UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

[Mark One]

For the quarterly period ended December 31, 2012

or

For the transition period from _____to______

Commission file number: 0-26028

IMAGING DIAGNOSTIC SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

Registrant's telephone number: (954) 581-9800

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x     No  o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non- accelerated filer.  See definition of "accelerated filer and large accelerated filer" in Rule 12b-2 of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.  Yes  ¨     No  x

The number of shares outstanding of each of the issuer's classes of equity as of February 19, 2013: 70,669,629 shares of common stock, no par value; and 20 shares of Series L convertible preferred stock outstanding.

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"We", "Us", "Our" and "IDSI" unless the context otherwise requires, means Imaging Diagnostic Systems, Inc.

 

 

 

 

 

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IMAGING DIAGNOSTIC SYSTEMS, INC.
(A Development Stage Company)
Balance Sheets
Assets
		Dec. 31, 2012				June 30, 2012
Current assets:		Unaudited					*
Cash		$	1,142			$	1,623
Accounts receivable, net of allowances for doubtful accounts
of $1,088 and $18,750, respectively			3,263				56,250
Inventory			245,262				246,020
Prepaid expenses			25,524				24,124
Total current assets			275,191				328,017
Property and equipment, net			121,177				131,152
Intangible assets, net			85,440				102,530
Total assets		$	481,808			$	561,699
Liabilities and Stockholders' (Deficit)
Current liabilities:
Accounts payable and accrued expenses		$	1,656,717			$	1,728,338
Accrued payroll taxes and penalties			1,369,487				1,489,640
Customer deposits			142,563				142,563
Short-term derivative liability			472,350				961,058
Short-term debt, net of debt discount of $411,352 and $156,539, respectively			1,432,751				1,657,223
Total current liabilities			5,073,868				5,978,822
Long-Term liabilities:
Long-term convertible debt, net of debt discount of $18,056 and $60,553, respectively			38,095				55,645
Total long-term liabilities			38,095				55,645
Convertible preferred stock (Series L), 9% cumulative annual dividend,
no par value, 20 and 20 shares issued, respectively			200,000				200,000
Stockholders' (Deficit):
Preferred stock, Series P, no par value, 58 and 55 shares issued, respectively			-				-
Preferred stock, Series Q, $.001 par value, 51 and 51 shares issued, respectively			1				1
Common stock			110,422,182				109,743,826
Common stock - Debt Collateral			(73,970	)			(73,970	)
Additional paid-in capital			5,639,492				5,630,411
Deficit accumulated during development stage			(120,817,860	)			(120,973,036	)
Total stockholders' (Deficit)			(4,830,155	)			(5,672,768	)
Total liabilities and stockholders' (Deficit)		$	481,808			$	561,699
* Derived from audited financial statements.
The accompanying notes are an integral part of these condensed financial statements.

 

 

 

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IMAGING DIAGNOSTIC SYSTEMS, INC.
(A Development Stage Company)
(Unaudited)
Condensed Statements of Operations
		Six Months Ended								Three Months Ended								Since Inception
		December 31,								December 31,								(12/10/93) to
		2012				2011				2012				2011				Dec. 31, 2012
Net Sales		$	26,000			$	48,520			$	25,000			$	10,111			$	2,617,502
Gain on sale of fixed assets			-				-				-				-				2,794,565
Cost of Sales			3,672				6,073				3,672				1,344				983,449
Gross Profit			22,328				42,447				21,328				8,767				4,428,618
Operating Expenses:
General and administrative			438,676				1,412,222				258,698				670,408				64,323,092
Research and development			82,079				400,152				42,005				187,247				24,042,995
Sales and marketing			52,147				284,874				29,474				183,317				9,976,551
Inventory valuation adjustments			6,181				14,805				1,965				7,065				4,973,088
Depreciation and amortization			19,563				29,829				9,782				13,115				3,474,798
Amortization of deferred compensation			-				-				-				-				4,064,250
			598,646				2,141,882				341,924				1,061,152				110,854,774
Operating Loss			(576,318	)			(2,099,435	)			(320,596	)			(1,052,385	)			(106,426,156	)
Interest income			-				383				-				195				311,217
Other income			54,626				122,912				19,303				116,508				1,266,725
Other income - LILA Inventory			-				-				-				-				(69,193	)
Derivative expense			-				-				-				-				(64,524	)
Change in fair value of derivative liability			1,040,218				1,085,657				245,200				696,129				2,141,460
Interest expense			(363,349	)			(894,330	)			(199,200	)			(629,841	)			(11,129,629	)
Net Income (Loss)			155,177				(1,784,813	)			(255,293	)			(869,394	)			(113,970,100	)
Dividends on cumulative Pfd. stock:
From discount at issuance			-				-				-				-				(5,402,713	)
Earned			-				-				-				-				(1,445,047	)
Net Income (Loss) applicable to
common shareholders		$	155,177			$	(1,784,813	)		$	(255,293	)		$	(869,394	)		$	(120,817,860	)
Net Income (Loss) per common share:
Basic and diluted		$	0.0118			$	(0.0017	)		$	(0.0143	)		$	(0.0008	)		$	(139.94	)
Weighted average number of
common shares outstanding:
Basic and diluted			13,142,711				1,020,664,048				17,843,873				1,075,234,747				863,585
The accompanying notes are an integral part of these condensed financial statements.

 

 

 

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IMAGING DIAGNOSTIC SYSTEMS, INC.
(A Development Stage Company)
(Unaudited)
Condensed Statement of Cash Flows
		Six Months								From Inception
		Ended December 31,								December 10, 1993 to
		2012				2011				December 31, 2012
Cash flows from operations:
Net Income (Loss)		$	155,177			$	(1,784,813	)		$	(113,970,100	)
Changes in assets and liabilities			(580,659	)			617,215				36,113,408
Net cash used in operations			(425,482	)			(1,167,598	)			(77,856,692	)
Cash flows from investing activities:
Proceeds from sale of property & equipment			-				-				4,390,015
Capital expenditures			-				-				(7,578,436	)
Net cash (used in) investing activities			-				-				(3,188,421	)
Cash flows from financing activities:
Repayment of capital lease obligation			-				-				(50,289	)
Other financing activities			425,001				984,604				10,775,007
Proceeds from issuance of preferred stock			-				-				18,389,500
Net proceeds from issuance of common stock			-				-				51,932,037
Net cash provided by financing activities			425,001				984,604				81,046,255
Net increase (decrease) in cash			(481	)			(182,994	)			1,142
Cash, beginning of period			1,623				189,135				-
Cash, end of period		$	1,142			$	6,141			$	1,142
The accompanying notes are an integral part of these condensed financial statements.

 

 

 

 

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IMAGING DIAGNOSTIC SYSTEMS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

NOTE 1 - BASIS OF PRESENTATION

We have prepared the accompanying unaudited condensed financial statements of Imaging Diagnostic Systems, Inc. in accordance with generally accepted accounting principles for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, the financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.  In our opinion, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included.  Operating results for the three month period ended December 31, 2012 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending June 30, 2013.  These condensed financial statements have been prepared in accordance with Financial Accounting Standards guidance for Development Stage Enterprises, and should be read in conjunction with our condensed financial statements and related notes included in our Annual Report on Form 10-K filed on October 15, 2012.

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires that management 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 expenses incurred during the reporting period. Actual results could differ from those estimates.

 

 

NOTE 2 - GOING CONCERN

 

NOTE 3 - INVENTORY

Inventories included in the accompanying condensed balance sheet are stated at the lower of cost or market as summarized below:

 

 

 

 

 

 

 

 

 

 

 

We review our Inventory for parts that have become obsolete or in excess of our manufacturing requirements and our Finished Goods for valuation pursuant to our Critical Accounting Policy for Inventory.  For the fiscal year ending June 30, 2012, we reclassified the net realizable value of $11,928 from Clinical Equipment to Consignment Inventory due to a CTLM® system being purchased by one of our Distributors.  For the fiscal year ending June 30, 2011, we reclassified the net realizable value of $6,525 of CTLM® systems in Inventory to Clinical equipment.  For the fiscal year ending June 30, 2009, we reclassified the net realizable value of $8,591 as this CTLM® system is being used as a clinical system at the University of Florida.  For the fiscal year ending June 30, 2008 since such finished goods are being utilized for collecting data for our FDA application, we reclassified the net realizable value of $311,252 of CTLM® systems in Inventory to Clinical equipment.  

NOTE 4 - REVENUE RECOGNITION

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NOTE 5 - RECENT ACCOUNTING PRONOUNCEMENTS

Various accounting pronouncements that have been issued or proposed by the FASB that do not require adoption until a further date are not expected to have a material impact on the Company's financial statements upon adoption.

 

 

NOTE 6 – STOCK-BASED COMPENSATION

The Company relies on the guidance provided by ASC 718, ("Share Based Payments").  ASC 718 requires companies to expense the value of employee stock options and similar awards and applies to all outstanding and vested stock-based awards.

In computing the impact, the fair value of each option is estimated on the date of grant based on the Black-Scholes options-pricing model utilizing certain assumptions for a risk free interest rate; volatility; and expected remaining lives of the awards. The assumptions used in calculating the fair value of share-based payment awards represent management's best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and the Company uses different assumptions, the Company's stock-based compensation expense could be materially different in the future. In addition, the Company is required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. In estimating the Company's forfeiture rate, the Company analyzed its historical forfeiture rate, the remaining lives of unvested options, and the amount of vested options as a percentage of total options outstanding. If the Company's actual forfeiture rate is materially different from its estimate, or if the Company reevaluates the forfeiture rate in the future, the stock-based compensation expense could be significantly different from what we have recorded in the current period. The impact of applying ASC 718 during the three and six months December 31, 2012 approximated $6,400 and $42,671, respectively, in additional compensation expense compared to $2,290 and $4,579 for the corresponding periods in 2011.

The fair value concepts were not changed significantly in ASC 718; however, in adopting this Standard, companies were given the option to choose among alternative valuation models and amortization assumptions.  We elected to continue to use the Black-Scholes option pricing model and expense the options as compensation over the requisite service period of the grant.  We will reconsider use of the Black-Scholes model if additional information becomes available in the future that indicates another model would be more appropriate, or if grants issued in future periods have characteristics that cannot be reasonably estimated using this model.

For purposes of the following disclosures the weighted-average fair value of options has been estimated on the date of grant using the Black-Scholes options-pricing model.  For the quarter ending December 31, 2012, the net income and earnings per share reflect the actual deduction for option expense as a non-cash compensation expense.

The weighted average fair value per option at the date of grant for the three months ended December 31, 2012 using the Black-Scholes Option-Pricing Model was $0.0008. The weighted average fair value per option at the date of grant for the three months ended December 31, 2011 was $0.015.  Assumptions were as follows:

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(1)  We calculate expected volatility through a mathematical formula using the last day of the week's closing stock price for the previous 61 weeks prior to the option grant date.  The expected volatility for the three months ending December 31, 2012 and 2011 in the table above are weighted average calculations.

(2)  We lowered our risk-free interest rate from 4% to 3% for stock option expensing effective for the quarter ending December 31, 2012.  If a significant increase or decrease occurs in the zero coupon rate of the U.S Treasury Bond, a new rate will be set.  The decrease in the risk-free interest rate will decrease compensation expense.

(3)  We continue to use an expected term assumption of eight years based on guidance provided by SEC Staff Accounting Bulletin 107 and subsequently, Staff Accounting Bulletin 110.  These bulletins enable us to use the simplified method for "plain vanilla" options for this calculation.

NOTE 7 - COMMON STOCK ISSUANCES – PRIVATE EQUITY CREDIT AGREEMENT

During the second quarter ending December 31, 2012, we did not draw from our Private Equity Credit Agreement with Southridge Partners II LP ("Southridge").  Subsequent to the end of the second quarter, we did not initiate any put notices from our Private Equity Credit Agreement with Southridge through the date of this report.

NOTE 8 – DEBT DISCOUNT

In connection with the sale of a Convertible Promissory Note Agreement on February 23, 2011, with an unaffiliated third party, JMJ Financial (the "Lender" or "JMJ"), relating to a private placement of a total of up to $1,800,000 in principal amount of a Convertible Promissory Note (the "Note") providing for advances of a gross amount of $1,600,000 in seven tranches, we recorded interest expense to amortize the debt discount in the amount of $9,723 during the quarter ending December 31, 2012.  

There remains a total of $429,408 of debt discount yet to be amortized as of December 31, 2012.

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NOTE 9 – SHORT-TERM DEBT

From November 10, 2009 to December 31, 2012 we borrowed $4,117,041 in the aggregate from 16 unaffiliated third party investors.

 

 

 

 

 

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NOTE 10 – LONG-TERM CONVERTIBLE DEBT

On February 23, 2011, we entered into a Convertible Promissory Note Agreement with an unaffiliated third party, JMJ Financial (the "Lender" or "JMJ"), relating to a private placement of a total of up to $1,800,000 in principal amount of a Convertible Promissory Note (the "Note") providing for advances of a gross amount of $1,600,000 in seven tranches.  Pursuant to the terms of a Registration Rights Agreement (the "Rights Agreement") dated February 23, 2011, between the Company and JMJ, we are required to file within 10 days from the effective date of an increase of authorized shares approved by our shareholders, an S-1 Registration Statement (the "Registration Statement") covering 130,000,000 shares of Company common stock to be reserved for conversion of the Note.  Although our shareholders on July 12, 2011, voted to increase our authorized shares to 2,000,000,000, we have not filed the registration statement as required by the Rights Agreement.

The Note provides for funding in seven tranches as stipulated in the Funding Schedule attached.  The first tranche of $300,000 was closed on February 24, 2011, and we received $258,000 after deductions of $30,000 for a 10% Finder's Fee and $12,000 for an Origination Fee.  The second tranche of $100,000 closed on May 20, 2011, and we received $93,000 after deduction of $7,000 for a 7% Finder's Fee.  A partial closing on the third tranche of $35,000 closed on October 7, 2011 and we received $32,250 after deduction of $2,750 for a 7% Finder's Fee.  A partial closing on the third tranche of $25,000 closed on February 8, 2012 and we received $25,000.  In connection with this partial third tranche we will pay a 7% Finder's Fee, which is $1,750.  A partial closing on the third tranche of $25,000 closed on February 29, 2012 and we received $25,000.  In connection with this partial third tranche we will pay a 7% Finder's Fee, which is $1,750.  A final closing on the third tranche of $15,000 closed on April 4, 2012 and we received $15,000.  In connection with this final third tranche we will pay a 7% Finder's Fee, which is $1,050.  We received $10,000 from a partial closing on the fourth tranche with JMJ on October 3, 2012.  In connection with this partial fourth tranche we will pay a 7% Finder's Fee, which is $700.  The remaining four tranches are to be funded based on achievement of milestones relating to the Registration Statement, with the final tranche of $300,000 being available 150 days after effectiveness of the Registration Statement, which must be effective 120 days after the date of the Agreement.  For the remaining four tranches, we are obligated to pay a Finder's Fee equal to 7% in cash at each closing date.  We may cancel the unfunded portion of the Agreement at a fee of 20% of the unfunded amount.  As of December 31, 2012, $1,290,000 in principal amount remains unfunded and if we choose to cancel we will have to pay JMJ $258,000 to terminate the agreement.

The Note, after the seven tranches are drawn, would generate net proceeds of $1,467,000 after payment of the Origination Fee and a 7% Finder's Fee.  JMJ has the option to provide an additional $1,600,000 of funding on substantially the same terms as the first Agreement; however, we have the right to cancel, without penalty, the Note Agreement within five days of JMJ's execution.  Once executed and accepted by both parties and five days has passed, cancellation of unfunded payments is permitted at a fee of 20% of the unfunded amount.  Cancellation of funded portions is not permitted.

The funding schedule of the seven tranches is as follows:

§	$300,000 paid to Borrower within 2 business days of execution and closing of the agreement.

§	$100,000 paid to Borrower within 5 business days of filing of Definitive Proxy to increase authorized shares to 2,000,000,000 or more.

§	$100,000 paid to Borrower within 5 business days of effective increase in authorized shares to 2,000,000,000 or more.

§	$100,000 paid to Borrower within 5 business days of filing of registration statement, and that registration statement must be filed no later than 10 days from the effective increase of authorized shares.

§	$400,000 paid to Borrower within 5 business days of notice of effective registration statement, and that registration statement must be effective no later than 120 days from the execution of the agreement.

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§	$300,000 paid to Borrower within 90 business days of notice of effective registration statement, and that registration statement must be effective no later than 120 days from the execution of the agreement.

§	$300,000 paid to Borrower within 150 business days of notice of effective registration statement, and that registration statement must be effective no later than 120 days from the execution of the agreement.

The conditions to funding each payment are as follows:

§	At the time of each payment interval, the Conversion Price calculation on Borrower's common stock must yield a Conversion Price equal to or greater than $0.015 per share (based on the Conversion Price calculation, regardless of whether a conversion is actually completed or not).

§

At the time of each payment interval, the total dollar trading volume of Borrower's common stock for the previous 23 trading days must be equal to or greater than $1,000,000.  The total dollar volume will be calculated by removing the three highest dollar volume days and summing the dollar volume for the remaining 20 trading days.

§	At the time of each payment interval, there shall not exist an event of default as described within any of the agreements between Borrower and Holder.

Prior to the maturity date of February 2, 2014, JMJ may convert both principal and interest into our common stock at 75% of the average of the three lowest closing prices in the 20 days previous to the conversion.  We have the right to enforce a conversion floor of $0.015 per share; however, if we receive a conversion notice in which the Conversion Price is less than $0.015 per share, JMJ will incur a conversion loss [(Conversion Loss = $0.015 – Conversion Price) x number of shares being converted] which we must make whole by either of the following options: pay the conversion loss in cash or add the conversion loss to the balance of principal due.  Prepayment of the Note is not permitted.

The Note has a 9% one-time interest charge on the principal sum.  No interest or principal payments are required until the Maturity Date, but both principal and interest may be included in conversions prior to the maturity date.

NOTE 11 – PREFERRED STOCK

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NOTE 12 – DERIVATIVE LIABILITY

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NOTE 13 – FAIR VALUE OF FINANCIAL INSTRUMENTS

The Company relies upon the guidance of ASC 820 ("Fair Value Measurements and Disclosures").  ASC 820 defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.  When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance.  ASC 820 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.  ASC 820 establishes three levels of inputs that may be used to measure fair value:

Level 1 - Quoted prices in active markets for identical assets or liabilities.

Level 2 - Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment.  In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.

Upon adoption of ASC 820, there was no cumulative effect adjustment to the beginning retained earnings and no impact on the consolidated financial statements.

The carrying value of the Company's cash and cash equivalents, accounts payable, short-term borrowings (including convertible notes payable), and other current liabilities approximate fair value because of their short-term maturity. All other significant financial assets, financial liabilities and equity instruments of the Company are either recognized or disclosed in the consolidated financial statements together with other information relevant for making a reasonable assessment of future cash flows, interest rate risk and credit risk. Where practicable the fair values of financial assets and financial liabilities have been determined and disclosed; otherwise only available information pertinent to fair value has been disclosed.

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		Quoted Prices in Active Markets for Identical Instruments Level 1			Significant Other Observable Inputs Level 2			Significant Unobservable Inputs Level 3			Assets at Fair Value
Liabilities:
Series L Convertible Preferred Stock		$			$			$	(200,000	)	$	(200,000	)
Series L Accrued Dividend Payable								$	(62,988	)	$	(62,988	)
Derivative Liability								$	(472,350	)	$	(472,350	)

		Quoted Prices in Active Markets for Identical Instruments Level 1			Significant Other Observable Inputs Level 2			Significant Unobservable Inputs Level 3			Assets at Fair Value
Liabilities:
Series L Convertible Preferred Stock		$			$			$	(200,000	)	$	(200,000	)
Series L Accrued Dividend Payable								$	(53,914	)	$	(53,914	)
Derivative Liability								$	(961,058	)	$	(961,058	)

 

 

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At June 30, 2012, the carrying amount of the Series L Convertible Preferred Stock at stated value is deemed to be the fair value.  The balance sheet also reflects a liability for the accrued dividend payable on the Series L Convertible Preferred Stock.

NOTE 14 – PROPERTY AND EQUIPMENT

The following is a summary of property and equipment, less accumulated depreciation:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the fiscal year ending June 30, 2008, we reclassified the net realizable value of $311,252 of CTLM® systems in Inventory to Clinical equipment as these CTLM® systems continue to be used as clinical systems associated with the data collection for our FDA application which we planned to submit to the FDA in December 2008.

For the fiscal year ending June 30, 2009, we reclassified the net realizable value of $8,591 of CTLM® systems in Inventory to Clinical equipment as this CTLM® system is being used as a clinical system at the University of Florida.

For the fiscal year ending June 30, 2011, we reclassified the net realizable value of $6,525 of CTLM® systems in Inventory to Clinical equipment.

For the fiscal year ending June 30, 2012, we reclassified the net realizable value of $11,928 from Clinical Equipment to Consignment Inventory.

The estimated useful lives of property and equipment for purposes of computing depreciation and amortization are:

Telephone equipment, acquired under a long-term capital lease at a cost of $50,289, is included in furniture and fixtures.  The CTLM® software is fully amortized.

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NOTE 15 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consist of the following:

 

 

 

 

 

 

 

 

 

 

As of December 31, 2012, we owe $557,269 in accrued wages and $1,362,302 in accrued payroll taxes.  The $1,362,302 in accrued payroll taxes represents unfunded payroll taxes, interest and penalties commencing with the quarter ending March 31, 2010.  The reason we incurred the penalties and interest was due to the difficulty in raising capital to have sufficient funds to pay the taxes.

From May 2010 to June 2012, claims were made by the IRS for payment of our accrued payroll taxes, interest and penalties, which as of June 30, 2012 was $1,489,640.  We engaged tax counsel to handle this matter and intend to fully satisfy our tax obligations.  In order to qualify for an IRS Installment Agreement, we must be current in our payment of payroll taxes in the period they are due.  We have paid all of our payroll taxes payable for the calendar year 2012.

 

The IRS sent formal collection demands for each quarter we were delinquent in payment of payroll taxes beginning with the quarter ending March 31, 2010.  On November 22, 2011, the IRS filed a lien with the Secretary of State of Florida in Tallahassee, Florida totaling $779,996.  Subsequently, on February 2, 2012, the IRS filed a lien with the Secretary of State of Florida in Tallahassee, Florida totaling $140,439; and on June 28, 2012, the IRS filed a lien with the Secretary of State of Florida in Tallahassee, Florida totaling $1,479.  Our tax counsel negotiated an Installment Agreement to make installment payments to satisfy outstanding taxes, penalties and interest due.  The Installment Agreement states that we must pay $15,000 a month for 12 months with the first payment due by November 28, 2012; $20,000 a month for 12 months beginning November 28, 2013; and $25,000 a month for 12 months beginning November 28, 2014 until such time as the balance owed is paid in full.  In the event that we are able to pay off the balance due to the IRS, our tax counsel would attempt to negotiate a waiver on the penalties.

From July 1, 2012 through December 31, 2012, we have made payments to the IRS totaling $165,951.  We have paid all of our payroll taxes payable for the calendar year 2012.  Of the $165,951, we made two $15,000 payments totaling $30,000 during the quarter ending December 31, 2012 as per our Installment Agreement.  We paid accrued payroll taxes totaling $67,359 for the quarter ending March 31, 2012 and $21,134 for the quarter ending June 30, 2012.  We paid a total of $33,091 in payroll taxes for the quarter ending September 30, 2012 and $14,368 for the quarter ending December 31, 2012.

If we ultimately are unable to pay the outstanding payroll tax, penalties and interest on a timetable pursuant to the terms of the Installment Agreement, we may have to cease operations.

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NOTE 16 – SUBSEQUENT EVENTS

In January 2013, we received $31,500 from Hanover Holdings I, LLC ("Hanover") pursuant to a short-term promissory note.  The note provides a maturity date of September 3, 2013.  Interest will accrue at 12% per annum.  Any amount on principal or interest that remains unpaid when due, shall bear an interest rate of 22% from the due date until paid.  Hanover may elect at an Event of Default to convert any part or all of the $31,500 plus interest into shares of our common stock at an Initial Conversion Price equal to 45% of the lowest closing bid price during the five trading days immediately prior to the date of the conversion notice.  We reserved 20,000,000 shares of our common stock in connection with this transaction.

On January 3, 2013, Magna Group, LLC ("Magna") purchased $100,000 principal of a Promissory Note dated December 10, 2009 from a private investor.  A new Convertible Promissory Note was issued to Magna on January 3, 2013 with a maturity date of September 3, 2013.  Interest will accrue at 12% per annum.  Any amount on principal or interest that remains unpaid when due, shall bear an interest rate of 22% from the due date until paid.  Magna may elect at an Event of Default to convert any part or all of the $100,000 plus interest into shares of our common stock at an Initial Conversion Price equal to 45% of the lowest closing bid price during the five trading days immediately prior to the date of the conversion notice.  We reserved 50,000,000 shares of our common stock in connection with this transaction.

In January 2013, we received $5,850 from a private investor pursuant to two short-term promissory notes with a maturity date ranging from January 3, 2014 to January 8, 2014.  The notes provide for a redemption premium of 15% of the principal amount upon maturity.  Interest will accrue at 8% per annum until maturity above and beyond the premium.  The holder may elect at an Event of Default to convert any part or all of the $5,850 Principal Amount of the Note plus accrued interest into shares of our common stock at a conversion price equal to 50% of the average of the lowest closing bid price during the ten trading days immediately prior to the date of the conversion notice.

In January 2013, we received $30,000 from Black Arch Opportunity Fund LP ("Black Arch") pursuant to a short-term promissory note.  The note provides a maturity date of November 9, 2013.  Interest will accrue at 12% per annum.  Any amount on principal or interest that remains unpaid when due, shall bear an interest rate of 22% from the due date until paid.  Black Arch may elect at an Event of Default to convert any part or all of the $30,000 plus interest into shares of our common stock at an Initial Conversion Price equal to 50% of the lowest closing bid price during the five trading days immediately prior to the date of the conversion notice.

In January 2013, we received $25,000 from Redwood Management LLC ("Redwood") pursuant to a $125,000 short-term promissory note dated January 18, 2013.  The terms of the note provide that the Redwood will pay $25,000 every 30 days from execution of the note until the entire $125,000 is paid in full.  The note provides a maturity date of January 18, 2014.  Interest will accrue at 12% per annum on the aggregate unconverted outstanding principal amount.  Redwood may elect at an Event of Default to convert any part or all of the outstanding balance plus interest into shares of our common stock at an Initial Conversion Price equal to 50% of the lowest closing bid price during the fifteen trading days immediately prior to the date of the conversion notice.  We reserved 100,000,000 shares of our common stock in connection with this transaction.

In January 2013, Redwood agreed to purchase five promissory notes held by a private investor totaling $365,688 of which $213,600 in principal and $123,752 in premium; $17,040 is cash redemption premium and $11,296 is interest.  Redwood may elect at an Event of Default to convert any part or all of the outstanding balance plus interest into shares of our common stock at an Initial Conversion Price equal to 45% of the lowest closing bid price during the fifteen trading days immediately prior to the date of the conversion notice.  We reserved 60,000,000 shares of our common stock in connection with this transaction.

In January 2013, we received $19,500 from Hanover Holdings I, LLC ("Hanover") pursuant to a short-term promissory note.  The note provides a maturity date of January 23, 2014.  Interest will accrue at 12% per annum.  Any amount on principal or interest that remains unpaid when due, shall bear an interest rate of 22% from the due

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date until paid.  Hanover may elect at an Event of Default to convert any part or all of the $19,500 plus interest into shares of our common stock at an Initial Conversion Price equal to 45% of the lowest closing bid price during the five trading days immediately prior to the date of the conversion notice.  We reserved 12,500,000 shares of our common stock in connection with this transaction.

In January 2013, we received $15,000 from WHC Capital, LLC pursuant to a short-term promissory note with a maturity date of January 25, 2014.  Interest will accrue at 12% per annum until maturity above and beyond the premium.  Any amount on principal or interest that remains unpaid when due, shall bear an interest rate of 22% from the due date until paid.  The holder may elect at an Event of Default to convert any part or all of the $15,000 Principal Amount of the Note plus accrued interest into shares of our common stock at a conversion price equal to 50% of the average of the lowest closing bid price during the ten trading days immediately prior to the date of the conversion notice.

In February 2013, we received $7,000 from a private investor pursuant to a short-term promissory note with a maturity date of February 7, 2014.  The note provides for a redemption premium of 15% of the principal amount upon maturity.  Interest will accrue at 8% per annum until maturity above and beyond the premium.  The holder may elect at an Event of Default to convert any part or all of the $7,000 Principal Amount of the Note plus accrued interest into shares of our common stock at a conversion price equal to 50% of the average of the lowest closing bid price during the ten trading days immediately prior to the date of the conversion notice.

In February 2013, we received $25,000 from Redwood Management LLC ("Redwood") pursuant to a $125,000 short-term promissory note dated January 18, 2013.  The terms of the note provide that the Redwood will pay $25,000 every 30 days from execution of the note until the entire $125,000 is paid in full.  The note provides a maturity date of January 18, 2014.  Interest will accrue at 12% per annum on the aggregate unconverted outstanding principal amount.  Redwood may elect at an Event of Default to convert any part or all of the outstanding balance plus interest into shares of our common stock at an Initial Conversion Price equal to 50% of the lowest closing bid price during the fifteen trading days immediately prior to the date of the conversion notice.

On January 8, 2013, SGI Group executed a partial debt to equity conversion of the $30,000 short-term promissory note originally dated August 25, 2011 and purchased on August 20, 2012 from Southridge, in which they converted $5,900 principal and $4,400 in interest.  We issued SGI Group 1,716,672 common shares pursuant to Rule 144 based on an agreed conversion price of $0.006 per share.

On January 10, 2013, Magna executed a partial debt to equity conversion of the $100,000 Promissory Note originally dated December 10, 2009 which was issued as a new Convertible Promissory Note to Magna on January 3, 2013 in which they converted $10,000 principal.  We issued Magna 1,554,002 common shares pursuant to Rule 144 based on an agreed conversion price of $0.006435 per share.

On January 15, 2013, WHC Capital LLC executed a partial debt to equity conversion of the $46,400 short-term promissory note originally dated December 10, 2010 and purchased on August 20, 2012 from a private investor, in which they converted $5,945 principal.  We issued WHC Capital LLC 1,033,900 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00575 per share.

On January 18, 2013, ASC Recap executed a partial debt to equity conversion of the $180,769 balance of a short-term promissory originally dated December 15, 2009 and purchased on December 12, 2012 from a private investor,

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in which they converted $11,100 principal.  We issued ASC Recap 1,850,000 common shares pursuant to Rule 144 based on an agreed conversion price of $0.006 per share.

On January 18, 2013, Magna executed a partial debt to equity conversion of the $100,000 Promissory Note originally dated December 10, 2009 which was issued as a new Convertible Promissory Note to Magna on January 3, 2013 in which they converted $13,600 principal.  We issued Magna 1,766,234 common shares pursuant to Rule 144 based on an agreed conversion price of $0.0077 per share.

On January 23, 2013, Redwood executed a partial debt to equity conversion of a $100,000 Promissory Note originally dated December 14, 2009 which they purchased from a private investor on January 18, 2013, in which they converted $12,500 principal.  We issued Redwood 2,192,982 common shares pursuant to Rule 144 based on an agreed conversion price of $0.0057 per share.

On January 28, 2013, WHC Capital LLC executed a partial debt to equity conversion of the $46,400 short-term promissory note originally dated December 10, 2010 and purchased on August 20, 2012 from a private investor, in which they converted $4,726 in principal and $5,019 in premium.  We issued WHC Capital LLC 1,949,000 common shares pursuant to Rule 144 based on an agreed conversion price of $0.005 per share.

On January 28, 2013, Magna executed a partial debt to equity conversion of the $100,000 Promissory Note originally dated December 10, 2009 which was issued as a new Convertible Promissory Note to Magna on January 3, 2013 in which they converted $9,900 principal.  We issued Magna 1,766,234 common shares pursuant to Rule 144 based on an agreed conversion price of $0.0055 per share.

On January 28, 2013, Redwood executed a partial debt to equity conversion of a $100,000 Promissory Note originally dated December 14, 2009 which they purchased from a private investor on January 18, 2013, in which they converted $12,500 principal.  We issued Redwood 2,272,727 common shares pursuant to Rule 144 based on an agreed conversion price of $0.0055 per share.

On February 1, 2013, Levin Consulting Group executed a partial debt to equity conversion of the $70,000 short-term promissory note originally dated August 25, 2011 and purchased on August 20, 2012 from Southridge, in which they converted $7,000 principal and $248 in interest.  We issued Levin Consulting Group 1,767,771 common shares pursuant to Rule 144 based on an agreed conversion price of $0.0041 per share.

On February 1, 2013, SGI Group executed a partial debt to equity conversion of the $30,000 short-term promissory note originally dated August 25, 2011 and purchased on August 20, 2012 from Southridge, in which they converted $2,857 in interest.  We issued SGI Group 696,878 common shares pursuant to Rule 144 based on an agreed conversion price of $0.006 per share.  On February 11, 2013 we issued SGI Group an additional 446,002 shares because the closing bid price on the clearing date fell below the Initial closing bid price.

On February 6, 2013, Southridge executed a debt to equity conversion of a $6,672 short-term promissory note dated June 18, 2012 in which they converted $6,672 principal and $338 in interest.  We issued Southridge 2,046,658 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00343 per share.

On February 6, 2013, Magna executed a partial debt to equity conversion of the $100,000 Promissory Note originally dated December 10, 2009 which was issued as a new Convertible Promissory Note to Magna on January 3, 2013 in which they converted $6,500 principal.  We issued Magna 4,166,667 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00156 per share.

On February 6, 2013, WHC Capital LLC executed a partial debt to equity conversion of the $46,400 short-term promissory note originally dated December 10, 2010 and purchased on August 20, 2012 from a private investor, in which they converted $5,843 in premium.  We issued WHC Capital LLC 2,050,000 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00285 per share.

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On February 6, 2013, ASC Recap executed a partial debt to equity conversion of the $180,769 balance of a short-term promissory originally dated December 15, 2009 and purchased on December 12, 2012 from a private investor, in which they converted $5,375 principal.  We issued ASC Recap 1,628,788 common shares pursuant to Rule 144 based on an agreed conversion price of $0.0033 per share.

On February 6, 2013, Redwood executed a partial debt to equity conversion of a $100,000 Promissory Note originally dated December 14, 2009 which they purchased from a private investor on January 18, 2013, in which they converted $3,500 principal.  We issued Redwood 2,121,212 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00165 per share.

On February 12, 2013, Redwood executed a partial debt to equity conversion of a $100,000 Promissory Note originally dated December 14, 2009 which they purchased from a private investor on January 18, 2013, in which they converted $5,000 principal.  We issued Redwood 3,030,303 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00165 per share.

On February 12, 2013, Southridge executed a partial debt to equity conversion of a $25,000 short-term promissory note dated August 2, 2012 in which they converted $7,475 principal and $1,058 in interest.  We issued Southridge 4,162,212 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00205 per share.

On February 14, 2013, Southridge executed a partial debt to equity conversion of a $25,000 short-term promissory note dated August 2, 2012 in which they converted $2,185 principal and $11 in interest.  We issued Southridge 1,626,636 common shares pursuant to Rule 144 based on an agreed conversion price of $0.00135 per share.

On January 16, 2013, JMJ executed a debt to equity conversion of $7,455 in principal of the fifth tranche of $25,000, which we closed on February 29, 2012.  We issued JMJ 895,000 common shares pursuant to Rule 144 based on a conversion price of $0.00833 per share.

On January 29, 2013, JMJ executed a debt to equity conversion of $6,334 in principal of the fifth tranche of $25,000, which we closed on February 29, 2012.  We issued JMJ 890,000 common shares pursuant to Rule 144 based on a conversion price of $0.007117 per share.

On February 11, 2013, JMJ executed a debt to equity conversion of $10,083 in principal of the fifth tranche of $25,000, which we closed on February 29, 2012.  We issued JMJ 2,900,000 common shares pursuant to Rule 144 based on a conversion price of $0.003477 per share.

All debt conversions were consummated at the contractual terms agreed upon for each loan.  Accordingly, there was no gain/loss on conversions.

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Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

CAUTIONARY STATEMENTS

The following discussion of the financial condition and results of operations of Imaging Diagnostic Systems, Inc. should be read in conjunction with the Management's Discussion and Analysis of Financial Condition and Results of Operations; the Condensed Financial Statements; the Notes to the Financial Statements; the Risk Factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2012, which are incorporated herein by reference; and all our other filings, including Current Reports on Form 8-K, filed with the SEC through the date of this report.  This quarterly report on Form 10-Q contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements using terminology such as "may," "will," "expects," "plans," "anticipates," "estimates," "projects", "potential," or "continue," or the negative or other comparable terminology regarding beliefs, plans, expectations, or intentions regarding the future.  These forward-looking statements involve substantial risks and uncertainties, and actual results could differ materially from those discussed and anticipated in such statements.  These forward-looking statements include, among others, statements relating to our business strategy, which is based upon our interpretation and analysis of trends in the healthcare treatment industry, especially those related to the diagnosis and treatment of breast cancer, and upon management's ability to successfully develop and commercialize its principal product, the CTLM®.  This strategy assumes that the CTLM® will provide benefits, from both a medical and an economic perspective, to alternative techniques for diagnosing and managing breast cancer.  Factors that could cause actual results to materially differ include, without limitation, the timely and successful submission of our U.S. Food and Drug Administration ("FDA") application to obtain marketing clearance; manufacturing risks relating to the CTLM®, including our reliance on a single or limited source or sources of supply for some key components of our products as well as the need to comply with especially high standards for those components and in the manufacture of optical imaging products in general; uncertainties inherent in the development of new products and the enhancement of our existing CTLM® product, including technical and regulatory risks, cost overruns and delays; our ability to accurately predict the demand for our CTLM® product as well as future products and to develop strategies to address our markets successfully; the early stage of market development for medical optical imaging products and our ability to gain market acceptance of our CTLM® product by the medical community; our ability to expand our international distributor network for both the near and longer-term to effectively implement our globalization strategy; our dependence on senior management and key personnel and our ability to attract and retain additional qualified personnel; our ability to obtain financing and the risks relating to financing utilizing convertible promissory notes, convertible debentures, convertible preferred stock, private equity credit agreements or other working capital financing arrangements; technical innovations that could render the CTLM® or other products marketed or under development by us obsolete; competition; risks and uncertainties relating to intellectual property, including claims of infringement and patent litigation; risks relating to future acquisitions and strategic investments and alliances; and reimbursement policies for the use of our CTLM® product and any products we may introduce in the future.  There are also many known and unknown risks, uncertainties and other factors, including, but not limited to, technological changes and competition from new diagnostic equipment and techniques, changes in general economic conditions, healthcare reform initiatives, legal claims, regulatory changes and risk factors detailed from time to time in our Securities and Exchange Commission filings that may cause these assumptions to prove incorrect and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  These risks and uncertainties include, but are not limited to, those described above or elsewhere in this quarterly report.  All forward-looking statements and risk factors included in this document or incorporated by reference from our Annual Report on Form 10-K for the fiscal year ended June 30, 2012, are made as of the date of this report based on information available to us as of the date of this report, and we assume no obligation to update any forward-looking statements or risk factors.  You are cautioned not to place undue reliance on these forward-looking statements.

 

 

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1)	The progress of our ongoing product development projects;
2)	The time and cost involved in obtaining regulatory approvals;
3)	The cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
4)	Competing technological and market developments;
5)	Changes and developments in our existing collaborative, licensing and other relationships and the terms of any new collaborative, licensing and other arrangements that we may establish;
6)	The development of commercialization activities and arrangements; and
7)	The costs associated with compliance to SEC regulations.

Issuance of Stock for Services/Dilutive Impact to Shareholders

We, from time to time, have issued and may continue to issue stock for services rendered by consultants, all of whom have been unaffiliated.

Since we have generated no significant revenues to date, our ability to obtain and retain consultants may be dependent on our ability to issue stock for services.  Since July 1, 1996, we have issued an aggregate of 2,306,500 shares of common stock according to registration statements on Form S-8.  The aggregate fair market value of the shares registered on Form S-8 when issued was $2,437,151.  On July 15, 2008, we entered into a Financial Services Consulting Agreement (the "Agreement") with R.H. Barsom Company, Inc. of New York, NY, an unaffiliated third-party, to provide us with investor relations services and guidance and assistance in available alternatives to maximize shareholder value.  The term of the Agreement was six months, with payment for services being made with shares of IDSI's common stock with a restricted legend to Richard E. Barsom.  The total payment was 5,000,000 restricted shares, with the first payment of 2,500,000 restricted shares paid on July 16, 2008, and the second payment of 2,500,000 restricted shares paid on October 3, 2008.  The aggregate fair market value of the 5,000,000 restricted shares when issued was $55,000.  The Company agreed to register as soon as practicable the aggregate of 5,000,000 shares in an S-1 Registration Statement.  In April 2010, we issued 250,000 restricted shares to Frederick P. Lutz to satisfy the balance of $2,250 previously owed to him for investor relation services and for additional investor relation services.  The aggregate fair market value of the 250,000 restricted shares when issued was $13,500.

The issuance of large amounts of our common stock, sometimes at prices well below market price, for services rendered or to be rendered and the subsequent sale of these shares may further depress the price of our common stock and dilute the holdings of our shareholders.  In addition, because of the possible dilution to existing shareholders, the issuance of substantial additional shares may cause a change-in-control.

Issuance of Stock in Connection with Short-Term Loans

 

 

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Item 3.  Quantitative and Qualitative Disclosures about Market Risk

As of the date of this report, we believe that we do not have any material quantitative and qualitative market risks.

Item 4.  Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that the information required to be disclosed in the reports that we file under the Securities Exchange Act of 1934 (the "Exchange Act") is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.  In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

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PART II

OTHER INFORMATION

In April 2008, we were served with a lawsuit filed against us in Venice, Italy, by Gio Marco S.p.A. and Gio IDH S.p.A., related Italian companies which, between them, had purchased three CTLM® systems in 2005.  One system was purchased directly from us, and the other two were purchased from our former Italian distributor and an affiliate of the distributor.

The plaintiffs alleged that they purchased the CTLM® systems for experimental purposes based on alleged oral assurances by our sales representative to the effect that we would promptly receive PMA approval for the CTLM® and that we would give them exclusive distribution rights in Italy.  The plaintiffs are seeking to recover a total of €628,595, representing the aggregate purchase price of the systems plus related expenses.

Based on our preliminary investigation of this matter, we believed that this claim was without merit, and we vigorously defended the case.  Our Italian counsel responded to the lawsuit in November 2008 and requested and was granted an extension to May 2009 to respond.  Our counsel filed our defenses in the Court of Venice at a hearing held in June 2009.  The judge set the next hearing for March 3, 2010 in order to allow the parties to clarify their claims and defenses.  At the hearing, the plaintiffs did not prove all of the facts underlying their claims.  The Judge set a hearing for November 10, 2010 for the "clarification of conclusions".  At that time, our counsel planned to present our demand for damages from "vexatious litigation" by the plaintiffs.  The November 10, 2010 hearing was postponed until November 17, 2010.  At the hearing, the plaintiffs failed to present their statements to the court in a timely manner and therefore, we believe that the plaintiffs should no longer be able to pursue any legal remedy in this matter.  The last hearing of the case was held on November 17, 2010.  A hearing was held on September 28, 2011 and the Judge declared that the case was closed.  Our counsel requested a copy of the order of the court to be sent to the Plaintiffs notifying them that the case was closed.  Because the court is sending notice to the plaintiffs, the time for appeal is reduced from one year to one month.  If the plaintiffs do not appeal, the court's decision becomes final.  We received a copy of the order of the court notifying us that the case was closed on September 12, 2012.

Our Annual Report on Form 10-K for the year ended June 30, 2012, includes a detailed discussion of our risk factors. The risks described in our Form 10-K are not the only risks facing IDSI.  Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.  During our second quarter ended December 31, 2012, there were no material changes in risk factors as previously disclosed in our Form 10-K filed on October 15, 2012.

Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds.

See Item 5. Other Information –"Financing/Equity Line of Credit".

Item 3.   Defaults Upon Senior Securities.

None

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Item 4.   Mine Safety Disclosures.

Not Applicable

Item 5.  Submission of Matters to a Vote of Security-Holders.

None

Item 6.  Other Information.

 

 

Country	Sold	Marketed	Regulatory Requirement	Regulatory Status
United States	No	No	Food & Drug Administration	Preparing for PMA Submission
Argentina	Yes	Yes	ANVISA	Expired(1)
Australia	No	Yes	TGA Approval	Canceled, Distributor Will Re-Submit(8)
Austria	No	Yes	CE Mark	Approved
Brazil	No	Yes	ANVISA	Expired(2)
Canada	No	Yes	Health Canada Approval	Approved
China	Yes	Yes	SFDA Approval	Approved
Croatia	No	Yes	CIHI(4)	Not Submitted Yet
Colombia	No	Yes	Register with MOH(3)	Not Submitted Yet
Curacao	No	Yes	MOH	Submitted by distributor-No Status(14)
Czech Republic	Yes	Yes	CE Mark	Approved
Egypt	No	Yes	CE Mark & Egypt MOH	Not Submitted Yet
Germany	No	Yes	CE Mark	Approved
Hong Kong	No	Yes	CE/SFDA	Not Submitted Yet
Hungary	Yes	Yes	CE Mark	Approved
India	Yes	Yes	CE Mark & BIS Certification	Not Required(9)
Indonesia	Yes	Yes	DirJen POM	Pending(12)
Israel	No	Yes	Import License	Approved
Italy	Yes	Yes	CE Mark	Approved
Jordan	No	Yes	JFDA(6)	Not Submitted Yet
Kazakhstan	No	Yes	Registration Cert. & GOSTR Cert.	Not Submitted Yet
Kuwait	No	Yes	MOH	Pending (15)
Macedonia	No	Yes	CE Mark	Not Submitted Yet
Malaysia	Yes	Yes	BPFK	Not Required(10)
Mexico	Yes	Yes	MOH - COFERPRIS	Pending(11)
Montenegro	No	Yes	MOH	Not Submitted Yet
New Zealand	No	Yes	CE Mark	Not Submitted Yet
Oman	No	Yes	MOH	Not Submitted Yet
Philippines	No	Yes	BHDT(7)	Not Submitted Yet
Poland	Yes	Yes	CE Mark	Approved
Romania	Yes	Yes	CE Mark	Approved
Russia	No	Yes	ROSZDRAVNADZOR	Pending(13)
Saudi Arabia	No	Yes	CE Mark & MOH	Not Submitted Yet
Serbia	No	Yes	CE Mark	Approved
Slovenia	No	Yes	CE Mark	Approved
South Africa	No	Yes	CE Mark & DOH(4)	Not Submitted Yet
Turkey	Yes	Yes	CE Mark	Approved
Ukraine	No	Yes	CE Mark	Not Submitted Yet
United Arab Emirates	Yes	Yes	UAE/MOH	Approved
Vietnam	No	Yes	MOH	Not Submitted Yet