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Delaware
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26-4333375
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
x
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(Do not check if a smaller reporting company)
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PART I.
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FINANCIAL INFORMATION
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|||
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ITEM 1
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3 | |||
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3
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||||
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4
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||||
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5
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||||
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6
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||||
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7-18
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||||
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ITEM 2.
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19-25
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|||
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ITEM 3.
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25
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|||
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ITEM 4.
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26
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|||
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PART II.
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OTHER INFORMATION
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|||
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ITEM 1.
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27
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|||
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ITEM 1A.
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27
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|||
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ITEM 2.
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27
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|||
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ITEM 3.
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27
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|||
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ITEM 4.
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27
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|||
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ITEM 5.
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27
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ITEM 6.
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28
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|||
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29
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||||
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BIOSIG
TECHNOLOGIES
, INC.
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||||||||
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|
||||||||
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March 31,
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December 31,
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|||||||
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2015
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2014
|
|||||||
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(unaudited)
|
||||||||
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ASSETS
|
||||||||
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Current assets:
|
||||||||
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Cash
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$ | 2,059,328 | $ | 239,781 | ||||
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Prepaid expenses
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159,768 | 75,537 | ||||||
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Total current assets
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2,219,096 | 315,318 | ||||||
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Property and equipment, net
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12,844 | 13,020 | ||||||
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Other assets:
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||||||||
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Deposits
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25,000 | 25,000 | ||||||
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Total assets
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$ | 2,256,940 | $ | 353,338 | ||||
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LIABILITIES AND STOCKHOLDERS' DEFICIT
|
||||||||
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Current liabilities:
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||||||||
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Accounts payable and accrued expenses, including $14,605 and $40,293 to related parties as of March 31, 2015 and December 31, 2014 respectively
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$ | 320,871 | $ | 554,026 | ||||
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Stock based payable
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646,066 | 226,305 | ||||||
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Dividends payable
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456,964 | 445,069 | ||||||
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Warrant liability
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4,097,444 | - | ||||||
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Derivative liability
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1,242,590 | - | ||||||
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Total current liabilities
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6,763,935 | 1,225,400 | ||||||
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Series C 9% Convertible Preferred stock, 2,461 and 2,711 shares issued and outstanding, liquidation preference of $2,461,000 and $2,711,000, respectively
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2,461,000 | 2,711,000 | ||||||
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Stockholders' deficit
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||||||||
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Preferred stock, $0.001 par value, authorized 1,000,000 shares, designated 200 shares of Series A, 600 shares of Series B and 4,200 shares of Series C Preferred Stock
|
||||||||
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Common stock, $0.001 par value, authorized 50,000,000 shares, 13,159,694 and 11,179,266 issued and outstanding as of March 31, 2015 and December 31, 2014, respectively
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13,160 | 11,179 | ||||||
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Additional paid in capital
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18,852,156 | 19,186,163 | ||||||
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Accumulated deficit
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(25,833,311 | ) | (22,780,404 | ) | ||||
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Total stockholders' deficit
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(6,967,995 | ) | (3,583,062 | ) | ||||
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Total liabilities and stockholders' deficit
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$ | 2,256,940 | $ | 353,338 | ||||
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BIOSIG
TECHNOLOGIES
, INC.
|
||||||||
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|
||||||||
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(unaudited)
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||||||||
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Three Months Ended March 31,
|
||||||||
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2015
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2014
|
|||||||
|
Operating expenses:
|
||||||||
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Research and development
|
$ | 302,079 | $ | 122,151 | ||||
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General and administrative
|
2,746,853 | 601,565 | ||||||
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Depreciation
|
2,860 | 4,435 | ||||||
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Total operating expenses
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3,051,792 | 728,151 | ||||||
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Loss from operations
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(3,051,792 | ) | (728,151 | ) | ||||
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Other income (expense):
|
||||||||
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Interest income (expense)
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(1,114 | ) | (1,098 | ) | ||||
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Financing costs
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- | (388,285 | ) | |||||
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Loss before income taxes
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(3,052,906 | ) | (1,117,534 | ) | ||||
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Income taxes (benefit)
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- | - | ||||||
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Net loss
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(3,052,906 | ) | (1,117,534 | ) | ||||
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Preferred stock dividend
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(79,395 | ) | (84,024 | ) | ||||
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NET LOSS AVAILABLE TO COMMON STOCKHOLDERS
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$ | (3,132,301 | ) | $ | (1,201,558 | ) | ||
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Net loss per common share, basic and diluted
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$ | (0.26 | ) | $ | (0.14 | ) | ||
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Weighted average number of common shares outstanding, basic and diluted
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12,256,418 | 8,482,710 | ||||||
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BIOSIG
TECHNOLOGIES
, INC.
|
||||||||||||||||||||
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CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT
|
||||||||||||||||||||
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THREE MONTHS ENDED MARCH 31, 2015
|
||||||||||||||||||||
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(unaudited)
|
||||||||||||||||||||
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Additional
|
||||||||||||||||||||
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Common stock
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Paid in
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Accumulated
|
||||||||||||||||||
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Shares
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Amount
|
Capital
|
Deficit
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Total
|
||||||||||||||||
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Balance, January 1, 2015
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11,179,266 | $ | 11,179 | $ | 19,186,163 | $ | (22,780,404 | ) | $ | (3,583,062 | ) | |||||||||
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Sale of common stock
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1,398,760 | 1,399 | 3,040,814 | - | 3,042,213 | |||||||||||||||
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Common stock issued upon conversion of Series C preferred stock and accrued dividends at $1.50 per share
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211,668 | 212 | 317,288 | - | 317,500 | |||||||||||||||
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Common stock issued for services
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370,000 | 370 | 928,530 | - | 928,900 | |||||||||||||||
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Reclassify fair value of warrant liability from equity
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- | - | (4,097,444 | ) | - | (4,097,444 | ) | |||||||||||||
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Reclassify fair value of derivative liability from equity
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- | - | (1,242,590 | ) | - | (1,242,590 | ) | |||||||||||||
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Fair value of vested options
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- | - | 798,789 | - | 798,789 | |||||||||||||||
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Preferred stock dividend
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- | - | (79,395 | ) | - | (79,395 | ) | |||||||||||||
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Net loss
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- | - | - | (3,052,906 | ) | (3,052,906 | ) | |||||||||||||
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Balance, March 31, 2015
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13,159,694 | $ | 13,160 | $ | 18,852,156 | $ | (25,833,311 | ) | $ | (6,967,995 | ) | |||||||||
|
BIOSIG
TECHNOLOGIES
, INC.
|
||||||||
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|
||||||||
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(unaudited)
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||||||||
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Three Months Ended March 31,
|
||||||||
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2015
|
2014
|
|||||||
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CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
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Net loss
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$ | (3,052,906 | ) | $ | (1,117,534 | ) | ||
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Adjustments to reconcile net loss to cash used in operating activities:
|
||||||||
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Depreciation
|
2,860 | 4,435 | ||||||
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Amortization of debt discount
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- | 388,285 | ||||||
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Equity based compensation
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1,634,714 | 343,837 | ||||||
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Changes in operating assets and liabilities:
|
||||||||
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Prepaid expenses
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8,744 | (3,924 | ) | |||||
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Accounts payable
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(233,155 | ) | (119,856 | ) | ||||
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Stock based payable
|
419,761 | - | ||||||
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Deferred rent payable
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- | (1,006 | ) | |||||
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Net cash used in operating activities
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(1,219,982 | ) | (505,763 | ) | ||||
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CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchase of property and equipment
|
(2,684 | ) | - | |||||
|
Net cash used in investing activity
|
(2,684 | ) | - | |||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds from sale of common stock
|
3,042,213 | 229,222 | ||||||
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Net repayments of related party advances
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- | (20,281 | ) | |||||
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Net cash provided by financing activities
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3,042,213 | 208,941 | ||||||
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Net (decrease) increase in cash and cash equivalents
|
1,819,547 | (296,822 | ) | |||||
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Cash and cash equivalents, beginning of the period
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239,781 | 302,187 | ||||||
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Cash and cash equivalents, end of the period
|
$ | 2,059,328 | $ | 5,365 | ||||
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Supplemental disclosures of cash flow information:
|
||||||||
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Cash paid during the period for interest
|
$ | 1,115 | $ | 1,098 | ||||
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Cash paid during the period for income taxes
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$ | - | $ | - | ||||
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Non-cash investing and financing activities:
|
||||||||
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Common stock issued upon conversion of Series C preferred stock and accrued dividends
|
$ | 317,500 | $ | - | ||||
|
Reclassify fair value of derivative and warrant liability from equity
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$ | 5,440,034 | $ | - | ||||
|
March 31,
2015
|
March 31,
2014
|
|||||||
|
Series A convertible preferred stock
|
-
|
501,089
|
||||||
|
Series B convertible preferred stock
|
-
|
451,726
|
||||||
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Series C convertible preferred stock
|
1,640,667
|
1,854,019
|
||||||
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Options to purchase common stock
|
6,205,190
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2,990,977
|
||||||
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Warrants to purchase common stock
|
7,561,820
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4,353,831
|
||||||
|
Totals
|
15,407,677
|
10,151,642
|
||||||
|
March 31,
2015
|
December 31,
2014
|
|||||||
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Computer equipment
|
$
|
57,584
|
$
|
54,900
|
||||
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Furniture and fixtures
|
7,803
|
7,803
|
||||||
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Subtotal
|
65,387
|
62,703
|
||||||
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Less accumulated depreciation
|
(52,543
|
)
|
(49,683
|
)
|
||||
|
Property and equipment, net
|
$
|
12,844
|
$
|
13,020
|
||||
|
March 31,
2015
|
December 31,
2014
|
|||||||
|
Accrued accounting and legal
|
$
|
71,952
|
$
|
190,767
|
||||
|
Accrued reimbursements
|
17,305
|
26,792
|
||||||
|
Accrued consulting
|
82,935
|
16,334
|
||||||
|
Accrued research and development expenses
|
42,409
|
93,407
|
||||||
|
Accrued credit card obligations
|
4,735
|
13,278
|
||||||
|
Accrued payroll
|
-
|
62,068
|
||||||
|
Accrued liquidated damages
|
55,620
|
55,620
|
||||||
|
Accrued office and other
|
5,915
|
29,093
|
||||||
|
Accrued settlement related to arbitration
|
40,000
|
66,667
|
||||||
|
$
|
320,871
|
$
|
554,026
|
|||||
|
Options Outstanding
|
Options Exercisable
|
|||||||||||||
|
Weighted
|
||||||||||||||
|
Average
|
Exercisable
|
|||||||||||||
|
Exercise
|
Number of
|
Remaining Life
|
Number of
|
|||||||||||
|
Price
|
Options
|
In Years
|
Options
|
|||||||||||
|
$
|
1.01-2.00
|
834,642
|
4.5
|
541,642
|
||||||||||
|
2.01-2.50
|
5,370,548
|
6.7
|
3,588,598
|
|||||||||||
|
6,205,190
|
6.4
|
4,130,240
|
||||||||||||
|
Weighted-Average
|
||||||||||||||||
|
Weighted-Average
|
Remaining
|
Aggregate
|
||||||||||||||
|
Shares
|
Exercise Price
|
Contractual Term
|
Intrinsic Value
|
|||||||||||||
|
Outstanding at January 1, 2015
|
5,990,190
|
$
|
2.25
|
6.7
|
3,267,692
|
|||||||||||
|
Grants
|
215,000
|
2.47
|
7.0
|
-
|
||||||||||||
|
Exercised
|
||||||||||||||||
|
Canceled
|
||||||||||||||||
|
Outstanding at March 31, 2015
|
6,205,190
|
$
|
2.26
|
6.4
|
$
|
1,098,888
|
||||||||||
|
Exercisable at March 31, 2015
|
4,130,240
|
$
|
2.25
|
5.9
|
$
|
797,753
|
||||||||||
|
Dividend yield:
|
-0- | % | ||
|
Volatility
|
129.54% to 130.30 | % | ||
|
Risk free rate:
|
1.19% to 1.79 | % | ||
|
Expected life:
|
7 years
|
|||
|
Estimated fair value of the Company’s common stock
|
$ | 1.99 to $2.24 | ||
|
Estimated forfeiture rate
|
0 | % | ||
|
Exercise
|
Number
|
Expiration
|
|||||
|
Price
|
Outstanding
|
Date
|
|||||
| $ | 0.001 | 383,320 |
January 2020
|
||||
| $ | 1.50 | 3,721,518 |
February 2018 to September 2018
|
||||
| $ | 1.84 | 35,076 |
January 2020
|
||||
| $ | 2.02 | 30,755 |
January 2020
|
||||
| $ | 2.50 | 1,603,600 |
July 2015
|
||||
| $ | 2.75 | 228,720 |
August 2019 to September 2019
|
||||
| $ | 3.67 | 218,275 |
December 2018 to January 2019
|
||||
| $ | 3.75 | 1,340,556 |
April 2019 to March 2020
|
||||
| 7,561,820 | |||||||
|
Weighted-Average
|
||||||||||||||||
|
Weighted-Average
|
Remaining
|
Aggregate
|
||||||||||||||
|
Shares
|
Exercise Price
|
Contractual Term
|
Intrinsic Value
|
|||||||||||||
|
Outstanding at January 1, 2015
|
5,113,990
|
$
|
1.71
|
3.6
|
6,041,436
|
|||||||||||
|
Grants
|
2,447,830
|
3.04
|
2.4
|
-
|
||||||||||||
|
Exercised
|
||||||||||||||||
|
Canceled
|
||||||||||||||||
|
Outstanding at March 31, 2015
|
7,561,820
|
$
|
2.14
|
3.0
|
$
|
4,300,280
|
||||||||||
|
Vested and expected to vest at March 31, 2015
|
7,561,820
|
$
|
2.14
|
3.0
|
$
|
4,300,280
|
||||||||||
|
Exercisable at March 31, 2015
|
7,561,820
|
$
|
2.14
|
3.0
|
$
|
4,300,280
|
||||||||||
|
Warrant
Liability
|
Derivative |
|
||||||
|
Balance, December 31, 2014
|
$
|
-
|
$
|
-
|
||||
|
Total (gains) losses
|
||||||||
|
Initial fair value of derivative at March 31, 2015, reclassified from equity
|
—
|
1,242,590
|
||||||
|
Initial fair value of warrant liability at March 31, 2015, reclassified from equity
|
4,097,444
|
—
|
||||||
|
Balance, March 31, 2015
|
$
|
4,097,444
|
$
|
1,242,590
|
||||
|
●
|
Higher quality cardiac signal acquisition for accurate and more efficient electrophysiology studies;
|
|
●
|
Precise, uninterrupted, real time evaluations of electrograms;
|
|
●
|
Reliable cardiac recordings to better determine precise ablation targets, strategy and end point of procedures; and
|
|
●
|
A portable device that can be fully integrated into existing electrophysiology lab environments.
|
|
●
|
Initial system concept validation has been performed in collaboration with physicians at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas in June 2011. The Texas Cardiac Arrhythmia Institute provided challenging recordings obtained with electrophysiology recording systems presently in use at the institute during various electrophysiology studies. Our technology team successfully imported the data into the PURE EP System software and using proprietary signal processing, the PURE EP System software was able to reduce baseline wander, noise, and artifacts from the data and therefore provide better diagnostic quality signals.
|
|
●
|
We have established clinical and/or advisory relationships for both technology development and validation studies with physicians and researchers affiliated with the following medical centers: Texas Cardiac Arrhythmia Institute, Austin, TX; Cardiac Arrhythmia Center at the University of California at Los Angeles, Los Angeles, CA; Mount Sinai Medical Center, New York, NY; Beaumont Medical Center, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; The Heart Rhythm Institute, University of Oklahoma Health Sciences Center, Oklahoma City, OK; and Mayo Clinic in Rochester, MN.
|
|
●
|
As part of our pre-clinical trials, physicians affiliated with the Texas Cardiac Arrhythmia Institute, University Hospitals Case Medical Center and Mount Sinai Medical Center provide us with recordings from challenging ablation procedures, mainly for ventricular tachycardia and atrial fibrillation, where the attending electrophysiologists face clinical dilemmas with the recordings obtained by their current recording systems. We believe that the recordings that the PURE EP System software has provided them, which show a reduction in baseline wander, noise, and artifacts, are of higher diagnostic value than the original recordings.
|
|
●
|
The Cardiac Arrhythmia Center at the University of California at Los Angeles and Dr. Kalyanam Shivkumar have played a significant role in the initial functional testing of our hardware. Dr. Shivkumar and his team have enabled us to learn the connectivity of the lab and its devices that pertain to where our PURE EP System will fit in. In June 2013, we commenced our first proof of concept animal study with the assistance of Dr. Shivkumar in order to further test the components of the PURE EP System hardware, as further explained below.
|
|
●
|
We are developing a confidence index that will assist electrophysiologists in further differentiating true signals from noise, which may potentially provide guidance in identifying ablation targets. The confidence index is expected to be an integral part of the software of the PURE EP System, which we believe will significantly facilitate the locating of ablation targets.
|
|
●
|
In the second and third quarters of 2013, we performed and finalized testing of our proof of concept unit by initially using an electrocardiogram/intracardiac simulator at our lab, and subsequently by obtaining animal recordings from the animal lab at the University of California at Los Angeles. As part of the testing, we simultaneously recorded electrocardiogram and intracardiac signals on our proof of concept unit and GE’s CardioLab recording system. An identical signal was applied to the input of both systems and the monitor of our proof of concept unit was positioned next to the monitor of GE’s CardioLab recording system to allow for visual comparison. We believe that our proof of concept unit performed well as compared to GE’s CardioLab recording system, in that the electrocardiogram and intracardiac signals displayed on our proof of concept unit showed less baseline wander, noise and artifacts compared to signals displayed on GE’s CardioLab recording system. However, because this was a proof of concept test, without any clearly established protocols, we cannot present this data for publication and we do not have any independent verification or peer review of these findings.
|
|
●
|
In the third quarter of 2013, we analyzed the results of our proof of concept unit to determine the final design of the PURE EP System prototype. Because the proof of concept unit was designed to verify the capabilities of the main components of the PURE EP System, we established a list of tasks necessary to complete the prototype (which we intend to use for end-user preference studies, animal studies and in-human recordings). The PURE EP System prototype is presently assembled.
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In the fourth quarter of 2014, we appointed Dr. Samuel J. Asirvatham from Mayo Clinic as a member of our Scientific Advisory Board and initiated plans for animal studies at Mayo Clinic. We expect to perform our initial study there in April 2015.
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In the first quarter of 2015, we appointed Dr. K. L. Venkatachalam from Mayo Clinic as a member of our Scientific Advisory Board. On March 31, 2015 Drs. Asirvatham and Venkatachalam performed our first animal study at the Mayo Clinic in Rochester, MN.
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31.01
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31.02
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32.01
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101 INS
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XBRL Instance Document
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101 SCH
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XBRL Taxonomy Extension Schema Document
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101 CAL
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XBRL Taxonomy Calculation Linkbase Document
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101 LAB
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XBRL Taxonomy Labels Linkbase Document
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101 PRE
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XBRL Taxonomy Presentation Linkbase Document
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101 DEF
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XBRL Taxonomy Extension Definition Linkbase Document
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BIOSIG TECHNOLOGIES, INC.
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||
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Date: May 1, 2015
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By:
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/s/ GREGORY D. CASH
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Gregory D. Cash
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||
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Chief Executive Officer (Principal Executive
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Officer)
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Date: May 1, 2015
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By:
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/s/ STEVEN CHAUSSY
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Steven Chaussy
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||
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Chief Financial Officer (Principal Financial Officer
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and Principal Accounting Officer)
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||
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* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
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Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
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