ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
3
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ARTVENTIVE MEDICAL GROUP, INC.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, 2016
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December 31, 2015
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(Unaudited)
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ASSETS
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Current assets
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Cash and cash equivalents
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$
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5,942
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$
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21,781
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Accounts receivable
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8,495
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18,118
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Prepaid expenses
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4,207
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11,655
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Inventory
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47,159
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303,044
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Total current assets
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65,803
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354,598
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Fixed assets
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Office equipment
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26,870
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26,870
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Accumulated depreciation
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(12,036)
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(9,582)
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Fixed assets, net
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14,834
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17,288
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Other assets
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Deposits
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5,742
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81,530
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Total other assets
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5,742
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81,530
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Total assets
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$
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86,379
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$
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453,416
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LIABILITIES AND STOCKHOLDERS' DEFICIT
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Current liabilities
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Accounts payable
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$
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1,646,592
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$
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924,089
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Total current liabilities
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1,646,592
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924,089
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Long-term liabilities
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Notes payable - shareholder
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500,000
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500,000
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Total long-term liabilities
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500,000
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500,000
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Total liabilities
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2,146,592
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1,424,089
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Stockholders' deficit
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Common stock, $0.001 par value, 100,000,000 shares authorized, 63,722,086 and 63,592,086 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
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63,722
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63,592
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Additional paid in capital
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17,087,950
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17,028,580
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Accumulated deficit
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(19,211,885)
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(18,062,845)
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Total stockholders' deficit
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(2,060,213)
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(970,673)
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Total liabilities and stockholders' deficit
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$
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86,379
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$
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453,416
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The accompanying notes are an integral part of these condensed consolidated financial statements.
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4
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ARTVENTIVE MEDICAL GROUP, INC.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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For the Three Months Ended June 30,
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For the Six Months Ended June 30,
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2016
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2015
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2016
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2015
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REVENUES
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$
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19,133
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$
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93,998
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$
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65,119
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$
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158,185
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COST OF SALES
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19,133
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93,998
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65,119
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158,185
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GROSS PROFIT
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-
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-
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-
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-
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OPERATING EXPENSES
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Research and development
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284,470
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324,136
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464,123
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626,062
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Selling, general and administrative
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240,302
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551,063
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682,463
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1,136,390
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Depreciation expense
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1,227
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1,295
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2,454
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2,225
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Total operating expenses
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525,999
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876,494
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1,149,040
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1,764,677
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Loss from operations
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(525,999)
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(876,494)
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(1,149,040)
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(1,764,677)
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OTHER INCOME (EXPENSE)
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Interest expense
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-
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-
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-
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-
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Interest income
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-
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1
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-
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2
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Total other income (expense)
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-
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1
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-
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2
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NET LOSS
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$
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(525,999)
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$
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(876,493)
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$
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(1,149,040)
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$
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(1,764,675)
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LOSS PER SHARE - Basic and Diluted
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$
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(0.01)
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$
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(0.01)
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$
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(0.02)
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$
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(0.03)
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WEIGHTED AVERAGE SHARES OUTSTANDING
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63,698,024
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60,370,475
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63,671,986
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60,038,298
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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5
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ARTVENTIVE MEDICAL GROUP, INC.
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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(Unaudited)
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For the Six Months Ended June 30,
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2016
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2015
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CASH FLOWS FROM OPERATING ACTIVITIES:
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Net loss
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$
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(1,149,040)
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$
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(1,764,675)
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Adjustments to reconcile net loss to net cash used in operating activities
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Depreciation expense
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2,454
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2,225
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Issuance of common stock and options for services
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9,500
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33,715
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Changes in operating assets and liabilities:
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Accounts receivable
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9,624
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(48,544)
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Prepaid expenses
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7,448
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-
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Inventory
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255,885
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(173,076)
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Deposits
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75,788
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(68,535)
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Accounts payable
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722,502
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179,174
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Payroll taxes payable
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-
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61
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Accrued expenses
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-
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-
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Cash used in operating activities
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(65,839)
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(1,839,655)
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CASH FLOWS FROM INVESTING ACTIVITIES:
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Cash paid for purchase of fixed assets
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-
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(5,848)
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Cash used in investing activities
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-
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(5,848)
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CASH FLOWS FROM FINANCING ACTIVITIES:
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Proceeds from sale of common stock
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50,000
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1,950,000
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Issuance of notes payable
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-
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-
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Cash provided by financing activities
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50,000
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1,950,000
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NET CHANGE IN CASH
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(15,839)
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104,497
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CASH AT BEGINNING OF PERIOD
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21,781
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104,030
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CASH AT END OF PERIOD
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$
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5,942
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$
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208,527
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CASH PAID DURING THE YEAR:
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Interest paid
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$
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-
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$
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-
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Income taxes paid
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-
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$
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-
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NON-CASH TRANSACTIONS:
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Accrual of Stock Issuance Cost
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$
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-
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$
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960,800
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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6
ARTVENTIVE MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 - BASIS OF FINANCIAL STATEMENT PRESENTATION
The accompanying unaudited condensed consolidated financial statements have been prepared by ArtVentive Medical Group, Inc. and its Subsidiary, ArtVentive Medical Group, Canada Inc., (the Company) pursuant to the rules and regulations of the United States Securities and Exchange Commission (SEC) and should be read in conjunction with our annual report on Form 10-K for the year ended December 31, 2015 as filed with the SEC under the Securities and Exchange Act of 1934 (theExchange Act). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted, as permitted by the SEC, although we believe the disclosures which are made are adequate to make the information presented not misleading. The condensed consolidated financial statements reflect, in the opinion of management, all normal recurring adjustments necessary to present fairly our financial position at June 30, 2016 and the results of our operations and cash flows for the periods presented.
The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year, or any other period.
NOTE 2 - ORGANIZATION
The Company is a medical device company focused on developing, manufacturing and marketing a family of endoluminal occlusion devices, known as the Endoluminal Occlusion System (EOS). Through its patented technology, the Company has developed minimally invasive occlusion devices and procedures capable of achieving immediate, complete, and permanent occlusion of peripheral vasculature. EOS was developed by the Company and serves as a proprietary technology platform for several major clinical areas including peripheral and neurological vascular disorders, women's health, interventional oncology and cardiology procedures.
The Company was incorporated on January 23, 2007. The Companys fiscal year end is December 31. To date, the Companys activities have been committed to the development of EOS, intellectual property, animal studies, human studies, patent filings, and developing a regulatory strategy for initial clinical indications pertinent to European, manufacturing and FDA submissions and approvals, corporate operations and the raising of equity capital. The Company conducted the required human clinical studies during 2011, achieving 100% clinical and procedural success, validating the safety and efficiency of the EOS
TM
device. The Company received its CE Mark certification for EOS on May 30, 2013. In 2014, the Company began commercialization and commenced marketing with its European distributors. On December 3, 2014, the Company received FDA approval for EOS for marketing and sales in the United States.
We currently have one wholly-owned subsidiary, ArtVentive Medical Group, Canada Inc.
NOTE 3 - SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
The consolidated financial statements include the transactions of the Company and its Subsidiary. All inter-company accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of the Companys financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Such estimates include deferred tax assets arising as a result of the operating loss carry forwards. Actual results could differ from those estimates. The Companys periodic filings with the SEC include, where applicable, disclosures of estimates, assumptions, uncertainties and markets that could affect the financial statements and future operations of the Company.
Common Stock Issued for Services
Services purchased and other transactions settled in the Companys common stock and stock options are recorded at the estimated fair value of the stock issued and options granted if that value is more readily determinable than the fair value of the consideration received.
7
Earnings Per Share of Common Stock
In accordance with accounting guidance now codified as FASB ASC Topic 260,
Earnings per Share
, basic earnings (loss) per share is computed by dividing net income (loss) by weighted average number of shares of common stock outstanding during each period.
Diluted earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock, common stock equivalents and potentially dilutive securities outstanding during the period.
The Company had the following potential common stock equivalents at June 30, 2016:
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Common stock warrants
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1,150,000
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Common stock options
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370,000
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Total common stock equivalents
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1,520,000
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Since the Company recorded net losses for the six months ended June 30, 2016 and 2015, the effect of considering any common stock equivalents, if outstanding, would have been anti-dilutive. Therefore, a separate computation of diluted earnings (loss) per share is not presented.
The following table sets forth the computation of earnings per share:
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June 30, 2016
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June 30, 2015
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Net income (loss)
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$
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(1,149,040)
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$
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(1,764,675)
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Weighted average common shares outstanding
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63,671,986
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60,038,298
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Net (loss) per share
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$
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(0.02)
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$
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(0.03)
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Property and Equipment
The Company records property and equipment at cost and uses straight-line depreciation methods over estimated useful lives of 5-7 years.
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June 30, 2016
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December 31, 2015
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Computer equipment
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$
|
22,124
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$
|
22,124
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Office furniture
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|
4,746
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4,746
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Less: Accumulated depreciation
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(12,036)
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(9,582)
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Net property and equipment
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$
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14,834
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$
|
17,288
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Inventory
The Companys inventory is valued at the lower of cost or market using the first-in, first-out (FIFO) method. As of June 30, 2016 and December 31, 2015, all inventory consisted of finished goods.
As the Company begins its transition from the research and development phase to production, management has estimated the cost of units sold to be equal to the revenue generated on those units. Other direct cost that may be associated with the production of these units has been reflected in research and development expenses.
On June 30, 2016, the Company wrote down the value of its finished goods inventory by approximately $264,000 to reflect obsolete items. The corresponding expense was recorded to research and development expenses.
Foreign Currency Translations
The Companys functional and reporting currency is the U.S. dollar. All transactions initiated in other currencies are translated into U.S. dollars using the exchange rate prevailing on the date of transaction. Monetary assets and liabilities denominated in foreign currencies are translated into the U.S. dollar at the rate of exchange in effect at the balance sheet date. Unrealized exchange gains and losses arising from such transactions are deferred until realization and are included as a separate component of stockholders equity (deficit) as a component of other comprehensive income or loss. Upon realization, the amount deferred is recognized in income in the period when it is realized.
Cash and Cash Equivalents
8
Cash and cash equivalents consist principally of funds on hand, on deposit with banks and liquid investment funds having maturity of three months or less at the time of the purchase. The Company has no cash equivalents. The Company had funds on deposit of $5,942 as of June 30, 2016.
Receivables
The accounts receivable balance of $8,495 as of June 30, 2016 is comprised of balances due from three customers totaling $4,711, $2,849 and $935. The accounts receivable balance as of December 31, 2015 was comprised of balances due from four customers totaling $5,760, $5,568, $3,210, and $3,580. The balance of the allowance for bad debts was $0 as of June 30, 2016 and December 31, 2015.
Revenue Recognition
Revenue for the sale of goods in the course of the ordinary activities is measured at the fair value of the consideration received or receivable, net of returns. Revenue for sale of goods is recognized when the significant risks and rewards of ownership have been transferred to the buyer, recovery of the consideration is probable, the associated costs and possible return of the goods can be estimated reliably, there is no continuing involvement with the goods, and the amount of revenue can be measured reliably.
Concentrations of Credit Risk
Certain financial instruments, which subject the Company to concentration of credit risk, consist of cash and accounts receivable. The Company maintains cash balances at financial institutions, which, from time to time, may exceed Federal Deposit Insurance Corporation insured limits of $250,000. As of June 30, 2016, the Company had no deposits in excess of federally insured limits in its U.S. bank. The Company has not experienced any losses with regard to its bank accounts and believes it is not exposed to any risk of loss on its cash in bank accounts. As of June 30, 2016, three customers represented 100% (55.46, %, 33.54%, and 11.0%) and as of December 31, 2015, four customers represented 100% (31.8%, 30.7%, 17.7% and 19.8%) of our accounts receivable.
As of June 30, 2016 and December 31, 2015, Medical Murray, accounted for more than 10% of our purchases and accounts payable.
NOTE 4 NOTES PAYABLE
On April 1, 2014, the Company borrowed $250,000 from a shareholder and issued a note payable due on or before December 31, 2014, with interest at 3% per annum. On December 31, 2014, the Company and the lender executed an extension of the note, which is due on or before December 31, 2017. The interest remains at 3%. The lender may convert all or part of the debt, including interest, into common stock of the Company at any time at the rate of $1.00 per share.
On April 1, 2014, the Company borrowed an additional $250,000 from this shareholder and issued a note payable due on or before December 31, 2014, with interest at 3% per annum. On December 31, 2014, the Company and the lender executed an extension of the note, which is due on or before December 31, 2017. The interest remains at 3%. The lender may convert all or part of the debt, including interest, into common stock of the Company at any time at the rate of $1.00 per share.
Long-term debt consists of the following:
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|
|
|
|
|
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|
|
June 30, 2016
|
|
December 31, 2015
|
|
|
|
|
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|
|
Note payable to a shareholder, interest at 3.0%,
interest and principal due December 31, 2017
|
|
$
|
250,000
|
|
$
|
250,000
|
Note payable to a shareholder, interest at 3.0%,
interest and principal due December 31, 2017
|
|
|
250,000
|
|
|
250,000
|
|
|
|
500,000
|
|
|
500,000
|
Less current maturities of long-term debt
|
|
|
-
|
|
|
-
|
Long-term debt
|
|
$
|
500,000
|
|
$
|
500,000
|
Maturities on long-term debt are as follows:
|
|
|
|
2016
|
|
$
|
-
|
2017
|
|
|
500,000
|
|
|
$
|
500,000
|
9
NOTE 5 - STOCKHOLDERS EQUITY
Effective April 22, 2008, the Company forward-split its issued common stock on a ratio of 5.8 shares for each original share. As a result of this transaction, 11,078,000 shares were issued. Effective February 12, 2010, the Company forward-split its issued common stock on a ratio of 1.65 shares for each one prior share. As a result of this transaction, 8,442,200 shares were issued.
Stock issuances in private placements during the six months ended June 30, 2016 and the years ended December 31, 2015 and December 31, 2014 are as follows:
|
|
|
|
|
|
Stock Issuance Date
|
|
Common
Shares
|
|
|
Proceeds
Received
|
|
|
|
|
|
|
January 7, 2014
|
|
400,000
|
|
$
|
400,000
|
February 11, 2014
|
|
400,000
|
|
|
400,000
|
March 6, 2014
|
|
300,000
|
|
|
300,000
|
May 23, 2014
|
|
100,000
|
|
|
100,000
|
June 24, 2014
|
|
1,000,000
|
|
|
1,000,000
|
July 23, 2014
|
|
500,000
|
|
|
500,000
|
August 29, 2014
|
|
250,000
|
|
|
250,000
|
September 29, 2014
|
|
150,000
|
|
|
150,000
|
September 30, 2014
|
|
100,000
|
|
|
100,000
|
October 15, 2014
|
|
100,000
|
|
|
100,000
|
November 7, 2014
|
|
80,000
|
|
|
80,000
|
November 28, 2014
|
|
70,000
|
|
|
70,000
|
December 4, 2014
|
|
250,000
|
|
|
250,000
|
December 15, 2014
|
|
250,000
|
|
|
250,000
|
December 29, 2014
|
|
250,000
|
|
|
250,000
|
|
|
|
|
|
|
Total for year ended December 31, 2014
|
|
4,200,000
|
|
$
|
4,200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
January 23, 2015
|
|
250,000
|
|
$
|
250,000
|
February 27, 2015
|
|
150,000
|
|
|
150,000
|
March 15, 2015
|
|
100,000
|
|
|
100,000
|
March 31, 2015
|
|
150,000
|
|
|
150,000
|
April 23, 2015
|
|
150,000
|
|
|
150,000
|
May 4, 2015
|
|
100,000
|
|
|
100,000
|
May 29, 2015
|
|
500,000
|
|
|
500,000
|
June 1 2015
|
|
500,000
|
|
|
500,000
|
July 17, 2015
|
|
200,000
|
|
|
200,000
|
August 8, 2015
|
|
50,000
|
|
|
50,000
|
August 27, 2015
|
|
300,000
|
|
|
300,000
|
September 28, 2015
|
|
250,000
|
|
|
250,000
|
October 26, 2015
|
|
150,000
|
|
|
150,000
|
November 20, 2015
|
|
100,000
|
|
|
100,000
|
December 12, 2015
|
|
100,000
|
|
|
100,000
|
|
|
|
|
|
|
Total for year ended December 31, 2015
|
|
3,050,000
|
|
$
|
3,050,000
|
|
|
|
|
|
|
January 18, 2016
|
|
15,000
|
|
$
|
15,000
|
April 25, 2016
|
|
15,000
|
|
|
15,000
|
May 23, 2016
|
|
20,000
|
|
|
20,000
|
|
|
|
|
|
|
Total for six months ended June 30, 2016
|
|
50,000
|
|
$
|
50,000
|
On May 5, 2015, 980,800 shares were issued for finders fees valued at $980,800.
10
On August 12, 2015, 25,000 shares were issued for finders fees valued at $25,000.
On January 22, 2016, 80,000 shares were issued for finders fees valued at $80,000.
NOTE 6 - GOING CONCERN AND LIQUIDITY CONSIDERATIONS
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. As of June 30, 2016, the Company had a negative working capital balance of $1,580,789 and an accumulated deficit of $19,211,885. These factors raise substantial doubt about the Company's ability to continue as a going concern. Management is in the process of evaluating various financing alternatives for operations, as the Company will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders. However, there is no assurance that the Company will be successful with those initiatives, and it does not have any firm commitments from investors at this time.
NOTE 7 - RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
The Company has reviewed Accounting Standards Update (ASU) through ASU No. 2016-13 which contain technical corrections to existing guidance or affect guidance to specialized industries or entities. These updates have no current applicability to the Company or their effect on the financial statements would not have been significant.
NOTE 8 - PROVISION FOR INCOME TAXES
The Company recognizes the tax effects of transactions in the year in which such transactions enter into the determination of net income, regardless of when reported for tax purposes. Deferred taxes are provided in the financial statements under ASC Topic 740,
Income Taxes
, to give effect to the resulting temporary differences which may arise from differences in the bases of fixed assets, depreciation methods, allowances, and start-up costs based on the income taxes expected to be payable in future years. Exploration and development stage deferred tax assets arising as a result of net operating loss carry forwards have been offset completely by a valuation allowance due to the uncertainty of their utilization in future periods. Tax operating loss carry forwards generated during the period from January 23, 2007 (date of inception) through June 30, 2016 of approximately $19 million will begin to expire in 2027. Accordingly, deferred tax assets of approximately $7,990,000 (2015 $7,594,000) related to net operating loss carryforwards and $168,000 related to stock-based compensation were offset in full by the valuation allowance.
The Company has no tax positions at June 30, 2016 and December 31, 2015 for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility.
The Companys tax returns for the years ended December 31, 2015, 2014, 2013 and 2012 are open for examination under Federal Statute of Limitations and for the years ended December 31, 2015, 2014 and 2013 under the State of California Statute of Limitations.
The Company recognizes interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses. The Company had no accruals for interest and penalties since inception.
A reconciliation of the provision for income tax expense with the expected income tax computed by applying the federal statutory income tax to income before provision for income taxes is as follows:
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30,
|
|
|
|
2016
|
|
|
2015
|
Income tax (benefit) computed at
|
|
|
|
|
|
|
Federal statutory tax rate of 34%
|
|
$
|
(390,674)
|
|
$
|
(599,990)
|
Change in valuation allowance
|
|
|
492,249
|
|
|
755,987
|
State taxes (net of federal benefit)
|
|
|
(101,575)
|
|
|
(155,997)
|
|
|
$
|
-
|
|
$
|
-
|
NOTE 9 - WARRANTS AND OPTIONS
During the year ended December 31, 2015, the Company granted 3,050,000 warrants to purchase shares of Common Stock of which all have a 1-year exercise term, of which 1,150,000 remain outstanding at June 30, 2016. During the six months ended June 30, 2016,
11
50,000 warrants were issued. The Company valued all warrants utilizing a Black-Scholes option-pricing model and the fair value was recorded as additional paid-in capital.
The following is a summary of the Companys warrant activity as of June 30, 2016:
|
|
|
|
|
|
|
|
Warrants
|
|
|
Weighted
Average
Exercise
Price
|
|
|
|
|
|
|
Outstanding - December 31, 2014
|
|
4,200,000
|
|
$
|
1.50
|
Granted
|
|
3,050,000
|
|
|
1.50
|
Exercised
|
|
-
|
|
|
-
|
Forfeited
|
|
(4,200,000)
|
|
|
1.50
|
Outstanding December 31, 2015
|
|
3,050,000
|
|
$
|
1.50
|
Exercisable December 31, 2015
|
|
3,050,000
|
|
$
|
1.50
|
|
|
|
|
|
|
Granted
|
|
50,000
|
|
$
|
1.50
|
Exercised
|
|
-
|
|
|
-
|
Forfeited
|
|
(1,950,000)
|
|
$
|
1.50
|
Outstanding June 30, 2016
|
|
1,150,000
|
|
$
|
1.50
|
Exercisable June 30, 2016
|
|
1,150,000
|
|
$
|
1.50
|
Warrants outstanding and exercisable at June 30, 2016 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants Outstanding
|
|
Warrants Exercisable
|
|
Exercise
Price
|
|
Number
Outstanding
|
|
Weighted
Average
Remaining
Contractual
Life (in Years
)
|
|
Weighted
Average
Exercise Price
|
|
|
Number
Exercisable
|
|
|
Weighted
Average
Exercise Price
|
$
|
1.50
|
|
200,000
|
|
0.04 years
|
|
$
|
1.50
|
|
|
|
200,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
300,000
|
|
0.16 years
|
|
$
|
1.50
|
|
|
|
300,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
250,000
|
|
0.24 years
|
|
$
|
1.50
|
|
|
|
250,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
150,000
|
|
0.32 years
|
|
$
|
1.50
|
|
|
|
150,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
100,000
|
|
0.39 years
|
|
$
|
1.50
|
|
|
|
100,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
100,000
|
|
0.45 years
|
|
$
|
1.50
|
|
|
|
100,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
15,000
|
|
0.55 years
|
|
$
|
1.50
|
|
|
|
15,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
15,000
|
|
0.82 years
|
|
$
|
1.50
|
|
|
|
15,000
|
|
|
$
|
1.50
|
$
|
1.50
|
|
20,000
|
|
0.90 years
|
|
$
|
1.50
|
|
|
|
20,000
|
|
|
$
|
1.50
|
Warrant activity is as follows:
Warrants issued during the first quarter of 2016, totaled 15,000.
Warrants issued during the second quarter of 2016, totaled 35,000.
Warrants issued during 2015, totaling 650,000, expired during the first quarter of 2016.
Warrants issued during 2015, totaling 1,300,000, expired during the second quarter of 2016
Warrants issued during 2014, totaling 4,200,000, expired during 2015.
Effective July 17, 2015, 200,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective August 12, 2015, 25,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
12
Effective August 27, 2015, 300,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective September 28, 2015, 250,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective October 26, 2015, 150,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective November 20, 2015, 100,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective December 12, 2015, 100,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective January 18, 2016, 15,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective April 25, 2016, 15,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
Effective May 23, 2016, 20,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year.
The following is a summary of the Companys stock options activity:
|
|
|
|
|
|
|
|
Options
|
|
|
Weighted
Average
Exercise
Price
|
Granted 2015
|
|
265,000
|
|
$
|
1.00
|
Exercised 2015
|
|
(50,000)
|
|
|
0.001
|
Forfeited 2015
|
|
(150,000)
|
|
|
1.00
|
Outstanding December 31, 2015
|
|
370,000
|
|
$
|
1.00
|
Exercisable December 31, 2015
|
|
230,000
|
|
$
|
1.00
|
|
|
|
|
|
|
Granted
|
|
-
|
|
$
|
-
|
Exercised
|
|
-
|
|
|
-
|
Forfeited
|
|
-
|
|
|
-
|
Outstanding June 30, 2016
|
|
370,000
|
|
$
|
1.00
|
Exercisable June 30, 2016
|
|
240,000
|
|
$
|
1.00
|
Options outstanding and exercisable at June 30, 2016 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
|
Range of
Exercise
Price
|
|
Number
Outstanding
|
|
Weighted Average
Remaining
Contractual
Life (in Years)
|
|
Weighted
Average
Exercise Price
|
|
|
Number
Exercisable
|
|
|
Weighted
Average
Exercise Price
|
|
$
|
1.00
|
|
35,000
|
|
1.59 years
|
|
$
|
1.00
|
|
|
|
35,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
10,000
|
|
1.67 years
|
|
$
|
1.00
|
|
|
|
10,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
10,000
|
|
2.49 years
|
|
$
|
1.00
|
|
|
|
10,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
50,000
|
|
7.42 years
|
|
$
|
1.00
|
|
|
|
50,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
10,000
|
|
8.56 years
|
|
$
|
1.00
|
|
|
|
10,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
100,000
|
|
8.83 years
|
|
$
|
1.00
|
|
|
|
100,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
40,000
|
|
8.96 years
|
|
$
|
1.00
|
|
|
|
10,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
15,000
|
|
9.16 years
|
|
$
|
1.00
|
|
|
|
15,000
|
|
|
$
|
1.00
|
$
|
1.00
|
|
100,000
|
|
9.23 years
|
|
$
|
1.00
|
|
|
|
-
|
|
|
$
|
1.00
|
The Companys stock option activity is as follows:
13
Effective November 2, 2010, the Board of Directors of the Company granted 50,000 non-statutory stock options to a current consultant at an exercise price of $.001 per share with the vesting date of November 2, 2013 and an expiration date of November 2, 2016. These options were exercised on August 7, 2015.
Effective February 1, 2013, the Board of Directors of the Company granted 20,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of February 1, 2013 and an expiration date of February 1, 2018.
Effective February 1, 2013, the Board of Directors of the Company granted 5,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of February 1, 2013 and an expiration date of February 1, 2018.
Effective February 1, 2013, the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of February 1, 2013 and an expiration date of February 1, 2018.
Effective March 1, 2013, the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of March 1, 2013 and an expiration date of March 1, 2018.
Effective December 27, 2013, the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of December 27, 2013, and an expiration date of December 27, 2018.
Effective January 1, 2015, the Board of Directors of the Company granted 200,000 non-statutory stock options to a then current employee at an exercise price of $1.00 per share with 50,000 of the shares vested on January 1, 2016 and the additional 75% of the shares exercisable on each of the next succeeding three anniversaries of January 1. The 50,000 vested stock options remain outstanding, while the 150,000 non-vested options were forfeited through a voluntary resignation on September 4, 2015.
Effective January 23, 2015, the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of January 23, 2015, and an expiration date of January 23, 2025.
Effective April 30, 2015, the Board of Directors of the Company granted 100,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of April 30, 2015, and an expiration date of April 30, 2025.
Effective June 15, 2015, the Board of Directors of the Company granted 40,000 non-statutory stock options to a current employee at an exercise price of $1.00 per share with 25% of the shares exercisable on June 15, 2016 and an additional 25% exercisable on each of the next succeeding three anniversaries of June 15, on a cumulative basis, so that the option, or any unexercised portion, shall be fully exercisable on and after June 15, 2019. The stock options have an expiration date of June 15, 2025.
Effective August 28, 2015, the Board of Directors of the Company granted 15,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of August 28, 2015, and an expiration date of August 28, 2025.
Effective September 22, 2015, the Board of Directors granted 100,000 stock options deemed an Incentive Stock Option (ISO) to a current employee, at an exercise price of $1.00 per share with 25% exercisable on September 22, 2016; and an additional 25% exercisable on each of the next succeeding three anniversaries of September 22nd, on a cumulative basis, so that the Option, or any unexercised portion, shall be fully exercisable on and after September 22, 2019. The stock options have an expiration date of September 22, 2025.
The Company valued these options utilizing a Black-Scholes option-pricing model and the fair value was recorded as additional paid-in capital.
NOTE 10 - SUBSEQUENT EVENTS
The Company evaluated all events or transactions that occurred after June 30, 2016, up through the date these unaudited condensed consolidated financial statements were issued and it was determined there were no reportable events.
14
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
This report contains forward-looking statements. The following discussion should be read in conjunction with the financial statements and related notes contained in our Annual Report on Form 10-K, as filed with the Securities & Exchange Commission on April 14, 2016. Certain statements made in this discussion are "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are projections in respect of future events or financial performance. In some cases, you can identify forward-looking statements by terminology such as may, should, expects, plans, anticipates, believes, estimates, predicts, potential, or continue or the negative of these terms or other comparable terminology. Forward-looking statements made in a quarterly report on Form 10-Q may include statements about our:
·
ability to obtain sufficient capital or strategic business arrangements to fund our operations and realize our business plan;
·
belief as to whether a meaningful and profitable global market can be established for the ArtVentive Endoluminal Occlusion Devices (ArtVentive EOS) as a minimally invasive occlusion device;
·
belief that our medical device seems superior to other options;
·
expectations regarding our ability to obtain and maintain intellectual property protection for our technology;
·
ability to commercialize products in light of the intellectual property rights of others;
·
ability to obtain funding for operations, inventory and scale-up of our medical devices;
·
future agreements with third parties in connection with the commercialization of our technologies;
·
size and growth potential of the markets for our product candidates, and our ability to serve those markets;
·
regulatory developments in the United States and foreign countries;
·
ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
·
success as it is compared to competing therapies that are or may become available;
·
ability to attract and retain key scientific or management personnel and to expand our management team;
·
accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing;
·
need to raise additional funds on an immediate basis which may not be available on acceptable terms or at all;
·
expenditures not resulting in commercially successful revenues; and
·
extensive industry regulation, and how that will continue to have a significant impact on our business, especially our product development, manufacturing and distribution capabilities.
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled Risk Factors set forth in this Annual Report on Form 10-K for the year ended December 31, 2015, any of which may cause our companys or our industrys actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks may cause the Companys or its industrys actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.
Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Moreover, neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The Company is under no duty to update any forward-looking statements after the date of this report to conform these statements to actual results.
As used in this quarterly report and unless otherwise indicated, the terms we, us, "our," Artventive Medical Group or the Company refer to Artventive Medical Group, Inc. and its wholly-owned Subsidiary, ArtVentive Medical Group, Canada Inc., (AMG Canada). Unless otherwise specified, all dollar amounts are expressed in United States dollars.
Corporate Overview
ArtVentive Medical Group, Inc. is a medical device corporation focused on developing, manufacturing and marketing a family of endoluminal occlusion devices, known as the ArtVentive Endoluminal Occlusion System (ArtVentive EOS or EOS). Through our patented technology, we have developed minimally invasive occlusion devices and procedures capable of achieving immediate, complete and permanent occlusion of peripheral vasculature. We believe EOS represents a paradigm shift in the vessel occlusion marketplace, through our use of a unique technology platform that, when deployed, immediately occludes a vessel and does not depend on waiting for blood or fluids to clot around the device. We believe that this new, novel technology significantly reduces risks to both patients and doctors, is more cost effective than currently available products, and has the potential to become the standard of care in the vessel occlusion market.
15
The ArtVentive EOS is our proprietary technology platform which we plan to expand from peripheral vascular to neurological vascular disorders, women's contraceptive health, varicose veins, interventional oncology and cardiology procedures.
We were incorporated on January 23, 2007 in the State of Nevada as Big Bear Resources, Inc. We changed our name to Uranium Plus Resource Corporation on March 21, 2008. On January 9, 2010, we completed the acquisition of all of the assets of ArtVentive Medical Inc., a California company, and changed our name, on January 26, 2010, to ArtVentive Medical Group, Inc. to concentrate on developing, manufacturing and marketing the ArtVentive EOS family of devices.
Based on the work of Dr. Leon Rudakov, Ph.D. and Dr. Philippe Gauilloud, MD, we developed our first prototype of the ArtVentive EOS in 2010. Since inception, our activities have been focused on our corporate operations, research and development, EOS device design and testing, implementation of quality controls and protocols, animal studies, and regulatory strategy for FDA and European submissions and approvals. In December 2010, the Company formally froze the EOS device design for the peripheral category of indications in preparation for the regulatory phase and prior to commercialization in Europe, followed by the United States. We protect our technology with 8 approved patents and 29 patents pending.
We outsource certain operations to assist us in the implementation of our strategic plan to develop, manufacture and commercialize our products. These companies provided the following services:
·
Medical Murray Inc. is our manufacturer and a leader in the field of medical device development and manufacturing that is ISO certified and FDA registered.
·
Alvamed, Inc. (formerly Northwest Clinical Research Group, Inc.) develops our regulatory and clinical strategy, provides a platform of quality control and communicates with the FDA and the European Notified Body.
·
Lublin University Clinic, Poland and University Clinic of UZ Leuven of Belgium conducted successful post-market clinical studies on 20 patients using ArtVentive EOS devices (for OCCLUDE I and II) to study and demonstrate, through clinicians experience, publications and conference presentations, EOS safety and clinical efficiency. These studies concluded in June 2016 and were reported in the CVIR Journal.
In September of 2010, we implemented our Quality Management System (QMS), based on the requirements of the following regulations and international standards:
·
US FDA Quality System Regulation, 21 CFR 820
·
EU Medical Device Directive (MDD), EEC 93/42
·
Canada Medical Devices Regulations (CMDR), SOR/98-282
·
ISO 13485:2003 Medical Devices Quality Management Systems - Requirements Regulatory Purposes
We completed a comprehensive ISO Certification audit performed by BSI Product Services (BSI). BSI is an international ISO 9000/ISO Registrar and CE Mark notified body required for the European regulatory approval and subsequent CE Mark certification. The audit confirmed that the Companys document and quality control systems were up to ISO standards and in compliance with international requirements for the maintaining quality of the products without non-conformities.
Our common stock is currently listed on the OTC Market, Pink tier, under the symbol AVTD.
Our Product
EOS is a minimally invasive occlusion device and procedure capable of achieving immediate, complete and permanent occlusion of peripheral vasculature. EOS is designed to be deployed into an artery, vein or tube using our patented catheter and placed precisely in the correct location to cut off blood or fluid supply immediately, completely and permanently. The EOS delivery catheter is designed to permit fast and controlled deployment, with instantaneous occlusion of the treated vessel, making it safer and more effective than other treatment modalities.
The major advantage of the ArtVentive EOS is its immediate action of occluding target sites. Most of all devices require much more time and radiation to perform the same type of procedure.
We received our CE Mark certification for EOS on May 30, 2013, and implemented the planned EOS peripheral device transfer from research and development to commercialization, marketing, and exploratory distribution throughout Europe, simultaneous to making our U.S. Food and Drug Administration (FDA) application. The FDA granted us 510(k) clearance for the following sizes of EOS as a therapy in patients with peripheral vasculature requiring occlusion:
16
|
|
|
|
|
FDA 510(k) Clearance
Granted
|
|
Product/Size
|
|
Commercial Introduction
|
December 9, 2014
|
|
5mm, 8mm EOS and Guide Catheter
|
|
February 2015
|
September 25, 2015
|
|
11mm EOS and Guide Catheter
|
|
December 2015
|
In 2015, we commenced limited commercialization of our product targeting key hospitals in Europe as proctoring centers. We plan to expand our efforts in Europe and the United States in 2016 as well as expand the sizes of EOS to perform occlusions in a wider variety of vascular applications.
Recent Corporate Developments
Since the commencement of the year through June 30, 2016, we have experienced the following corporate developments:
Resignation of Directors
On April 25, 2016, the Board of Directors accepted the resignation of H. James Graham as Executive Chairman and a member of the Board of Directors, effective May 31, 2016.
On July 11, 2016, the Board of Directors accepted the resignation of Christopher Thorson as a member of the Board of Directors, effective July 11, 2016.
Appointment of Director
On May 17, 2016, the Board of Directors appointed Tom Brauser a member of the Board of Directors, effective June 1, 2016.
Results of Operations
Comparison of the Three Months Ended June 30, 2016 to the Three Months Ended June 30, 2015
Revenue
We recognize revenue via the sale of the EOS device to the Companys distributors in Europe and through direct sales in the U.S. We invoice customers when products are shipped.
For the three months ended June 30, 2016, our total revenues were $19,133, as compared to $93,998 for the same period in 2015, a decrease of 80%. The decrease in revenue is attributable to decreased sales of the EOS device to European distributors that was mainly due to a realignment of the the Companys sales strategy in the Europen market. This realignment includes new packaging and two-year shelf life.
Expenses
Our expenses for the three months ended June 30, 2016 are summarized as follows in comparison to our expenses for the three months ended June 30, 2015:
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
|
|
Revenues
|
|
$
|
19,133
|
|
$
|
93,998
|
Cost of sales
|
|
|
19,133
|
|
|
93,998
|
Research and development
|
|
|
284,470
|
|
|
324,136
|
Selling, general and administration
|
|
|
240,302
|
|
|
551,063
|
Depreciation expense
|
|
|
1,227
|
|
|
1,295
|
Financial expenses (income), net
|
|
|
-
|
|
|
(1)
|
Loss before income taxes
|
|
$
|
(525,999)
|
|
$
|
(876,493)
|
17
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
|
2016
|
|
2015
|
Salaries and related expenses
|
|
$
|
48,921
|
|
|
78,431
|
Other research and development expenses
|
|
|
235,549
|
|
|
245,705
|
Total
|
|
$
|
284,470
|
|
$
|
324,136
|
For the three months ended June 30, 2016 and 2015, our gross profit was zero since the volume of unit production was not enough to achieve profitable per unit costs of sales. We expect manufacturing costs to decrease over the next twelve months with increased sales volume and the successful negotiation of a unit price cost from our manufacturing partner. Research and development costs decreased by $39,666 for the three months ended June 30, 2016, from the comparative period of 2015. The decrease is due to our transitioning from the research and development stage of our product to the commercial stage. We expect research and development costs to be ongoing due to the enhancement of current products and the development of new devices.
Selling, General and Administrative Expenses
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
2016
|
|
2015
|
Salaries and related expenses
|
|
$
|
26,213
|
|
$
|
88,171
|
Stock-based compensation
|
|
|
-
|
|
|
-
|
Professional fees
|
|
|
62,018
|
|
|
89,259
|
Rent and related expenses
|
|
|
3,062
|
|
|
3,157
|
Business development
|
|
|
30,208
|
|
|
71,003
|
Other general and administrative expenses
|
|
|
118,301
|
|
|
299,473
|
Total
|
|
$
|
240,302
|
|
$
|
551,063
|
For the three months ended June 30, 2016, selling, general and administrative expenses decreased by $310,761 from the comparative period in 2015. This was due in part to an effort by management to reduce certain general and administrative expenses and business development expenses. Salaries and related expenses decreased by $61,958 due to the reduced executive personnel and use of sales personnel and the realignment of the Companys sales strategy in the Europen market during the first quarter of 2016. We expect wages and salaries to increase substantially in the next twelve months as we expand our management, support staff and the sales team. Any increases are expected to be due to the initialization and transfer of the EOS device from research and ongoing development to commercialization. We anticipate continued professional fees, mainly from regulatory, legal and accounting, due to ongoing public company reporting requirements.
Comparison of the Six Months Ended June 30, 2016 to the Six Months Ended June 30, 2015
Revenue
For the six months ended June 30, 2016, our total revenues were $65,119, as compared to $158,185 for the same period in 2015, a decrease of 59%. The decrease in revenue is attributable to decreased sales of the EOS device to European distributors that was mainly due to a realignment of the the Companys sales strategy in the Europen market.
Expenses
Our expenses for the six months ended June 30, 2016 are summarized as follows in comparison to our expenses for the six months ended June 30, 2015:
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
|
|
Revenues
|
|
$
|
65,119
|
|
$
|
158,185
|
Cost of sales
|
|
|
65,119
|
|
|
158,185
|
Research and development
|
|
|
464,123
|
|
|
626,062
|
Selling, general and administration
|
|
|
682,463
|
|
|
1,136,390
|
Depreciation expense
|
|
|
2,454
|
|
|
2,225
|
Financial expenses (income), net
|
|
|
-
|
|
|
(2)
|
Loss before income taxes
|
|
$
|
(1,149,040)
|
|
$
|
(1,764,675)
|
18
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2016
|
|
2015
|
Salaries and related expenses
|
|
$
|
97,991
|
|
|
150,753
|
Other research and development expenses
|
|
|
366,132
|
|
|
475,309
|
Total
|
|
$
|
464,123
|
|
$
|
626,062
|
For the six months ended June 30, 2016 and 2015, our gross profit was zero since the volume of unit production was not enough to achieve profitable per unit costs of sales. We expect manufacturing costs to decrease over the next twelve months with increased sales volume and the successful negotiation of a unit price cost from our manufacturing partner. Research and development costs decreased by $161,939 for the six months ended June 30, 2016, from the comparative period of 2015. The decrease is due to our transitioning from the research and development stage of our product to the commercial stage. We expect research and development costs to be ongoing due to the enhancement of current products and the development of new devices.
Selling, General and Administrative Expenses
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
Salaries and related expenses
|
|
$
|
50,489
|
|
$
|
188,878
|
Stock-based compensation
|
|
|
-
|
|
|
-
|
Professional fees
|
|
|
215,905
|
|
|
246,883
|
Rent and related expenses
|
|
|
6,454
|
|
|
6,445
|
Business development
|
|
|
70,221
|
|
|
143,376
|
Other general and administrative expenses
|
|
|
339,394
|
|
|
550,808
|
Total
|
|
$
|
682,463
|
|
$
|
1,136,390
|
For the six months ended June 30, 2016, selling, general and administrative expenses decreased by $453,927 from the comparative period in 2015. This was due in part to an effort by management to reduce certain general and administrative expenses and business development expenses. Salaries and related expenses decreased by $138,389 due to the reduced use of sales personnel and the realignment of the Companys sales strategy in the Europen market during the first quarter of 2016. We expect wages and salaries to increase substantially in the next twelve months as we expand our management, support staff and the sales team. Any increases are expected to be due to the initialization and transfer of the EOS device from research and ongoing development to commercialization. We anticipate continued professional fees, mainly from regulatory, legal and accounting, due to ongoing public company reporting requirements.
Liquidity and Financial Condition
Working Capital Deficiency
|
|
|
|
|
|
|
|
|
|
June 30,
2016
|
|
|
December 31,
2015
|
Current assets
|
|
$
|
65,803
|
|
$
|
354,598
|
Current liabilities
|
|
|
1,646,592
|
|
|
924,089
|
Working capital deficiency
|
|
$
|
(1,580,789)
|
|
$
|
(569,491)
|
The increase in current liabilities is mainly due to an increase in accounts payable.
Cash Flows
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
Net loss
|
|
$
|
(1,149,040)
|
|
$
|
(1,764,675)
|
Net cash used in operating activities
|
|
|
(65,839)
|
|
|
(1,839,655)
|
Net cash used in investing activities
|
|
|
-
|
|
|
(5,848)
|
Net cash provided by financing activities
|
|
|
50,000
|
|
|
1,950,000
|
Increase (decrease) in cash and cash equivalents
|
|
$
|
(15,839)
|
|
$
|
104,497
|
19
As of June 30, 2016, our cash and cash equivalents balance was $5,942. The Company does not expect its current cash and operating income to be sufficient to meet its financial needs for continuing operations over the next twelve months.
Net cash used in operations for the six months ended June 30, 2016 was $65,839, mainly due to the net loss of $1,139,540 that was incurred during the period.
Net cash provided by financing activities for the six months ended June 30, 2016 was $50,000, due to issuances of common stock for cash.
Private Placement Offering
During the six months ended June 30, 2016, the Company issued 50,000 common shares to private investors for proceeds of $50,000.
Going Concern
The unaudited condensed consolidated financial statements contained in this annual report on Form 10-Q have been prepared assuming that the Company will continue as a going concern. Since inception, the Company has financed its operations primarily through proceeds from the issuance of common stock. As of June 30, 2016, the Company had an accumulated deficit of $19,211,885. During the six months ended June 30, 2016, the Company incurred a net loss of $1,149,040 and used cash in operating activities of $65,839. These factors raise substantial doubt about the Companys ability to continue as a going concern. We expect that our operating expenses will increase over the next twelve months to build-up our sales and marketing efforts to sell EOS into existing and new markets. As of June 30, 2016, we had cash and cash equivalents of $5,942. Management is in the process of evaluating various financing alternatives in order to finance our research and development activities and general and administrative expenses. These alternatives include raising funds through public or private equity markets and either through institutional or retail investors. We do not expect to raise capital through debt financing from traditional lending sources since we are not currently producing revenue and cannot assure a lender that we will be able to successfully achieve commercial revenues from the development of our technology in order to service such debt or pay back any principal. Therefore, we only expect to raise money through equity financing via the sale of our common stock. If we cannot raise the money that we need in order to continue to operate our business, we will be forced to delay, scale back or eliminate some or all of our proposed operations. If any of these were to occur, there is a substantial risk that our business would fail. If we are unsuccessful in raising additional financing, we may need to curtail, discontinue or cease operations. Although there is no assurance that the Company will be successful with our fund raising initiatives, management believes that the Company will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders.
The condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. The Companys continuation as a going concern is dependent on its ability to obtain additional financing as may be required and ultimately to attain profitability. If the Company raises additional funds through the issuance of equity, the percentage ownership of current shareholders could be reduced, and such securities might have rights, preferences or privileges senior to its common stock. Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, the Company may not be able to take advantage of prospective business endeavors or opportunities, which could significantly and materially restrict its future plans for developing its business and achieving commercial revenues. If the Company is unable to obtain the necessary capital, the Company may have to cease operations.
Future Financing
We need to raise additional operating capital on an immediate basis. There is no historical financial information about the Company on which to base an evaluation of our performance. We have generated minimal revenues from operations. Management cannot guarantee that it will be successful in its business operations. The business is subject to risks inherent in the medical device business enterprise in a highly competitive industry, including limited capital resources, and possible cost overruns due to the price and cost increases in supplies and services.
The Company believes it does not have enough cash on hand or will be able to generate enough income from operations to pay operating costs for the next twelve months. In order to carry out the business plan, including the expansion of the product line and manufacturing of the EOS medical devices, the Company will be required to seek equity or debt financing. If management is unable to raise sufficient funds to increase its manufacturing and deliver products, as well as enhance and develop new innovative devices, the Company will have to curtail its operations until such funds are received. There is no guarantee that the Company will be successful in raising such funds.
Management believes that current cash resources will not allow us to meet current working capital requirements through 2016. Without additional sources of cash and/or the deferral, reduction, or elimination of significant planned expenditures, the Company will
20
not have the cash resources to remain as a going concern thereafter. Management anticipates that it will require an additional $5,000,000 over the next 12 to 18 months to further develop its devices and increased manufacturing projections, for marketing, branding and launching into North American markets, in addition to the continued development of its research and development pipeline and new and innovative devices based on the EOS technology platform.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in the notes to our financial statements included herein for the quarter ended June 30, 2016 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2015.
Recently Issued Accounting Pronouncements
Any recently issued accounting pronouncements are more fully described in Note 7 to our financial statements included herein for the quarter ended June 30, 2016.
Recently Adopted Accounting Pronouncements
Our recently adopted accounting pronouncements are more fully described in Note 3 to our financial statements included herein for the quarter ended June 30, 2016.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Companys reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms, and that such information is accumulated and communicated to the Companys management, including the Companys president and chief executive officer (who is the Companys principal executive officer) and the Companys chief financial officer, treasurer, and secretary (who is the Companys principal financial officer and principal accounting officer) to allow for timely decisions regarding required disclosure. In designing and evaluating the Companys disclosure controls and procedures, the Companys management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and the Companys management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. The ineffectiveness of the Companys disclosure controls and procedures was due to material weaknesses identified in the Companys internal control over financial reporting, described below.
Managements Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over the Companys financial reporting. In order to evaluate the effectiveness of internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act of 2002. Our management, with the participation of the Companys principal executive officer and principal financial officer has conducted an assessment, including testing, using the criteria in Internal Control - Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) (2013). Our system of internal control over financial reporting is designed 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. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. This assessment included review of the documentation of controls, evaluation of the design effectiveness of controls, testing of the operating effectiveness of controls and a conclusion on this evaluation. Based on this evaluation, the Companys management concluded its internal control over financial reporting was not effective as of
21
June 30, 2016. The ineffectiveness of the Companys internal controls over financial reporting was due to the following material weaknesses which are indicative of many small companies with limited staff:
(i)
inadequate segregation of duties consistent with control objectives;
(ii)
an ineffective internal audit function or risk assessment function for which such functions are important to the monitoring or risk assessment component of internal control;
(iii)
ineffective controls over period end financial disclosure and reporting processes; and
(iv)
Lack of an independent board and, therefore, lack of oversight by a functioning audit committee.
Our management believes the weaknesses identified above have not had any material effect on our financial statements. However, we are currently reviewing our disclosure controls and procedures related to these material weaknesses and expect to implement changes as soon as practicable, including identifying specific areas within our governance, accounting and financial reporting processes to add adequate resources to remediate these material weaknesses.
Our management will continue to monitor and evaluate the effectiveness of our internal controls and procedures and our internal controls over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.
Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended June 30, 2016 that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company knows of no material pending legal proceedings to which the Company or its Subsidiaries are a party or of which any of its properties, or the properties of its Subsidiaries, are the subject. In addition, the Company does not know of any such proceedings contemplated by any governmental authorities.
The Company knows of no material proceedings in which any of the Companys directors, officers or affiliates, or any registered or beneficial stockholder is a party adverse to the Company or its Subsidiaries or has a material interest adverse to the Company or its Subsidiaries.
ITEM 1A. RISK FACTORS
An investment in the Companys common stock involves a number of very significant risks. You should carefully consider the risk factors included in the Risk Factors section of the Annual Report on Form 10-K for the year ended December 31, 2015 that was filed on April 14, 2016, in addition to other information contained in those reports and in this quarterly report in evaluating the Company and its business before purchasing shares of its common stock. The Companys business, operating results and financial condition could be adversely affected due to any of those risks.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
During the six months ended June 30, 2016, the Company issued 50,000 common shares to private investors for proceeds of $50,000.
On January 22, 2016, 80,000 common shares were issued for finders fees valued at $80,000.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
22
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
ITEM 5. OTHER INFORMATION
On April 25, 2016, the Board of Directors accepted the resignation of H. James Graham as Executive Chairman and a member of the Board of Directors, effective May 31, 2016.
On May 17, 2016, the Board of Directors approved the appointment of Mr. Tom Brauser to the Board of Directors, effective June 1, 2016. Mr. Brauser replaced H. James Graham as a Director following his resignation.
On July 11, 2016, the Board of Directors accepted the resignation of Christopher Thorson as a member of the Board of Directors, effective July 11, 2016.
ITEM 6. EXHIBITS
Exhibits required by Regulation S-K
|
|
No.
|
Description
|
31.1*
|
Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
|
31.2*
|
Certification Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
|
32.1*
|
Certification Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
|
32.2*
|
Certification Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
|
101*
|
Interactive Data Files pursuant to Rule 405 of Regulation ST.
|
*Filed herewith
23
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ARTVENTIVE MEDICAL GROUP, INC.
|
|
By:
/s/ Leon Rudakov______________
|
|
Leon Rudakov
|
|
President and Chief Technology Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
|
|
Date: August 15, 2016
|
|
24