
2,058,746 | 320,314 | ||||||
Increase (decrease) in cash resulting from changes in:
|
||||||||
Accounts receivable
|
242,950 | (8,024 | ) | |||||
Inventory
|
(20,596 | ) | (85,272 | ) | ||||
Prepaid expenses and other current assets
|
(37,155 | ) | 15,863 | |||||
Other assets
|
1,101 | - | ||||||
Accounts payable and accrued expenses
|
(333,165 | ) | 763,579 | |||||
Related party deferred revenue
|
(650,000 | ) | (650,000 | ) | ||||
Net cash flows from operating activities
|
(1,884,020 | ) | (1,568,452 | ) | ||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
(4,521 | ) | - | |||||
Net cash flows from investing activities
|
(4,521 | ) | - | |||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of convertible notes
payable, net of issuance costs
|
3,424,950 | - | ||||||
Net cash flows from financing activities
|
3,424,950 | - | ||||||
Net change in cash and cash equivalents
|
1,536,409 | (1,568,452 | ) | |||||
Cash and cash equivalents, beginning of period
|
145,478 | 1,577,314 | ||||||
Cash and cash equivalents, end of period
|
$ | 1,681,887 | $ | 8,862 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION
|
||||||||
Cash paid for:
|
||||||||
Income taxes
|
$ | - | $ | - | ||||
Interest
|
$ | - | $ | - |
●
|
In February 2012, the terms of related party notes payable were modified (see Note 6) and accrued interest of $838,601 was added to the principal balances of the original notes.
|
●
|
Upon the effectiveness of the Company’s Form 10 registration statement in February 2012, the principal balance of convertible notes payable totaling $10,811,500 and the related accrued interest of $974,311 were converted into shares of the Company’s common stock (see Note 7). In addition, unamortized debt discounts totaling $405,602 at the conversion date related to the relative fair value of warrants issued in connection with the issuance of the convertible notes (originally accounted for as equity) were offset against additional paid-in capital.
|
●
|
In February 2012, warrants with a fair value of $237,299 (recorded as deferred financing costs and additional paid-in capital) were issued to the placement agent and its sub-placement agents in connection with the Company’s sale of units consisting of secured convertible notes and common stock warrants (see Note 7).
|
●
|
In January and February 2012, both the $383,204 relative fair value of warrants and the $383,204 intrinsic value of the beneficial conversion feature associated with notes issued by the Company in an offering of units (see Note 7) were recorded as additional paid-in capital and a discount to the convertible notes payable.
|
●
|
ClearPoint reusable components with costs of $29,626 were transferred from inventory to loaned systems, which is a component of property and equipment, during the three months ended March 31, 2012.
|
Carrying Value |
Estimated
Fair Value
|
|||||||
Related party BSC convertible notes payable
|
$ | 4,338,601 | $ | 3,386,366 | ||||
Convertible note payable
|
2,000,000 | 2,000,000 | ||||||
Junior secured notes payable
|
193,217 | 1,789,162 |
●
|
Related Party Revenue Recognition under BSC Neuro Agreement (Note 5)
—
The Company analyzed whether the components of the arrangement represent separate units of accounting as defined by GAAP. Application of these standards requires subjective determinations and requires management to make judgments about the value of the individual elements and whether delivered elements are separable from the other aspects of the contractual relationship. The Company determined it does not have clear and objective evidence of fair value of the various elements of the agreement and, therefore, under GAAP regarding Multiple-Element Arrangements, the deliverables are being treated as one unit of accounting.
|
●
|
Related Party Revenue Recognition under BSC Cardiac Agreement (Note 5)
—
The Company analyzed whether the components of the arrangement represent separate units of accounting as defined by GAAP. Application of these standards requires management to make subjective judgments about the value of the individual elements and whether delivered elements are separable from the other aspects of the contractual relationship. The Company determined it does not have clear and objective evidence of fair value of the various elements of the agreement and, therefore, under GAAP regarding Multiple-Element Arrangements, the deliverables are being treated as one unit of accounting.
|
●
|
Service Revenues -
In September 2011, the Company entered into an agreement to provide development services to a third party. Under this agreement, the Company earns revenue equal to costs incurred for outside expenses related to the development services provided, plus actual direct internal labor costs (including the cost of employee benefits), plus an overhead markup of the direct internal labor costs incurred. Revenue is recognized in the period in which the Company incurs the related costs. During the three month period ended March 31, 2012, the Company recorded development service revenues of approximately $108,000 related to this agreement.
|
Three Months Ended March 31,
|
||||||||
2012
|
2011
|
|||||||
Stock options
|
3,503,811 | 3,762,477 | ||||||
Warrants
|
4,776,982 | 435,986 | ||||||
Shares under convertible note agreements
|
3,662,037 | 4,498,276 | ||||||
11,942,830 | 8,696,739 |
March 31,
2012
|
December 31,
2011
|
|||||||
Work in process
|
$ | 348,921 | $ | 454,366 | ||||
Software
|
449,500 | 467,000 | ||||||
Finished goods
|
161,297 | 47,452 | ||||||
$ | 959,718 | $ | 968,818 |
March 31,
2012
|
December 31,
2011
|
|||||||
Equipment
|
939,451 | $ | 934,253 | |||||
Furniture and fixtures
|
105,376 | 106,054 | ||||||
Leasehold improvements
|
157,236 | 157,236 | ||||||
Computer equipment and software
|
101,482 | 101,482 | ||||||
Loaned systems
|
753,672 | 723,975 | ||||||
2,057,217 | 2,023,000 | |||||||
Less accumulated depreciation and amortization
|
(898,303 | ) | (804,170 | ) | ||||
Total property and equipment, net
|
1,158,914 | $ | 1,218,830 |
March 31,
2012
|
December 31,
2011
|
|||||||
BSC Notes - principal
|
$ | 4,338,601 | $ | 3,500,000 | ||||
Summer 2011 Notes - principal
|
- | 1,310,000 | ||||||
Total related party notes payable - principal
|
4,338,601 | 4,810,000 | ||||||
BSC Notes - unamortized discount
|
- | (432,706 | ) | |||||
Summer 2011 Notes - unamortized discount
|
- | - | ||||||
Total related party notes payable - unamortized discount
|
- | (432,706 | ) | |||||
BSC Notes - net
|
4,338,601 | 3,067,294 | ||||||
Summer 2011 Notes - net
|
- | 1,310,000 | ||||||
Total related party notes payable - net
|
$ | 4,338,601 | $ | 4,377,294 |
Current
|
Long-term
|
|||||||||||||||
March 31,
2012
|
December 31,
2011
|
March 31,
2012
|
December 31,
2011
|
|||||||||||||
March 2010 Notes - principal
|
$ | - | $ | 4,071,000 | $ | - | $ | - | ||||||||
2011 Unit Offering Notes - principal
|
- | - | - | 1,625,000 | ||||||||||||
April 2011 Note - principal
|
- | - | 2,000,000 | 2,000,000 | ||||||||||||
Total convertible notes payable - principal
|
- | 4,071,000 | 2,000,000 | 3,625,000 | ||||||||||||
March 2010 Notes - unamortized discount
|
- | (117,405 | ) | - | - | |||||||||||
2011 Unit Offering Notes - unamortized discount
|
- | - | - | (316,610 | ) | |||||||||||
April 2011 Note - unamortized discount
|
- | - | - | - | ||||||||||||
Total convertible notes payable - unamortized discount
|
- | (117,405 | ) | - | (316,610 | ) | ||||||||||
March 2010 Notes - net
|
- | 3,953,595 | - | - | ||||||||||||
2011 Unit Offering Notes - net
|
- | - | - | 1,308,390 | ||||||||||||
April 2011 Note - net
|
- | - | 2,000,000 | 2,000,000 | ||||||||||||
Total convertible notes payable - net
|
$ | - | $ | 3,953,595 | $ | 2,000,000 | $ | 3,308,390 |
Impact to Balance Sheet
|
Increase in
|
|||||||||||||||
Before
|
Impact of
|
After
|
Common Shares
|
|||||||||||||
Conversions
|
Conversions
|
Conversions
|
Outstanding
|
|||||||||||||
Impact on assets
|
||||||||||||||||
Deferred costs
|
$ | 799,123 | $ | (799,123 | ) | $ | - | - | ||||||||
Impact on liabilities and equity
|
||||||||||||||||
Accrued interest on converted notes
|
$ | 974,311 | $ | (974,311 | ) | $ | - | 1,092,559 | ||||||||
Summer 2011 Notes, net
|
904,397 | (904,397 | ) | - | 2,183,334 | |||||||||||
March 2010 Notes, net
|
4,057,500 | (4,057,500 | ) | - | 4,071,000 | |||||||||||
2011 Unit Offering Notes, net
|
4,367,482 | (4,367,482 | ) | - | 9,050,834 | |||||||||||
Total impact on liabilities
|
10,303,690 | (10,303,690 | ) | - | 16,397,727 | |||||||||||
Series A convertible preferred stock
|
7,965,000 | (7,965,000 | ) | - | 7,965,000 | |||||||||||
Additional paid-in capital and common stock
|
- | 19,345,209 | 19,345,209 | - | ||||||||||||
Accumulated deficit
|
- | (1,875,642 | ) | (1,875,642 | ) | - | ||||||||||
Total impact on equity
|
7,965,000 | 9,504,567 | 17,469,567 | 7,965,000 | ||||||||||||
Total impact on liabilities and equity
|
$ | 18,268,690 | $ | (799,123 | ) | $ | 17,469,567 | 24,362,727 |
Shares
|
Weighted - Average Exercise Price
|
|||||||
Warrants outstanding at January 1, 2012
|
1,922,944 | $ | 0.43 | |||||
Warrants issued during three
months ended March 31, 2012
|
2,854,038 | 0.70 | ||||||
Warrants outstanding at March 31, 2012
|
4,776,982 | 0.59 |
Dividend yield
|
0%
|
Expected Volatility
|
47.8% to 49.0%
|
Risk free Interest rates
|
0.88% to 0.93%
|
Expected lives
|
5.0 years
|
Three Months Ended March 31,
|
Percentage
|
|||||||||||
($s in thousands)
|
2012
|
2011
|
Change
|
|||||||||
Revenues
|
$ | 980 | $ | 776 | 26 | % | ||||||
Cost of product revenues
|
102 | 83 | 23 | % | ||||||||
Research and development costs
|
690 | 1,165 | (41 | )% | ||||||||
Selling, general and administrative expenses
|
1,340 | 1,236 | 8 | % | ||||||||
Other income (expense):
|
||||||||||||
Interest income (expense), net
|
(2,324 | ) | (541 | ) | 330 | % | ||||||
Other income (expense), net
|
2 | (2 | ) |
NM
|
||||||||
Net loss
|
(3,474 | ) | (2,251 | ) | (54 | )% |
Impact to Balance Sheet
|
Increase in
|
|||||||||||||||
Before
|
Impact of
|
After
|
Common Shares
|
|||||||||||||
Conversions
|
Conversions
|
Conversions
|
Outstanding
|
|||||||||||||
(in 000s except for share amounts)
|
||||||||||||||||
Impact on assets
|
||||||||||||||||
Deferred costs
|
$ | 799 | $ | (799 | ) | $ | - | - | ||||||||
Impact on liabilities and equity
|
||||||||||||||||
Accrued interest on converted notes
|
$ | 974 | $ | (974 | ) | $ | - | 1,092,559 | ||||||||
Summer 2011 Notes, net
|
904 | (904 | ) | - | 2,183,334 | |||||||||||
March 2010 Notes, net
|
4,058 | (4,058 | ) | - | 4,071,000 | |||||||||||
2011 Unit Offering Notes, net
|
4,367 | (4,367 | ) | - | 9,050,834 | |||||||||||
Total impact on liabilities
|
10,304 | (10,304 | ) | - | 16,397,727 | |||||||||||
Series A convertible preferred stock
|
7,965 | (7,965 | ) | - | 7,965,000 | |||||||||||
Additional paid-in capital and common stock
|
- | 19,345 | 19,345 | - | ||||||||||||
Accumulated deficit
|
- | (1,876 | ) | (1,876 | ) | - | ||||||||||
Total impact on equity
|
7,965 | 9,505 | 17,470 | 7,965,000 | ||||||||||||
Total impact on liabilities and equity
|
$ | 18,269 | $ | (799 | ) | $ | 17,470 | 24,362,727 |
Three Months Ended March 31,
|
||||||||
($s in thousands)
|
2012
|
2011
|
||||||
Cash used in operating activities
|
$ | (1,884 | ) | $ | (1,568 | ) | ||
Cash used in investing activities
|
(5 | ) | - | |||||
Cash provided by financing activities
|
3,425 | - | ||||||
Net increase (decrease) in cash and cash equivalents
|
$ | 1,536 | $ | (1,568 | ) |
●
|
the cost and timing of expanding our sales, marketing and distribution capabilities and other corporate infrastructure;
|
●
|
the cost of establishing inventories;
|
●
|
the effect of competing technological and market developments;
|
●
|
the scope, rate of progress and cost of our research and development activities;
|
●
|
the achievement of milestone events under, and other matters related to, our agreements with Boston Scientific and Siemens;
|
●
|
the terms and timing of any future collaborative, licensing or other arrangements that we may establish;
|
●
|
the cost and timing of any clinical trials;
|
●
|
the cost and timing of regulatory filings, clearances and approvals; and
|
●
|
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
|
|
●
|
the shift in location of the procedure from the operating room to the MRI suite;
|
|
●
|
the hospital’s ability and willingness to satisfy the increased demand for the MRI suite;
|
|
●
|
the cost to the hospital to purchase or otherwise use our products;
|
|
●
|
the amount of reimbursement available from third-party payors;
|
|
●
|
insufficient supporting clinical data; and
|
|
●
|
the familiarity of the physician, and the physician having achieved successful results, with other devices and approaches.
|
|
●
|
differences in treatment protocols and methods across the markets in which we expect to market our ClearPoint system;
|
|
●
|
requirements necessary to obtain product reimbursement;
|
|
●
|
product reimbursement or price controls imposed by foreign governments;
|
|
●
|
difficulties in compliance with foreign laws and regulations;
|
|
●
|
changes in foreign regulations and customs;
|
|
●
|
changes in foreign currency exchange rates and currency controls;
|
|
●
|
changes in a specific country’s or region’s political or economic environment;
|
|
●
|
trade protection measures, import or export licensing requirements or other restrictive actions by U.S. or foreign governments; and
|
|
●
|
negative consequences from changes in tax laws.
|
|
●
|
broad product offerings, which address the needs of physicians and hospitals in a wide range of procedures;
|
|
●
|
greater experience in, and resources for, launching, marketing, distributing and selling products, including strong sales forces and established distribution networks;
|
|
●
|
existing relationships with physicians and hospitals;
|
|
●
|
more extensive intellectual property portfolios and resources for patent protection;
|
|
●
|
greater financial and other resources for product research and development;
|
|
●
|
greater experience in obtaining and maintaining FDA and other regulatory clearances or approvals for products and product enhancements;
|
|
●
|
established manufacturing operations and contract manufacturing relationships; and
|
|
●
|
significantly greater name recognition and more recognizable trademarks.
|
|
●
|
decreased demand for our products;
|
|
●
|
injury to our reputation;
|
|
●
|
diversion of management’s attention;
|
|
●
|
significant costs of related litigation;
|
|
●
|
payment of substantial monetary awards by us;
|
|
●
|
product recalls or market withdrawals;
|
|
●
|
a change in the design, manufacturing process or the indications for which our marketed products may be used;
|
|
●
|
loss of revenue; and
|
|
●
|
an inability to commercialize product candidates.
|
|
●
|
the scope, rate of progress and cost of our research and development activities;
|
|
●
|
the achievement of milestone events under, and other matters related to, our agreements with Boston Scientific and Siemens;
|
|
●
|
the terms and timing of any future collaborative, licensing or other arrangements that we may establish;
|
|
●
|
the cost and timing of clinical trials;
|
|
●
|
the cost and timing of regulatory filings, clearances and approvals;
|
|
●
|
the cost and timing of establishing sales, marketing and distribution capabilities and other corporate infrastructure;
|
|
●
|
the cost of establishing product inventories;
|
|
●
|
the effect of competing technological and market developments; and
|
|
●
|
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
|
|
●
|
design, development and manufacturing;
|
|
●
|
testing, labeling and storage;
|
|
●
|
product safety;
|
|
●
|
marketing, sales and distribution;
|
|
●
|
premarket clearance or approval;
|
|
●
|
recordkeeping procedures;
|
|
●
|
advertising and promotions;
|
|
●
|
recalls and field corrective actions;
|
|
●
|
post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; and
|
|
●
|
product export.
|
|
●
|
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
|
|
●
|
customer notifications or orders for the repair or replacement of our marketed products or refunds;
|
|
●
|
recall, detention or seizure of our marketed products;
|
|
●
|
operating restrictions or partial suspension or total shutdown of production;
|
|
●
|
refusing or delaying requests for 510(k) clearances or PMA approvals of new products or modified products;
|
|
●
|
withdrawing 510(k) clearances or PMA approvals that have already been granted; or
|
|
●
|
refusing to grant export approval for our marketed products.
|
|
●
|
The federal healthcare programs’ Anti-Kickback Statute, which prohibits, among other things, individuals or entities from knowingly and willfully soliciting, receiving, offering or providing any kickback, bribe or other remuneration, directly or indirectly, in exchange for or to induce the purchase, lease or order, or arranging for or recommending of, any item or service for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs.
|
|
●
|
Federal false claims laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid or other federally- funded healthcare programs that are false or fraudulent, or are for items or services not provided as claimed, and which may apply to entities like us to the extent that our interactions with customers may affect their billing or coding practices. Changes to the Federal false claims law enacted as part of the Health Care Reform Law will likely increase the number of whistleblower cases brought against providers and suppliers of health care items and services.
|
|
●
|
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, in addition to the privacy and security rules normally associated with it, which are discussed below, established new federal crimes for knowingly and willfully executing a scheme to defraud any healthcare benefit program or making false statements in connection with the delivery of or payment for healthcare benefits, items or services.
|
|
●
|
State and foreign law equivalents and analogues of each of the above federal laws, such as anti-kickback and false claims laws and the Foreign Corrupt Practices Act, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, or when physicians are employees of a foreign government entity.
|
|
●
|
The Health Care Reform Law imposes certain reporting obligations on manufacturers of drugs, devices and biologics. Specifically, on March 31, 2013, and on the 90th day of each calendar year thereafter, these manufacturers must report all payments or other transfers of value to or on behalf of a physician or teaching hospital by such manufacturers as well as any ownership or investment interest held by physicians in such manufacturers. On December 19, 2011, CMS issued proposed regulations to implement this so-called “Sunshine” provision of the Health Care Reform Law. The proposed regulations suggest that we will be subject to such data collecting, reporting and public disclosure obligation. Data collecting obligations will commence on the effective date of final regulations, which is expected in 2012 with reporting obligations beginning on March 31, 2013. Violations of the reporting requirements are subject to civil monetary penalties, capped at $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report. Reported data will be made publicly available by September 30, 2013.
|
|
●
|
The Health Care Reform Law also grants the Office of Inspector General additional authority to obtain information from any individual or entity to validate claims for payment or to evaluate the economy, efficiency or effectiveness of the Medicare and Medicaid programs, expands the permissible exclusion authority to include any false statements or misrepresentations of material facts, enhances the civil monetary penalties for false statements or misrepresentation of material facts, and enhances the Federal Sentencing Guidelines for those convicted of Federal healthcare offenses.
|
|
●
|
keeping us informed of new developments in their respective fields of practice;
|
|
●
|
advising us on our research and development projects related to their respective fields;
|
|
●
|
advising us on improvements to methods, processes and devices related to their respective fields (such as advice on the development of prototype devices);
|
|
●
|
assisting us with the technical evaluation of our methods, processes and devices related to their respective fields;
|
|
●
|
advising us with respect to the commercialization of products in their respective fields; and
|
|
●
|
providing training and other similar services on the proper use of our products.
|
|
●
|
HIPAA and its implementing regulations, the HIPAA Privacy and Security Rules, apply to covered entities, which include most healthcare facilities that purchase and use our products. The HIPAA Privacy and Security Rules set forth minimum standards for safeguarding individually identifiable health information, impose certain requirements relating to the privacy, security and transmission of individually identifiable health information and provide certain rights to individuals with respect to that information. HIPAA also requires covered entities to contractually bind third parties, known as business associates, in the event that they perform an activity or service for or on behalf of the covered entity that involves access to patient identifiable health information.
|
|
●
|
The federal Health Information Technology for Economic and Clinical Health Act, or HITECH, which was enacted in February 2009, strengthens and expands the HIPAA Privacy and Security Rules and its restrictions on use and disclosure of patient identifiable health information, including imposing liability on business associates of “covered entities”.
|
|
●
|
Both HITECH and most states have data breach laws that necessitate the notification in certain situations of a breach that compromises the privacy or security of personal information.
|
|
●
|
Other federal and state laws restricting the use and protecting the privacy and security of patient information may apply, many of which are not preempted by HIPAA.
|
|
●
|
Federal and state consumer protection laws are being applied increasingly by the United States Federal Trade Commission, or FTC, and state attorneys’ general to regulate the collection, use, storage and disclosure of personal or patient information, through websites or otherwise, and to regulate the presentation of website content.
|
|
●
|
Other countries also have, or are developing, laws governing the collection, use and transmission of personal or patient information.
|
|
●
|
Federal and state laws regulating the conduct of research with human subjects.
|
|
●
|
implementing appropriate operational and financial systems and controls;
|
|
●
|
expanding our assembly capacity and increasing production;
|
|
●
|
expanding our sales and marketing infrastructure and capabilities;
|
|
●
|
improving our information systems;
|
|
●
|
identifying, attracting and retaining qualified personnel in our areas of activity; and
|
|
●
|
hiring, training, managing and supervising our personnel.
|
●
|
stock analysts, stock brokers, institutional investors and other members of the investment community may be reluctant to follow us or create a market in our stock;
|
●
|
our stock may be deemed to be “penny stock,” which means stock traded at a price less than $5.00 per share, which will make it unsuitable for some investors to purchase; and
|
●
|
there are a limited number of stock brokers that will be willing to act as market makers for our common stock, which is essential for establishing an active trading market.
|
●
|
delaying, deferring or preventing a change in corporate control;
|
●
|
impeding a merger, consolidation, takeover or other business combination involving us; or
|
●
|
discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
|
●
|
permit our Board of Directors to issue shares of preferred stock, with any rights, preferences and privileges as they may designate, including the right to approve an acquisition or other change in our control;
|
●
|
provide that the authorized number of directors may be changed only by resolution of the Board of Directors;
|
●
|
provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;
|
●
|
require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent;
|
●
|
provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and also specify requirements as to the form and content of a stockholder’s notice;
|
●
|
do not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose);
|
●
|
provide that special meetings of our stockholders may be called only by the chairman of the Board of Directors, our Chief Executive Officer or by the Board of Directors pursuant to a resolution adopted by a majority of the total number of authorized directors; and
|
●
|
provide that stockholders will be permitted to amend our amended and restated bylaws only upon receiving at least 66 2/3% of the votes entitled to be cast by holders of all outstanding shares then entitled to vote generally in the election of directors, voting together as a single class.
|
MRI INTERVENTIONS, INC.
|
||
By:
|
/s/ Kimble L. Jenkins
|
|
Kimble L. Jenkins
|
||
Chief Executive Officer
(Principal Executive Officer)
|
||
By:
|
/s/ David W. Carlson
|
|
David W. Carlson
|
||
Chief Financial Officer
(Principal Financial Officer and Chief Accounting Officer)
|
Exhibit
Number
|
Description
|
|
3.1
|
Amended and Restated Certificate of Incorporation
|
|
3.2
|
Amended and Restated Bylaws
|
|
3.3**
|
Third Amended and Restated Investor Rights’ Agreement dated September 20, 2006
|
|
3.4***
|
Form of Subscription Agreement for 10% Secured Convertible Promissory Note Due 2014
|
|
4.1
|
Referenced is made to Exhibits 3.1, 3.2, 3.3 and 3.4
|
|
4.2*
|
Specimen of Common Stock Certificate
|
|
4.3*
|
Form of 10% Senior Unsecured Convertible Note Due 2012
|
|
4.4*
|
Form of Junior Secured Promissory Note Due 2020, as amended by that certain Omnibus Amendment dated as of April 5, 2011, as further amended by that certain Second Omnibus Amendment dated as of October 14, 2011
|
|
4.5*
|
10% Subordinated Secured Convertible Note Due 2016 issued to Brainlab AG, as amended
|
|
4.6*
|
Form of Unsecured Convertible Promissory Note Due 2013, as amended
|
|
4.7*
|
Form of 10% Secured Convertible Promissory Note Due 2014
|
|
4.8*
|
Form of Amendment to 10% Senior Unsecured Convertible Note Due 2012
|
|
10.1*+
|
1998 Stock Option Plan
|
|
10.2*+
|
2007 Stock Incentive Plan
|
|
10.3*+
|
Amended and Restated Key Personnel Incentive Program
|
|
10.4*+
|
2010 Incentive Compensation Plan
|
|
10.5*+
|
2010 Non-Qualified Stock Option Plan
|
|
10.6*
|
Junior Security Agreement by and between MRI Interventions, Inc. and Landmark Community Bank, in its capacity as collateral agent, dated as of November 5, 2010, as amended by that certain First Amendment dated April 5, 2011, and as further amended by that certain Second Amendment dated October 14, 2011
|
|
10.7*
|
Security Agreement by and between MRI Interventions, Inc. and Landmark Community Bank, in its capacity as collateral agent, dated as of October 14,2011
|
|
10.8*+
|
Form of Indemnification Agreement
|
|
10.9†*
|
License Agreement by and between SurgiVision, Inc. and The Johns Hopkins University entered into on or around June 20, 1998, as amended by that certain Amendment to License Agreement dated as of January 15, 2000, and as further amended by that certain Addendum to License Agreement entered into on or around December 7, 2004
|
|
10.10†*
|
License Agreement by and between SurgiVision, Inc. and The Johns Hopkins University entered into on or around December 7, 2006
|
10.11†*
|
Technology License Agreement dated as of December 30, 2005 by and between SurgiVision, Inc. and Boston Scientific Neuromodulation Corporation (formerly known as Advanced Bionics Corporation), as amended by that certain Omnibus Amendment dated June 30, 2007, as further amended by that certain Omnibus Amendment #2 dated March 19, 2008
|
|
10.12†*
|
System and Lead Development and Transfer Agreement dated as of December 30, 2005 by and between SurgiVision, Inc. and Boston Scientific Neuromodulation Corporation (formerly known as Advanced Bionics Corporation), as amended by that certain Amendment No. 1 dated May 31, 2006, as further amended by that certain Omnibus Amendment dated June 30, 2007, as further amended by that certain Omnibus Amendment #2 dated March 19, 2008
|
|
10.13†*
|
Technology License Agreement dated as of March 19, 2008 by and between SurgiVision, Inc. and Cardiac Pacemakers, Inc.
|
|
10.14†*
|
Development Agreement dated as of March 19, 2008 by and between SurgiVision, Inc. and Cardiac Pacemakers, Inc.
|
|
10.15†*
|
Cooperation and Development Agreement, dated as of May 4, 2009, by and between SurgiVision, Inc. and Siemens Aktiengesellschaft, Healthcare Sector
|
|
10.16*+
|
Consulting Agreement with Dr. Paul Bottomley
|
|
10.17†*
|
Co-Development and Distribution Agreement dated as of April 5, 2011 by and between SurgiVision, Inc. and Brainlab AG, as amended by that certain First Amendment dated as of July 18, 2011
|
|
10.18†*
|
Master Security Agreement dated April 5, 2011 by and between SurgiVision, Inc. and Brainlab AG
|
|
10.19†*
|
Patent License Agreement – Nonexclusive entered into on or around April 27, 2009 by and between SurgiVision, Inc. and National Institutes of Health
|
|
10.20†*
|
Master Services and Licensing Agreement dated as of July 20, 2007 by and between SurgiVision, Inc. and Cedara Software Corp., as amended by that certain First Amendment dated January 18, 2011
|
|
10.21†*
|
Exclusive License Agreement entered into on or around June 30, 2008 by and between SurgiVision, Inc. and The Johns Hopkins University
|
|
10.22†*
|
Exclusive License Agreement entered into on or around June 30, 2008 by and between SurgiVision, Inc. and The Johns Hopkins University
|
|
10.23†*
|
Exclusive License Agreement entered into on or around June 30, 2008 by and between SurgiVision, Inc. and The Johns Hopkins University
|
|
10.24*
|
Loan Agreement dated as of October 16, 2009 by and between SurgiVision, Inc. and Boston Scientific Corporation
|
|
10.25†*
|
Patent Security Agreement dated as of October 16, 2009 by and between SurgiVision, Inc. and Boston Scientific Corporation
|
|
10.26†*
|
Research Agreement by and between SurgiVision, Inc. and The University of Utah entered into on or around July 2, 2007, as amended by that certain First Amendment to the Research Agreement entered into on or around January 8, 2008, as further amended by that certain Second Amendment to the Research Agreement dated April 24, 2009, as further amended by that certain Third Amendment to the Research Agreement dated May 1, 2009, as further amended by that certain Fourth Amendment to the Research Agreement entered into on or around February 25, 2010, as further amended by that certain Fifth Amendment to the Research Agreement dated December 31, 2010, and as further amended by that certain Sixth Amendment to the Research Agreement dated November 28, 2011
|
10.27
|
Lease Agreement, dated as of April 21, 2008, by and between Shaw Investment Company, LLC and Surgi-Vision, Inc., as amended by that certain Amendment to Lease dated January 20, 2011, as further amended by that certain Amendment to Lease dated March 26, 2012
|
|
10.29*+
|
SurgiVision, Inc. Cardiac EP Business Participation Plan
|
|
10.30*+
|
Cardiac EP Business Participation Plan Award Agreement, dated June 3, 2010, by and between SurgiVision, Inc. and Nassir F. Marrouche
|
|
10.31*+
|
Amended and Restated Key Personnel Incentive Award Agreement, dated June 2, 2010, by and between SurgiVision, Inc. and Paul A. Bottomley
|
|
10.32*+
|
Key Personnel Incentive Award Agreement, dated June 2, 2010, by and between SurgiVision, Inc. and Paul A. Bottomley
|
|
10.33*+
|
Amended and Restated Key Personnel Incentive Award Agreement, dated June 2, 2010, by and between SurgiVision, Inc. and Parag V. Karmarkar
|
|
10.34*+
|
MRI Interventions, Inc. 2012 Incentive Compensation Plan
|
|
10.35*+
|
MRI Interventions, Inc. 2012 Incentive Compensation Plan Form of Incentive Stock Option Agreement
|
|
10.36*+
|
MRI Interventions, Inc. 2012 Incentive Compensation Plan Form of Non-Qualified Stock Option Agreement
|
|
10.37†*
|
Amendment No. 1 to Loan Agreement Secured Convertible Promissory Notes and Patent Security Agreement effective February 2, 2012, between MRI Interventions, Inc. and Boston Scientific Corporation
|
|
10.38†*
|
Omnibus Amendment No. 3 to Technology License Agreement and System and Lead Development and Transfer Agreement effective February 2, 2012, between MRI Interventions, Inc. and Boston Scientific Neuromodulation Corporation
|
|
31.1
|
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934
|
|
31.2
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934
|
|
32#
|
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Rule 13a-14(b) Under the Securities Exchange Act of 1934 and Section 1350 of Chapter 63 of Title 18 of the United States Code.
|
|
101++
|
Interactive Data File
|
*
|
Incorporated by reference to the Company’s registration statement on Form 10 filed with the Securities and Exchange Commission.
|
**
|
Incorporated by reference to Exhibit 3.5 of the Company’s registration statement on Form 10 filed with the Securities and Exchange Commission.
|
***
|
Incorporated by reference to Exhibit 3.7 of the Company’s registration statement on Form 10 filed with the Securities and Exchange Commission.
|
+
|
Indicates management contract or compensatory plan.
|
++
|
To be filed by amendment as permitted by Rule 405 of Regulation S-T adopted by the Securities and Exchange Commission.
|
#
|
This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, and it is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
|
†
|
Confidential treatment requested under Rule 24b-2 under the Securities Exchange Act of 1934. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions have been filed separately with the Securities and Exchange Commission pursuant to the confidential treatment request.
|
MRI INTERVENTIONS, INC.
By:
/s/ Kimble L. Jenkins
Kimble L. Jenkins
Chief Executive Officer
|
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© 2001 - AIR COMMERCIAL REAL ESTATE ASSOCIATION |
FORM STN-8-5/05E
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Federal ID No.
|
Federal ID No.
|
|||||||
BROKER:
|
BROKER:
|
|||||||
Lee & Associates - Irvine, Inc.
|
Asbury Brokerage Services, Inc.
|
|||||||
Attn:
|
Guy LaFerrara
|
Attn:
|
Dennis Asbury
|
|||||
Title:
|
President
|
Title:
|
||||||
Address:
|
7700 Irvine Center Dr., Suite 600
|
Address:
|
26882 Vista Terrace
|
|||||
Irvine, CA 92618
|
Lake Forest, CA 92630
|
|||||||
Telephone:
|
(
949
) 727-1200
|
Telephone:
|
(
949
) 454-8995
|
|||||
Facsimile:
|
(
949
) 727-1299
|
Facsimile:
|
(
)
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Federal ID No.
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Federal ID No.
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PAGE 18 OF 18 | ||||
INITIALS
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INITIALS
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© 2001 - AIR COMMERCIAL REAL ESTATE ASSOCIATION |
FORM STN-8-5/05E
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Term
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Monthly Base Rent/SF
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August 1, 2008 - July 31, 2009
|
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$8,514.60 NNN
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August 1, 2009 - July 31, 2010
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$8,684.89 NNN
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August 1, 2010 - July 31, 2011
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$8,858.59 NNN
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August 1, 2011 - July 31, 2012
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$9,035.76 NNN
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Term
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Monthly Base Rent/SF
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August 1, 2012 - July 31, 2013
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$9,216.48 NNN
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August 1, 2013 - July 31, 2014
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$9,400.80 NNN
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August 1, 20l4 - July 3l, 20l5
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$9,588.82 NNN
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LESSOR:
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SHAW INVESTMENT COMPANY, LLC
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By:
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Name:
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Charles E. Crookall
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Title:
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Manager
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LESSEE:
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SURGI-VISION, INC.
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By:
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Name:
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Oscar Thomas
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Title:
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Vice President, Business Affairs
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LESSEE
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SurgiVision, Inc
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By:
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/s/ David W. Carlson
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Its:
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Chief Financial Officer
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LESSOR
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Shaw Investment Company, LLC
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By: The Joanne Shaw Reynolds Revocable Trust, its Manager
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By:
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/s/ Joanne Shaw Reynolds
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Joanne Shaw Reynolds, Trustee
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Lessor:
Shaw Investment Company, LLC,
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Lessee:
MRI Interventions, Inc.
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By /s/ Joanne S. Reynolds
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By /s/ David Carlson
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Title
Managing Member
Date
4/13/2012
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Title
Chief Financial Officer
Date
4/3/2012
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i.
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I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2012, of MRI Interventions, Inc.;
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ii.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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iii.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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iv.
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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A.
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designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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B.
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designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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C.
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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D.
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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v.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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A.
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all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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B.
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 11, 2012
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/s/ Kimble L. Jenkins
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Kimble L. Jenkins
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Chief Executive Officer
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i.
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I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2012, of MRI Interventions, Inc.;
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ii.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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iii.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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iv.
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
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A.
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designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
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B.
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designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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C.
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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D.
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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v.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
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A.
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all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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B.
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 11, 2012
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/s/ David W. Carlson
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David W. Carlson
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Chief Financial Officer
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/s/ Kimble L. Jenkins
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Kimble L. Jenkins
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Chief Executive Officer
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/s/ David W. Carlson
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David W. Carlson
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Chief Financial Officer
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